Articles - History

Antisoma Initiates Phase IIb Trial Of AS1411 In Acute Myeloid Leukaemia

Antisoma plc (LSE: ASM; USOTC: ATSMY) announces that it has started a randomised, controlled, multi-territory, phase IIb trial of AS1411 in patients with acute myeloid leukaemia (AML). Dr Ursula Ney, Chief Operating Officer of Antisoma, said: "AML is a devastating disease for which new treatment options are desperately needed...

Non-resorbable Injectable Dermal Filler For The Correction Of Wrinkles - Completion Of Enrollment And Treatment In ArteFill Skin Test Study

Artes Medical, Inc. (Nasdaq:ARTE), a medical aesthetics company, today announced completion of the enrollment and treatment of patients in the ArteFill® Skin Test study. The Company reports that 498 study participants are enrolled in the study and have received ArteFill Skin Test injections. The lead investigator in the study is David Wilson, M.D., of The Education and Research Foundation in Lynchburg, VA.

Geron Receives FDA Clearance To Begin World's First Human Clinical Trial Of Embryonic Stem Cell-Based Therapy

Geron Corporation (Nasdaq:GERN) announced that the U.S. Food and Drug Administration (FDA) has granted clearance of the company's Investigational New Drug (IND) application for the clinical trial of GRNOPC1 in patients with acute spinal cord injury. The clearance enables Geron to move forward with the world's first study of a human embryonic stem cell (hESC)-based therapy in man.

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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Vectibix(R) In Combination With Chemotherapy Significantly Improves Progression-Free Survival In First-Line Metastatic Colorectal Cancer

Amgen (Nasdaq: AMGN) announced detailed results from the Phase 3 '203' trial evaluating Vectibix(R) (panitumumab) administered in combination with FOLFOX (an oxaliplatin-based chemotherapy) as the first-line treatment of metastatic colorectal cancer (mCRC). In this trial, Vectibix significantly improved median progression-free survival (PFS) by 1.6 months (9.6 versus 8.0 months for patients treated with FOLFOX alone, (hazard ratio 0.80; p=0.

Children With Congenital Blindness Able To See Following Just 1 Shot Of Gene Therapy

Born with a retinal disease that made him legally blind, and would eventually leave him totally sightless, the nine-year-old boy used to sit in the back of the classroom, relying on the large print on an electronic screen and assisted by teacher aides. Now, after a single injection of genes that produce light-sensitive pigments in the back of his eye, he sits in front with classmates and participates in class without extra help.

Implant-Based Cancer Vaccine Is First To Eliminate Tumors In Mice

A cancer vaccine carried into the body on a carefully engineered, fingernail-sized implant is the first to successfully eliminate tumors in mammals, scientists report this week in the journal Science Translational Medicine. The new approach, pioneered by bioengineers and immunologists at Harvard University, uses plastic disks impregnated with tumor-specific antigens and implanted under the skin to reprogram the mammalian immune system to attack tumors.

ClinQua Inc. is one of CRO's focusing the Investigator on aspects critical for validating the drugs' therapeutic benefits.

ClinQua Inc. www.clinqua.com is one of CRO's (Contract Research Organizations), who specialize in evaluating the demands of the trial and eliminating redundant protocols and focusing the Investigator on aspects critical for validating the drugs' therapeutic benefits. Common sense would ...
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Cytopia Doses First Brain Cancer Patient In Phase Ib/II Study

Cytopia Limited (ASX:CYT) has commenced dosing patients in its Phase Ib/II study of CYT997, the company's novel vascular-disrupting anticancer agent, to treat glioblastoma multiforme (GBM), an aggressive brain cancer. The GBM clinical trial is the company's first Phase II efficacy study in highly vascular, solid tumour indications and the first time CYT997 is being investigated in a tumour of the central nervous system.

Survival Of Patients With Idiopathic Pulmonary Fibrosis (IPF) Does Not Improve With Interferon Gamma-1b Treatment

An article published Online First and in an upcoming edition of The Lancet reports the findings of the INSPIRE trial on treatment of idiopathic pulmonary fibrosis (IPF) with interferon gamma-1b (Ifn-g1b). It is written by Professor Talmadge E King Jr, of the University of California, San Francisco (UCSF), USA and his team. Results show no improvement in survival compared with placebo. There is no effective treatment for IPF which is a fatal disease.

Anadys Pharmaceuticals Commences Dosing In Phase II Study Of ANA598

Anadys Pharmaceuticals, Inc. (Nasdaq: ANDS) announced that dosing has begun in a Phase II trial of ANA598 in patients chronically infected with hepatitis C virus (HCV). The study will evaluate ANA598 over 12 weeks, taken in combination with pegylated interferon-alpha and ribavirin, in treatment naive HCV patients. ANA598 is an investigational, oral, non-nucleoside polymerase inhibitor.

Kriger's Instructors Provide A Sound Foundation For Anyone Wishing To Seek A Meaningful Career In The Clinical And Biopharmaceutical Industry

As a drug makes its way through the different phases of pre-clinical and clinical trials in human testing, the public and the company can rest assured that their product has been thoroughly tested and that each progression through its development has been predicated upon safe, sound, efficient ...
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Antioxidant Compound Reduced Incidence Of Colorectal Metachronous Adenomas

Supplementation with a selenium-based antioxidant compound decreased the risk of developing new polyps of the large bowel called colorectal metachronous adenomas in people who previously had colorectal polyps removed...

