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Interim Phase II data of Cotara reveals signs of efficacy in GBM patients

Peregrine Pharmaceuticals, Inc. today reported that clinical investigators are presenting interim Phase II data showing that its brain cancer agent Cotara(R) appeared well tolerated and demonstrated encouraging signs of efficacy in patients with glioblastoma multiforme (GBM), the deadliest form of brain cancer.

3 Sep 2009

Peplin announces merger agreement with LEO Pharma

Peplin, Inc. (ASX:PLI) today announced a definitive merger agreement whereby LEO Pharma A/S (LEO), a privately-held, leading global pharmaceutical company within Dermatology and Critical Care, will acquire all outstanding securities of Peplin for approximately US$287.5 million (currently A$348.4 million) in cash. This represents a purchase price of US$16.99 per common share of Peplin stock or A$1.03 per Peplin CHESS Depositary Interest (CDI).

3 Sep 2009

GDC-0449 inhibits the Hedgehog signaling pathway

The Hedgehog signaling pathway is involved in a preliminary study and case report describing positive responses to an experimental anticancer drug in a majority of people with advanced or metastatic basal cell skin cancers. One patient with the most common type of pediatric brain cancer, medulloblastoma, also showed tumor shrinkage.

3 Sep 2009

FDA's Oncologic Drugs Advisory Committee votes in favor of FOLOTYN NDA

Allos Therapeutics, Inc. (Nasdaq: ALTH) today announced that the U.S. Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) voted 10-4 that the response rate and duration of response observed with FOLOTYNTM (pralatrexate) are reasonably likely to predict clinical benefit in patients with relapsed or refractory peripheral T-cell lymphoma (PTCL).

3 Sep 2009

New therapy for advanced and metastatic basal cell skin cancer

A study published today in the New England Journal of Medicine reports a potential new investigational therapy for advanced and metastatic basal cell skin cancer tested at the Virginia G. Piper Cancer Center at Scottsdale Healthcare and other sites appears to demonstrate tumor shrinkage and limited side effects in patients.

3 Sep 2009

New method for treating hand disorder discovered

Researchers in the Department of Orthopaedics at Stony Brook University Medical Center have developed an injectable form of the enzyme, collagenase, that significantly improves outcomes of Dupuytren's contracture (or disease), a debilitating disorder caused by progressive accumulation of collagen that deforms fingers and limits motion. Reported in September 3, 2009, issue of The New England Journal of Medicine, the study involved treatment of 308 patients with Duputren's disease in 16 sites nationwide. The results indicate that the injections are safe and effective.

3 Sep 2009

Innovative way for culturing liver cells improves drug toxicity screening

A team led by Massachusetts General Hospital (MGH) researchers has developed an innovative way to culture liver cells for drug toxicity screening. In a report to be published in Proceedings of the National Academy of Sciences that has been released online, the investigators describe how liver cells grown in a high-oxygen environment and in a culture medium free of animal-derived serum quickly begin to function as they do within the liver.

2 Sep 2009

Phase 1 single dose clinical trial of Acceleron Pharma's ACE-031 increases lean body mass

Acceleron Pharma, Inc., a biopharmaceutical company developing novel therapeutics that modulate the growth of cells and tissues including red blood cells, bone, and muscle, today announced preliminary results from the ACE-031 Phase 1 single dose clinical trial indicating that ACE-031 was safe and well-tolerated at all dose levels and increased lean body mass.

2 Sep 2009

Patents for treatment for obesity acquired by Madrona Ventures, to start clinical trials soon

A groundbreaking new treatment for obesity is to begin clinical trials in January. Madrona Ventures Inc., an American publicly listed company (OTCBB:MDRV), has acquired the treatment's European patent and the pending American patent application.

2 Sep 2009

Research is active and diverse in U.S. academic medical centers

A survey indicates that research is active and diverse at U.S. academic medical centers and that a substantial proportion of faculty conduct research and publish without sponsorship, according to a study in the September 2 issue of JAMA.

2 Sep 2009

Lupus Foundation of America to educate people with lupus on clinical trial participation

It has been more than 50 years since the U.S. Food and Drug Administration (FDA) last approved a new medicine specifically for lupus – when Dwight D. Eisenhower was president. Existing treatments have been "borrowed" from other disorders and the risk/benefit ratio of these treatments is far from optimal. However, hope is on the horizon.

2 Sep 2009

FDA: Randomized clinical trial necessary to better interpret Clolar’s efficacy and safety in adult AML

Genzyme Corporation (Nasdaq: GENZ) announced today that the FDA’s Oncologic Drugs Advisory Committee voted 9 to 3 that a randomized, controlled trial is needed to support the currently proposed label expansion for Clolar® (clofarabine) in adult myeloid leukemia (AML). The committee found that the single-arm clinical study results submitted to support the label expansion showed Clolar was an active agent in acute AML patients, but concluded that a randomized clinical trial should be necessary to better interpret Clolar’s efficacy and safety in the proposed patient population.

