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Allos Therapeutics, Idis collaborate in named patient program for FOLOTYN

Allos Therapeutics, Inc. today announced the execution of a collaborative agreement with Idis, a UK-based global company, to manage the named patient program for FOLOTYN™ (pralatrexate injection) outside of the United States. The U.S. Food and Drug Administration (FDA) has granted accelerated approval for FOLOTYN for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL).

4 Dec 2009

Type 2 diabetics with CAD experience greater antiplatelet activity with prasugrel compared to clopidogrel

Results from a new study showed patients with type 2 diabetes who also had coronary artery disease (CAD) experienced greater antiplatelet activity with the investigational antiplatelet drug prasugrel compared to Plavix(R) (clopidogrel). Patients who received a 60 mg loading dose and 10 mg maintenance dose of prasugrel achieved significantly greater platelet inhibition compared with a 600 mg loading dose and 150 mg maintenance dose of Plavix.

4 Dec 2009

Genzyme announces reopening of enrollment in its Pompe disease ATAP program

Genzyme Corporation announced today that it will reopen enrollment in the Alglucosidase Alfa Temporary Access Program (ATAP), a program which provides access to treatment for severely affected adults with Pompe disease prior to commercial approval of Lumizyme™ (alglucosidase alfa). Genzyme and the FDA have also agreed on a path toward approval of Lumizyme.

4 Dec 2009

Lightlake Therapeutics granted ethical approval for gene testing subjects in obesity treatment trial

After two decades of scientifically and medically proven success in their field, Lightlake Therapeutics' experts have been granted ethical approval to begin selecting and gene testing subjects for a trial of a simple, safe and effective treatment for what the World Health Organisation has described as a global epidemic of unhealthy eating and obesity.

3 Dec 2009

Last patient visit complete in VIA Pharmaceuticals' Phase 2 FDG-PET trial

VIA Pharmaceuticals, Inc., a biotechnology company focused on the development of compounds for the treatment of cardiovascular and metabolic disease, today announced that it has completed the last patient visit in its Phase 2 FDG-PET clinical trial of VIA-2291.

3 Dec 2009

iCo Therapeutics to present an overview of its iCo-007 VEGF "+" agent at the ISOPT conference

iCo Therapeutics Inc. is pleased to announce that an overview of iCo-007, entitled "iCo-007 a VEGF "+" Agent for the Potential Treatment of Diabetic Macular Edema and Diabetic Retinopathy" will be presented at the 8th International Symposium on Ocular Pharmacology and Therapeutics ("ISOPT"), a major international ocular conference.

3 Dec 2009

Initial positive data from Amira Pharmaceuticals' Phase 1 clinical study of AM461 DP2 antagonist

Amira Pharmaceuticals, Inc. announced today initial positive data from a Phase 1 clinical study of AM461, the Company's second oral selective antagonist of the DP2 (also known as CRTH2) receptor.

3 Dec 2009

Hyperion Therapeutics commences enrollment in its HPN-100 episodic hepatic encephalopathy trial

Hyperion Therapeutics, Inc. today announced that the first patient has been enrolled in its phase II clinical trial of investigational compound HPN-100 (glycerol phenylbutyrate).

3 Dec 2009

Update on Celsion's ThermoDox Phase III “HEAT” trial for HCC

Celsion Corporation, a leading oncology drug development company, today provided an update on the progress of its pivotal ThermoDox® Phase III “HEAT” trial for the treatment of hepatocellular carcinoma (HCC), the most common form of primary liver cancer. Following recent regulatory approvals in China, Malaysia, Thailand and the Philippines, the study is now enrolling patients in eleven countries, with the majority of clinical sites located in the Asia Pacific region where HCC is most prevalent.

3 Dec 2009

Tripep receives approval to extend ChronVac-C study

Today Tripep (STO:TPEP) received the approval from the Swedish Medical Products Agency and the local ethical committee to give three patients in the highest dose group in the ChronVac-C® study one additional treatment with the therapeutic vaccine.

3 Dec 2009

More than 80 abstracts highlighting Bristol-Myers Squibb's oncology compound to be presented

Bristol-Myers Squibb Company today announced that more than 80 abstracts highlighting compounds from the company’s oncology portfolio will be presented at the 51st Annual Meeting of the American Society of Hematology (ASH) to be held December 5-8 in New Orleans.

3 Dec 2009

European Phase III clinical trial of budesonide MMX completes patient enrollment

Santarus, Inc., a specialty biopharmaceutical company, today announced that its collaboration partner, Cosmo Technologies Ltd., a subsidiary of Cosmo Pharmaceuticals SpA (SIX: COPN), has completed enrollment of 514 patients in the European Phase III clinical trial to evaluate budesonide MMX® administered over eight weeks for the induction of remission of mild or moderate active ulcerative colitis.