Pluristem Therapeutics Collaborates With Pharmicell Europe GmbH To Distribute Pluristem's Cell Therapy Product For Clinical Trials In Germany

Pluristem Therapeutics Inc. (NasdaqCM: PSTI) (DAX: PJT), a bio-therapeutics company dedicated to the commercialization of unrelated donor-patient (allogeneic) cell therapy products for a variety of disorders, announced today that it has signed a collaboration agreement with Pharmicell Europe GmbH.

Anemia In Chronic Kidney Disease Patients On Dialysis Treated By New Form Of Intravenous Iron

Ferumoxytol, a novel intravenous form of iron that permits rapid administration of large doses, has been shown to be effective for treating iron deficiency in chronic kidney disease (CKD) patients on dialysis, according to a clinical trial appearing in the February 2009 issue of the Clinical Journal of the American Society Nephrology (CJASN). The results indicate that this new agent may become an important treatment option for CKD patients.

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 ...
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Starpharma Holdings Limited Announce New VivaGel(R) Clinical Trial Commences

Starpharma Holdings Limited (ASX:SPL)(PINK:SPHRY) announced the start of its next clinical trial of VivaGel(R). The study will measure the level of antiviral activity retained by VivaGel(R) after vaginal administration. Assessment will be by laboratory assay of vaginal samples collected up to 24 hours after VivaGel(R) application. The study in 12 women will determine the timescale over which VivaGel(R) retains activity against HIV and HSV-2 (genital herpes).

ARIAD's Ponatinib Shows Clinical Evidence Of Improving Anti-Leukemic Activity In Patients With Drug-Resistant CML

ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) announced updated clinical data from a fully enrolled and ongoing Phase 1 study of its investigational pan-BCR-ABL inhibitor, ponatinib, in patients with resistant and refractory chronic myeloid leukemia (CML) and Philadelphia-positive acute lymphoblastic leukemia (Ph+ ALL)...

Talecris Biotherapeutics Enrolls Patients In Clinical Trial Evaluating Two Doses Of PROLASTIN®-C

Talecris Biotherapeutics, Inc. (Nasdaq: TLCR) announced the initiation of a clinical trial evaluating the safety and the pharmacokinetic profile of two doses of PROLASTIN®-C (Alpha(1)-Proteinase Inhibitor [Human]) (A1PI), a therapy indicated for chronic augmentation and maintenance in adults with emphysema due to alpha(1)-antitrypsin (AAT) deficiency...

ClinQua Inc. : The overall cost of clinical trials depends on an array of factors

In a progressive global market of supply and demand, it remains unthinkable to engage in practices that are ambitiously over-priced when there are endless opportunities to utilize more cost-efficient methods which would yield the same results. As per Mr. David Mills former ClinQua Clinical ...
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Antidepressant Use For Magnetic Stimulation

Some depressed patients who don't respond to or tolerate antidepressant medications may benefit from a non-invasive treatment that stimulates the brain with a pulsing electromagnet, a study suggests...

Neuralstem Receives FDA Approval To Commence Drug Trial For Major Depression

Neuralstem, Inc. (NYSE Amex: CUR) announced that the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application to initiate a Phase Ia safety trial to test NSI-189, its first small molecule compound, in major depression...

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.

What the Title of Home-based Clinical Research Associate Really Means

The title of Clinical Research Associate is deceiving to some degree. Many people think of “associate” as a secondary low paying job. “Clinical Monitor” is a title that better describes what CRA job entails. A clinical research associate does not, in fact, assist anyone; the associate ...
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Magnetic Stimulation Effective For Treatment Resistant Depression

Magnetic stimulation therapy can beat depression when medication and therapy haven't worked, according to the December issue of Mayo Clinic Health Letter. The therapy, called transcranial magnetic stimulation (TMS), involves using brief powerful electromagnetic pulses to alter brain activity. The U.S...

University Of Florida To Receive $29.5 Million In Recovery Act Funds To Begin Study Of Whether Exercise Prevents Disability In Older Adults

The University of Florida will receive $29.5 million in federal stimulus funds over the next two years from the National Institute on Aging to begin a six-year study on whether a program of structured physical activity can prevent or delay major movement disability in older adults. When completed, funding for the project is expected to total more than $60 million from the NIA, including the $29.5 million through the American Recovery and Reinvestment Act of 2009.

Children With Newly Diagnosed Epilepsy At Risk For Cognitive Problems

Children who have normal IQs before they experience a first seizure may also have problems with language, memory, learning and other cognitive skills, according to a study published in the August 12, 2009, online issue of Neurology®, the medical journal of the American Academy of Neurology.

Clinical Trials Do Not Need To Be Expensive!

Many CRO Directors will argue that the foreseeable burden of clinical investigation is cost and the weight of that burden falls onto clients. The clinical climate has seen extraordinary escalation in federal regulations to make sure that the integrity of the products that are ...
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Paloma Pharmaceuticals Receives Approval To Enter Phase I Clinical Trials

Paloma Pharmaceuticals, Inc. announced that it has received acceptance of its IND to enter Phase I studies with Palomid 529 (P529) in patients with age-related macular degeneration (AMD)...

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.

Newly Published Study Showed Axiron® (testosterone) Topical Solution Restored Testosterone Levels To Normal Range In Hypogonadal Men

Eli Lilly and Company (NYSE: LLY) announced that a pivotal Phase III Axiron study, published on the Clinical Endocrinology website, showed that Axiron® (testosterone) topical solution CIII, when applied to the underarm, met the primary study objective to restore testosterone levels to the normal range (300 - 1050 ng/dL) in men with low testosterone...

