Articles - History

MicroRNA First Disclosed By Rosetta Genomics May Increase Efficacy Of Imatinib (Gleevec(R)(1)) In Glioblastoma

A Collaborative Study by Scientists at the Weizmann Institute of Science and Scientists at Sheba Medical Center, With the aid of Rosetta Genomics, Demonstrated That Overexpression of miR-451 Inhibited Growth of Glioblastoma (GBM) Cells - Furthermore, Combining Imatinib (Gle

Enrollment In EmbraceAC Study -- Phase 2/3 Clinical Trial Comparing Anticoagulant ATI-5923 Against Warfarin Completed

ARYx Therapeutics Inc. (NASDAQ:ARYX), a biopharmaceutical company, today announced it has completed enrollment in EmbraceAC, a Phase 2/3 double-blind clinical trial comparing its oral anticoagulation therapy, ATI-5923, against the leading anticoagulant agent, warfarin.

Idenix Pharmaceuticals Advances HCV Discovery Program To Clinic

Idenix Pharmaceuticals, Inc. (Nasdaq: IDIX), a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral and other infectious diseases, today announced that it has initiated a first-in-man study of IDX184 under a United States investigational new drug (IND) application. IDX184 is a once-daily, oral nucleotide prodrug polymerase inhibitor for the treatment of chronic hepatitis C.

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 ...
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Study Finds No Breast Cancer Reduction From Calcium, Vitamin D Supplements

Women who took vitamin D and calcium supplements developed breast cancer at the same rate as those who did not take the supplements, according to a study by the Women's Health Initiative that is published in the Journal of the National Cancer Institute, the

Making Omega-6 Fatty Acids A Part Of Heart-Healthy Eating

Omega-6 fatty acids - found in vegetable oils, nuts and seeds - are a beneficial part of a heart-healthy eating plan, according to a science advisory published in Circulation: Journal of the American Heart Association. View the full Omega-6 Advisory here.

Hepatitis C Drug Trial Results Not Good Enough For Investors

Although the experimental drug Albuferon made by US biopharmaceutical company Human Genome Sciences for the treatment of hepatitis C met its primary goal in trials, it was not sufficiently more effective than the existing standard of care drug Pegasys (from Hoffman La Roche) to convince analysts that doctors will switch to the new drug, and reports are coming in that the drug company's shares have plunged to an all time low as investors come to the same conclusion.

Use of the Cereprotex prior to and after the CABG procedures to substantially reduce or eliminate the effects of neuro-impairment.

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 ...
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Biogen Idec And Abbott Announce Enrollment Of First Patient In Global Phase III Study Of Daclizumab For Relapsing-Remitting Multiple Sclerosis

Biogen Idec (NASDAQ: BIIB) and Abbott (NYSE: ABT) announced enrollment of the first patient in a global Phase III study evaluating the efficacy and safety of daclizumab compared to interferon beta-1a (AVONEX®) in patients with relapsing-remitting multiple sclerosis (RRMS), the most common form of multiple sclerosis (MS)...

The 2008 San Antonio Breast Cancer Symposium, December 10-14, 2008

The CTRC-AACR San Antonio Breast Cancer Symposium features the latest findings in laboratory, translational and clinical breast cancer research. This year's meeting focuses on new and promising therapeutic approaches, as well as strides being made in diagnosing and preventing breast cancer.

Malignant Signature Identifies Possible Response To Therapy

A molecular signature that helps account for the aggressive behavior of a variety of cancers such as pancreatic, breast and melanoma may also predict the likelihood of successful treatment with a particular anti-cancer drug. The finding, which could lead to a personalized approach to treatment for a variety of solid tumors that are currently resistant to therapies, will be published September 6 in the advance online edition of Nature Medicine.

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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Half Of Group Free Of Phobia After A Single Treatment

"Children who are not cured of their phobias run a great risk of developing other areas of anxiety later on. It's therefore important to find effective forms of treatment that can reduce this risk. The method we have now tested also functions for other types of phobias," says Lena Reuterskiöld. In a one-session treatment the children, together with their therapist, gradually approach what they are afraid of in a controlled and planned manner.

Heart Drugs: Brand Names No Better Than Generics, Study

US scientists reviewing 20 years of research and expert opinion on generic versus brand name drugs in the treatment of cardiovascular diseases found no clinical evidence showing brand names were superior to generic versions even though a substantial number of experts writing editorials advised against interchanging them.

POZEN Announces Positive Top Line Results For Its PN 400 Phase 3 Trials

POZEN Inc. (NASDAQ: POZN), today announced positive Phase 3 trial results for its PN 400 product candidate (enteric coated naproxen 500 mg and immediate release esomeprazole 20 mg) conducted by POZEN under an agreed Special Protocol Assessment with the FDA. Both the PN 400-301/302 studies achieved the primary endpoints.

Clinproxy is on the leading edge of adaptive clinical trials.

Clinproxy, www.clinproxy.com believes that adaptive clinical trials can drastically reduce the cost, time and subject drug exposure of clinical development. Classical clinical trials are planned with extreme dutiful details but once initiated fails to acknowledge that changes often need to be ...
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New Study Published In The New England Journal Of Medicine Shows Superiority Of CareFusion ChloraPrep(R) Compared To Povidone Iodine

Data published in The New England Journal of Medicine demonstrates that use of CareFusion's patient preoperative skin preparation ChloraPrep® (2 percent chlorhexidine gluconate and 70 percent isopropyl alcohol) reduced total surgical site infections (SSIs) by 41 percent, from 16.1 percent to 9...

SOMA 250 MG Shown To Significantly Improve Functionality And Reduce Disability In Patients With Low Back Pain In Three Days

A recent analysis of two pivotal clinical trials in patients with acute low back pain (ALBP) who were treated with SOMA® (carisoprodol) 250 mg showed significantly improved functionality and reduced disability after three days of treatment, as measured by the Roland-Morris Disability Questionnaire (RMDQ)...

