Articles - History

First Results From Hospital Trials Testing: Objects Closest To Patients Are Most Contaminated

The first stage of the U.S. Department of Defense-funded clinical trials exploring the role of hospital touch surfaces in the transmission of infectious pathogens has been completed and the researchers reported their findings in a poster session at the Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in Washington, D.C. on Tuesday, October 28.

Sucampo Completes Enrollment In Phase 3 Pivotal Studies Of Oral Lubiprostone To Treat Opioid-Induced Bowel Dysfunction

Sucampo Pharmaceuticals, Inc. (NASDAQ:SCMP) today announced that it has completed enrollment and initial dosing of patients in two pivotal phase 3 trials of lubiprostone for the treatment of Opioid-Induced Bowel Dysfunction (OBD). "If lubiprostone is successful in Phase 3, we believe that it could represent a breakthrough in the treatment of patients suffering from OBD," said Ryuji Ueno, M.D., Ph.D., Ph.D.

IDRI Initiates Therapeutic Vaccine Clinical Trial In Sudan Against Leishmaniasis

IDRI (Infectious Disease Research Institute) announced today the start of a clinical trial in Sudan to test its leishmaniasis vaccine candidate for the treatment of post kala-azar dermal leishmaniasis (PKDL), a complication of visceral leishmaniasis (VL) which is observed in 50% of patients treated for VL in the country, predominantly affecting children.

Kriger Courses Are Indispensable To Break Into The Biopharmaceutical And Clinical Research Industry.

From what many of our students have said, Kriger www.kriger.com and their professional development courses are not only inspiring but also indispensable when trying to start a career in the biopharmaceutical and clinical research industry. These courses provide the necessary detailed ...
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Karmanos Cancer Institute Seeks Breast Cancer Patients To Participate In A New Drug Trial

The Barbara Ann Karmanos Institute is looking for women with HER2 positive metastatic breast cancer to participate in a clinical trial. The Phase II trial at Karmanos is part of an international study to further test a new drug Trastuzumab-DM1, in development by Genentech. The trial will be under the direction of Patricia LoRusso, D.O.

Drinking Wine May Increase Survival Among Non-Hodgkin's Lymphoma Patients

Pre-diagnostic wine consumption may reduce the risk of death and relapse among non-Hodgkin's lymphoma patients, according to an epidemiology study presented at the American Association for Cancer Research 100th Annual Meeting 2009.

Lifestyle Changes Help Reduce Child Obesity

A new review of studies spread over five continents finds that overweight or obese children and teens can lose weight with lifestyle changes sometimes coupled with medication. Lead reviewer Hiltje Oude Luttikhuis, M.D., with the Beatrix Children's Hospital in Groningen, the Netherlands, and her colleagues analyzed 64 randomized controlled trials of lifestyle therapy and drug interventions. Behavioral lifestyle therapy aims to change thinking patterns and actions.

Pharmalef Inc. is starting collaboration in development of new oral delivery platform

Pharmalef Inc. www.pharmalef.com is starting collaboration in development of new oral delivery platform offers pharmaceutical companies the ability to extend the shelf life and stability of medicinal compounds.Moreover, oral delivery improves patient compliance, improves treatment, ...
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Pathological Gambling May Be Successfully Treated With Medications For Substance Addiction

Pathological gambling can be successfully treated with medications that decrease urges and increase inhibitions, according to researchers at the annual meeting of the American College of Neuropsychopharmacology (ACNP). Researchers found positive outcomes in gamblers treated with medications often used for substance addictions. Dr...

Biological H1N1 Vaccines: Too Little, Too Late

Biotech firm Replikins Ltd., which has analyzed the H1N1 virus' genomic data from the 1918 pandemic through the prediction, outbreak, and progress of the current H1N1 pandemic, issued its latest biochemical analysis of the virus. The new data shows that the lethality of the H1N1 ("Swine Flu") virus has dropped from its peak of 3.7 (s.d. 4.5) during the virus's current outbreak in the spring of 2009 to resting non-epidemic levels this week of 2.0 (s.d. 0.1).

ImVisioN Therapeutics Reports Positive Phase I Clinical Results For Treatment Of Cat Dander Allergy

ImVisioN Therapeutics AG, a biopharmaceutical company pioneering intralymphatic immunotherapy (ILITT), today announced that it has obtained positive Phase I clinical results for its lead product, IVN201 (Cat-MAT), an immunotherapeutic product for the treatment of cat dander allergy. The study was conducted from August 2008 to March 2009 in a total of 20 patients with allergy to cat dander.

Cereprotec Inc: Cerebral dysfunction is a significant complication of coronary artery bypass graft (CABG) surgery using cardiopulmonary bypass (CPB).

Cerebral dysfunction is a significant complication of coronary artery bypass graft (CABG) surgery using cardiopulmonary bypass (CPB). Cognitive dysfunction is detectable in up to 70% of patients.In Phase II Cereprotec Inc. www.cereprotec.com study patients will undergo a ...
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Evotec Announces Phase I Initiation With P2X7 Antagonist

Evotec AG (Frankfurt Stock Exchange: EVT; NASDAQ: EVTC) announced today that Phase I clinical studies for its proprietary, small molecule P2X7 receptor antagonist have been initiated. The P2X7 receptor is an ATP-gated ion channel primarily expressed on cells of the immune system and is thought to play an important role in inflammatory processes through the regulation of a number of proinflammatory cytokines.

Premier International Meeting Highlights Breakthroughs In Cancer Research, Denver, Colo., April 18-22, 2009

What: The 100th AACR Annual Meeting 2009 features the latest findings in laboratory, translational and clinical cancer research. This year's meeting focuses on new and promising therapeutic approaches, as well as strides being made in diagnosing and preventing cancer. To help you take the best advantage of the meeting's scientific abstracts and related activities, the meeting's program schedule and related abstracts will be available online at

University Of Southern California Faculty Present Cancer Research At ASCO Annual Meeting

Researchers at the University of Southern California (USC) and USC Norris Comprehensive Cancer Center will present breakthrough research in a number of researchstudy areas at the 2009 American Society of Clinical Oncology (ASCO) annual meeting in Orlando, Florida. Researchers are also available at the meeting to provide expert commentary on cancer research. Colorectal Cancer: A study led by Heinz-Josef Lenz, M.D.

Compliance in Developing countries is a balancing act

Clinproxy’s, www.clinproxy.com global spread continues to acknowledge to issues with regards to developing countries and the compliance required for clinical trials. Compliance is a balancing act between home-country regulations, international guidelines, and local rules and customs. ...
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Azaya Therapeutics Receives FDA Authorization To Start Phase I Cancer Trial

Azaya Therapeutics, Inc. announced that the Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application for its lead product "ATI-1123," a novel and improved formulation of Taxotere® (docetaxel), a leading chemotherapy drug with worldwide annual sales of over $2.8 billion...

BioVex Initiates Phase 1 Clinical Trial With Its Genital Herpes Vaccine, ImmunoVEXHSV2

BioVex Inc, a private biotechnology company developing new generation biologics for the treatment of cancer and prevention of infectious disease, announced that the first subject had been dosed in the Phase 1 study of its live attenuated genital herpes vaccine, ImmunoVEXHSV2. The Phase 1 study is an open label ascending dose trial, assessing safety and immune response in healthy volunteers...

Positive Data From Lung Study May Lead To First FDA Approved Treatment For Pulmonary Fibrosis

The Coalition for Pulmonary Fibrosis (CPF) is calling this a historic time in the research and treatment of PF, as a pivotal Phase III clinical trial is completed for Pirfenidone and data released. The positive data could pave the way for the first FDA-approved therapy to treat PF - a relentlessly progressive and ultimately fatal lung disease affecting more than 128,000 people and claiming 40,000 lives each year.

Clinical outsourcing and current trends: How are they affecting business?

The clinical research industries growth is skyrocketing, the portion of the market outsourced to CROs is said to have grown from US$1 billion dollars in the early 1990’s to over US$17 billion in 2007. Analysts predict that by the year 2010 the industry could see numbers well into and over ...
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Roche, InterMune And Pharmasset Announce Initiation Of INFORM-1, The First Dual-Combination Clinical Trial With Oral Antivirals In Hepatitis C

Roche (SWX:ROG), InterMune, Inc. (Nasdaq: ITMN) and Pharmasset (Nasdaq: VRUS) today announced that the first patients have been dosed in an innovative clinical trial in patients chronically infected with the hepatitis C virus (HCV). The trial (run in centers in Australia and New Zealand) is the first to investigate the combination of two oral antiviral molecules in the absence of interferon.

