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Synta commences Phase 1/2 clinical study of novel Hsp90 inhibitor in hematologic malignancies

Synta Pharmaceuticals Corp., a biopharmaceutical company focused on discovering, developing, and commercializing small molecule drugs to treat severe medical conditions, today announced that it has initiated a Phase 1/2 clinical study of its novel heat shock protein 90 (Hsp90) inhibitor, STA-9090 in hematologic malignancies with a once-a-week dosing schedule.

29 Sep 2009

Acrux reports Phase III trial results evaluating AXIRON for testosterone deficiency

Australian company, Acrux, today announced positive results from a Phase III trial evaluating the safety and efficacy of AXIRON™ in 155 men with testosterone deficiency (hypogonadism), across 26 sites in six countries.

29 Sep 2009

BioClinica to demonstrate integrated eClinical technology at the SCDM conference

BioClinica, Inc., a leading global provider of clinical trial services, is helping to advance the discipline of clinical data management and will demonstrate integrated eClinical and imaging data management technology and expertise at the 2009 Society of Clinical Data Management (SCDM) Annual Conference, October 4-6, 2009 in Seattle, WA (Booth # 401).

From Clario 29 Sep 2009

Also in Global Health news: News outlets explore AIDS vaccine research; chloroquine resistance unraveled; authorities contest maternal mortality report

The Associated Press examines the role of the Thai participants in the recent clinical trial of an experimental HIV vaccine which showed modest potential for preventing infection. "Nearly 16,000 Thais ignored the false rumors that they were being infected by the AIDS virus, and overcame their fears of becoming social outcasts to participate in trials of the first vaccine found to prevent infection with the deadly virus," the news service writes (Ahuja/Casey, 9/27).

29 Sep 2009

AAPS Annual Meeting to discuss new research and technologies in pharmaceutical sciences

More than 8,500 individuals from the field of pharmaceutical research are expected to attend this year's AAPS Annual Meeting and Exposition November 8 - 12, 2009 at the Los Angeles Convention Center in California.

29 Sep 2009

NovoCure initiates newly-diagnosed GBM clinical trial

NovoCure, Ltd., a privately held medical device company focused on developing the Novo-TTF device, a non-invasive portable medical device for the treatment of cancer, announced the completion of a new funding round today. Key investors in this round included Pfizer Inc, Johnson & Johnson Development Corporation and Index Ventures.

29 Sep 2009

Conditional IDE approval for Flexstent Femoropopliteal Self Expanding Stent System

Flexible Stenting Solutions Inc. (“FSS”), a leading developer of next generation peripheral arterial and biliary stents, announced today that it has received Conditional Investigational Device Exemption (IDE) approval for its FlexStent® Femoropopliteal Self Expanding Stent System.

29 Sep 2009

Hookworms can prevent asthma

A study conducted in Vietnam has added further weight to the view that parasitic gut worms, such as hookworm, could help in the prevention and treatment of asthma and other allergies.

29 Sep 2009

International Medica Foundation sponsors rotavirus vaccine trial in Ghana

More than half a million children – or 1,400 to 1,600 each day – die from rotavirus, the most common cause of severe childhood diarrhea. Almost all of these deaths occur in developing countries, where lifesaving medical care may not be affordable or available to the families with the most critical needs. In addition, income loss due to the need for parents to take care of sick children can have a very significant economic burden on families that can least afford it.

29 Sep 2009

Halozyme Therapeutics announces Phase 1 clinical study to assess three insulin analogs

Halozyme Therapeutics, Inc. today announced the commencement of a Phase 1 clinical study that will assess the effects of three approved prandial (mealtime) insulin analogs administered with its proprietary rHuPH20 (PH20) hyaluronidase enzyme compared to each of the analogs alone. This randomized, three-way cross-over design, euglycemic clamp study will compare the postprandial pharmacokinetics (PK) and glucodynamics (GD) of the insulin analogs.

28 Sep 2009

Increasing insulin levels can aid muscle building in the elderly

Recently, scientists have recognized that loss of responsiveness to insulin plays a major role in the loss of physical strength that occurs as people grow older. Now, University of Texas Medical Branch at Galveston researchers have demonstrated that by increasing insulin levels above the normal range in elderly test subjects, they can restore the impaired muscle-building process responsible for age-related physical weakness.

28 Sep 2009

Preliminary results from procedural review of Menaflex released by the FDA

The U.S. Food and Drug Administration (FDA) yesterday released preliminary results of a review of its internal procedures surrounding the review of ReGen Biologics’Menaflex collagen meniscus implant for use in the U.S.