Folic Acid Treatment May Help Allergies, Asthma

Folic acid, or vitamin B9, essential for red blood cell health and long known to reduce the risk of spinal birth defects, may also suppress allergic reactions and lessen the severity of allergy and asthma symptoms, according to new research from the Johns Hopkins Children's Center.

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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Transcept Pharmaceuticals Submits New Drug Application For Intermezzo(R) For Treatment Of Middle-of-the-Night Awakenings

Transcept Pharmaceuticals, Inc., a privately-held specialty pharmaceutical company, announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its lead product candidate, Intermezzo(R) (zolpidem tartrate sublingual lozenge).

Multiple Sclerosis Head-to-Head Study Comparing TYRABRI To Copaxone And Rebif

Biogen Idec (NASDAQ: BIIB) and Elan Corporation, plc (NYSE: ELN) today announced enrollment of the first patient in a global Phase IIIb, randomized, rater-blinded, active-controlled study designed to evaluate switching to TYSABRI® (natalizumab) from Copaxone® (glatiramer acetate) or Rebif® (interferon beta-1a) in patients with relapsing remitting multiple sclerosis (RRMS)...

Bayer's Xarelto(R) Shows Encouraging Results In Patients With Acute Coronary Syndrome

Findings from the ATLAS ACS TIMI 46 study - a Phase II study of the novel oral anticoagulant Xarelto® (rivaroxaban) - were presented today as a late-breaking clinical trial at the American Heart Association's Scientific Sessions 2008 in New Orleans by C. Michael Gibson, M.D., Director of the TIMI Data Coordinating Center, Harvard Medical School, Boston, Massachusetts, USA.

The Cerebroprotective Properties of Cereprotex (2,4,6,8-tetramethyl-2,4,6,8-tetraazabicyclo[3.3.0]-octane-3,7-dione) after traumatic and hypoxic brain injury

The cerebroprotective effect of Cereprotex (Patent pending – Cereprotec Inc. www.cereprotec.com ) (2,4,6,8-tetramethyl-2,4,6,8-tetraazabicyclo[3.3.0]-octane-3,7-dione) , previously known as (CombiCNS1), was assessed in a model of closed head injury in mice. This type of trauma produces ...
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Pharmasurgics To Begin Phase II Clinical Trial For Prevention Of Post-Surgical Adhesions

Pharmasurgics AB - part of the Karolinska Development dermatology and wound healing company "Pergamum" announced that Pharmasurgics has received approval from the Swedish Medical Products Agency to begin a Phase II clinical trial...

Disclosing Your Feelings May Help The Course Of Rheumatoid Arthritis: Results From A Randomized Clinical Trial

The health and physiological effects of an intervention which facilitates the opening of feelings are described in a paper published in the current issue of Psychotherapy and Psychosomatics. The efficacy of emotional disclosure in alleviating psychological and physical stress has been well documented in controlled laboratory studies. A next step is to evaluate its clinical utility in 'real world' settings.

Acute Heart Failure More Accurately Diagnosed In Emergency Rooms By New Mathematical Model

Researchers at St. Michael's Hospital have developed the first mathematical model in cardiology and emergency medicine to more quickly and reliably diagnose acute heart failure (AHF) in emergency room patients. Research findings published in the Journal of the American College of Cardiology, have been shown to help physicians diagnose AHF with greater accuracy. "In Canada, more than 100,000 people are hospitalized each year for acute heart failure while an estimated $1.

US Patent Application No.11/723,011 to be assigned to CEREPROTEC INC. Method for Neuroprotection with Glycoluril Derivatives

Cereprotec Incorporated www.cereprotec.com is a US company involved in the development of neuroprotective drug Cereprotex. This company is also developing a family of other promising novel chemical compounds. Proof of efficacy of these compounds has been obtained in ...
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BioVex To Report Phase I/II Clinical Trial Results For The Front Line Treatment Of Head And Neck Cancer

BioVex Inc, a company developing next generation biologics for the treatment and prevention of cancer and infectious disease, announced that the results from a Phase I/II combination study in previously untreated patients with head and neck cancer will be presented at the 2009 American Society of Clinical Oncology (ASCO) Annual Meeting, which will take place May 29, 2009 - June 2, 2009 in Orlando, FL.

ThromboGenics Announces Publication Of Positive Microplasmin Phase II Data In The Journal Retina

ThromboGenics NV (Euronext Brussels: THR), a biopharmaceutical company focused on the discovery and development of innovative treatments for eye disease, vascular disease and cancer, announces that positive microplasmin Phase II trial results, evaluating the product for the nonsurgical treatment of vitreomacular adhesion, have been published in the July/August issue of the journal Retina...

Emphysema Severity Directly Linked To Coal Dust Exposure

Coal dust exposure is directly linked to severity of emphysema in smokers and nonsmokers alike, according to new research from the National Institute for Occupational Safety and Health (NIOSH). "In this study we have shown that coal mine dust exposure is a significant predictor of emphysema severity," said Eileen Kuempel, Ph.D., a senior scientist at NIOSH and lead author of the study.

Injury to myelinated axons in the CNS often has a devastating outcome in terms of neuronal loss, with accompanying loss of function.

Damage to the nervous system may result from traumatic injury, such as penetrating or blunt trauma, stroke, or neurodegenerative disorders such as Alzheimer's disease, Parkinson's disease, Huntington's disease, amyotrophic lateral sclerosis (ALS), diabetic neuropathy or senile dementia. ...
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Bortezomib Shows Promise In Reducing GVHD And Reconstituting Immune System In Some Patients

A drug that has become a mainstay of multiple myeloma treatment may outperform alternative therapies in re-establishing the immune system of patients who have received stem cell transplants from unrelated, partially matched donors, according to early clinical trial results to be presented by Dana-Farber Cancer Institute investigators at the American Society of Hematology's (ASH...