KAI Pharmaceuticals Initiates Phase 2b Clinical Study Of KAI-9803 In Heart Attack Patients

KAI Pharmaceuticals, Inc., a privately held drug discovery and development company, announced today the enrollment of the first patient in the Company's Phase 2b efficacy study of KAI-9803, KAI's proprietary, first-in-class inhibitor of the delta protein kinase C pathway (delta PKC).

Quintiles Increases Capacity To Support European Clinical Trials

To enhance service offerings throughout Europe, Quintiles Transnational Corp. announced the opening of an expanded regional facility near Edinburgh, Scotland. The purpose-built facility consolidates three buildings into a single state-of-the-art complex.

Accurate Data Management can be the make or break for the success of the clinical trial.

It is widely known throughout the clinical research industry that the accurate and precise collection of data is crucial to the success of any trial. Limdato www.limdato.com along with its partners have created a software system dedicated to compiling all data collected in a precise and user ...
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Delcath Systems Granted Orphan-Drug Designations For Cutaneous And Ocular Melanoma

Delcath Systems, Inc. (Nasdaq: DCTH), a medical technology company testing its proprietary liver cancer treatment for melanoma metastatic to the liver, announced that the United States Food and Drug Administration ("FDA") granted to Delcath two orphan-drug applications for the drug melphalan. Delcath was granted designations of the drug melphalan for the treatment of patients with cutaneous as well as ocular melanoma.

Mesoblast Limited (ASX:MSB) Stem Cells Approved For World First Osteoathritis Clinical Trial

Regenerative medicine company, Mesoblast Limited (ASX:MSB)(PINK:MBLTY), today announced that it had received Australian institutional ethics approval to begin the first human trial of adult stem cell treatment for prevention of knee osteoarthritis after an acute traumatic knee injury.

Phase 2 Trial Of RP101 In Late-Stage Pancreatic Cancer Discontinued

SciClone Pharmaceuticals, Inc. (NASDAQ: SCLN) announced the discontinuation of the investigational treatments under its randomized, placebo-controlled, double-blind Phase 2 trial that is evaluating RP101 -- a nucleoside analog known as BvdU -- for the treatment of late-stage pancreatic cancer.

Streamlining the process of Clinical Trials

The process of clinical trials can be costly to say the least. Clinical affairs consumes an average of 37% of R&D budgets. Despite decades of practice, sponsors continue to underestimate the time required to complete 80% of studies, with the average Phase 1 study running over by 42%, ...
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Kristalose(R) Preferred By Patients With Chronic Constipation Compared To Similar Products In A Recent Study

Cumberland Pharmaceuticals Inc. ( CPIX) announced new top-line results for a patient preference study evaluating Kristalose (lactulose) for Oral Solution, a prescription laxative packaged as a crystalline powder, compared to similar products in liquid forms. Kristalose is the only prescription-strength laxative available in pre-measured powder packets...

US FDA Approves Extavia(R) - The First In A New Portfolio Of Planned MS Therapies From Novartis To Help Patients With This Devastating Disease

The US Food and Drug Administration (FDA) has approved Extavia(R) (interferon beta-1b), the first in a new planned portfolio of multiple sclerosis (MS) medicines from Novartis to help patients manage this devastating disease. Extavia is approved by the FDA for the treatment of relapsing forms of MS to reduce the frequency of clinical exacerbations.

Simple Test Helps Predict Heart Attack Risk

The use of common and readily available screening tests--like the ankle brachial index (ABI)--along with traditional risk scoring systems--such as the Framingham Risk Score--has the potential to prevent devastating heart attacks in thousands of individuals who are not originally thought to be at high risk (according to Framingham alone), say researchers at the Society of Interventional Radiology's 34th Annual Scientific Meeting.

Limdato: Patient recruitment is essential to the accelerated success of a clinical trial.

Often one of the biggest burdens facing clinical trials is patient recruitment. The act of recruiting patients for a trail can be tedious at the best of times and often results in missed deadlines and an incredible hit to the sponsor’s budget. Limdato www.limdato.com along with its team of ...
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New Data Shows ACTEMRA Inhibits Progression Of Joint Destruction And Improves Physical Function Of Patients With Rheumatoid Arthritis

Roche announced that the innovative new therapy ACTEMRA (tocilizumab) can significantly inhibit structural damage to joints in patients with rheumatoid arthritis (RA) this is a critical measure of effectiveness of an RA treatment. ACTEMRA was also found to improve the patients' physical function after one year of therapy and to significantly increase the disease remission rate.

Developing New Treatments For Triple-Negative Breast Cancer

Brian Rowan, Ph.D., professor of Cancer Research for the Tulane Cancer Center, is studying treatment options for an aggressive type of breast cancer that is prevalent in New Orleans among African-American women triple-negative breast cancer. The term triple-negative refers to the fact that these tumors do not have estrogen, progesterone or HER2 receptors, effectively eliminating hormonal and targeted herceptin therapy from the list of possible treatment options.

Can Child Health Care Reduce Poverty Related School Failure?

Young children whose parents are active participants in their development by reading, talking, teaching and playing at every opportunity help their children become better prepared for school according to Alan Mendelsohn, M.D., Associate Professor of Pediatrics at NYU School of Medicine and Bellevue Hospital Center in New York City and his colleagues in developmental-behavioral pediatrics, developmental psychology, public policy and education.

Limdato’s Grasp On Streamlining Clinical Trials

Limdato, www.limdato.com understands that executing a successful clinical trial requires a seamless coordination and communication with all individuals involved on levels on the trial. On average clinical trials in Phases 1,2,3 go beyond deadlines by 30%. These delays cost the ...
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Compliance And Cost: Bitter Pills To Swallow In The Age Of Oral Chemotherapy

Though the growing shift toward oral chemotherapy agents offers cancer patients greater freedom and independence during their treatment, physicians say use of the new medications also poses more chances for patients to skip doses, miss prescription refills, and take their drugs in a dangerous way.

New Studies Support Use Of Intravenous Vimpat(R) (lacosamide) (C-V) In Hospital And Emergency Settings

Results of two new studies support the use of the intravenous formulation of the antiepileptic drug (AED) Vimpat® for patients requiring add-on therapy in clinical settings where oral AED therapy is temporarily not feasible...

Peregrine Pharmaceuticals Doses First Patient In Phase II Trial Of Bavituximab In Patients With Non-Small Cell Lung Cancer

Peregrine Pharmaceuticals, Inc. (Nasdaq: PPHM) announced that patient screening and dosing has begun in a Phase II trial designed to evaluate the safety and efficacy of bavituximab in combination with chemotherapy in patients with non-small cell lung cancer (NSCLC). The primary objective of the study is to assess the overall response rate to the combination of bavituximab with a standard regimen of carboplatin and paclitaxel in NSCLC patients.

EBRecruiters has a well established database of over 60,000 candidates all over the world

EBRecruiters www.ebrecruiters.com consultants have a wealth of knowledge and experience in Clinical Research, Data Management, Quality Assurance, Regulatory Affairs and all aspects of Information Technology and Office Support. EBRecruiters has a well established database of ...
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Phase III Study Showed Patients Lived Longer Without Low-Grade Lymphoma Progressing When Rituxan Was Used First-Line For Maintenance

Genentech, Inc., a wholly-owned member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY) and Biogen Idec (Nasdaq:BIIB), today announced that a Phase III study (PRIMA) showed that patients with follicular lymphoma who continued receiving Rituxan® (rituximab) alone after responding to Rituxan and chemotherapy lived longer without their disease worsening (progression-free survival or PFS) than those who did not continue to receive Rituxan.

Stratatech Successfully Completes Clinical Trial Of StrataGraft® Skin Substitute - Trial's Primary Clinical Endpoint Achieved

Stratatech Corp. , a regenerative medicine company focused on the development and commercialization of cell-based, tissue-engineered skin substitute products, today announced that it has successfully completed the multi-center, 15-patient clinical trial of its StrataGraft®

Glybera(TM) Shows Long-Term Health Benefits

Amsterdam Molecular Therapeutics (Euronext: AMT), a leader in the field of human gene therapy, announced today new data showing that a one-time administration of its lead product GlyberaTM results in significant long-term health benefits. Long-term follow-up data from two clinical trials show that one administration with GlyberaTM brings significant and clinically important reduction in acute pancreatitis in lipoprotein lipase deficient patients.