28 Sep 2009

Phase 2 clinical trial results of IMO-2055 announced

Idera Pharmaceuticals, Inc., today announced the presentation of final data from a clinical trial evaluating IMO-2055, an agonist of Toll-like Receptor (TLR) 9, as monotherapy in patients with Renal Cell Carcinoma (RCC). The data are being presented during the Eighth International Kidney Cancer Symposium being held in Chicago, September 25-26, 2009.

28 Sep 2009

FDA grants accelerated approval for Allos Therapeutics’ FOLOTYN

Allos Therapeutics, Inc. (Nasdaq:ALTH) today announced that last night the U.S. Food and Drug Administration (FDA) granted accelerated approval for FOLOTYNTM (pralatrexate injection) for use as a single agent for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL).

28 Sep 2009

Quintiles opens an expanded regional facility

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

28 Sep 2009

Investigational vaccine regimen 31% effective in preventing HIV infection

In an encouraging development, an investigational vaccine regimen has been shown to be well-tolerated and to have a modest effect in preventing HIV infection in a clinical trial involving more than 16,000 adult participants in Thailand. Following a final analysis of the trial data, the Surgeon General of the U.S. Army, the trial sponsor, announced today that the prime-boost investigational vaccine regimen was safe and 31 percent effective in preventing HIV infection.

27 Sep 2009

Pfizer to commence Phase 3 trial of oral c-Met and ALK inhibitor

Pfizer Oncology announced today that it will initiate a global, Phase 3 clinical trial of its investigational oral c-Met and ALK inhibitor, PF-02341066, versus standard of care chemotherapy in patients with advanced non-small cell lung cancer (NSCLC) carrying the ALK (anaplastic lymphoma kinases) fusion gene, who have progressed on one prior treatment with a platinum-based chemotherapy.

26 Sep 2009

HORIZONS-AMI clinical trial demonstrates efficacy of drug-eluting stent

Late-breaking data from the landmark HORIZONS-AMI clinical trial, presented at the 21st annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, demonstrated that after two years, in heart attack patients, the use of a drug-eluting stent (paclitaxel) was safer and more effective than a bare-metal stent; and that the administration of the anticoagulant medication bivalirudin enhanced safety and efficacy compared to the use of heparin + GPIIb/IIIa inhibitors.

25 Sep 2009

Affymax may sell up to.$60 million of its registered common stock to Azimuth Opportunity

Affymax, Inc. (Nasdaq:AFFY) today announced that it has obtained an issuer managed equity facility under which it may sell up to $60 million of its registered common stock to Azimuth Opportunity, Ltd. Affymax is not obligated to utilize any of the facility, which has a term of 24 months.

25 Sep 2009

NCI awards Altor Bioscience a $3 MM grant to develop its targeted cancer therapeutic ALT-801

Altor BioScience Corporation announced today that it has been awarded a Small Business Innovation Research (SBIR) Phase II Bridge Grant by the National Cancer Institute (NCI). The award of $3 MM over three years will help Altor further its clinical development of ALT-801, a novel tumor-targeted immunotherapeutic designed to improve the efficacy and safety of the FDA-approved anticancer cytokine, interleukin-2 (IL-2).

25 Sep 2009

Clinical Trial News and Research

Synta commences Phase 1/2 clinical study of novel Hsp90 inhibitor in hematologic malignancies

Acrux reports Phase III trial results evaluating AXIRON for testosterone deficiency

BioClinica to demonstrate integrated eClinical technology at the SCDM conference

Also in Global Health news: News outlets explore AIDS vaccine research; chloroquine resistance unraveled; authorities contest maternal mortality report

AAPS Annual Meeting to discuss new research and technologies in pharmaceutical sciences

NovoCure initiates newly-diagnosed GBM clinical trial

Conditional IDE approval for Flexstent Femoropopliteal Self Expanding Stent System

Hookworms can prevent asthma

International Medica Foundation sponsors rotavirus vaccine trial in Ghana

Halozyme Therapeutics announces Phase 1 clinical study to assess three insulin analogs

Increasing insulin levels can aid muscle building in the elderly

Preliminary results from procedural review of Menaflex released by the FDA

Phase 2 clinical trial results of IMO-2055 announced

FDA grants accelerated approval for Allos Therapeutics’ FOLOTYN

Quintiles opens an expanded regional facility

Investigational vaccine regimen 31% effective in preventing HIV infection

Pfizer to commence Phase 3 trial of oral c-Met and ALK inhibitor

HORIZONS-AMI clinical trial demonstrates efficacy of drug-eluting stent

Affymax may sell up to.$60 million of its registered common stock to Azimuth Opportunity

NCI awards Altor Bioscience a $3 MM grant to develop its targeted cancer therapeutic ALT-801

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