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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VIVUS Initiates Second Pivotal Phase 3 Trial Of Avanafil For Treatment Of Erectile Dysfunction

VIVUS, Inc. (NASDAQ: VVUS), a pharmaceutical company dedicated to the development and commercialization of novel therapeutic products, today announced it has initiated a second pivotal Phase 3 study of avanafil, its investigational new drug for the treatment of erectile dysfunction (ED). Avanafil is a next-generation, fast-acting, selective, investigational oral phosphodiesterase type 5 (PDE5) inhibitor.

ChemoCentryx Reports CCX140, A Novel Oral CCR2 Antagonist, Demonstrates Clinical Activity On Glycemic Indices In A Phase II Study In Type 2 Diabetes

ChemoCentryx, Inc. announced that CCX140, the Company's novel, orally active CCR2 antagonist successfully met its primary endpoint of safety and tolerability and demonstrated clinical efficacy in a Phase II study in patients with type 2 diabetes on stable doses of metformin...

Lack Of Adverse Interaction Between Clopidogrel And Stomach Medicine Shown By Cogent Trial

Results from a late breaking clinical trial called COGENT demonstrate that the combination of giving patients clopidogrel, a blood thinner commonly prescribed to patients with cardiovascular disease, and stomach medicines such as omeprazole, known as proton pump inhibitors (PPIs), did not lead to adverse events, as some prior studies had suggested.

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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Phase I Clinical Trial Of A Preventive AIDS Vaccine Shows Encouraging Outcome

A second Phase I AIDS vaccine clinical trial in India was successfully completed, the Indian Council of Medical Research, the National AIDS Control Organization and the International AIDS Vaccine Initiative have announced. The results of the trial of an MVA-based AIDS vaccine candidate (TBC-M4), which was conducted in Chennai, indicated that the vaccine candidate had acceptable levels of safety and was well tolerated.

Sosei And Vectura Announce Start Of Phase III Clinical Study With NVA237

Sosei Group Corporation ("Sosei"; TSE Mothers Index: 4565) and Vectura Group plc ("Vectura"; LSE: VEC) announce the commencement of a Phase III clinical study by Novartis, with NVA237, a once-daily, long-acting muscarinic antagonist (LAMA) for the treatment of chronic obstructive pulmonary disease (COPD). NVA237 is a dry powder formulation for oral inhalation of glycopyrronium bromide, a LAMA with a rapid onset of activity. The study has now appeared on clinicaltrials.

First Trial To Compare Autologous Cells With Donor Cells For Dilated Cardiomyopathy

Stem cell researchers at the University of Miami Miller School of Medicine's Interdisciplinary Stem Cell Institute are preparing to embark on another research milestone. Joshua M. Hare, M.D., professor of medicine and director of the Interdisciplinary Stem Cell Institute (ISCI), has received approval from the U.S...

ClinQua Inc. is one of CRO's focusing the Investigator on aspects critical for validating the drugs' therapeutic benefits.

ClinQua Inc. www.clinqua.com is one of CRO's (Contract Research Organizations), who specialize in evaluating the demands of the trial and eliminating redundant protocols and focusing the Investigator on aspects critical for validating the drugs' therapeutic benefits. Common sense would ...
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Study Shows Novartis Drug Afinitor® Plus Hormonal Therapy Delays Disease Progression In Advanced Metastatic Breast Cancer Patients

A new study shows that the addition of everolimus (Afinitor® tablets) to the hormonal therapy tamoxifen in patients with hormone-receptor positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) metastatic breast cancer who have been previously treated with an aromatase inhibitor (AI) delays disease progression compared to tamoxifen alone...

NOXXON Announces Initiation Of First-in-Human Clinical Trial With Hematopoietic Stem Cell Mobilizing Spiegelmer(R) NOX-A12

NOXXON Pharma AG, the biopharmaceutical company focusing on the development of novel drugs based on its unique proprietary Spiegelmer® technology, announced today the successful initial dosing of healthy volunteers in a first-in-human clinical trial with Spiegelmer® NOX-A12. NOX-A12 is NOXXON's second drug candidate entering the clinical stage of development within only five months.

Inviragen Initiates Phase 1 Study Of Hand, Foot And Mouth Disease Vaccine In Singapore

Inviragen announced today the initiation of the first clinical trial of the Company's proprietary Hand, Foot and Mouth Disease (HFMD) investigational vaccine, INV21, a highly purified virus particle preparation designed to protect against HFMD caused by enterovirus 71 (EV71)...

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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Boehringer Ingelheim Initiates First Phase III Clinical Trial In Ovarian Cancer

Boehringer Ingelheim announced today the initiation of a new phase III clinical trial to evaluate one of its two late-stage oncology pipeline compounds for the treatment of patients with advanced ovarian cancer...

Vertex Initiates Phase 3 Registration Program For VX-770, An Oral CFTR Potentiator Targeting The Defective Protein Responsible For Cystic Fibrosis

Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced the initiation of a Phase 3 registration program for VX-770, an investigational Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) potentiator that targets the defective CFTR protein that causes cystic fibrosis (CF).

Argos Therapeutics Presents Positive Phase 2 Data For Arcelis™ Dendritic Cell-based Immunotherapy In Advanced RCC At ASCO

Argos Therapeutics announced the presentation of positive interim data from a Phase 2 trial that evaluated the clinical activity, safety and immune response of AGS-003 treatment, given in combination with sunitinib, in patients with newly diagnosed advanced renal cell carcinoma (RCC)...

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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Afinitor(R) Phase II Data Show Positive Results For Patients With Multiple Types Of Lymphoma, Leading To Phase III Trial

New data show that Afinitor(R) (everolimus) tablets significantly shrunk tumors in 33% of patients with relapsed non-Hodgkin's lymphoma (NHL) and Hodgkin's disease(1). Based on results from this study and other early-stage research, Novartis has initiated a Phase III trial in the most common NHL, diffuse large B-cell lymphoma (DLBCL).