Kriger Graduates Have Come To Realize Their Potential Within The Industry And Have Gone On To Successful Careers.

Kriger www.krigerinternational.com has maintained it's status within the industry because these training courses lead to the creation of highly trained individuals, due to the rigorous tasks that each student must perform in the projects. It results in individuals who are motivated to make the ...
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Data Indicates Rising Adoption Of Technology In Canadian Clinical Trials

A research team led by Dr. Khaled El Emam, the Canada Research Chair in Electronic Health Information at the CHEO Research Institute, evaluated the use of technology in Canadian clinical trials, and found that a significant proportion (41%) have moved away from collecting and managing trial data using only paper records...

FivePrime Initiates Phase I Clinical Trial Of FP-1039 In Patients With Advanced Cancers

Five Prime Therapeutics, Inc. announced the first patient has been enrolled in a Phase I clinical trial of its investigational protein therapeutic, FP-1039, in patients with advanced solid tumors. FP-1039 is an FGFR1:Fc fusion protein shown in pre-clinical studies to inhibit angiogenesis and slow the growth of tumors. "We are excited to begin clinical testing of FP-1039, a biologic that may have broad potential application in cancer treatment," stated Dr. Lewis T.

Tocilizumab Shows Sustained Efficacy In Rheumatoid Arthritis

PHILADELPHIA - Investigators are reporting that tolicizumab is an effective, long-term treatment option in multiple subgroups of rheumatoid arthritis (RA) patients. These include patients who have an inadequate response to disease-modifying anti-rheumatic drugs (DMARD-IR), patients who have an inadequate response to anti-TNF inhibitors (TNF-IR), and patients who have not failed methotrexate.

Anestvise Inc will Create New Jobs at New Manufacturing Facility in Eastern Europe

Anestvice Inc. www.anestvice.com , whose customers include major pharmaceutical industry players, specializes in manufacturing of medical devices. The company’s long-term plans call for it’s new facility to serve as a device manufacturing center, using advanced technology in ...
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SOLX Receives FDA 510(k) Clearance For New Glaucoma Laser

SOLX, Inc. announced U.S. Food and Drug (FDA) 510(k) clearance for the SOLX 790 to perform Titanium:Sapphire laser trabeculoplasty (TLT).

Medarex Announces Preclinical Data From Multiple Research Programs Demonstrating Anti-Tumor Activity In Cancer

Medarex, Inc. (Nasdaq: MEDX) announced preclinical efficacy and safety data from multiple programs, including antibodies to novel and potentially important cancer targets (CXCR4, fucosyl-GM1, glypican-3, mesothelin, CD70) and additional research in the area of antibody-drug conjugates. Data from the studies were presented at the Annual Meeting of the American Association for Cancer Research (AACR), April 18-22, 2009, in Colorado.

Two New Clinical Studies Show That Limited Exposure To Blood Transfusion Significantly Increases Morbidity And Mortality After Surgery

Masimo (Nasdaq: MASI), the inventor of Pulse CO-Oximetry(TM) and Measure-Through Motion and Low-Perfusion pulse oximetry, announced that two new studies - one conducted in patients undergoing general surgery and published in the Journal of American College of Surgeons and another conducte

Kriger Research Group International provides clinical research services on a truly global scale.

Kriger Research Group International www.krigerclinical.com provides clinical research services for pharmaceutical and biotechnology product development from phase II through phase IV for US, Canadian, European and multinational pharmaceutical companies. KRGI is your way to high quality ...
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Lack Of Sleep Could Be More Dangerous For Women Than Men

Women who get less than the recommended eight hours sleep a night are at higher risk of heart disease and heart-related problems than men with the same sleeping patterns. Research by the University of Warwick and University College London has found that levels of inflammatory markers vary significantly with sleep duration in women, but not men.

Healthpoint Initiates Phase II, Dose-Finding Study To Evaluate Effectiveness Of A Unique Cell Based Therapy In Venous Leg Ulcers

Healthpoint announced that it has initiated a Phase II clinical trial investigating the efficacy of HP802-247 in venous leg ulcers. HP802-247 is a topical spray containing living keratinocytes and fibroblasts. The study is designed to determine the effectiveness of two cell concentrations and two dosing frequencies of HP802-247, when combined with standard care, compared to placebo plus standard care, in healing venous leg ulcers over a 12 week treatment period.

Viron To Present Data From Phase II Trial At American Heart Association Conference

Viron Therapeutics Inc., a biopharmaceutical company pioneering the development of viral protein therapeutics, announced that the Company's research collaborator, Dr. Jean-Claude Tardif, Director of the Research Center at the Montreal Heart Institute, will present data from a Phase IIa clinical trial evaluating VT-111 at the American Heart Association (AHA) Scientific Sessions 2009 conference. The conference will take place in Orlando, Florida from November 14 to 18, 2009.

Primarily, problems arise between sponsors and CRO-s when there are fundamental breakdowns in the delegation of responsibilities

As per ClinQua Inc. www.clinqua.com relationships exist on all levels of clinical development. Primarily, problems arise when there are fundamental breakdowns in the delegation of responsibilities or rather when someone is given control over a critical area when they are otherwise ...
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Oxygen Biotherapeutics, Inc. Receives Letter From FDA Outlining Path Forward To Resume Oxycyte Clinical Trials In TBI In U.S.A.

Oxygen Biotherapeutics, Inc. (OTC Bulletin Board: OXBO) announced that the company has received a letter from the FDA that outlines what the agency termed a "path forward" as a basis to resume clinical studies of Oxycyte(R) in TBI. Oxycyte is the company's perfluorocarbon (PFC) therapeutic oxygen carrier. The letter was in response to the company's request for formal dispute resolution that was submitted to the FDA Ombudsman's office.

Acucela Launches ENVISION Clarity Trial; Initiates Phase 2 Clinical Trial Of Oral Visual Cycle Modulator In Patients With Dry AMD

Acucela, a clinical-stage biotechnology company focused on developing new treatments for blinding eye diseases, today announced the launch of its ENVISION Clarity Trial, a Phase 2 clinical trial of ACU-4429, an investigational oral treatment for dry age-related macular degeneration (dry AMD)...

Galmed Medical Research Initiates Phase I Study Of Aramchol, Leading Drug Candidate For Fatty Liver Disease

Galmed Medical Research Ltd., a leading biopharmaceutical company that develops innovative proprietary drugs for the treatment of cholesterol and liver diseases, announced today that it has started its Phase-I study in healthy human volunteers of its novel drug, Aramchol, developed for Fatty Liver Disease.

Streamlining the process of Clinical Trials

The process of clinical trials can be costly to say the least. Clinical affairs consumes an average of 37% of R&D budgets. Despite decades of practice, sponsors continue to underestimate the time required to complete 80% of studies, with the average Phase 1 study running over by 42%, ...
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Clinical Genomics Continues Progress In Developing Biomarker Portfolio For Colorectal Cancer Testing

Clinical Genomics Pty Ltd, an Australian biotechnology company, announced that Quest Diagnostics Incorporated, the world's leading provider of diagnostic testing, information and services, has agreed to provide milestone payments over the next two years to Clinical Genomics to further develop its portfolio of gene-based biomarkers associated with early onset of colorectal cancer. Clinical Genomics was awarded the payments after successfully achieving key research and development goals.

ThromboGenics Announces Results From A Phase IIa Trial Evaluating Microplasmin For The Treatment Of Diabetic Macular Edema (MIVI II DME)

ThromboGenics NV (Euronext Brussels: THR), a biopharmaceutical company focused on the discovery and development of innovative medicines for eye disease, vascular disease and cancer, today announces results of a Phase IIa trial evaluating microplasmin intravitreal injection for the treatment of Diabetic Macular Edema (MIVI II DME).