Phase 1 Trial Of Quadramet In Combination With Velcade Shows Positive Results

Quadramet (153 Samarium-lexidronam) is a radioactive medication that targets the bone, specifically bone cancer, and is used to treat pain caused by cancer that has metastasized or spread to the bone. Velcade (bortezomib) is approved for the treatment of multiple myeloma alone and in addition to chemotherapy. Preclinical studies have reported that the combination of Velcade with Quadramet is much more effective than either drug alone in its anti-myeloma effects.

Cymbalta Receives European Approval For The Treatment Of Generalised Anxiety Disorder

Eli Lilly and Co (NYSE: LLY) and Boehringer Ingelheim have announced that the European Commission has approved the use of Cymbalta(R) (duloxetine) for the treatment of Generalised Anxiety Disorder (GAD). This approval -- the fourth for duloxetine in Europe -- was issued on 28 July following an initial positive opinion issued by the European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP) on 26 June 2008.

The concept of outsourcing should not be new to pharmaceutical companies

The idea of outsourcing clinical trials took a dramatic increase two decades ago and continues to increase at a rapid pace. It is estimated that by 2006 close to 45% of all drug development finances will be allocated to outsourcing to such companies as Limdato, www.limdato.com. Prior to the ...
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JAMA Publishes Study Results On Efficacy Of The Bard Agento(R) I.C. Silver-Coated Endotracheal Tube In Preventing Ventilator-Associated Pneumonia

C. R. Bard, Inc. (NYSE: BCR) announced the publication of the North American Silver-Coated Endotracheal Tube (NASCENT) clinical study results in the August 20, 2008 edition of the Journal of the American Medical Association (JAMA). The NASCENT study - which enrolled 2,003 patients in 54 hospitals - evaluated the efficacy of the Agento® I.C. silver-coated endotracheal tube (ETT) in the reduction of microbiologically confirmed ventilator-associated pneumonia (VAP). The U.S.

Pharmacyclics Announces Multiple Presentations At The American Association For Cancer Research Annual Meeting

Pharmacyclics, Inc. (Nasdaq: PCYC) announced multiple presentations covering its Btk and HDAC programs at the American Association for Cancer Research (AACR) 2010 Annual Meeting being held April 17-21 in Washington, DC. The oral presentation describes efficacy of the company's first-in-human Btk inhibitor PCI-32765 in a mouse model of pancreatic cancer (Soucek et al)...

DURECT Announces The IND Submission For A Third Abuse-Resistant Opioid Pain Medication Based On Its ORADUR(TM) Technology

DURECT Corporation (Nasdaq: DRRX) reported that Pain Therapeutics (Nasdaq: PTIE), its licensee, has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for an abuse-resistant opioid pain drug candidate based on DURECT's patented ORADUR(TM) technology.

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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A Revision Of The EU Clinical Trials Directive Supported By European Cancer Organization

In response to a European Commission consultation on the EU Clinical Trials Directive, ECCO - the European CanCer Organisation - has supported proposals by its member organisations for adapting the Directive's requirements to reflect practical necessities in cancer research and treatment...

A Simple Intervention For General Practice To Improve Depression Care

German researchers from the Institutes for General Practice in Frankfurt / Main and Jena have achieved positive results from a sustainable intervention in the primary care practice (Annals of Internal Medicine, volume 151, number 6, Sep. 15, 2009). The international relevance of the trial is also highlighted in the editorial. The cluster-randomized controlled intervention trial (PRimary care Monitoring for depressive Patients Trial -

Patient Enrollment For AspenBio Pharma's FDA 510(k) Clinical Trial For AppyScore(TM), World's First Appendicitis Blood Test, Nearing Halfway Point

AspenBio Pharma, Inc. (NASDAQ: APPY) an emerging bio-pharmaceutical company dedicated to the development of novel drugs and diagnostics for humans and animals, reported enrollment levels are approaching fifty percent in the ongoing FDA 510(k) clinical trial for AppyScore(TM), the world's first blood-based diagnostic tool for human appendicitis.

The Birth of the Profession of Clinical Research Associate

According to the ICH Good Clinical Practice Guidelines, clinical research should be monitored by professionals—Clinical Research Associates, also known as Clinical Monitors. We asked Bruce Kriger, CEO of Kriger Research Group International www.kriger.com , leading training institution and ...
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Results Of Human Safety Study For Hepatitis-C Patients Treated With The Aethlon Hemopurifier®

Aethlon Medical, Inc. (OTCBB:AEMD) today announced the completion of a human safety study conducted at the Fortis Hospital in Delhi, India. The primary objective of the study was to evaluate the safety of the Aethlon Hemopurifier® in health compromised end-stage renal disease (ESRD) patients that require kidney dialysis.

ELASTIderm Eye Treatment Regenerates Elastic Fibers In Skin Around The Eyes, New Study Finds

Obagi Medical Products, Inc. (Nasdaq:OMPI), a leader in topical aesthetic and therapeutic skin health systems, announced today the publication of a study of its copper-zinc malonate eye treatment ELASTIdermT in the September 2008 issue of Experimental Dermatology, a premier journal of investigative dermatology. The results of the study suggest that six weeks of treatment with ELASTIderm can enhance the biosynthesis of elastin in skin.

FDA Stem Cell Approval Breakthrough Laudable

Today the FDA announced approval for the first clinical trials on humans using Embryonic Stem Cells but Adult Stem Cell scientist Christian Drapeau says the experts may not be telling the whole story; Adult Stem Cells have greater potential with less risk. "While the FDA approval is an exciting step forward toward freeing science from the shackles of politics," said Drapeau. "The expert commentary we're seeing surrounding the FDA's action is misleading.

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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Intarcia Therapeutics, Inc. Announces Completion Of Enrollment Of ITCA 650 Phase 1b Study For The Treatment Of Type 2 Diabetes

Intarcia Therapeutics, Inc. announced the completion of patient accrual to a phase 1b clinical study evaluating ITCA 650 (DUROS(R) continuous delivery of exenatide). The study is being conducted at multiple centers in the United States and involves the treatment of 44 patients with type 2 diabetes for a period of 4 weeks. Intarcia began the development of ITCA 650 in 2007 after acquiring an exclusive worldwide license to the DUROS delivery technology.

