 
 |
|
Debiopharm starts phase IIb study after record time patient randomisation
Date: April 30, 2009
Client: Debiopharm Group
Summary: Lausanne, Switzerland - Debiopharm Group (Debiopharm), a global biopharmaceutical development specialist that focuses on serious medical conditions, particularly in the field of oncology, announced that on April 7, 2009 the last patient was randomised to take part in a phase IIb clinical study with Debio 025, a selective cyclophilin (Cyp) inhibitor with a potent anti-hepatitis C (HCV) effect. In a record time of three months, a total of 290 patients were randomised in seven countries, including Poland, Germany, Belgium, France, Spain, Italy and Romania. This double-blind, placebo-controlled, parallel-group study will investigate the efficacy and safety of three different treatment regimens combining Debio 025 with Peg interferon alpha 2a (peg-IFNα2a) and ribavirin in treatment naïve chronic HCV genotype 1 patients.
|
|
|
|
 |
|
Cougar Biotechnology Initiates Phase III Trial of CB7630 (Abiraterone Acetate) in Chemotherapy-Naïve Castration-Resistant Prostate Cancer Patients
Date: April 29, 2009
Client: Cougar Biotechnology
Summary: Los Angeles, CA - Cougar Biotechnology, Inc. (NASDAQ: CGRB) today announced the initiation of a Phase III clinical trial (COU-AA-302) of its lead drug candidate CB7630 (abiraterone acetate) in patients with chemotherapy-naïve castration-resistant prostate cancer (CRPC). The COU-AA-302 Phase III trial is a randomized, double-blind, placebo-controlled trial of CB7630 plus prednisone in patients with metastatic CRPC who have not yet received treatment with chemotherapy. The trial is expected to enroll approximately 1,000 patients who will be randomized (1:1) to receive either CB7630 plus prednisone or placebo plus prednisone. The trial will be conducted at approximately 150 sites in North America, Europe and Australia.
|
|
|
|
|
|
|
Debiopharm presents promising phase IIa results showing potent antiviral activity
Date: April 28, 2009
Client: Debiopharm Group
Summary: Lausanne, Switzerland - Debiopharm Group (Debiopharm), a global biopharmaceutical development specialist that focuses on serious medical conditions, particularly in the field of oncology, presented results from a phase IIa study with Debio 025, a selective cyclophilin (Cyp) inhibitor with a potent anti-hepatitis C (HCV) effect. Revealed at the 44th Annual Meeting of the European Association for the Study of the Liver, in Copenhagen, these findings showed potent antiviral activity.
|
|
|
|
 |
|
Ardea Biosciences and Bayer HealthCare Enter into Global Agreement Focused on the Development of MEK Inhibitors for the Treatment of Cancer
Date: April 28, 2009
Client: Ardea
Summary: SAN DIEGO--(BUSINESS WIRE)- Ardea Biosciences, Inc. (Nasdaq:RDEA) today announced that it has entered into a global agreement with Bayer HealthCare focused on the development of small molecule mitogen-activated ERK kinase (MEK)inhibitors for the treatment of cancer. The lead compound in this program, RDEA119, is currently being evaluated in advanced cancer patients as a single agent in a Phase 1 study and in a Phase 1/2 study in combination with sorafenib (Nexavar®, Onyx Pharmaceuticals, Bayer HealthCare).
|
|
|
|
 |
|
Prostate Cancer Drugs Get Street's Attention - Dendreon skyrockets on Provenge news; Cougar shares also push higher - Peter Benesh
Date: April 27, 2009
Client: Cougar Biotechnology
Summary: When your stock price rises fivefold in less than a month - including a one-day climb of more than 200% - you tend to draw some attention. That's what's happening at Dendreon, a developer of anti-cancer drugs. Dendreon isn't the only developer of prostate cancer drugs to gain favor on Wall Street lately. Cougar Biotechnology have risen more than 55% since early March. Cougar's abiraterone, an oral drug, is about to start Phase three trials. It's intended to help men with advanced cancer that persists after other treatments.
|
|
|
|
 |
|
GlobeImmune’s Tarmogen Cuts HCV Viral Loads in Phase II Trial
Date: April 27, 2009
Client: GlobeImmune
Summary: The European Association of the Study of the Liver (EASL) annual meeting in Copenhagen, Denmark, continued Friday, with GlobeImmune Inc. reporting interim 12-week, Phase II data showing that its Tarmogen drug GI-5005, when combined with the standard-of-care treatment for hepatitis C virus, resulted in a 94 percent early virologic response rate in treatment-naïve patients.
|
|
|
|
 |
|
Helix BioPharma to Present at the BioFinance 2009 Conference
Date: April 24, 2009
Client: Helix BioPharma
Summary: AURORA, Ontario, April 24 /PRNewswire/ -- Helix BioPharma Corp. (TSX, FSE: "HBP") today announced that John Docherty, president and chief operating officer, will present at the BioFinance 2009 Investor Conference at 3:00 p.m. EDT on Wednesday, April 29, at The Toronto Marriott in Toronto. Mr. Docherty will provide an overview of the company's leading technology platforms, DOS47 and Biphasix(TM), and its current product development programs, L-DOS47 and Topical Interferon Alpha-2b. The slide show portion of the presentation will be posted on the Company's website, www.helixbiopharma.com, on April 29, 2009.