Biovitrum Advances Novel Factor VIII Long-Acting Hemophilia A Therapy Into Clinical Trials

Biovitrum AB (publ) (STO: BVT) announced that the first patient was dosed in a phase I/IIa study of its long-acting fully-recombinant Factor VIII Fc fusion (rFVIIIFc) protein. The phase I/IIa open-label study will assess the safety, tolerability and pharmacokinetics of rFVIIIFc in severe, previously-treated, hemophilia A patients...

Clinical Research Professionals are Still in Demand despite the World Economic Crisis

Despite the world economic crisis, the clinical research field is currently expanding faster than the introduction of newly qualified professionals that inevitably creates a demand. Most people are under the impression that the barriers to enter this industry are extremely difficult to ...
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Bionovo's VG101 Shows Greater Efficacy Than Estrogen In The Treatment Of Vaginal Dryness

Bionovo, Inc. (Nasdaq: BNVI) will present an abstract in a presentation on their new drug candidate, VG101, for the treatment of vaginal dryness, at the 19th Annual Meeting of the North American Menopause Society in Orlando, Florida on September 26, 2008. Dr. Mary Tagliaferri, president and chief medical officer of Bionovo, will provide seminal information on the company's second estrogen receptor beta selective drug candidate that will be entering clinical trials shortly.

Dynavax Presents Data From Novel Universal Flu Vaccine Candidate

Dynavax Technologies Corporation (Nasdaq:DVAX) announced the presentation of preclinical data from its novel Universal Flu vaccine at two medical conferences this week. Through the addition of highly conserved antigens, Dynavax's Universal Flu vaccine is designed to offer protection against divergent influenza strains, increase the efficacy of standard vaccines, and potentially reduce the dose of vaccine to extend the quantity available during a pandemic.

New Drug Substantially Extends Survival In Pancreatic Cancer

A new form of chemotherapy that destroys new blood vessels that grow around tumors has produced excellent results in a phase II trial of patients with inoperable pancreatic cancer, researchers report at the 33rd Congress of the European Society for Medical Oncology (ESMO) in Stockholm. European investigators led by Prof.

Pharmalef Developments introduces several new products in Rheumatology, Immunology and Respiratory Diseases.

With a focus on familiar, everyday health problems, Pharmalef Developments . www.pharmalef.com aims to develop and deliver products that meet the individual’s health care needs, developing a wide range of products.In addition to its established range of highly effective and ...
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EPIX Pharmaceuticals Announces FDA Approval Of A Physician-Sponsored IND For Fourth 6-month Open Label Extension Of PRX-03140 For Alzheimer's Disease

The FDA has approved a Physician-Sponsored IND and continuation of the fourth 6-month open label extension of PRX-03140, a novel 5HT4 partial agonist for the potential treatment of Alzheimer's Disease. The patient was enrolled initially in a two week Phase 2a study in August 2007 where she received 100 mg per day of PRX-03140 in combination with her normal daily dose of Aricept(®)(10 mg).

New Pre-Clinical Data On OmniGuide's BeamPath NEURO(TM) Demonstrates Precise Cutting In Brain Tissue

OmniGuide, Inc., the developer of the first and only flexible CO2 laser fiber based on breakthrough photonic bandgap technology, announced the results of a pre-clinical study comparing the Company's fiber scalpels to conventional incision methods in neurosurgery.

Independent Data Monitoring Board Recommends Continuation To Completion Of Genta's Phase 3 Trial Of Genasense(R) In Advanced Melanoma

Genta Incorporated (OTCBB:GNTA.OB) announced that the independent Data Monitoring Board (DMB) for AGENDA, a randomized Phase 3 trial of Genasense® in patients with advanced melanoma, has informed the Company that the study has passed its final futility analysis for progression-free survival (PFS). Accordingly, the Board has recommended that the study should continue to completion.

Legal Issues in Clinical Research

Bruce Kriger, CEO of Kriger Research Group International www.kriger.com, leading training institution and clinical research organization told in the interview to our edition that one hundred years ago, any doctor could prepare a new medication without any external approval. Since the ...
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Penn Researchers Find Reproductive Germ Cells Survive And Thrive In Transplants, Even Among Species

Reproductive researchers from the University of Pennsylvania and The Children's Hospital of Philadelphia have succeeded in isolating and transplanting pure populations of the immature cells that enable male reproduction in two species - human spermatogonia and mouse gonocytes...

REGURIN(R) XL (trospium Chloride) Once Daily Tablets Now Available In The UK For The Treatment Of Overactive Bladder

Regurin(R) XL (trospium chloride), a once-daily, prolonged-release capsule to treat patients with overactive bladder (OAB) has been launched in the UK. Regurin(R) XL provides rapid, significant and consistent improvements in the symptoms of OAB1 and has a reduced potential for central nervous system (CNS) side effects(2-7). OAB, also known as irritable bladder, is a condition that results from sudden, involuntary contraction of the muscle in the wall of the urinary bladder.

NOXXON Is Awarded Research And Development Grant For First-in-Human Clinical Trial With Spiegelmer(R) NOX-A12

NOXXON Pharma AG (NOXXON), clinical-stage developer of L-RNA based scaffolds (Spiegelmers®) that bind their targets conceptually similar to antibodies, announced that the company was awarded a research grant from Germany's Federal Ministry of Education and Research (BMBF) under the ministry's small and medium enterprise innovation initiative ("KMU-Innovativ"). The grant was presented to NOXXON following the completion of a peer reviewed selection process.

Pharmalef Developments is a home for team-oriented professionals

Pharmalef Developments www.pharmalef.com is a home for team-oriented professionals and their aim is to be the first choice in the industry for licensing and academic collaborations that bring mutual benefits to each party.They entered into many collaborations with leading ...
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Synexus Poland Celebrates Success Of First 'Importance Of Clinical Trials In Medical Practice' Conference

Synexus in Poland organised the first 'Importance of Clinical Trials in Medical Practice' conference last week, in conjunction with Wroclaw Medical University. The event, targeting senior medical professionals, aimed to raise awareness of the role of clinical research in drug development and the importance of the business to Poland. Radoslaw Janiak M...

MannKind Reports Successful Completion Of Device Bioequivalence Trial

MannKind Corporation (Nasdaq: MNKD) announced successful completion of its trial to demonstrate equivalence of its commercial inhaler to the version of the device that was used in clinical trials to deliver AFRESA(TM), MannKind's ultra rapid acting insulin that recently completed Phase 3 clinical trials.

Orexo Announces Positive Phase III Results For KW-2246 In Japan

Orexo's (STO:ORX) partner in Japan, Kyowa Hakko Kirin, has obtained positive phase III results in Japan for KW-2246, which is approved for the treatment of breakthrough pain in cancer patients and marketed under the brand AbstralTM in Europe. Kyowa Hakko Kirin will now proceed with preparations for a new-drug application for KW-2246 in Japan for use in continuous pain management of acute cancer pain (breakthrough pain).

Accurate Data Management can be the make or break for the success of the clinical trial.

It is widely known throughout the clinical research industry that the accurate and precise collection of data is crucial to the success of any trial. Limdato www.limdato.com along with its partners have created a software system dedicated to compiling all data collected in a precise and user ...
(613) 686-5745 Cerepotec Pharmalef

Researchers Find Room Design Can Enhance Patient Care

The design of a consultation room can improve the quality of a visit to the physician's office. A collaborative research study developed by Nurture by Steelcase and Mayo Clinic, was conducted to understand the extent to which a consultation room designed to support present-day clinical encounters could affect the consultation between patients and clinicians.

One Dose Provides 'Strong Immune Response In 'World-First Swine-Flu Vaccine Trial

Results from the first swine-flu vaccine trials taking place in Leicester reveal a strong immune response after just one dose. The pilot study, run by the University of Leicester and Leicester Hospitals, was trialled with 100 healthy volunteers, aged between 18 and 50.

Better Health And Prosperity In Europe Via Improved Clinical Research

Improved patient-oriented research in Europe will benefit European citizens and the European medical industry and facilitate the transfer of scientific discoveries from the laboratory bench to the bedside. For Europe and for the rest of the world this effort will be of great importance for the quality of life of individuals and the wellbeing of society as a whole.

Patients enrolment is a greatest challenge for the clinical research industry in the USA, Canada and European Union.