Advanced BioMedical Technologies Inc. Begins Phase II Animal Test On PA Miniscrews And Plates

Advanced BioMedical Technologies Inc. (OTCBB: ABMT) announced that the Company's subsidiary, Shenzhen Changhua Biomedical Engineering Co., Ltd. ("ABT-CHANGHUA"), has signed a cooperative agreement with The First Affiliated Hospital of Guangdong Pharmaceutical University ("GDPU Hospital") in Guangzhou.

MAP Pharmaceuticals Phase 3 Trial Of LevadexT Migraine Product Candidate Meets All Four Primary Endpoints

MAP Pharmaceuticals, Inc. (Nasdaq: MAPP) announced that the efficacy portion of its first Phase 3 clinical trial evaluating its novel LEVADEXT orally inhaled migraine therapy met all four primary endpoints. Additional endpoints showed that LEVADEX provided rapid and sustained pain relief for up to 48 hours after dosing.

Biopharmaceutical companies focus their attention on outsourcing

In the world of clinical trails it is crucial that the process in which a product goes through the testing and regulatory process be swift at the same time remaining within the budget.This expedited process is achieved when pharmaceutical companies make the decision to outsource ...
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Javelin Pharmaceuticals Reports Ereska (Intranasal Ketamine) Phase III Trial Results In Postoperative Orthopedic Pain

Javelin Pharmaceuticals, Inc. (NYSE Amex: JAV - News) today described its initial review of top line results from a Phase III study of Ereska™ (intranasal ketamine 30mg). This randomized, multicenter, double-blind, 1:1 placebo-controlled study assessed the safety and analgesic efficacy of repeated doses of Ereska over 6 hours in 259 patients with acute moderate-to-severe pain following orthopedic surgery.

New Trial To Evaluate Nexavar® As Adjuvant Therapy In Liver Cancer

Bayer HealthCare Pharmaceuticals, Inc. and Onyx Pharmaceuticals, Inc. announced the start of a Phase III study with Nexavar® (sorafenib) tablets in liver cancer. The randomized, double-blind, placebo-controlled study is evaluating Nexavar as an adjuvant therapy for patients with hepatocellular carcinoma (HCC), or primary liver cancer. An adjuvant treatment is given as an additional systemic therapy after the initial tumor treatment, e.g.

BioCryst's CTCL Pivotal Study Achieves Enrollment Target

BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) announced that it has achieved its protocol specified objective of enrolling 100 late-stage patients (Stage IIB to IVA) in its pivotal study for forodesine in the treatment of cutaneous T-cell lymphoma (CTCL). Top-line data is expected in the second half of 2010...

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, ...
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MultiCell Hires Clinical Research Organization To Manage MCT-125 Phase IIb Clinical Trial

MultiCell Technologies, Inc. (OTC Bulletin Board: MCET) has retained Clinical Development & Support Services, Ltd. (CDSS) of Cheshire, England to manage its planned Phase IIb clinical trial in the United Kingdom for MCT-125, the Company's lead drug candidate for treatment of primary multiple sclerosis-related fatigue (PMSF)...

Investigational Dual Orexin Receptor Antagonist Almorexant Meets Primary Endpoint In Two-week Phase III Study Of Primary Insomnia

Actelion Ltd (SIX: ATLN) announced today that the first phase III study with almorexant (RESTORA 1) has met its primary endpoint, superiority of the dual orexin receptor antagonist almorexant compared to placebo on objective and subjective wake after sleep onset (WASO). The finding was highly significant (p In RESTORA 1, the use of almorexant was well-tolerated...

Two-Year Phase III Data Presented At AAN 61st Annual Meeting Show Positive Outcome Of Cladribine Tablets In Patients With Multiple Sclerosis

Merck KGaA announced detailed results of the two-year (96-week) placebo-controlled CLARITY (1) Phase III trial using Cladribine Tablets (Merck's proprietary investigational oral formulation of cladribine) to treat patients with relapsing-remitting multiple sclerosis (MS).

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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PATH Malaria Vaccine Initiative Shares Strategy For Developing 'Next-Generation' Malaria Vaccines

Marking its tenth anniversary year, the PATH Malaria Vaccine Initiative (MVI) unveiled a new strategy that sets the stage for an aggressive push targeting the long-term goal of eliminating and eradicating malaria. Malaria is one of the world's deadliest infectious diseases, killing nearly 900,000 people a year, most of them children in sub-Saharan Africa.

Stiefel Laboratories Reaps First Fruits Of Barrier Acquisition With Completion Of Pivotal Phase III Clinical Trial For 200 Mg Hyphanox(TM)

Stiefel Laboratories, Inc. announced the completion and analysis of a pivotal phase III clinical trial for Hyphanox(TM) (itraconazole) tablet. The 200 mg itraconazole tablet formulation was developed using the proprietary Meltrex(R) technology. This trial is the largest randomized controlled clinical study in onychomycosis ever undertaken.

Drinking Milk To Ease Milk Allergy?

Giving children with milk allergies increasingly higher doses of milk over time may ease, and even help them completely overcome, their allergic reactions, according to the results of a study led by the Johns Hopkins Children's Center and conducted jointly with Duke University.

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 ...
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FDA Allows Phase 2 Study For Sound Pharmaceuticals' Novel Drug To Prevent Chemotherapy Induced Hearing Loss

Sound Pharmaceuticals (SPI) has received FDA notification that it may proceed with its Phase II study to prevent chemotherapy induced hearing loss. The Ph-II study will enroll 80 patients with advanced head and neck, and non-small cell lung cancer at the National Center for Rehabilitative Auditory Research at the Veterans Administration Hospital and the Oregon Health and Science University in Portland, Oregon.

