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Cardium Therapeutics reports positive findings from Excellarate Phase 1/2 clinical study

Cardium Therapeutics today announced the publication of positive findings from the open label multi-center Phase 1/2 clinical study of Excellarate(TM) (GAM501, Ad5PDGF-B / 2.6% collagen), its product candidate for the potential treatment of non-healing diabetic foot ulcers.

19 Oct 2009

Phase I clinical study of PENNVAX-B preventive DNA vaccine using electroporation technology

Inovio Biomedical Corporation, a leader in DNA vaccine design, development and delivery, and the HIV Vaccine Trials Network (HVTN) announced today the initiation of a phase I clinical study of Inovio’s PENNVAX-B preventive DNA vaccine delivered using its proprietary electroporation technology.

19 Oct 2009

FDA grants marketing approval for Elitek

Sanofi-aventis U.S. announced that the U.S. Food and Drug Administration (FDA) has granted marketing approval for Elitek (rasburicase) to be used for the initial management of plasma uric acid (PUA) levels in adult patients with leukemia, lymphoma, and solid tumor malignancies who are receiving anti-cancer therapy expected to result in tumor lysis syndrome (TLS) and subsequent elevations of plasma uric acid.

19 Oct 2009

China's SFDA approves Celsion’s global Phase III ThermoDox HEAT trial for treating liver cancer

Celsion Corporation announced today that it has received official approval from China’s State Food and Drug Administration (“SFDA”) for its Clinical Trial Application for ThermoDox that permits Celsion to include Chinese clinical trial sites in its Phase III ThermoDox HEAT trial for the treatment of primary liver cancer, also known as hepatocellular carcinoma (HCC).

15 Oct 2009

Soligenix commences enrollment in its Phase 3 Orbec clinical trial for acute GI GVHD

Soligenix, Inc., formerly known as DOR BioPharma, Inc., a late-stage biotechnology company, announced today that it has initiated enrollment in its confirmatory Phase 3 randomized, double-blind, placebo-controlled, multicenter clinical trial evaluating orBec(®) for the treatment of acute gastrointestinal Graft-versus-Host disease (GI GVHD).

15 Oct 2009

Inspire to present its denufosol tetrasodium cystic fibrosis program data at the 23rd NACFC

Inspire Pharmaceuticals, Inc. announced today Inspire scientists and collaborators will present data from the denufosol tetrasodium cystic fibrosis (CF) program in a poster presentation at the 23rd Annual North American Cystic Fibrosis Conference (NACFC) October 15 - 17, 2009 in Minneapolis, MN.

15 Oct 2009

Positive results from Protalix BioTherapeutics Phase III UPLYSO clinical trial

Protalix BioTherapeutics, Inc., announced today positive top-line results from the Company's pivotal Phase III clinical trial of UPLYSO (taliglucerase alfa, previously referred to as prGCD) in treatment naive patients diagnosed with Gaucher disease.

15 Oct 2009

pSivida achieves milestone in Phase III Iluvien trial, last patient completes two-year follow up visit

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 announced that the last patient in the Phase III clinical trial being conducted by its collaborative partner, Alimera Sciences, for a new treatment for diabetic macular edema (DME) has completed the two-year follow up visit.

15 Oct 2009

Cytheris initiates Phase I/IIa dose escalation study of patients suffering from ICL

Cytheris SA, a clinical stage biopharmaceutical company focused on research and development of new therapies for immune modulation, today announced the initiation of a Phase I/IIa dose escalation study of patients suffering from idiopathic CD4 lymphocytopenia (ICL).

15 Oct 2009

Jazz Pharmaceuticals to present Phase III sodium oxybate trial data at ACR 2009 meetings

Jazz Pharmaceuticals, Inc. announced that data from the company's first Phase III clinical trial of sodium oxybate (JZP-6) for the treatment of fibromyalgia will be presented during the American College of Rheumatology 2009 Annual Meeting (ACR) in Philadelphia, Pennsylvania and also in November during the US Psychiatric and Mental Health Congress (US Psych Congress) in Las Vegas, Nevada.

15 Oct 2009

Positive data from Cardium Therapeutics' Matrix Phase 2b Excellarate trial

Cardium Therapeutics today reported positive data from its Matrix Phase 2b clinical trial of Excellarate(TM) for the potential treatment of patients with chronic non-healing diabetic foot ulcers based on the Company's Gene Activated Matrix (GAM) technology platform.

15 Oct 2009

FDA approves ZyStor Therapeutics' ZC-701 for Phase I human safety trial

ZyStor Therapeutics, Inc., a biotechnology company developing a new class of targeted protein therapeutics for the treatment of Lysosomal Storage Diseases using the Company's proprietary Glycosylation Independent Lysosomal Targeting technology, today announced that it has received clearance from the U. S. Food and Drug Administration to proceed into a clinical trial for its first drug candidate, ZC-701, an enzyme replacement therapy for the treatment of Pompe disease.