3 Dec 2009

Favorable initial results from Novavax' 2009 H1N1 VLP pandemic influenza vaccine Phase II study

Novavax, Inc. today reported favorable initial results from the first stage of a two-stage pivotal Phase II study evaluating the safety and immunogenicity of the company's 2009 H1N1 virus-like particle (VLP) pandemic influenza vaccine. Novavax is conducting this study in collaboration with Avimex Laboratories of Mexico to support registration of the vaccine in Mexico and potentially other countries.

2 Dec 2009

FDA grants Fast Track designation for AEterna Zentaris' perifosine

AEterna Zentaris Inc., a global biopharmaceutical company focused on endocrine therapy and oncology, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the Company's PI3K/Akt pathway inhibitor compound, perifosine (KRX-0401), for the treatment of relapsed/refractory multiple myeloma.

2 Dec 2009

Genta to supply Ganite for new CF clinical trial

Genta Incorporated announced that the Company will supply Ganite® (gallium nitrate injection) for a new clinical trial that will be initiated in patients with cystic fibrosis (CF) who may develop serious infections.

2 Dec 2009

Sepracor to present clinical study data of STEDESA at the 2009 AES meeting

Sepracor Inc. today announced that clinical study data for STEDESA™ (eslicarbazepine acetate) will be presented at the 2009 annual meeting of the American Epilepsy Society (AES) in Boston. Seven posters describing new safety analyses will be presented at the Hynes Convention Center during the formal poster session on Saturday, December 5, 2009 between 1:00 pm and 8:00 pm EST.

2 Dec 2009

New data demonstrating the strength of Novartis' hematology portfolio to be presented

Novartis announced today that new data, including a late-breaking presentation on Tasigna® (nilotinib) 200 mg capsules in a form of chronic myeloid leukemia, demonstrate the strength of the company's hematology portfolio in advancing the care of patients.

2 Dec 2009

University of Texas M.D. Anderson Cancer Center and Stemline Therapeutics enter into research collaboration

Stemline Therapeutics, Inc., a private clinical stage biopharmaceutical company and leading developer of oncology compounds directed to cancer stem cells, today announced that The University of Texas M.D. Anderson Cancer Center (Houston, TX) and Stemline have entered into a research collaboration.

2 Dec 2009

Updated results from MYTHOS clinical trial of RenalGuard presented at AHA meeting

PLC Systems Inc., a company focused on innovative cardiac and vascular medical device-based technologies, today announced that updated results from the MYTHOS investigator-sponsored clinical trial of RenalGuard(®) were presented at the American Heart Association (AHA) Scientific Sessions 2009, on Sunday, November 15 in Orlando, Florida.

2 Dec 2009

Roche announces results of phase III taspoglutide study in diabetes patients

Ipsen, an innovation-driven global specialty pharmaceutical group, today announced that its partner Roche has disclosed the results of the second and third of eight T-emerge phase III studies in patients with diabetes for taspoglutide, the first human once weekly glucagon-like peptide-1 (GLP-1) analogue originating from Ipsen’s research and developed by Roche.

2 Dec 2009

Drug Trial News

Allos Therapeutics, Idis collaborate in named patient program for FOLOTYN

Type 2 diabetics with CAD experience greater antiplatelet activity with prasugrel compared to clopidogrel

Genzyme announces reopening of enrollment in its Pompe disease ATAP program

Lightlake Therapeutics granted ethical approval for gene testing subjects in obesity treatment trial

Last patient visit complete in VIA Pharmaceuticals' Phase 2 FDG-PET trial

iCo Therapeutics to present an overview of its iCo-007 VEGF "+" agent at the ISOPT conference

Initial positive data from Amira Pharmaceuticals' Phase 1 clinical study of AM461 DP2 antagonist

Hyperion Therapeutics commences enrollment in its HPN-100 episodic hepatic encephalopathy trial

Update on Celsion's ThermoDox Phase III “HEAT” trial for HCC

Tripep receives approval to extend ChronVac-C study

More than 80 abstracts highlighting Bristol-Myers Squibb's oncology compound to be presented

European Phase III clinical trial of budesonide MMX completes patient enrollment

Favorable initial results from Novavax' 2009 H1N1 VLP pandemic influenza vaccine Phase II study

FDA grants Fast Track designation for AEterna Zentaris' perifosine

Genta to supply Ganite for new CF clinical trial

Sepracor to present clinical study data of STEDESA at the 2009 AES meeting

New data demonstrating the strength of Novartis' hematology portfolio to be presented

University of Texas M.D. Anderson Cancer Center and Stemline Therapeutics enter into research collaboration

Updated results from MYTHOS clinical trial of RenalGuard presented at AHA meeting

Roche announces results of phase III taspoglutide study in diabetes patients

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