Diabetes Patients With High Triglycerides And Low HDL Cholesterol Get The Most Benefit From Fenofibrate Treatment: New Data From The FIELD Study

Fenofibrate treatment reduces cardiovascular disease (CVD) risk (defined by total cardiovascular events: the composite of cardiovascular death, myocardial infarction, stroke, and coronary and carotid revascularization) in patients with type 2 diabetes and atherogenic dyslipidemia, that is, the combination of high triglyceride (2.3 mmol/L-200mg/dL or higher) and low high-density lipoprotein (HDL) cholesterol (

Botanicals Have No Effect On Hot Flashes Or Cognition

Two studies conducted by researchers at the University of Illinois at Chicago and Northwestern University have found that commonly used botanicals do not have an effect on hot flashes or on cognitive function in menopausal women. The studies appear online and will be published in an upcoming issue of Menopause, the journal of The North American Menopause Society.

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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Depomed Initiates Phase 3 Program In Menopausal Hot Flashes

Depomed, Inc. (NASDAQ:DEPO) announced the enrollment and dosing of the first patient in Breeze 1, the first of two pivotal Phase 3 clinical trials in Depomed's registration program for Gabapentin GR® for the treatment of menopausal hot flashes. "We believe that Gabapentin GR could become the first single-agent, safe, effective, non-hormonal and non-antidepressant treatment to address menopausal hot flashes, one of the largest unmet needs in women's health.

Caffeine Abstinence: An Ineffective And Potentially Distressing Tinnitus Therapy

New research has found giving up caffeine does not relieve tinnitus and acute caffeine withdrawal might add to the problem. This is the first study of its kind to look at the effect of caffeine consumption on tinnitus...

PS-Targeting Antibodies May Represent A New Class Of Drugs With Broad Potential To Treat Viral Infections

Peregrine Pharmaceuticals, Inc. (NASDAQ: PPHM) has reported publication of data in Nature Medicine that supports the broad anti-viral potential of the company's novel anti-phosphatidylserine (anti-PS) antibody platform, showing that its PS-targeting drug bavituximab can cure lethal virus infections in animal disease models.

The Difference Between GCP Certification and CRA Certification

As per Bruce Kriger, CEO of Kriger Research Group International www.kriger.com , leading training institution and clinical research organization, Good Clinical Practice Guidelines is a general document used by various clinical research professionals who perform different functions in clinical ...
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Anika Therapeutics Completes Enrollment In MONOVISCT Pivotal U.S. Clinical Trial

Anika Therapeutics, Inc. (NASDAQ:ANIK), a leader in products for tissue protection, healing and repair based on hyaluronic acid (HA) technology, announced today that it has completed enrollment for its pivotal U.S. clinical trial for MONOVISCT.

Reduction Of Frown Lines - Mentor Corporation Announces Completion Of PurTox(R) 3A Study

Mentor Corporation (NYSE:MNT), a leading supplier of medical products for the global aesthetic market, today announced completion of the first of three Phase 3 clinical trials with its purified botulinum Type A neurotoxin (PurTox®) for the reduction of glabellar rhytides (frown lines). This newly completed study involved 400 subjects at ten investigational sites in the United States. Subjects received a single treatment with PurTox or placebo.

Flu Vaccination Investigated In PLoS Medicine

With the new flu season beginning, the open-access journal PLoS Medicine has released two studies related to influenza vaccination, each showing that the population burden of the flu can be decreased overall by increasing the number of people vaccinated. The flu vaccine is often recommended for specific groups of people who are at a higher risk of spreading or suffering from influenza in targeted vaccination programs.

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 ...
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Research Ethics Committees Identify And Correct Problems In Applications To Do Cancer Trials, UK

Researchers running cancer trials are often critical of the Research Ethics Committee (REC) process they have to go through to get their trials approved, complaining that it's too complex, burdensome and sometimes unreasonable. In the UK only 17% of research study applications are given immediate favourable opinion by RECs.

FDA Approves SyntheMed's REPEL-CV(R) Adhesion Barrier For Use In Pediatric Cardiac Surgery

SyntheMed, Inc. (OTC Bulletin Board: SYMD), a biomaterials company engaged in the development and commercialization of anti-adhesion products, announced that the U.S. Food and Drug Administration (FDA) has approved the Pre-market Approval (PMA) application for REPEL-CV(R) Adhesion Barrier for use in pediatric cardiac surgery patients.

Rheumatoid Arthritis Incidence On The Rise In Women

The incidence of rheumatoid arthritis (RA) in women has risen during the period of 1995 to 2007, according to a newly published study by researchers from the Mayo Clinic...

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 ...
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SNM Gears Up For Annual Mid-Winter Meeting

SNM's Conjoint Mid-Winter Meetings, Jan. 27 - Feb. 2, 2010, in Albuquerque, N.M., will bring together four scientific meetings under one umbrella. The meeting, which provides attendees with the opportunity to earn up to 25 continuing education credits, will highlight the latest advancements in molecular imaging and nuclear medicine...

Cortex Sells Selected AMPAKINE Compounds And Rights To Respiratory Depression Indication To Biovail

Cortex Pharmaceuticals, Inc. (OTCBB: CORX) announced that it has entered into an agreement with Biovail Laboratories International SRL ("Biovail") in which Biovail acquired certain AMPAKINE compounds and the rights to the patent filing for respiratory depression and vaso-occlusive crises associated with sickle cell disease...

Patient Trial Of Personalized Two-Drug Therapy For Brain Tumors Launched

Patients suffering from recently diagnosed malignant brain tumors called glioblastoma multiforme or a rare variant called gliosarcoma may be eligible to participate in a Phase II clinical trial at Cedars-Sinai Medical Center that combines two innovative drugs...

Clinproxy believes in the concept that cooperation with other CROs is the key to unlocking great accomplishments in the biopharmaceutical research industry.