14 Oct 2009

Positive data from ZIOPHARM's palifosfamide sarcoma Phase II trial

ZIOPHARM Oncology, Inc. announced today positive top line interim data from the multicenter randomized Phase II trial of palifosfamide (ZymafosTM, ZIO-201) treating patients with unresectable or metastatic soft tissue sarcoma. The analysis evaluated 62 patients treated as of the end of September, with 58 being analyzed.

14 Oct 2009

EMEA grants ArQule's ARQ 197 orphan drug designation

ArQule, Inc. today announced that the European Medicines Evaluation Agency (EMEA) has designated ARQ 197 as an orphan medical product for the treatment of soft tissue sarcoma.

14 Oct 2009

Provectus Pharmaceuticals commences compassionate use program of PV-10 for cancer

Provectus Pharmaceuticals, Inc., a development-stage oncology and dermatology biopharmaceutical company, has expanded its compassionate use program for PV-10, making the agent, which is being developed as a therapeutic agent for a broad spectrum of cancers, available for select cancer patients in the United States. The program is already in progress in Australia, where it was initiated in June 2009.

14 Oct 2009

Nobilon initiates a clinical Proof of Concept trial with SCH 900795 vaccine

Nobilon, the human vaccine business unit of Schering-Plough Corporation (NYSE: SGP), today announced that it has initiated a clinical Proof of Concept trial with SCH 900795, a new intranasal Live Attenuated Influenza Vaccine (LAIV) for annual seasonal use.

14 Oct 2009

Galapagos extends collaboration with Merck to develop new therapies for atherosclerosis

Galapagos NV announced today that it has expanded its global strategic alliance in metabolic diseases with an affiliate of Merck & Co., Inc to incorporate the development of new therapies for atherosclerosis.

14 Oct 2009

Positive results from Metabolex' Phase 1 MBX-2982 clinical trial for treating type 2 diabetes

Metabolex, Inc., a biopharmaceutical company focused on the discovery and development of proprietary new medicines for the treatment of metabolic diseases, announced positive results from two multiple ascending dose Phase 1 clinical trials of MBX-2982.

14 Oct 2009

AVANIR Pharmaceuticals announces results of Zenvia double-blind Phase III STAR trial

AVANIR Pharmaceuticals, Inc. today announced detailed results from the confirmatory double-blind Phase III STAR trial evaluating two doses of the investigational drug Zenvia™ (dextromethorphan/quinidine) compared to placebo in the treatment of pseudobulbar affect (PBA) in patients with underlying multiple sclerosis (MS) or amyotrophic lateral sclerosis (ALS).

14 Oct 2009

Positive results from Alkermes' ALKS 33 clinical trials announced

Alkermes, Inc. today announced positive topline data from two clinical trials of ALKS 33, an investigational oral opioid modulator for the treatment of addiction and other central nervous system disorders. Data from the studies, ALK33-003 and ALK33-004, showed that ALKS 33 was generally well tolerated and successfully blocked the effects of an opioid, with a duration of action that supports once daily dosing.

13 Oct 2009

Drug Trial News

Cardium Therapeutics reports positive findings from Excellarate Phase 1/2 clinical study

Phase I clinical study of PENNVAX-B preventive DNA vaccine using electroporation technology

FDA grants marketing approval for Elitek

China's SFDA approves Celsion’s global Phase III ThermoDox HEAT trial for treating liver cancer

Soligenix commences enrollment in its Phase 3 Orbec clinical trial for acute GI GVHD

Inspire to present its denufosol tetrasodium cystic fibrosis program data at the 23rd NACFC

Positive results from Protalix BioTherapeutics Phase III UPLYSO clinical trial

pSivida achieves milestone in Phase III Iluvien trial, last patient completes two-year follow up visit

Cytheris initiates Phase I/IIa dose escalation study of patients suffering from ICL

Jazz Pharmaceuticals to present Phase III sodium oxybate trial data at ACR 2009 meetings

Positive data from Cardium Therapeutics' Matrix Phase 2b Excellarate trial

FDA approves ZyStor Therapeutics' ZC-701 for Phase I human safety trial

Positive data from ZIOPHARM's palifosfamide sarcoma Phase II trial

EMEA grants ArQule's ARQ 197 orphan drug designation

Provectus Pharmaceuticals commences compassionate use program of PV-10 for cancer

Nobilon initiates a clinical Proof of Concept trial with SCH 900795 vaccine

Galapagos extends collaboration with Merck to develop new therapies for atherosclerosis

Positive results from Metabolex' Phase 1 MBX-2982 clinical trial for treating type 2 diabetes

AVANIR Pharmaceuticals announces results of Zenvia double-blind Phase III STAR trial

Positive results from Alkermes' ALKS 33 clinical trials announced

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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