Young Adults Who Exercise Get Higher IQ

The results were published in the prestigious Proceedings of the National Academy of Sciences (PNAS). The study involved 1.2 million Swedish men doing military service who were born between 1950 and 1976. The research group analysed the results of both physical and IQ tests when the men enrolled. The study shows a clear link between good physical fitness and better results for the IQ test...

Roche, InterMune And Pharmasset Announce Initiation Of INFORM-1, The First Dual Combination Clinical Trial With Oral Antivirals In Hepatitis C

Pharmasset, Inc. (Nasdaq: VRUS), Roche (SWX: ROG) and InterMune, Inc. (Nasdaq: ITMN) 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.

Clinical Trials Do Not Need To Be Expensive!

Many CRO Directors will argue that the foreseeable burden of clinical investigation is cost and the weight of that burden falls onto clients. The clinical climate has seen extraordinary escalation in federal regulations to make sure that the integrity of the products that are ...
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Clinical Trial For Dry Mouth Funded By International Oral Care Award

A clinical trial using an all-natural lozenge to treat dry mouth, a condition that impacts 40 percent of American adults, is under way at Georgia Health Sciences University College of Dental Medicine. "These patients' mouths are as dry as if you've closed the faucet, and we want to turn that faucet back on," said Dr. Stephen Hsu, Molecular and Cell Biologist and co-investigator of the study...

Minimally Invasive Treatments For Pancreatic Cancer And Possible Links To GI Diseases

Researchers have confirmed a suspected link between pancreatic cancer and inflammatory bowel disease, while other science shows that intra-abdominal fat serves as a predictor of survival in pancreatic cancer patients, and new technology shows promising results for improvements in complicated surgery for pancreatic pseudocysts...

MEDIHONEY(TM) Dressings Shown To Help Improve Outcomes Of Non-Healing Venous Leg Ulcers In Recent Case Series

Derma Sciences, Inc. (OTC Bulletin Board: DSCI), a provider of advanced wound care products, announced that its MEDIHONEY Dressings were the focus of a case series on eleven non-healing venous leg ulcers. These wounds had previously failed to heal while being managed with such therapeutic modalities as multi-layered compression, silver antimicrobial dressings, antibiotic therapy, and hyperbaric oxygen.

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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CHMP Recommends Approval Of New Indication For Enbrel(R) As Treatment For Severe Psoriasis In Paediatric Patients

The European Committee for Medicinal Products for Human Use (CHMP) announced its positive recommendation for the approval of Enbrel(R) (etanercept) as a treatment for children aged 8 years and over and adolescents with severe plaque psoriasis. If approved by the European Commission, following the Committee's recommendation, Enbrel will become the first biologic treatment indicated for severe psoriasis in children and adolescents.

First Heart Attack Patient Treated In European Cardioprotection Phase III Trial With NeuroVive's CicloMulsion(TM)

NeuroVive Pharmaceutical and Hospices Civils de Lyon (HCL) announced the enrollment and treatment of the first patient in the European multicenter trial of myocardial infarction (the CIRCUS study)...

Abbott's XIENCE V® Shows Continued Strong Performance In Key Safety And Efficacy Measures At Two Years In Investigator-Initiated COMPARE Trial

Late-breaking data were presented from the investigator-initiated COMPARE trial of 1,800 real-world patients involving Abbott's market-leading XIENCE V® Everolimus Eluting Coronary Stent System and the TAXUS® Liberte® Paclitaxel-Eluting Coronary Stent System (TAXUS). The results from COMPARE at two years were presented by Peter Smits, M.D...

Clinproxy: In general the overall expense of clinical trials depends on a multitude of factors

In an ever growing global market of supply and demand, it remains unimaginable to engage in practices that are ambitiously expensive when there are endless opportunities to utilize more appropriately priced methods which would in turn yield the same results. The overall cost of clinical trials ...
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State Of The Art Lecture: What Are The Most Important Ongoing Clinical Trials In Urologic Oncology Worldwide?

ORLANDO, FL (UroToday.com) - Dr. E. David Crawford presented information on challenges facing clinical trials from SWOG, ECOG and CALGB. Patient accrual for clinical trials is only 2-3%. Innumerable layers of rules and regulations have been created with numerous layers that increase costs and delays. He applauded prevention trials such as PCPT, SELECT, Toremifene for PIN and REDUCE. He gave poor marks for randomized treatment trials.

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:

Positive Clinical Data From Endologix Suprarenal Study To Be Introduced March 19 At SCVS Symposium

Endologix, Inc. (NASDAQ: ELGX), the developer and manufacturer of the Powerlink® System for the minimally invasive treatment of abdominal aortic aneurysms (AAA), announced that data from its prospective, multicenter clinical trial of the Powerlink Suprarenal Proximal Extension System will be presented for the first time on March 19, 2009 at the Society for Clinical Vascular Surgery's (SCVS) 37th Annual Symposium being held in Ft. Lauderdale, Fla.

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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Enrollment In EMERALD 1 Complete, 3rd Of 4 Phase 3 Clinical Trials Of HematideT To Treat Anemia In Chronic Renal Failure Patients

Affymax, Inc. (Nasdaq:AFFY) today announced that enrollment has been completed in EMERALD 1, one of its Phase 3 clinical trials of its lead investigational therapy, HematideT, which is being evaluated for the treatment of anemia in chronic renal failure patients. EMERALD 1 includes over 800 dialysis patients from over 90 sites in the United States.