Clinproxy is a Contract Research Organization www.clinproxy.com that is attempting to change the idea that has overwhelmed the Biopharmaceutical Industry, that for a company to survive it had to exist in competition with all others.Clinproxy, on the other hand has embraced the ...
(613) 686-5745 Cerepotec Pharmalef

NicOx Completes Enrollment Of Two Ambulatory Blood Pressure Measurement (ABPM) Studies For Naproxcinod In Hypertensive OA Patients

NicOx S.A. (Euronext Paris: COX) announced it has successfully completed the enrollment of 417 osteoarthritis (OA) patients with controlled hypertension in two clinical pharmacology studies in the United States, in line with previously announced timelines. These trials are designed to assess the blood pressure profile of naproxcinod, in comparison to ibuprofen and naproxen, using the Ambulatory Blood Pressure Monitoring (ABPM) technique.

MAP Pharmaceuticals Announces Results From LEVADEX Pharmacokinetics Trial In Smokers

MAP Pharmaceuticals, Inc. (Nasdaq: MAPP) announced results from a clinical trial comparing the pharmacokinetics (PK) and safety of LEVADEX™ orally inhaled migraine therapy with intravenous dihydroergotamine mesylate (DHE) in smokers and non-smokers. The trial was designed to measure whether systemic absorption and exposure in smokers is greater than in non-smokers...

Anemic Patients With MDS Gain Long-Term Benefits From Erythropoietin And Myeloid Growth Factor Hormones

Myelodysplastic syndromes (MDS), a group of blood disorders that can lead to acute myeloid leukemia (AML) in some patients, often cause severe anemia (when the body lacks a sufficient number of functional red blood cells). While certain treatments can help manage the symptoms of anemia, some studies have suggested that they may lead to complications.

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

Fatty Liver Disease Medication May Be Ineffective

A new randomized, prospective trial has shown that orlistat, a commonly prescribed inhibitor of fat absorption, does not help patients with fatty liver disease (FLD) lose weight, nor does it improve their liver enzymes or insulin resistance. These findings are in the January issue of Hepatology, a journal published by John Wiley & Sons on behalf of the American Association for the Study of Liver Diseases (AASLD).

Interleukin Genetics Presents Research Linking Vertebral Fractures To Gene Variations In Asian Women With Osteoporosis

Interleukin Genetics, Inc. (NYSE Amex: ILI), announced that the company will present research findings from a large clinical study on the genetics of osteoporosis and vertebral fractures at the 8th International Symposium on Osteoporosis: Translating Research into Clinical Practice, on April 4, 2009 at the Marriott Wardman Park Hotel in Washington, D.C.

CEL-SCI Enters Agreement With National Institutes Of Health Clinical Center To Determine The Molecular Basis Of Multikine Anti Tumor Effect

CEL-SCI Corporation (NYSE: CVM) announced that it has entered into a Material Transfer Agreement (MTA) with the National Institutes of Health Clinical Center (NIHCC) and the laboratory of Dr. Francesco M. Marincola, M.D., to investigate the molecular basis of changes to the tumor microenvironment caused by CEL-SCI's cancer drug Multikine. Dr.

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%, ...
(613) 686-5745 Cerepotec Pharmalef

ZymoGenetics Presents Interim IL-21 Phase 2 Results In Renal Cell Cancer

ZymoGenetics, Inc. (NASDAQ: ZGEN) presented interim results today from a Phase 2 clinical trial evaluating Interleukin 21 (IL-21) in combination with Nexavar® (sorafenib) tablets in patients with metastatic renal cell cancer. Outpatient therapy with IL-21 and Nexavar as a second or third-line therapy for metastatic renal cell cancer was associated with anti-tumor activity, with manageable side effects.

Indevus Pharmaceuticals Announces Completion Of Enrollment In Phase III Trial Of PRO 2000

Indevus Pharmaceuticals, Inc. (Nasdaq: IDEV) announced the completion of enrollment in Protocol MDP 301, a Phase III clinical trial of PRO 2000, the Company's candidate vaginal microbicide for the prevention of HIV and other sexually transmitted infections.

ANAVEX Completes Scale-up Manufacturing Of ANAVEX 2-73 For Phase I Alzheimer's Disease Clinical Trials

Anavex Life Sciences Corp., ("ANAVEX") (OTCBB: AVXL) announced the completion of scale-up manufacturing of ANAVEX 2-73, its lead compound for the treatment of Alzheimer's disease. "With sufficient quantities of ANAVEX 2-73 in hand we are an important step closer to the commencement of Phase I clinical trials, which are scheduled to begin in early 2010," said Dr. Herve de Kergrohen, CEO of ANAVEX.

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 ...
(613) 686-5745 Cerepotec Pharmalef

New Stress-Related Gene Modulates High Blood Pressure In Mice & Men

Does stress increase blood pressure? This simple question has been the focus of intense research for many years. Now new research has for the first time established a link between a novel gene, phosducin, and the blood pressure response to stress in mice as well as humans. The studies were directed by scientists at the University of Freiburg and Muenster in Germany, and the Medical College of Wisconsin in Milwaukee, in collaboration with other institutions in Europe and Canada.

Data Suggests Proton Pump Inhibitors Can Induce Acid-Related Symptoms In Healthy Adults

Treatment with proton pump inhibitors (PPIs) for eight weeks induces acid-related symptoms like heartburn, acid regurgitation and dyspepsia once treatment is withdrawn in healthy individuals, according to a new study in Gastroenterology, the official journal of the American Gastroenterological Association (AGA) Institute.

Lab-In-A-Cartridge Licensed By Singapore Scientists

Rapid, easy and affordable tests for cancer and avian flu and other infectious diseases move a step closer to patients as DYAMED Biotech Pte Ltd licenses a unique all-in-one automated diagnostic system called MicroKit from Singapore's Institute of Bioengineering and Nanotechnology (IBN).

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 ...
(613) 686-5745 Cerepotec Pharmalef

Viralytics To Test CAVATAKT In Head And Neck Cancer

Viralytics Limited (ASX: VLA) has received approval to undertake a new phase I intratumoural (direct injection of accessible solid tumours) trial in Head and Neck Cancer. a cancer previously unchallenged with CAVATAKT. Approximately 45,000 new cases of Head and Neck Cancer are diagnosed each year in the US (approximately six percent of all cancers).

