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Polymedix commences Phase 1B study of novel anticoagulant reversing agent

PolyMedix, Inc., an emerging biotechnology company developing new therapeutic drug products to treat infectious diseases and acute cardiovascular disorders based on biomimetics, has initiated dosing and commenced a second clinical trial, a Phase 1B pilot proof of concept study, in the U.S. with its anticoagulant reversing agent PMX-60056 under an Investigational New Drug application (IND) filed with the U.S. Food and Drug Administration (FDA).

30 Sep 2009

Plexxikon commences patient dosage in PLX4032 trials for metastatic melanoma

Plexxikon Inc. announces that enrollment has been initiated and the first patient has been treated in the first of two pivotal trials of PLX4032 (RG7204) in patients with metastatic melanoma. PLX4032 is a novel, oral and highly selective drug that targets the BRAFV600E cancer-causing mutation occurring in about 50 percent of melanomas and about eight percent of all solid tumors.

30 Sep 2009

Results from Phase 2 clinical study of LCP-Tacro tablets in stable liver transplant patients announced

LifeCycle Pharma A/S today announced positive results from a completed 12 month extension phase of the Phase 2 clinical study of LCP-Tacro tablets in stable liver transplant patients.

30 Sep 2009

AFRESA Inhalation Powder and AFRESA Inhaler NDA under FDA review

AFRESA® (insulin human [rDNA origin]) Inhalation Powder is a well-tolerated, ultra rapid acting insulin able to more closely replicate normal glucose suppression than currently available insulins, according to data presented at the 45th Annual Meeting of the European Association for the Study of Diabetes.

30 Sep 2009

Vitae receives 11Beta-HSD-1 program milestone payment from Boehringer Ingelheim

Vitae Pharmaceuticals, Inc., an integrated discovery and development company, today announced that it has earned an $8 million milestone payment from Boehringer Ingelheim for achievement of a performance milestone in their 11beta-hydroxysteroid dehydrogenase (HSD)-1 diabetes and metabolic disease strategic alliance.

29 Sep 2009

NIH awards Novelos and MGH $1M grant for the study of compounds for radiation-induced lung injury

Novelos Therapeutics, Inc. (OTCBB: NVLT), a biopharmaceutical company focused on the development of therapeutics to treat cancer and hepatitis, today announced that the Massachusetts General Hospital (MGH), in collaboration with Novelos, was awarded a $950,371 competitive grant by the National Institutes of Health (NIH) to study two Novelos compounds – NOV-002 and NOV-205 – for the mitigation and treatment of radiation-induced pulmonary injury.

29 Sep 2009

pSivida reports interim results of human PK study of Iluvien

pSivida Corp, a leading drug delivery company that has developed two of the only three products approved by the FDA for the long-term, sustained release delivery of drug to treat chronic back of the eye disease, today reported the interim 18-month safety and efficacy results from the first human pharmacokinetic study (PK Study) of Iluvien®. The PK trial is being conducted by Alimera Sciences, the licensee for Iluvien.

29 Sep 2009

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

Dynavax commences Phase 3 trial for HEPLISAV hepatitis B vaccine

Dynavax Technologies Corporation (Nasdaq:DVAX) today announced the initiation of a Phase 3 registration trial for HEPLISAVTM hepatitis B vaccine in individuals with chronic kidney disease. A second registration trial, a Phase 3 lot-to-lot consistency trial, is expected to begin in early 2010. HEPLISAV is an investigational adult hepatitis B vaccine designed to provide increased, rapid protection with fewer doses than current licensed vaccines.

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

Kane Biotech's Dispersinb Topical Wound Gel passes cytotoxicity and primary skin irritation tests

Kane Biotech Inc., a biotechnology company engaged in the development of products that prevent and remove microbial biofilms is pleased to announce that DispersinB® Topical Wound Gel has passed the FDA-recommended Cytotoxicity and Primary Skin Irritation tests conducted by WuXi AppTec Inc. (St. Paul, MN) in compliance with Good Laboratory Practice (GLP). Thus, DispersinB® wound gel is considered non-cytotoxic and non-irritant.

28 Sep 2009

NIH awards DiscoveryBioMed a Phase 2 SBIR grant for research on hypertension and cystic fibrosis

DiscoveryBioMed, Inc. (DBM) today announced that it has been awarded a $750,000 Small Business Innovations Research (SBIR) Phase 2 grant by the National Institutes of Health (NIH) to continue the research into the discovery and development of small molecules to alleviate multiple chronic human diseases including cystic fibrosis (CF), hypertension and chronic kidney diseases with hypertension.

28 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

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

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

Morphotek announces preliminary data from Phase II trial of farletuzumab

Morphotek(R), Inc., a subsidiary of Eisai Corporation of North America, today announced preliminary data from a Phase II trial evaluating the safety and efficacy of farletuzumab in platinum-sensitive epithelial ovarian cancer subjects experiencing their first relapse. Farletuzumab (MORAb-003) is a humanized monoclonal antibody that targets the Folate Receptor Alpha (FRA).

26 Sep 2009

Dyax to present an update of its clinical development programs

Dyax Corp., a developer of novel biotherapeutics for unmet medical needs, announced today that Gustav A. Christensen, President and Chief Executive Officer of Dyax, will present at the Fourth Annual JMP Securities Healthcare Focus Conference, being held October 5-6th at The New York Palace Hotel in New York City, NY.

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

Drug Trial News

Polymedix commences Phase 1B study of novel anticoagulant reversing agent

Plexxikon commences patient dosage in PLX4032 trials for metastatic melanoma

Results from Phase 2 clinical study of LCP-Tacro tablets in stable liver transplant patients announced

AFRESA Inhalation Powder and AFRESA Inhaler NDA under FDA review

Vitae receives 11Beta-HSD-1 program milestone payment from Boehringer Ingelheim

NIH awards Novelos and MGH $1M grant for the study of compounds for radiation-induced lung injury

pSivida reports interim results of human PK study of Iluvien

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

Dynavax commences Phase 3 trial for HEPLISAV hepatitis B vaccine

International Medica Foundation sponsors rotavirus vaccine trial in Ghana

Kane Biotech's Dispersinb Topical Wound Gel passes cytotoxicity and primary skin irritation tests

NIH awards DiscoveryBioMed a Phase 2 SBIR grant for research on hypertension and cystic fibrosis

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

Phase 2 clinical trial results of IMO-2055 announced

Investigational vaccine regimen 31% effective in preventing HIV infection

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

Morphotek announces preliminary data from Phase II trial of farletuzumab

Dyax to present an update of its clinical development programs

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

Bringing real-time analytics to downstream bioprocess monitoring

Designing fluidic architecture for scalable diagnostic platforms

Evaluating new approaches for rare disease genomics

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