Major Adult Vaccine Clinical Trial For Pneumonia Prevention Begins

Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), announced the initiation of the Community Acquired Pneumonia Immunization Trial in Adults a major study in adults of an investigational 13-valent conjugate vaccine designed to help prevent pneumococcal pneumonia -- the leading cause of bacterial pneumonia in adults.

New Legislation Seeks To Boost Participation In Clinical Trials For Rare Diseases

New legislation introduced would allow patients with rare diseases to participate in clinical drug studies without losing their eligibility for government healthcare coverage. The "Improve Access to Clinical Trials Act" is co-sponsored by Representatives Edward J. Markey (D-MA) and Cliff Stearns (R-FL) and nearly 30 members of the House of Representatives.

Ground breaking companies within the CRO industry

With over 1200 companies within the CRO industry Limdato www.limdato.com is one who is able to utilize cutting edge technology and innovations to ensure complete success for your clinical trial. During the 1970’s the industry was extremely limited to the services it could provide for ...
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International Trial Investigating Lung Cancer Treatment

Scott & White Healthcare in Round Rock, Texas is recruiting patients for a Phase III lung cancer trial aimed at preventing the disease's recurrence in previously treated patients. The trial will evaluate the potential of an immunotherapy called Antigen-Specific Cancer Immunotherapeutic (ASCI) for the treatment of Non-Small Cell Lung Cancer (NSCLC)...

Everolimus Improves Progression-Free Survival For Patients With Rare Pancreatic Cancer

In an international Phase III randomized study, an inhibitor of the mammalian target of rapamycin (mTOR), has shown to dramatically improve progression-free survival for patients with advanced pancreatic neuroendocrine tumors (pNET). James C. Yao, M.D...

Clinical Remission Figures Double For People With Rheumatoid Arthritis Following Multiple Courses Of MabThera (rituximab)

Results of the REFLEX study1 show that the number of people with rheumatoid arthritis (RA) achieving clinical remission from their disease doubled over three successive treatment courses with MabThera (rituximab) when used in combination with methotrexate (from 8.8% achieving clinical remission* after the first course to 17.6% after the third course).

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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Cylene Pharmaceuticals Initiates Phase II Clinical Trial Of Quarfloxin (CX-3543) In Patients With Carcinoid/Neuroendocrine Tumors

Cylene Pharmaceuticals announced the initiation of a Phase II clinical trial of quarfloxin (CX-3543) in patients with carcinoid/neuroendocrine tumors (C/NET), which are malignant cancers arising from neural crest cells. "Quarfloxin (CX-3543) is a small molecule that disrupts a protein:rDNA complex that forms in the abnormal nucleoli of cancer cells, thereby selectively inducing apoptotic cell death in cancers," said Dr.

Pioneering Bristol Academic Raises $2.3 Million Investment For 'Cell Bandage'

A company co-founded by Professor Anthony Hollander, an academic from the University of Bristol, has raised over ÂŁ1.6 million to fund trials, including the first human study, of its pioneering 'cell bandage' technology, which aims to save thousands of patients from the type of knee surgery that currently leads to premature osteoarthritis.

JACC Intervention Publishes MIV's VESTASYNC I Trial Preliminary Results - Hydroxyapatite Non-Polymer-Based Sirolimus-Eluting Stent

MIV Therapeutics, Inc. (OTCBB: MIVI) (FRANKFURT: MIVN), a leading developer of next-generation coatings and advanced drug-delivery systems for cardiovascular stents and other implantable medical devices, announced that the Journal of the American College of Cardiology Intervention (JACC Intervention) published preliminary results from the VESTASYNC I trial.

Ground breaking companies within the CRO industry

With over 1200 companies within the CRO industry Limdato www.limdato.com is one who is able to utilize cutting edge technology and innovations to ensure complete success for your clinical trial. During the 1970’s the industry was extremely limited to the services it could provide for ...
(613) 686-5745 Cerepotec Pharmalef

Avastin Plus Commonly Used Chemotherapies Improves Time Without The Disease Getting Worse In Women With Previously Treated Advanced Breast Cancer

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced that a Phase III study of Avastin (bevacizumab) in combination with a range of chemotherapies met its primary endpoint of increasing the time women with previously treated advanced HER2 negative breast cancer lived without the disease getting worse (progression-free survival or PFS) compared to chemotherapy alone.

Traumatic Brain Injury Collaboration Between Arbor Vita And WRAIR

The U.S. Department of Applied Neurobiology at the Walter Reed Army Institute of Research (WRAIR) and Arbor Vita Corporation (AVC) have signed a Cooperative Research and Development Agreement (CRADA) for research and development of treatments for traumatic brain injury (TBI). The alliance is based on discoveries made from a collaborative effort between AVC and NoNO Inc.

Abbott Announces Positive Results From Phase 2 Study Of Low Dose Atrasentan For Treatment Of Diabetic Kidney Disease

Abbott (NYSE: ABT) announced positive results from a Phase 2 dose-ranging study of atrasentan, a highly selective endothelin A receptor antagonist in development to help slow chronic kidney disease (CKD) progression in patients with type 2 diabetic nephropathy (diabetic kidney disease)...

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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Patient Enrollment Completed In First Randomized Clinical Study Of OrbusNeich's Combo™ Bio-engineered Sirolimus Eluting Stent

OrbusNeich announced at the Transcatheter Cardiovascular Therapeutics (TCT) 2010 in Washington the completion of patient enrollment in the randomized clinical trial of the Combo Bio-engineered Sirolimus Eluting Stent (Combo Stent) with 183 patients included at sites in Asia, Australia, Europe and South America...