The efficiency of a clinical trial can be greatly compromised by the challenge of efficiently enrolling patients, securing clinical trial sites, and collecting data. Pressure to expedite clinical trials, while reducing the cost of the trials, has led to yet another new, rapidly evolving ...
(613) 686-5745 Cerepotec Pharmalef

STALLERGENES: Immunotherapy Tablet Containing Recombinant Allergen (rBet V 1) Of Birch Pollen: Positive Results For A Phase IIb/III Trial

Stallergenes S.A. has announced the first results of a new phase IIb/III clinical trial (VO59.08) conducted in allergic rhinitis caused by birch pollen and concerning the development of a sublingual immunotherapy tablet containing the recombinant allergen of this pollen, rBet v 1. This study is the first ever to use a recombinant allergen as an active substance. To Stallergenes' knowledge, the use of a recombinant protein in dry form is also a world first. The VO59.

Lethality Of H1N1 Influenza Virus Increasing According To Latest Analysis Of Virus Peptide Genomic Data

An analysis of the latest peptide genomic data for the H1N1 influenza virus indicates that the current global outbreak of H1N1 is increasing in its capacity for lethality. The new sequence data on PubMed of the past two weeks through June 10, 2009 showed an increase in the Replikin Count* of the Replikin Lethality Gene in the pB1 genomic area from a mean of 2+/-0.2 in 2008 to a mean of 3.2+/-3.7 in 2009 (p

Research Identifies Gene With Likely Role In Premenstrual Disorder

Scientists have identified a gene they say is a strong candidate for involvement in premenstrual dysphoric disorder (PMDD) and other maladies associated with the natural flux in hormones during the menstrual cycle...

CROs in the new millennium

The Clinical Research Organization industry has reached a new level of development in clinical trials. There are now more than twelve hundred CROs with the greatest number existing in Europe, followed by North America and Asia. With research and development costs at an all time high, product ...
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OrBIT Study Long Term Results Show Sustained Therapeutic Effect Of Percutaneous Tibial Nerve Stimulation At 12 Months

Uroplasty, Inc. (NYSE Amex: UPI), a medical device company that develops, manufactures and markets innovative proprietary products to treat voiding dysfunctions, highlighted the 12-month results of the OrBIT Trial of its Urgent® PC Neuromodulation System that will be published in the January 2010 print edition of THE JOURNAL OF UROLOGY®...

Continuous Sivelestat Sodium Hydrate Infusion Averts Lipopolysaccharide-Induced Intestinal Paralysis And Hypotension In Conscious Guinea-Pigs

This study examined the effects of continuous administration of sivelestat sodium hydrate (sivelestat) on guinea pigs induced with intestinal paralysis and hypotension. Findings suggest that sivelestat - a neutrophil elastase (NE) inhibitor- can effectively reduce intestinal dysfunction and attenuate hypotension. NE is a protease released in response to inflammation and is believed to trigger acute respiratory distress syndrome (ARDS) and ARDS-related lung injury.

Arena Pharmaceuticals Announces Merck Discontinues Development Of Investigational Niacin Receptor Agonist Program For Atherosclerosis

Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) announced Merck and Co., Inc.'s decision (through an affiliate) to discontinue development of MK-1903, an investigational niacin receptor agonist to treat atherosclerosis being developed under its research collaboration with Arena. Merck also informed Arena that the company will not continue the collaboration...

Anestvice Inc. Phase II Clinical Trials for PC-LM Device have been successfully completed.

The research was conducted on 24 patients ranging in age from 13 to 74 years (the average age was 46.6 ±5.4), who underwent surgery in the urology clinic of the Rostov State Medical University. It was sponsored by Anestvice Inc. www.anestvice.com Baltimore based research and development ...
(613) 686-5745 Cerepotec Pharmalef

Schering-Plough Announces Phase II And III Data For Corifollitropin Alfa

Schering-Plough Corp., (NYSE: SGP) announced results from the Phase III ENGAGE clinical trial demonstrating that a single injection of corifollitropin alfa, first in the class of sustained follicle stimulants, achieved similar efficacy to recombinant follicle stimulating hormone (rFSH) given once daily for seven days.

Children With Cystic Fibrosis Not Well Covered By Guidelines For Vitamin D Needs

Existing recommendations for treating vitamin D deficiency in children with cystic fibrosis (CF) are too low to cover the serious need, leaving most at high risk for bone loss and rickets, according to researchers at Johns Hopkins Children's Center.

Statement By Merck & Co., Inc. Regarding FOSAMAX® (alendronate Sodium) And Rare Cases Of Osteonecrosis Of The Jaw

Merck is committed to putting patients first and providing accurate information regarding the efficacy, safety and tolerability of our medicines. Merck offers the following statement concerning the osteoporosis medication FOSAMAX® (alendronate sodium) and reports of jaw problems associated with delayed healing and infection of the jaw often following tooth extraction. The condition is known as osteonecrosis of the jaw (ONJ).

Cereprotex displayed a significant anti-edema effect in a model of closed head injury.

Cereprotex displayed a significant anti-edema effect in a model of closed head injury. It significant decreases in the degree of edema developed after injury was found following treatment postponed one hour after traumatic injury. About 35% less water accumulated in the traumatized hemisphere ...
(613) 686-5745 Cerepotec Pharmalef

DSMB Again Supports Continuation Of Alimera Sciences' Phase 3 Clinical Trial Of Iluvien(TM) For The Treatment Of DME

Alimera Sciences, Inc.

Geron Initiates Clinical Trial Of GRN163L In Combination With Paclitaxel And Bevacizumab In Patients With Breast Cancer

Geron Corporation (Nasdaq: GERN) announced the enrollment of the first patient in a clinical trial of its telomerase inhibitor drug, GRN163L, in locally recurrent or metastatic breast cancer. The primary objective of the Phase I/II, dose escalation study is to determine the safety, maximum tolerated dose (MTD) and objective response rate of GRN163L when administered intravenously in combination with a paclitaxel/bevacizumab regimen in this patient population.

Kidney Damage From Medical Imaging Procedures Can Cause Long-Term Health Problems

Kidney injury that can arise after undergoing certain medical imaging procedures increases a patient's risk of having a stroke or heart attack over the next year or two, according to a study appearing in an upcoming issue of the Clinical Journal of the American Society Nephrology (CJASN). The findings indicate that seemingly minor and reversible kidney damage from these common clinical procedures is a serious health threat.

ClinQua Inc: Regulatory Agencies Do Not Require Clinical Trials To Be Expensive!

Mr. David Mills former ClinQua Clinical Trials Inc. www.clinqua.com executive argues that the inevitable burden of clinical investigation is cost, and unfortunately, the weight of that burden falls onto consumers. Consequently, the clinical climate has seen unprecedented ...
(613) 686-5745 Cerepotec Pharmalef

Medical News From The American Chemical Society -- April 1, 2009

"Magic potion" in fly spit may shoo away blinding eye disease Researchers are reporting the first identification of a "magic potion" of proteins in the saliva of the black fly that help this blood-sucking pest spread parasites that cause "river blindness," a devastating eye-disease. A better understanding of these proteins may lead to better drugs and a vaccine for river blindness and other diseases spread by biting insects.

Genzyme's Campath Meets Primary Endpoint In Phase 3 Combination Therapy Trial For Chronic Lymphocytic Leukemia

Genzyme Corporation (Nasdaq: GENZ) announced today that its randomized Phase 3 clinical trial investigating Campath® (alemtuzumab) in combination with Fludara® (fludarabine phosphate) in relapsed or refractory chronic lymphocytic leukemia (CLL) patients met its primary endpoint by demonstrating a significant improvement in progression free survival (PFS).

BSI-201 Enters Phase III In Metastatic Triple Negative Breast Cancer

Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) and its wholly owned subsidiary, BiPar Sciences, announced the initiation of the pivotal Phase III trial for BSI-201 in combination with chemotherapy in patients with metastatic triple-negative breast cancer (mTNBC), defined by tumors lacking expression of estrogen, progesterone receptors and without over-expression of HER2.

Esploron is one of the innovative companies within the CRO industry.

Esploron www.esploron.com is one of the innovative companies within the CRO industry. This industry has evolved from providing limited clinical trial services in the 1970s to a full-service industry that today encompasses the entire drug development process, including preclinical evaluations, ...
(613) 686-5745 Cerepotec Pharmalef

CuraGen Completes Enrollment In Phase II Trial Of CR011-vcMMAE In Metastatic Melanoma

CuraGen Corporation (Nasdaq: CRGN), a clinical-stage biopharmaceutical company focused on oncology, today announced that it has completed the enrollment of patients into its Phase II trial evaluating CR011-vcMMAE for the treatment of advanced melanoma.