High Insulin Levels Raise Risk Of Breast Cancer In Postmenopausal Women

Higher-than-normal levels of insulin place postmenopausal women at increased risk of breast cancer, researchers at Albert Einstein College of Medicine of Yeshiva University report. Their findings, published in the January 7 issue of the Journal of the National Cancer Institute, suggest that interventions that target insulin and its signaling pathways may decrease breast cancer risk in these women. Breast cancer is the most common cancer among women in the United States.

VEGF Trap-Eye: New Data Confirm Successes In The Treatment Of Age Related Macular Degeneration

VEGF Trap-Eye can achieve durable improvements in visual acuity and in biologic measurement parameters in the formation of new blood vessels in the treatment of age-related macular degeneration (AMG). This was shown in the final evaluation of a Phase 2 study presented at the annual meeting of the Retina Society in Scottsdale, Arizona. These parameters include retinal thickness and active choroidal neovascularization lesion size (the damaged part of the retina).

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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CardioGenics Selects Clinical Test Sites For Its High Speed Portable Blood Analyzer

CardioGenics Holdings Inc...

First Patients Enrolled In Cordis Trial Of New Stent Graft System To Treat Abdominal Aortic Aneurysm

Cordis Corporation, a worldwide leader in the development and manufacture of interventional vascular technologies, announced that the first patients have been enrolled in the INNOVATION trial, which will assess the safety and performance of a new stent graft system, called INCRAFT(TM), to treat abdominal aortic aneurysm (AAA)...

Nomir Medical To Present Positive Onychomycosis Data For Its Noveon(R) Dual Wavelength Device

Nomir Medical Technologies, a leader in the development of optical energy technologies for anti-infective medical applications, announced that the Company will present an abstract detailing positive in vitro and in vivo human data from its study of onychomycosis (toe nail fungus) using Noveon®, a novel dual wavelength optical energy device.

The paramount responsibility of Kriger Research Group International CRA-s is to ensure timely subjects recruitment, patient rights, safety and data integrity.

The paramount responsibility of Kriger Research Group International CRA-s is to ensure timely subjects recruitment, patient rights, safety and data integrity. In addition to on-site responsibilities each CRA is responsible for site management documentation and follow-up activities ...
(613) 686-5745 Cerepotec Pharmalef

Income, Race Combine To Make Perfect Storm For Kidney Disease

African Americans with incomes below the poverty line have a significantly higher risk of chronic kidney disease (CKD) than higher-income African-Americans or whites of any socioeconomic status, research led by scientists at Johns Hopkins and the National Institute on Aging shows. Conducted in a racially and socioeconomically diverse sample of participants from the city of Baltimore, Md...

Bilcare GCS Expands Phase III Clinical Trial Service Capabilities

As part of its commitment to providing its customers with comprehensive services that span the entire clinical supply chain, Bilcare Global Clinical Supplies, a leading single-source provider of clinical trial supplies and services, has enhanced its global Phase III capabilities.  Its latest Phase III investments include the upgrade of its Kalish large-scale bottling line at its U.S.

Synexus Leads The Way In South Africa With Vital Paediatric Vaccines Trial

UK-based Synexus, the world's largest multi-national company dedicated to the recruitment and running of clinical trials, recruited the highest number of patients to the South African study investigating a paediatric vaccine against rotavirus. The company recruited more than 2000 children aged between 5 and 10 weeks in 3 months, making Synexus the largest single source of subjects for this Phase III trial involving over 3167 children across South Africa.

The Cerebroprotective Properties of Cereprotex (2,4,6,8-tetramethyl-2,4,6,8-tetraazabicyclo[3.3.0]-octane-3,7-dione) after traumatic and hypoxic brain injury

The cerebroprotective effect of Cereprotex (Patent pending – Cereprotec Inc. www.cereprotec.com ) (2,4,6,8-tetramethyl-2,4,6,8-tetraazabicyclo[3.3.0]-octane-3,7-dione) , previously known as (CombiCNS1), was assessed in a model of closed head injury in mice. This type of trauma produces ...
(613) 686-5745 Cerepotec Pharmalef

ARCA Launches First Therapeutic Trial With GeoVax Vaccine

GeoVax Labs, Inc. (OTC Bulletin Board: GOVX), a biotechnology company that creates, develops and tests innovative HIV/AIDS vaccines, announced The AIDS Research Consortium of Atlanta (ARCA) has received approval to begin enrollment of the first therapeutic trial ever conducted using a promising HIV vaccine candidate from GeoVax, Inc...

FDA Approved Drug May Slow Beta Cell Destruction In Type 1 Diabetes Patients

New findings by UT Southwestern researchers suggest that a drug already used to treat autoimmune disorders might also help slow the destruction of insulin-producing cells in patients recently diagnosed with insulin-dependent (type 1) diabetes...

NEJM Publishes Trial Results Demonstrating Bard FLAIR(R) Endovascular Stent Graft Is Superior To Balloon Angioplasty For Failing Dialysis Grafts

C. R. Bard, Inc. (NYSE: BCR) announced the publication of trial results by The New England Journal of Medicine (NEJM) showing the Bard FLAIR® Endovascular Stent Graft maintains the patency of dialysis access grafts more effectively than balloon angioplasty alone. The FLAIR® Endovascular Stent Graft is the only implant approved by the U.S...

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%, ...
(613) 686-5745 Cerepotec Pharmalef

NanoBio Demonstrates New Topical Approach To Treating Nail Fungus That Circumvents Problems With Current Therapy

A novel topical therapy for nail fungus, NB-002, has demonstrated a new topical approach to healing nail fungus by penetrating skin pores and diffusing through the skin that surrounds the entire nail plate, according to a study conducted by NanoBio Corporation.