Novartis Receives FDA Approval For Valturna(R), A Single-Pill Combination Of Valsartan And Aliskiren, To Treat High Blood Pressure

The US Food and Drug Administration (FDA) has approved Valturna((R)) (aliskiren and valsartan) tablets, the first and only medicine to target two key points within the renin system, also known as the renin angiotensin aldosterone system (RAAS), an important regulator of blood pressure.

Researchers Seeking Safe Treatment For Parasitic Diseases

With the help of another $2 million in funding from the Bill & Melinda Gates Foundation, researchers are moving closer to setting up human clinical trials for a reformulated drug that could be the linchpin of treatment efforts against two debilitating tropical diseases...

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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Access Pharmaceuticals Presents CobOral™ Insulin Research At 10th Annual Diabetes Technology Meeting On November 11-13, 2010

ACCESS PHARMACEUTICALS, INC...

Experimental Breast, Lung Cancer Drug Shows Promise Against Prostate And Brain Cancers

US researchers have completed two preclinical studies, one on isolated human cells and the other on rodents, that concluded an experimental breast and lung cancer drug shows promise against prostate cancer, and glioblastoma, a type of brain cancer...

BioVex Announces Publication Of Phase 2 Melanoma Results With OncoVEX (GM-CSF) In The Journal Of Clinical Oncology

BioVex Inc, a company developing new generation biologics for the treatment and prevention of cancer and infectious disease, announced that the data from its completed Phase 2 clinical study of OncoVEX (GM-CSF) for the treatment of advanced melanoma has been published in the Journal of Clinical Oncology (JCO). The previously announced top line results report a high objective durable response rate and a high complete response rate, combined with a relatively benign side effect profile.

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 ...
(613) 686-5745 Cerepotec Pharmalef

GTx-758, An Oral LH Inhibitor For First Line Treatment Of Advanced Prostate Cancer, Advances Into Second Phase I Clinical Trial

GTx, Inc. (Nasdaq: GTXI), announced the initiation of a Phase I multiple ascending dose clinical trial evaluating GTx-758, an oral LH inhibitor for first line treatment of advanced prostate cancer. A Phase I single ascending dose clinical trial in 96 subjects was successfully completed in June. In the completed Phase I single ascending dose clinical trial, GTx-758 was well tolerated.

ChemoCentryx Reports CCX140-B Meets Primary Endpoint And Demonstrates Clinical Efficacy In Phase II Study In Type 2 Diabetes

ChemoCentryx, Inc. today announced that the Company's novel, orally active CCR2 antagonist, CCX140-B, demonstrated an excellent safety profile and exhibited clear signs of biological and clinical effect in a Phase II study in patients with type 2 diabetes on stable doses of metformin...

Bioheart Reports Promising Results From SDF-1 Modified MyoCell(R) Therapy In Heart Failure Study

Results of a preclinical study involving the injection of myoblasts modified to express stromal derived factor-1(alpha) protein (SDF-1) into the scar tissue of the myocardium of rats, which suggest improved heart function, were recently presented at two scientific meetings -- the International Society for Magnetic Resonance in Medicine (ISMRM) in Toronto, and the American Society of Gene Therapy Meeting (ASGT) in Boston.

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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Vast Majority Of Psychiatric Treatment In Community Hospitals Occurs In Specialty Units

Over 90 percent of psychiatric patients who received treatment in community hospitals were cared for in hospital-based psychiatric specialty units, according to a study sponsored by the Substance Abuse and Mental Health Services Administration (SAMHSA) and the U.S. Agency for Healthcare Research and Quality (AHRQ) and published in Psychiatric Services...

New Study On Vyvanse(R) (lisdexamfetamine Dimesylate) Capsules CII Shows Administration Of Vyvanse Through Two Different Routes

Shire plc (LSE: SHP, Nasdaq: SHPGY), the global specialty biopharmaceutical company, announced new data about the pharmacokinetics of its Attention-Deficit/Hyperactivity Disorder (ADHD) medication, Vyvanse® (lisdexamfetamine dimesylate) Capsules CII, which showed that Vyvanse provided similar concentrations of its active medication in the blood when administered either intranasally or when administered orally.

Australian Authorities (TGA) First To Grant Final Product Approval For Intercell's Vaccine To Prevent Japanese Encephalitis

Intercell AG (VSE: ICLL) announced that the Australian Therapeutic Goods Administration (TGA) granted product approval for the company's vaccine to prevent Japanese Encephalitis. This final decision step for the new vaccine follows the positive recommendation provided by Australian Drug Evaluation Committee (ADEC) in December 2008. This decision of the Australian authorities represents the first regulatory approval for the vaccine in any country.

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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Patience Recruitment For Oncological Clinical Trials: Seminar By Jai Balkissoon, From Oxigene, 15-17th February, 2011

Jai Balkisson, Senior Medical Director, Oncology from Oxigene will lead the session focused on establishing a multidisciplinary network to improve patience take up and assess the eligibility at Optimising Clinical Development in Oncology conference, taking place 15-17th of February 2011 in London...

Cardiac Biomarker Indicates Fluid Overload In Dialysis Patients

Nephrologists must consider fluid overload effects when prescribing dialysis, according to a study appearing in an upcoming issue of the Clinical Journal of the American Society of Nephrology (CJASN)...

Emotion Recognition Improved By Oxytocin

Autism spectrum disorders (ASD) are developmental disorders usually diagnosed in childhood. Children with ASDs have impairments in social interactions and communication, and a tendency towards repetitive behaviors. A hallmark of autism is a difficulty in understanding and reciprocating the emotion of others...