Merck & Co., Inc. Receives Complete Response Letter From The Food And Drug Administration For Use Of GARDASIL® In Women Ages 27 Through 45

Merck & Co., Inc. announced that the U.S. Food and Drug Administration has issued a second complete response letter regarding the supplemental biologics license application (sBLA) for the use of GARDASIL® [Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, Recombinant] in women ages 27 though 45.

Nexavar In Combination With Chemotherapy Demonstrates Activity In Patients With Advanced Breast Cancer In Two Phase 2 Studies

Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX) announced results from two collaborative group-sponsored randomized, double-blind, placebo-controlled Phase 2 trials were presented at the 32nd Annual San Antonio Breast Cancer Symposium (SABCS)...

Cereprotec Inc: Cerebral dysfunction is a significant complication of coronary artery bypass graft (CABG) surgery using cardiopulmonary bypass (CPB).

Cerebral dysfunction is a significant complication of coronary artery bypass graft (CABG) surgery using cardiopulmonary bypass (CPB). Cognitive dysfunction is detectable in up to 70% of patients.In Phase II Cereprotec Inc. www.cereprotec.com study patients will undergo a ...
(613) 686-5745 Cerepotec Pharmalef

Array BioPharma To Present Clinical Results On Diabetes Drug At European Diabetes Meeting

Array BioPharma Inc. (NASDAQ: ARRY) announced that a poster on ARRY-403, a novel, oral, glucokinase activator (GKA), will be presented at the European Association for the Study of Diabetes annual meeting, on October 2, 2009, in Vienna, Austria. The poster will provide preclinical and Phase 1 single ascending dose (SAD) clinical data on ARRY-403. The poster will be available as a PDF after it is presented on Array's website at:

Study Looks At Clinical Trial That Tested Estrogen-Plus-Progestin Combination

Women who developed new-onset breast tenderness after starting estrogen plus progestin hormone replacement therapy were at significantly higher risk for developing breast cancer than women on the combination therapy who didn't experience such tenderness, according to a new UCLA study. The research, published in the Oct.

Mixed Results From Trials Of DHA In Alzheimer's Disease And Age-Related Cognitive Decline Emphasize The Need For Earlier Detection And Intervention

Results from two large studies using DHA, an omega 3 fatty acid, were reported at the Alzheimer's Association 2009 International Conference on Alzheimer's Disease (ICAD 2009) in Vienna. One of the trials was conducted by the Alzheimer's Disease Cooperative Study (ADCS) supported by the National Institute on Aging (NIA), and the second by Martek Biosciences Corporation (Martek), the primary company that makes algal DHA for supplementation.

Volunteers Respect Accurate and Personalized Information From Study Results

Many CRO’s and investigators believe that even though volunteer patients in clinical trials expose themselves to a great deal of risk, there is no legal mandate for investigators to inform them of study results. However, Clinproxy, www.clinproxy.com as well as many investigators have ...
(613) 686-5745 Cerepotec Pharmalef

FDA Approves Tekturna HCT(R) As Initial Treatment In Patients Unlikely To Achieve Their Blood Pressure Goals With A Single Agent

The US Food and Drug Administration (FDA) has approved Tekturna HCT((R)) (aliskiren and hydrochlorothiazide) tablets as initial therapy for patients who are likely to need multiple drugs to achieve their blood pressure goals. Tekturna HCT is a single-pill combination of Tekturna((R)) (aliskiren), the first and only approved direct renin inhibitor, and the diuretic hydrochlorothiazide (HCTZ), one of the most commonly-used high blood pressure medications.

Data From Phase 1 Study Confirm High Response Rate Of Micromet's Blinatumomab In Patients With Non Hodgkins Lymphoma

Micromet, Inc...

WorldCare Clinical Expands Early-Stage And Phase II Clinical Trial Capabilities With Introduction Of New Collect, Ready, Hold Service Offering

WorldCare Clinical, LLC (WCC), a leading imaging CRO for clinical trials in the pharmaceutical, biotechnology, and medical device industries, today introduced a new service offering to support sponsors conducting early-stage and Phase II clinical trials.

Cereprotex displayed a significant anti-edema effect in a model of closed head injury.

Cereprotex displayed a significant anti-edema effect in a model of closed head injury. It significant decreases in the degree of edema developed after injury was found following treatment postponed one hour after traumatic injury. About 35% less water accumulated in the traumatized hemisphere ...
(613) 686-5745 Cerepotec Pharmalef

Rituxan Data In Patients With Rheumatoid Arthritis To Be Presented At The American College Of Rheumatology Annual Scientific Meeting

Genentech, Inc. (NYSE: DNA) and Biogen Idec, Inc. (Nasdaq: BIIB) announced that Rituxan®: (rituximab) data including results from Phase II and III studies of Rituxan in patients with moderately-to-severely active rheumatoid arthritis (RA) will be featured in two podium presentations and eight poster presentations at the American College of Rheumatology (ACR) Annual Scientific Meeting in San Francisco this week.

New Prognostic Indicator For Patients With IPF

There may be a new way to predict mortality in patients with idiopathic pulmonary fibrosis (IPF), a devastating disease that slowly petrifies the lungs. Most patients live only three years after diagnosis on average; however, some remain stable for many years, while for others, the disease progresses more rapidly. "There is no effective treatment [for IPF] and many patients, if eligible, are referred for lung transplantation.

Midlife Coffee And Tea Drinking And The Risk Of Late Life Dementia

Midlife coffee drinking can decrease the risk of dementia/Alzheimer's disease (AD) later in life. This conclusion is made in a Finnish Cardiovascular Risk Factors, Aging and Dementia (CAIDE) Study published in the January 2009 issue of the Journal of Alzheimer's Disease (Volume 16:1). This study has been conducted at the University of Kuopio, Finland in collaboration with Karolinska Institutet, Stockholm, Sweden, and the National Public Health Institute, Helsinki, Finland.

Professor Esther Shohami has joined the board of advisors of Cereprotec Incorporated

Professor Esther Shohami has joined the board of advisors of Cereprotec Incorporated. Her research interests include: Pathophysiology of brain injury - mediators of delayed neuronal damage e.g., prostaglandins, reactive oxygen species, cytokines, cannabinoids, and the cholinergic system in ...
(613) 686-5745 Cerepotec Pharmalef

Idera Pharmaceuticals Presents Interim Data From Phase 1b Clinical Trial Of IMO-2055 In Combination With Tarceva And Avastin In NSCLC

Idera Pharmaceuticals (Nasdaq: IDRA) today presented interim data from a phase 1b, single arm clinical trial evaluating IMO-2055, an agonist of Toll-like Receptor (TLR) 9, in combination with Tarceva® and Avastin® in patients with non-small cell lung cancer (NSCLC). The data were presented during the joint 15th Congress of the European CanCer Organisation (ECCO) and 34th Congress of the European Society for Medical Oncology (ESMO) in Berlin, Germany (Abstract number 9.148).

Largest International Cardiac Surgery Study Will Compare Open-Heart Surgery With Or Without Heart-Lung Machine

The world's largest cardiac surgery clinical trial, expected to involve 4,700 patients, will be undertaken by researchers at the Population Health Research Institute of Hamilton Health Sciences and McMaster University. The trial will investigate the differences in outcomes of using on-pump versus off-pump techniques during coronary artery bypass surgery, to document and compare short- and long-tem benefits of both. The CORONARY trial, lead by Drs.

First-Line Nab-Paclitaxel Is Superior To Docetaxel For Metastatic Breast Cancer

CHICAGO, May 26, 2009 - New data show that nab-paclitaxel (AbraxaneR for Injectable Suspension) prolongs investigator-assessed, median progression-free survival (PFS) by almost seven months versus the highest standard dose of docetaxel in women with metastatic breast cancer. Nab-paclitaxel is a novel albumin-bound paclitaxel, an established chemotherapy agent, combined with albumin, a very small naturally-occurring protein.

