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Gentium reports results from phase 3 trial of defibrotide for severe veno-occlusive disease

Gentium S.p.A. has announced top-line results from a historically controlled, multicenter, open label, Phase III trial designed to evaluate the safety and efficacy of 25 mg/kg/day of Defibrotide for the treatment of severe veno-occlusive disease (sVOD) in hematopoietic stem cell transplant (SCT) patients.

19 Aug 2009

Sinovac Biotech announces positive results from clinical trial of H1N1 vaccine

Sinovac Biotech Ltd. announced today positive top-line results from the completed clinical trial for its internally-developed H1N1 vaccine. The clinical data unblinding conference was held in Beijing on the afternoon of August 17, 2009. Notably, Sinovac is the first company worldwide to complete clinical trials for the H1N1 vaccine.

19 Aug 2009

Arzoxifene phase 3 study results reported by Lilly

Eli Lilly and Company announced today that initial results from its pivotal, five-year, Phase III GJAD "GENERATIONS" trial for arzoxifene met its primary endpoints of significantly reducing the risk of vertebral fracture and invasive breast cancer in postmenopausal women.

19 Aug 2009

Hard to Treat Diseases' swine flu clinical trials in progress

Hard to Treat Diseases (HTDS.PK) Mellow Hope, an operating subsidiary of HTDS, is pleased to report that its clinical trial is currently being processed.

19 Aug 2009

Low-dose estrogen effective for metastatic breast cancer

When estrogen-lowering drugs no longer control metastatic breast cancer, the opposite strategy might work. Raising estrogen levels benefited 30 percent of women whose metastatic breast cancer no longer responded to standard anti-estrogen treatment, according to research conducted at Washington University School of Medicine in St. Louis and collaborating institutions.

19 Aug 2009

Results of Phase IIb dose range finding of oglemilast in chronic obstructive pulmonary disease announced

Forest Laboratories, Inc. (NYSE: FRX) and Glenmark Pharmaceuticals S.A. (Switzerland), a wholly owned subsidiary of Glenmark Pharmaceuticals India (GPL) today announced top-line results from a Phase IIb dose range-finding study of oglemilast in patients with Chronic Obstructive Pulmonary Disease (COPD). Once-daily treatment with oglemilast did not show a statistically meaningful increase from baseline compared to placebo in the primary endpoint trough FEV1, a measure of pulmonary function that is decreased in patients with COPD. Oglemilast was well tolerated at all doses studied.

19 Aug 2009

Amarex joins OmniComm Systems' CRO Preferred Program

OmniComm Systems, Inc., a leader in integrated electronic data capture (EDC) solutions for clinical trials, announced today that it has been selected by Amarex, a Mid-Atlantic based Contract Research Organization (CRO) to provide eClinical solutions for an upcoming Phase III trial investigating the use of a medical device for wound healing.

19 Aug 2009

4SC starts phase 2 trial in hepatocellular carcinoma with 4SC-201 (resminostat)

4SC AG, the German drug discovery and development company, today announced the dosing of the first patient in its Phase II trial with 4SC-201 (resminostat), a pan-histone deacetylase (HDAC) inhibitor, as a new potential treatment option for patients with advanced hepatocellular carcinoma (HCC), the most frequent form of liver cancer.

18 Aug 2009

Genentech announces Phase III study results for Avastin (bevacizumab) in combination with chemo in HER2-negative breast cancer

Genentech, Inc. today announced that a Phase III study (RIBBON 2) of Avastin (bevacizumab) in combination with chemotherapy increased the time women with metastatic HER2-negative breast cancer whose initial chemotherapy had stopped working lived without the disease worsening (progression-free survival or PFS), compared to chemotherapy alone.

18 Aug 2009

Human Genome Sciences achieves systemic lupus goals with candidate drug

Human Genome Sciences announced that BENLYSTA™ met the primary endpoint in BLISS-52, the first of two pivotal Phase 3 trials in patients with serologically active systemic lupus erythematosus (SLE). These results show that BENLYSTA™ has the potential to become the first new approved drug in decades giving hope to people living with systemic lupus.

17 Aug 2009

Aeterna Zentaris announces results from trials of Cetrorelix in benign prostatic hyperplasia

AEterna Zentaris Inc. today reported Phase 3 results for its North American efficacy trial Z-033 and the safety trial Z-041 in benign prostatic hyperplasia (BPH), with its lead endocrinology compound for urology, cetrorelix pamoate. As announced on March 6, 2009, sanofi-aventis U.S. LLC entered into an agreement with AEterna Zentaris for the development, registration and marketing of cetrorelix in BPH for the U.S. market.

17 Aug 2009

New immune therapy for kidney cancer tested

Researchers at The Cancer Institute of New Jersey (CINJ) have opened a clinical trial to evaluate whether the standard treatment for a common form of kidney cancer works better by itself or when combined with a certain type of blood cell that comes from a patient’s relative. CINJ is a Center of Excellence of UMDNJ-Robert Wood Johnson Medical School.

14 Aug 2009

First batch of cancer vaccine from Cancer Vaccine Collaborative goes into trial

The first batch of NY-ESO-1 recombinant protein produced in a facility supported entirely by non-profit entities has successfully cleared regulatory review and has entered clinical testing. The clinical trials are part of the Cancer Vaccine Collaborative, a joint program of the Cancer Research Institute, Inc. (CRI) and the Ludwig Institute for Cancer Research Ltd. (LICR).

13 Aug 2009

Antigenics’ Oncophage cancer vaccine trial starts enrolling patients

Antigenics Inc. (NASDAQ:AGEN) today announced that the Brain Tumor Research Center at the University of California, San Francisco, has begun enrolling patients into a Phase 2 clinical trial of Oncophage (vitespen) in combination with the standard of care - radiation therapy plus Temodar (temozolomide) - for newly diagnosed glioma patients.

13 Aug 2009

Study looks at imipramine in the treatment of irritable bowel syndrome

IBS remains a common intestinal disorder causing significant discomfort and poor quality of life in patients who have the diagnosis. TCAs have been shown to improve abdominal pain in patients with IBS; however, there is insufficient evidence of global symptom relief. The search for an optimal treatment to improve symptoms and quality of life in IBS remains ongoing.

12 Aug 2009

Cannabis Science reports on future plans for cannabis drug trials

Cannabis Science, Inc. (OTCBB: CBIS) has announced that it has completed its review of the FDA licensing requirements and has made key progress with mapping out its initial cannabis drug medicines for FDA clinical trials.

12 Aug 2009

Investigational, orally-inhaled therapy effective in treating migraines

A new study conducted at the Jefferson Headache Center at Thomas Jefferson University Hospital in Philadelphia, Pennsylvania shows an investigational, orally-inhaled therapy is effective in treating migraines.

12 Aug 2009

Researchers respond to concerns about international insulin drug trial

Accumulating safety data from the large, international ORIGIN trial have been reviewed by its independent data monitoring committee, who have concluded that there is no cause for concern.

12 Aug 2009

Endocyte announces results from study of EC145 in patients with advanced non-small cell lung cancer

Results were presented at the 13th World Conference on Lung Cancer in San Francisco. The single arm Phase II study evaluated the therapeutic agent EC145 and the molecular imaging agent EC20 in 42 patients with advanced adenocarcinoma of the lung. Forty percent of patients involved in the clinical trial had already failed at least four chemotherapy regimens prior to enrollment in the study.

12 Aug 2009

Britain's first swine flu vaccine trials start

Britain's first swine flu vaccine trials, led by the University of Leicester and University Hospitals of Leicester NHS Trust, are taking place at the Leicester Royal Infirmary.

11 Aug 2009