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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Diabetes Drug Shows Potential For Treating One Cause Of Chronic Kidney Disease

The antidiabetes drug rosiglitazone may have the potential to protect kidney function in patients with a condition called focal segmental glomerulosclerosis (FSGS), according to a study appearing in the January 2009 issue of the Clinical Journal of the American Society Nephrology (CJASN). The phase I clinical findings indicate that the drug warrants further study in phase II and phase III trials.

PAREXEL Reaches Milestone In Management Of Oncology Trials Over Last Five Years Involving 175,000 Patients Worldwide

PAREXEL International Corporation (Nasdaq: PRXL), a leading global biopharmaceutical services provider, announced it has reached a milestone in managing oncology-based clinical trials over the last five years, which have involved over 175,000 patients in hundreds of programs across 80 countries. PAREXEL will be marking this milestone during the American Society of Clinical Oncology (ASCO) Annual Meeting, to be held May 29 - June 2, 2009 in Orlando, Florida.

Obesity Combo Drug Effective In Trial

Obese adults who took a combination of two drugs already approved to treat obesity, migraine and epilepsy achieved up to 10% weight loss in 12 months, according to results of a clinical trial in the US published in The Lancet this week. First author Dr Kishore M...

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 ...
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Zenith Endovascular Graft Continues To Show Durability

A multicenter trial with up to five years of follow-up continues to support the mid- and long-term durability and safety of the Zenith endovascular graft used for aneurysm repair. "Our study showed that the risk of aneurysm-related death or rupture were exceptionally low, and complications of migration, limb occlusion and device integrity issues were uncommon," said Roy Greenberg, MD, director of endovascular research at The Cleveland Clinic Foundation.

Arcion Therapeutics' Topical Pain Candidate, ARC-4558, Significantly Reduces Pain Caused By Diabetic Neuropathy

Arcion Therapeutics, Inc., a venture backed clinical stage biotechnology company that develops pain therapies, announced the presentation of data demonstrating that its lead candidate, ARC-4558, significantly reduced pain caused by diabetic neuropathy in a double-blind, placebo-controlled trial. The abstract will be presented in a poster session on May 8th from 4:00-5:30 PM at the American Pain Society Annual Meeting, held May 7-9 in San Diego. ARC-4558 is a 0.

How To Better Predict Success In HIV Prevention Clinical Trials

New research from the University of North Carolina at Chapel Hill schools of medicine and pharmacy may help explain the failure of some recent clinical trials of prevention of HIV infection, compared to the success of others that used the same drugs...

Skyrocketing growth of the CRO market

The combination of the growing trend by pharmaceutical companies to outsource a wider range of services, and the need to pass products through the testing and regulatory process in a rapid, cost-effective manner, has lead to skyrocketing growth of the CRO market. The CRO market grew from $1 ...
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NIH Women's Health Public Forum And Scientific Workshop In Chicago

The Northwestern University Feinberg School of Medicine and Northwestern Memorial Hospital will host a public forum and scientific workshop Oct. 14 to 16 to discuss emerging issues of importance for the National Institutes of Health (NIH) for women's health research in the coming decade. "We're challenging people to think beyond traditional women's health issues and look to the future," said Andrea Dunaif, M.D., who is moderating the public hearing and is the Charles F.

Older People Who Diet Without Exercising Lose Valuable Muscle Mass

A group of sedentary and overweight older people placed on a four-month exercise program not only became more fit, but burned off more fat, compared to older sedentary people who were placed on a diet but did not exercise. The new study also showed that when older people diet without exercising, they lose more lean muscle compared to those who exercise, said senior researcher Bret H. Goodpaster.

Spinal Restoration Initiates Patient Enrollment For Phase III Study Of Company's Biostat(R) System

Spinal Restoration, Inc. announced that patient enrollment in the company's Phase III study of the Biostat System for the treatment of discogenic chronic low back pain is now underway. The study, which will be conducted at 15 U.S...

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 ...
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Anti-HIV Therapy Boosts Life Expectancy

The life expectancy for patients with human immunodeficiency virus (HIV) has increased by more than 13 years since the late 1990s thanks to advancements in antiretroviral therapy, according to researchers at the University of Alabama at Birmingham (UAB) and Simon Fraser University in Vancouver, British Columbia.

Excaliard Announces Positive Data From Phase 2 Clinical Trial Of Its Anti-Scarring Drug, EXC 001

Excaliard Pharmaceuticals, Inc., announced positive results from its Phase 2 clinical trial of EXC 001, a new chemical entity for reducing fibrosis. Results showed that EXC 001 treatment significantly reduced scar severity in subjects undergoing an elective abdominoplasty compared to placebo. In the randomized, double-blind multicenter study conducted in the U.S...

News From The Journal Of The National Cancer Institute, August 26 2008

Novel Trial Design Aims to Speed Drug Development Researchers propose a novel multi-arm trial design that can test several therapies simultaneously and could speed drug development in cancer. Scientists have gained important insights into the biological underpinnings of cancer, but this knowledge has not led to a jump in the number of therapies approved for clinical use.

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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Mardil, Inc. Announces Positive Preliminary Results Of Pilot Study With BACE(TM) Device At Annual TCT Conference

Mardil, Inc. announced positive interim data from a pilot study investigating the safety and efficacy of its novel cardiac device - BACE (Basal Annuloplasty of the Cardia Externally) -- in treating mitral valve regurgitation. The condition arises when the heart's mitral valve leaks blood backward into the heart, causing a range of severe and debilitating symptoms.

FDA Approves Therapy To Treat Gaucher Disease

The U.S. Food and Drug Administration has approved velaglucerase alfa for injection (VPRIV) to treat children and adults with a form of the rare genetic disorder Gaucher disease. Gaucher disease occurs in people who do not produce enough of an enzyme called glucocerebrosidase...