Volunteers Respect Accurate and Personalized Information From Study Results

Many CRO’s and investigators believe that even though volunteer patients in clinical trials expose themselves to a great deal of risk, there is no legal mandate for investigators to inform them of study results. However, Clinproxy, www.clinproxy.com as well as many investigators have ...
(613) 686-5745 Cerepotec Pharmalef

MicroPhage Successfully Completes Beta Trial For Rapid MRSA Test

A new bacterial identification test that rapidly identifies MRSA infections moved closer to market with conclusion of its first multicenter clinical trial, which was announced by MicroPhage, Inc., http://www.microphage.com. The company also reported the trial results have surpassed its early-stage performance expectations.

IRX Therapeutics To Present Phase 2 Results At 7th International Conference On Head And Neck Cancer

IRX Therapeutics, a privately-held company dedicated to the discovery and development of proprietary therapies for the treatment of cancer and viral diseases, today announced that a symposium on findings from its Phase 2 clinical trial of IRX-2 will be held on July 22, 2008 at 6:30 am (PDT) during the 7th International Conference on Head and Neck Cancer at the San Francisco Marriot Hotel.

Non-Invasive Uterine Fibroid Treatment With ExAblate(R) Shows Significantly Fewer Complications And Faster Recovery Than Hysterectomy

InSightec Ltd. announced that three new papers published in the November issue of Ultrasound in Obstetrics and Gynecology add to the growing body of data supporting the use of ExAblate(R) as a safe, effective and durable treatment for uterine fibroids.

Why Clinical Research Companies Cannot Hire CRA’s Without Experience?

As per Bruce Kriger, CEO of Kriger Research Group International www.kriger.com , leading training institution and clinical research organization, there are three main reasons that actual experience is essential:Theoretical knowledge of GCP and CRA functions does not ensure the ...
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Prolonged Nevirapine In Breast-Fed Babies Prevents HIV Infection But Leads To Drug-Resistant HIV

Babies born to HIV-positive mothers and given the antiretroviral drug nevirapine through the first six weeks of life to prevent infection via breast-feeding are at high risk for developing drug-resistant HIV if they get infected anyway, a team of researchers report. But the investigators highlight the proven superiority of the six-week regimen in preventing mother-to-child HIV transmission in breast-fed infants.

FDA Advisory Committee Recommends Approval Of PEGINTRON(R) For The Adjuvant Treatment Of Stage III Malignant Melanoma

Schering-Plough Corp. (NYSE: SGP) announced that the U.S. Food and Drug Administration's (FDA) Oncologic Drugs Advisory Committee (ODAC) recommended approval by a vote of six to four for PEGINTRON® (pegylated interferon alfa-2b) in the adjuvant treatment of patients with Stage III malignant melanoma. PEGINTRON is a longer-acting form of the protein interferon alfa-2b (INTRON® A). PEGINTRON is administered subcutaneously once-weekly via self-injection.

New Published Study Shows Masimo Rainbow SET(R) Pulse CO-Oximetry(TM) Reliably Determines Carbon Monoxide Levels In The Blood

Masimo (Nasdaq: MASI), the inventor of Pulse CO-Oximetry(TM) and Measure-Through Motion and Low-Perfusion pulse oximetry, announced that a new peer-reviewed clinical study published in this month's Inhalation Toxicology demonstrates that Masimo Rainbow SET® Pulse CO-Oximetry (SpCO) provides reliable measurements of carbon monoxide (CO) in the blood that facilitate fast, accurate diagnosis of CO poisoning in pre-hospital emergency and rescue environments.

Clinproxy is a CRO with a focus on the Investigator with aspects essential for validating a drug’s remedial benefits.

Clinproxy, www.clinproxy.com is a CRO (Contract Research Organizations), who specializes in evaluating the burden of the trial and eliminating surplus protocols by focusing the Investigator on aspects critical for validating the drug’s remedial benefits. Efficiency is all about resource ...
(613) 686-5745 Cerepotec Pharmalef

Another LNA-based RNA Inhibitor Enters Clinical Trials

Santaris Pharma announced that the fourth LNA-based drug has been brought into the clinic. In the USA several patients with cancer have now been treated with the Company's Survivin inhibitor, which is jointly developed by Santaris Pharma and Enzon Pharmaceuticals. The U.S. Food and Drug Administration (FDA) recently accepted Enzon Pharmaceutical's Investigational New Drug (IND) application for the use of the LNA-based Survivin inhibitor.