2 Sep 2009

Patient enrollment completed for the Berlin Heart EXCOR Pediatric IDE clinical study

Berlin Heart Inc. reported today that it has completed enrollment in Cohort 1 of the Berlin Heart EXCOR(R) Pediatric IDE Study after having received unconditional approval of the study from the FDA in November 2008.

2 Sep 2009

New research on post-traumatic stress disorder to be presented at MHRF

New research on post-traumatic stress disorder (PTSD) is being presented this week at the Military Health Research Forum (MHRF), a scientific conference hosted by the Department of Defense (DOD) Congressionally Directed Medical Research Programs (CDMRP). Depending on the conflict in which they served, 10 to 30 percent of soldiers who have spent time in war zones experience the debilitating and life-altering symptoms of post-traumatic stress disorder (PTSD).

2 Sep 2009

Eye disease medication lowers death rate among Ethiopian children

Children in Ethiopia who received the antibiotic azithromycin as a method for controlling the contagious eye disease trachoma had a lower odds of death compared to children who did not receive the antibiotic, according to a study in the September 2 issue of JAMA.

2 Sep 2009

BioClinica offers streamlined electronic transport solutions with the acquisition of CardioNow

BioClinica, Inc., (NASDAQ: BIOC), a global provider of clinical trial services, today announced that it has acquired the CardioNow unit of Agfa HealthCare.

From Clario 1 Sep 2009

Six-month period financial results released by Cannasat Therapeutics

Cannasat Therapeutics Inc., a clinical stage pharmaceutical company developing products to treat neurological disorders such as neuropathic pain and schizophrenia, today announced its results for the six months ended June 30, 2009. Unless specified otherwise, all amounts are in Canadian dollars.

1 Sep 2009

Daxor's signed trial agreement with Pacific Cardiology to provide the BVA-100 instrument

Daxor Corporation, a medical instrumentation and biotechnology company, today announced the receipt of a signed trial agreement from Pacific Cardiology, LLC of Honolulu, Hawaii. This will provide Pacific Cardiology with a Blood Volume Analyzer-100 (BVA-100), an instrument which enables semi-automated measurement of a patient's total blood volume, red blood cell volume and plasma volume.

1 Sep 2009

Psychological therapy for breast cancer patients reduces blood inflammation levels

A psychological intervention for newly diagnosed breast cancer patients with symptoms of depression not only relieves patients' depression but also lowers indicators of inflammation in the blood.

1 Sep 2009

Research study to identify the appropriate amount of DHA required for promoting optimal heart health

A team of French scientists have found the dose of DHA (docosahexaenoic acid) that is "just right" for preventing cardiovascular disease in healthy men. In a research report appearing in the September 2009 print issue of The FASEB Journal, the scientists show that a 200 mg dose of DHA per day is enough to affect biochemical markers that reliably predict cardiovascular problems, such as those related to aging, atherosclerosis, and diabetes. This study is the first to identify how much DHA is necessary to promote optimal heart health.

1 Sep 2009

Clinical Trial News and Research

Interim Phase II data of Cotara reveals signs of efficacy in GBM patients

Peplin announces merger agreement with LEO Pharma

GDC-0449 inhibits the Hedgehog signaling pathway

FDA's Oncologic Drugs Advisory Committee votes in favor of FOLOTYN NDA

New therapy for advanced and metastatic basal cell skin cancer

New method for treating hand disorder discovered

Innovative way for culturing liver cells improves drug toxicity screening

Phase 1 single dose clinical trial of Acceleron Pharma's ACE-031 increases lean body mass

Patents for treatment for obesity acquired by Madrona Ventures, to start clinical trials soon

Research is active and diverse in U.S. academic medical centers

Lupus Foundation of America to educate people with lupus on clinical trial participation

FDA: Randomized clinical trial necessary to better interpret Clolar’s efficacy and safety in adult AML

Patient enrollment completed for the Berlin Heart EXCOR Pediatric IDE clinical study

New research on post-traumatic stress disorder to be presented at MHRF

Eye disease medication lowers death rate among Ethiopian children

BioClinica offers streamlined electronic transport solutions with the acquisition of CardioNow

Six-month period financial results released by Cannasat Therapeutics

Daxor's signed trial agreement with Pacific Cardiology to provide the BVA-100 instrument

Psychological therapy for breast cancer patients reduces blood inflammation levels

Research study to identify the appropriate amount of DHA required for promoting optimal heart health

Achieving and maintaining ISO/IEC 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

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