Diamyd Medical: Diamyd Phase II Study In Cancer Pain Posted On ClinicalTrials.gov

Diamyd Medical´s (STO:DIAMB)(Pink Sheets:DMYDY) US Phase II clinical trial, evaluating the ability of the candidate drug NP2 Enkephalin to reduce cancer pain, is posted on the clinicaltrials.gov website...

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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Boston Scientific Completes Enrollment In EVOLVE Clinical Trial To Evaluate SYNERGY™ Drug-Eluting Coronary Stent

Boston Scientific Corporation (NYSE: BSX) announced the completion of patient enrollment in the EVOLVE clinical trial, which is designed to assess the safety and performance of the Company's fourth-generation SYNERGY™ Coronary Stent...

New Studies Presented At European Society Of Anaesthesia Further Validate Masimo PVI(TM) For Noninvasive And Continuous Fluid Monitoring

Masimo (Nasdaq: MASI), the inventor of Pulse CO-Oximetry(TM) and Measure-Through Motion and Low-Perfusion pulse oximetry, announced that three new independent studies demonstrating the clinical accuracy and utility of Masimo PVI as a noninvasive and continuous measure of patient fluid status and responsiveness were presented this week at the European Society of Anaesthesiology (ESA) Annual Congress in Milan, Italy.

Spherix Phase 2 Trial With D-tagatose Determines Minimum Dose For HbA1c And Triglycerides

Spherix Incorporated (Nasdaq: SPEX), an innovator in biotechnology for therapy in diabetes, metabolic syndrome and atherosclerosis; and providers of technical and regulatory consulting services to food, supplement, biotechnology and pharmaceutical companies, announced that its Phase 2 diabetes clinical trial, designed to determine the minimum dose of D-tagatose capable of reduc...

Ground breaking companies within the CRO industry

With over 1200 companies within the CRO industry Limdato www.limdato.com is one who is able to utilize cutting edge technology and innovations to ensure complete success for your clinical trial. During the 1970’s the industry was extremely limited to the services it could provide for ...
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Observational Data From One-Year Follow-up Study Validate Six-Minute Walk Distance As An Outcome Measure In Duchenne And Becker Muscular Dystrophy

Data published in the December issue of the medical journal Muscle and Nerve confirm the utility of six-minute walk distance (6MWD) as a clinically meaningful endpoint in dystrophinopathy, a disease continuum comprising Duchenne and Becker muscular dystrophy (DBMD)...

Clinical Trial At The Cancer Institute Of New Jersey Examines Shorter Course Of Radiation Treatment For Early-Stage Breast Cancer

Researchers at The Cancer Institute of New Jersey (CINJ) have launched a clinical trial that focuses on a shorter course of radiation treatment for those with early-stage breast cancer. CINJ is a Center of Excellence of UMDNJ-Robert Wood Johnson Medical School. Studies have shown that giving radiation therapy to the breast after the cancer is removed through surgery (lumpectomy) helps keep the disease from coming back in that area.

Acurian Announces Its Contribution Of Over 600 Randomized Patients In Global, Phase III Diabetes Trial At Therapeutic Conference In Amsterdam

Acurian, Inc., a leading, full-service provider of patient recruitment and retention solutions, announced at the Patient Recruitment & Retention for Diabetes & Obesity Studies Conference in Amsterdam that it recently completed its enrollment contribution of over 600 diabetes patients for a global, nine-protocol diabetes study...

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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Echo Therapeutics Initiates Clinical Study Of Its Symphony(TM) Transdermal Continuous Glucose Monitoring System In Patients With Diabetes

Echo Therapeutics, Inc. (OTC Bulletin Board: ECTE) announced that it has initiated a clinical study of its Symphony(TM) Transdermal Continuous Glucose Monitoring System (tCGM System) in patients with Type 1 and Type 2 diabetes. The Company expects to complete and announce the results of the study in the third quarter of 2008.

Ground-Breaking Study To Cap The Growing Trend Of Type 2 Diabetes In Overweight Adolescents

Researchers at The Children's Hospital at Westmead are embarking on a ground-breaking new study to investigate whether a different dietary approach to insulin resistance in overweight adolescents can put the brakes on its progression to type 2 diabetes. Type 2 diabetes affects 85 to 90 per cent of all people with diabetes. While it usually affects mature adults, younger people and children are increasingly being diagnosed.

CYTAVIS' Aviscumine Improves Survival Of Patients With Metastatic Melanoma In A Phase II Trial

CYTAVIS BioPharma GmbH, a biopharmaceutical company developing derivatives of natural compounds for the treatment of oncological and immunological diseases, today announced Phase II data demonstrating that its lead compound Aviscumine (CY503), an immune potentiator, may improve survival of patients with refractory metastatic melanoma (stage IV)...

It is recommended that sponsor companies should first check what budget they can allocate, and then seek Clinqua Inc. expertise in achieving their goal.

It is an undesirable reality, but the development of pharmaceutical drugs is a costly undertaking. Yet, these costs are necessitated by the substantial investment of both time and resources of the companies in question. It stands to reason that if a company is willing to invest millions of ...
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Cyclacel Announces Recommendations Of Data Review Committee For Seliciclib Phase 2b Non-Small Cell Lung Cancer APPRAISE Trial

Cyclacel Pharmaceuticals, Inc. (NASDAQ:CYCC) (NASDAQ:CYCCP) announced that an independent data review committee (IDRC) has completed a review of the first interim analysis data from the Phase 2b seliciclib APPRAISE study.

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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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