Well-Tolerated Radiotherapy Provides Longer Life To Patients With Recurrent Brain Cancer

Patients who received hypofractionated stereotactic radiotherapy for their recurrent brain cancers lived longer lives, according to researchers at Thomas Jefferson University. Not only does hypofractionated stereotactic radiotherapy (H-SRT) provide longer survival, patients do not experience side effects commonly seen with use of chemotherapies and targeted therapies, the researchers found...

Ardea Biosciences Advances Lead Product Candidate For The Treatment Of Gout, RDEA594, Into Phase 1 Clinical Trial

Ardea Biosciences, Inc. (Nasdaq: RDEA) announced that the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom has authorized a Phase 1 study evaluating RDEA594 in normal healthy volunteers. RDEA594 is the Company's lead product candidate for the treatment of gout.

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. Pharmalef Developments www.pharmalef.com can play a vital role in documenting the drug development process. By ...
(613) 686-5745 Cerepotec Pharmalef

Magnetic Device Studied As Treatment For Heartburn And Acid Reflux

More than 20 million Americans suffer from gastroesophageal reflux disease (GERD), experienced by many as chronic heartburn. Medication offers short-term relief for some sufferers of this disease. For those seeking a non-prescription alternative, a magnetic device, currently being evaluated at UC San Diego Medical Center, may provide a long-term solution.

Minimally Invasive Spine Surgery And Spinal Cord Stimulation Show Promise In Alleviating Back Pain

Results from the first prospective study of minimally invasive facet arthrodesis and long-term data on spinal cord stimulation demonstrate the viability of these options to achieve pain relief in patients with various back pain conditions. The studies were presented at the American Academy of Pain Medicine's 26th Annual Meeting in San Antonio, TX...

Lifting Weights Reduces Lymphedema Symptoms Following Breast Cancer Surgery

Breast cancer survivors who lift weights are less likely than their non-weightlifting peers to experience worsening symptoms of lymphedema, the arm- and hand-swelling condition that plagues many women following surgery for their disease, according to new University of Pennsylvania School of Medicine research published in the August 13 issue of the New England Journal of Medicine.

Clinproxy believes in the concept that cooperation with other CROs is the key to unlocking great accomplishments in the biopharmaceutical research industry.

Clinproxy is a Contract Research Organization www.clinproxy.com that is attempting to change the idea that has overwhelmed the Biopharmaceutical Industry, that for a company to survive it had to exist in competition with all others.Clinproxy, on the other hand has embraced the ...
(613) 686-5745 Cerepotec Pharmalef

Study Supports DNA Repair-Blocker Research In Cancer Therapy

Scientists at Dana-Farber Cancer Institute have uncovered the mechanism behind a promising new approach to cancer treatment: damaging cancer cells' DNA with potent drugs while simultaneously preventing the cells from repairing themselves. The findings being reported in the Aug.

GenVec Announces Interim Survival Data In Pivotal Trial Of TNFeradeT In Locally Advanced Pancreatic Cancer

GenVec, Inc. (Nasdaq:GNVC) announced today top-line results of an interim analysis from its ongoing Phase III Pancreatic Cancer Clinical Trial with TNFeradeT (PACT) in patients with locally advanced pancreatic cancer. This interim analysis of overall survival, conducted after the 92nd death (one-third of total expected events), was designed to determine whether the study should continue and took place in the time frame originally estimated.

Aeterna Zentaris Receives Orphan-Drug Designation From The FDA For AEZS-108 In Ovarian Cancer

Aeterna Zentaris Inc. ( AEZS, TSX: AEZ), ("the Company") a late-stage drug development company specialized in oncology and endocrinology, announced that it has received from the U.S. Food and Drug Administration (FDA), orphan-drug designation for AEZS-108, its doxorubicin targeted conjugate compound, for the treatment of ovarian cancer...

Clinproxy is on the leading edge of adaptive clinical trials.

Clinproxy, www.clinproxy.com believes that adaptive clinical trials can drastically reduce the cost, time and subject drug exposure of clinical development. Classical clinical trials are planned with extreme dutiful details but once initiated fails to acknowledge that changes often need to be ...
(613) 686-5745 Cerepotec Pharmalef

First Epidemiological Study To Enroll Up To 1,000 Infants And Children In Cambodia Announced By Aeras And CHC

The Aeras Global TB Vaccine Foundation and the Cambodian Health Committee have announced the initiation of a study of tuberculosis prevalence in Svay Rieng Province, Cambodia, beginning this month. This is the first study conducted in partnership by the two non-profit research organizations and the first Aeras-sponsored study to be conducted in Cambodia...

JHP Pharmaceuticals Introduces A Dantrium(R) IV (dantrolene Sodium For Injection), Rapidly Mixing At 20 Seconds

JHP Pharmaceuticals, LLC ("JHP") announced that it had developed, and received approval by the FDA for Dantrium® IV (dantrolene sodium for injection), a rapidly mixing product. Dantrium® IV now reconstitutes in approximately 20 seconds, which is 4 times faster than before, saving valuable time and effort during a malignant hyperthermia (MH) emergency.

La Jolla Institute Teams With Dana-Farber And Washington University On Sickle Cell Clinical Trial

Researchers from the La Jolla Institute for Allergy & Immunology have joined forces with the Dana-Farber Cancer Institute in Boston and Washington University in St. Louis to investigate a potential new therapy for sickle cell disease, a severe and chronic illness affecting more than 70,000 Americans and several million people worldwide...

Over the past few years, CROs have received the lion's share of outsourced clinical research revenue.

CROs were first organized as outsourcing service companies that provided only clinical trial management. Today, many CROs have expanded their scope of services to provide comprehensive management of the complex drug trial processes for their client companies, as well as providing access to ...
(613) 686-5745 Cerepotec Pharmalef

Reassurance On Drug Eluting Stent Safety Provided By SCAAR Registry

A study published in the New England Journal of Medicine (May 7, 2009) (1), analysed the outcomes of 47,967 patients entered into the Swedish Coronary Angiography and Angioplasty Registry (SCAAR) between 2003 and 2006.

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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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