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Cereprotec Inc. and Institute of Applied Chemistry at Hebrew University are working together to synthesise new Glycoluril Derivatives with Possible Neuroprotection Effects.According to report of Institute of Applied Chemistry they have performed the third step as it appears in the synthesis route scheme. This took much longer than the other steps, after all, this reaction doesn't appear in any literature and in the end only took two and half weeks. This research is fully sponsored by Cereprotec Incorporated www.cereprotec.com a US company that already runs clinical tests of their first drug Cereprotex .<br />In the reaction between compound II and III, one gets two main products, three additional compounds in small quantities plus unreacted starting materials and one main side product. All together there were 8 compounds in the reaction mixture. <br /><br />One of the main materials precipitated out from the mixture and was removed via filtration from the reaction mixture. This material was cleaned up via crystallization but turned out not to be the desired compound. <br />The second main material was separated via silica gel column chromatography. Unfortunately, this main material came off at the same Rf value as another material. They tested out several solvents and found that ethyl acetate was able to crystallize out the main material. <br /><br />Using NMR and elemental analysis, Institute of Applied Chemistry were able to prove that the crystallized out material is indeed Compound III. Yield was 17%. Two grams of material was obtained, enough to try out Stage IV. <br /><br />This step can be repeated in the future in order to produce more of compound III. <br />Cereprotec Inc. Phase II clinical study of efficacy and safety of Cereprotex as preventive treatment of cognitive dysfunction as a complication of coronary artery bypass graft (CABG) surgery.Cerebral dysfunction is a significant complication of coronary artery bypass graft (CABG) surgery using cardiopulmonary bypass (CPB).While overt neurological dysfunction occurs in 3% of patients, cognitive dysfunction is detectable in most patients early after CABG and in up to half of patients at six months.<br /><br />Cereprotec Inc. www.cereprotec.com proposes to use Cereprotex prior to and after CABG procedures in order to minimize or eliminate entirely the effects of neuro-impairment. Based on the successful animal trials Cereprotec Inc. believes that the human trials will show significant reduction in neuro-impairment. <br /><br />At this moment Cereprotec Inc. www.cereprotec.com is prepared to start clinical trials and is actively seeking serious investors.<br />Cereprotec Inc: Cerebral dysfunction is a significant complication of coronary artery bypass graft (CABG) surgery using cardiopulmonary bypass (CPB). Cerebral dysfunction is a significant complication of coronary artery bypass graft (CABG) surgery using cardiopulmonary bypass (CPB). Cognitive dysfunction is detectable in up to 70% of patients.<br /><br />In Phase II Cereprotec Inc. www.cereprotec.com study patients will undergo a standard battery of 10 cognitive tests performed by one examiner before surgery and at 7 and one month after CABG. Four tests (auditory verbal learning test (AVLT), adult memory and information processing battery (AMIBP), trail-making test B (TMTB), and verbal fluency test (VFT)) will be used to calculate a composite cognitive index.<br />US Patent Application No.11/723,011 to be assigned to CEREPROTEC INC. Method for Neuroprotection with Glycoluril DerivativesCereprotec Incorporated www.cereprotec.com is a US company involved in the development of neuroprotective drug Cereprotex. <br /><br />This company is also developing a family of other promising novel chemical compounds. <br /><br />Proof of efficacy of these compounds has been obtained in three animal studies including hypoxia in both mice and rats and brain trauma in mice. The proof of neuroprotection concept has been shown not only for prevention (hypoxia model), but also for the treatment paradigm post brain trauma which reflects a potential realistic situation in humans. <br />Professor Esther Shohami has joined the board of advisors of Cereprotec IncorporatedProfessor Esther Shohami has joined the board of advisors of Cereprotec Incorporated. Her research interests include: Pathophysiology of brain injury - mediators of delayed neuronal damage e.g., prostaglandins, reactive oxygen species, cytokines, cannabinoids, and the cholinergic system in rat and mouse models of injury (closed head injury, CHI). Evaluation of potential therapeutic strategies. CHI as a risk factor for delayed onset of Alzheimer's disease. Genetic manipulations (cytokines or apoE knockouts, acetylcholine-esterase transgenics, and more) as tools for investigating the role of specific mediators in traumatic brain injury. Interrelationship between traumatic brain injury and bone remodeling. Role of endocannabinoids in blood-brain barrier function and in bone remodeling after brain trauma. Mechanisms of neuroprotection induced by pre-conditioning (ischemic or heat acclimation). In vitro model for stretch injury that simulates traumatic conditions in astrocytes.<br /><br />Dr. Roman Kamburg CEO of Cereprotec and the registered owner of 1125 shares in CEREPROTEC Incorporated (the "Corporation") www.cereprotec.com a corporation incorporated in and under the laws of the State of Delaware, having its registered office at 108 West 13th Street, Wilmington, Delaware, transfered to Dr. Esther Shohami 40 Shares of Common Stock, for no consideration, to be held by the Transferee, her administrators and assignees, subject to all the terms and conditions on which such shares were held by the Transferor, and Transferee agreed to receive such shares.<br />Pharmalef Inc. is starting collaboration in development of new oral delivery platformPharmalef Inc. www.pharmalef.com is starting collaboration in development of new oral delivery platform offers pharmaceutical companies the ability to extend the shelf life and stability of medicinal compounds.<br /><br />Moreover, oral delivery improves patient compliance, improves treatment, reduces patient inconvenience, and reduces treatment costs.<br /><br />Our partners have completed proof of concept and development of a proliposomal formulation for the model drug, calcitonin, which is used in the treatment of osteoporosis and thyroid cancer. <br /><br />Clinical trials are expected to begin at a number of centers across the United States, Canada and European Union. <br />Pharmalef Developments introduces several new products in Rheumatology, Immunology and Respiratory Diseases.With a focus on familiar, everyday health problems, Pharmalef Developments . www.pharmalef.com aims to develop and deliver products that meet the individual’s health care needs, developing a wide range of products.<br /><br />In addition to its established range of highly effective and distinctive products Pharmalef Developments will introduce several new products in new fields, including Rheumatology, Immunology and Respiratory Diseases.<br />Pharmalef Developments plays a vital role in proper documenting the drug development process.New drugs are the lifeblood of the pharmaceutical industry. Yet strict testing and documentation requirements mean only one in many drug candidates make it to market. <br /><br />Pharmalef Developments www.pharmalef.com can play a vital role in documenting the drug development process. By leveraging our expertise in business process management and the latest technologies, we can also help you develop a documentation process for clinical trials that is easy and efficient, while satisfying strict government requirements and regulations. <br />Pharmalef Developments is a home for team-oriented professionalsPharmalef Developments www.pharmalef.com is a home for team-oriented professionals and their aim is to be the first choice in the industry for licensing and academic collaborations that bring mutual benefits to each party.<br /><br />They entered into many collaborations with leading academic centers, CRO-s and biotechnology companies to complement our in-house R&D capabilities. <br /><br />They are always interested in forming new partnerships covering early-stage research, novel compounds or technologies and implementation of clinical trials.<br />CEREPROTEC Method for Neuroprotection with Glycoluril Derivatives Patent Application has been Published September 18, 2008<br /><br />A method for prevention, inhibition or treatment of neuronal degeneration caused by injury, disease, disorder or condition in the central nervous system (CNS) comprises administering a glycoluril derivative to an individual in need thereof. View document here: http://appft1.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PG01&p=1&u=/netahtml/PTO/srchnum.html&r=1&f=G&l=50&s1=20080227838.PGNR.&OS=DN/20080227838&RS=DN/20080227838<br /><br />1. A method for prevention, inhibition or treatment of neuronal degeneration caused by injury, disease, disorder or condition in the central nervous system (CNS), comprising administering to an individual in need thereof an amount effective to treat said injury, disease, disorder or condition, of a compound of the formula I:whereinR.sub.1, R.sub.2 and R.sub.3, the same or different, each is H or (C.sub.1-C.sub.6) alkyl;R.sub.4 is selected from the group consisting of (C.sub.1-C.sub.6) alkyl, --R.sub.5--COOR, --R.sub.5--OH, --R.sub.5--NH--CO--R and --R.sub.5--CO--NH--(CH.sub.2).sub.n--COOR;R.sub.5 is (C.sub.1-C.sub.6) alkylene;R is H or (C.sub.1-C.sub.3) alkyl;n is an integer of 1 to 6; or an enantiomer thereof or a pharmaceutically acceptable salt thereof.<br /><br />2. The method according to claim 1 wherein R.sub.1 to R.sub.3 each is H or (C.sub.1-C.sub.6) alkyl and R.sub.4 is (C.sub.1-C.sub.6) alkyl.<br /><br />3. The method according to claim 2, wherein R.sub.1 to R.sub.4 each is methyl.<br /><br />4. The method according to claim 1, wherein R.sub.1 to R.sub.3 each is H or (C.sub.1-C.sub.6) alkyl, R.sub.4 is --R.sub.5---COOR, R.sub.5 is (C.sub.1-C.sub.6) alkylene and R is H or (C.sub.1-C.sub.3) alkyl.<br /><br />5. The method according to claim 1, wherein R.sub.1 and R.sub.3 each is methyl, R.sub.2 is H and R.sub.4 is --(CH.sub.2).sub.3COOH.<br /><br />6. The method according to claim 1, wherein said injury, disease, disorder or condition is selected from the group consisting of: (i) a neurological injury: (ii) brain damage caused by a cardiovascular event; (iii) a cerebrovascular disorder or disease; (iv) a neurodegenerative disease or disorder; and (v) a dementia.<br /><br />7. The method according to claim 6, wherein said injury is a neurological traumatic injury selected from the group consisting of head trauma injury and spinal cord injury.<br /><br />8. The method according to claim 7, wherein said head trauma injury is selected from the group consisting of blunt trauma, closed head injury and penetrating trauma injury.<br /><br />9. The method according to claim 8, wherein said head trauma injury is closed head injury.<br /><br />10. The method according to claim 6, wherein said injury, disease, disorder or condition is brain damage caused by a cardiovascular event.<br /><br />11. The method according to claim 10, wherein said cardiovascular event is cardiac arrest or cardiac surgery.<br /><br />12. The method according to claim 6, wherein said injury, disease, disorder or condition is a cerebrovascular disorder or disease.<br /><br />13. The method according to claim 12, wherein said cerebrovascular disorder is brain ischemia or stroke.<br /><br />14. The method according to claim 6, wherein said injury, disease, disorder or condition is a neurodegenerative disease or disorder.<br /><br />15. The method according to claim 14, wherein said neurodegenerative disease or disorder is selected from the group consisting of Alzheimer's disease, Parkinson's disease, facial nerve (Bell's) palsy, multiple sclerosis, glaucoma, Huntington's chorea, amyotrophic lateral sclerosis and macular degeneration.<br /><br />16. The method according to claim 6, wherein said injury, disease, disorder or condition is dementia.<br /><br />17. The method according to claim 16, wherein said dementia is Alzheimer's disease or a non-Alzheimer's dementia selected from the group consisting of senile dementia, Lewy body dementia, vascular dementia and a dementia caused by Parkinson's disease, Huntington's chorea, Creutzfeld-Jacob disease or HIV infection.<br /><br />18. A method for conferring neuroprotection to an individual afflicted with a neurological injury, which comprises administering to said individual a compound of formula I in claim 1 or an enantiomer or a pharmaceutically acceptable salt thereof in an amount effective to ameliorate the neurodegeneration associated with said neurological injury.<br /><br />19. The method according to claim 18, wherein said neurological injury is selected from the group consisting of head trauma injury and spinal cord injury.<br /><br />20. A method for conferring neuroprotection to an individual suffering from a neurological or neurodegenerative disease or disorder, which comprises administering to said individual a compound of formula I in claim 1 or an enantiomer or a pharmaceutically acceptable salt thereof in an amount effective to ameliorate the neurodegeneration associated with said neurological or neurodegenerative disease or disorder.<br /><br />21. The method according to claim 20, wherein said neurological or neurodegenerative disease or disorder is selected from the group consisting of Alzheimer's disease, Parkinson's disease, facial nerve (Bell's) palsy, multiple sclerosis, glaucoma, Huntington's chorea, amyotrophic lateral sclerosis, macular degeneration and dementia.
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