|
|
|
|
 |
|
GlobeImmune's Hepatitis C Therapeutic Vaccine, GI-5005, Improves EVR Rates to 94 Percent in Phase 2 Clinical Trial
Date: April 23, 2009
Client: GlobeImmune
Summary: LOUISVILLE, CO - Twelve-week Phase 2 clinical trial data show that patients treated with GI-5005, GlobeImmune's targeted molecular immunogen (Tarmogen®) for the treatment of hepatitis C virus infection, had 94 percent early virologic response (EVR) rate in treatment naïve patients. The study compared GI-5005 plus standard of care (SOC) -- pegylated interferon and ribavirin -- versus SOC alone in patients with chronic genotype 1 hepatitis C infection.
|
|
|
|
 |
|
ANA598 Demonstrates Potent Antiviral Activity at all Dose Levels in Completed Phase Ib Study in Hepatitis C Patients
Date: April 23, 2009
Client: Anadys Pharmaceuticals
Summary: SAN DIEGO - Anadys Pharmaceuticals, Inc. (Nasdaq: ANDS) today announced that ANA598, the Company's investigational non-nucleoside polymerase inhibitor, demonstrated potent antiviral activity at all dose levels and was well tolerated in a Phase Ib study in which patients chronically infected with the Hepatitis C virus (HCV) were treated for three days. The results from the recently completed study are being presented today during the late-breaker poster session at the 44th Annual Meeting of the European Association for the Study of the Liver (EASL) in Copenhagen, Denmark.
|
|
|
|
 |
|
febit Receives European Patent for Gene Extraction Procedure
Date: April 22, 2009
Client: febit
Summary: LEXINGTON, Mass. (USA), and HEIDELBERG - febit holding gmbh announced today that the company has been granted the first European patent (EP1436609) for a microarray-based nucleic acid extraction procedure. In conjunction with the US patent US7320862, febit now holds a unique patent position in the dynamic market of sample preparation for second-generation sequencers.
|
|
|
|
|
|
|
New Compound Spots Heart Attack Damage - Peter Benesh
Date: April 17, 2009
Client: Molecular Insight
Summary: For heart attack victims, minutes equal muscle. The longer it takes to determine that a patient has had a heart attack, the more the person's heart muscle will deteriorate, says John Babich, founder of Molecular Insight Pharmaceuticals (MIPI) . And the longer it takes to determine that a heart attack has occurred, the more time, technology and money will be spent on a patient who may have nothing more than indigestion. That's the dilemma Molecular Insight aims to solve with Zemiva, an injected, radioactive compound that shows changes in the heart caused by reduced blood flow.
|
|
|
|
|
|
|
GlobeImmune Initiates Phase 1 Clinical Trial with NCI in CEA Over-expressing Cancers
Date: April 16, 2009
Client: GlobeImmune
Summary: LOUISVILLE, CO - GlobeImmune, Inc. today announced the initiation of a Phase 1 clinical trial to investigate the safety and tolerability of a new Tarmogen, GI-6207, in patients with metastatic cancers that over-express carcinoembryonic antigen (CEA). This is the third new Tarmogen® product candidate to enter human clinical trials over the last four years. James L. Gulley, M.D., Ph.D., F.A.C.P., Director of the Clinical Trials Group LTIB at the National Cancer Institute (NCI), will be the Principal Investigator for the study. This will be a single center Phase 1 study funded by the NCI.
|
|
|
|
|
|
|
Paul Keim Appointed to febit’s Scientific Advisory Board
Date: April 14, 2009
Client: febit
Summary: LEXINGTON, Mass. (USA), and HEIDELBERG, Germany – febit today announced the recruitment of Paul Keim, Ph.D., for its Scientific Advisory Board. Dr. Keim is Senior Investigator and Director of the Pathogen Genomics Division at TGen (The Translational Genomics Research Institute) in Phoenix, Ariz., and Regents Prof. of Biology at the Northern Arizona University. As an expert in the field of medical microbiology, biosecurity and the genomics of pathogens he brings deep knowledge from these fields to febit.
|
|
|
|
 |
|
Cohera Medical Names William M. Cotter as Company’s First Vice President of Manufacturing
Date: April 7, 2009
Client: Cohera
Summary: PITTSBURGH, PA – Cohera Medical Inc. today named William M. Cotter to the newly created position of vice president of manufacturing. The addition of Cotter, who has over 29 years of manufacturing and operations experience in the medical device, diagnostics, biologics and life science industries, comes at a time when Cohera Medical is preparing to enter the clinical stage of development with its lead surgical adhesive product, TissuGlu®.
|
|
|
|
 |
|
Aerovance Secures $38 Million in Equity Financing
Date: April 7, 2009
Client: Aerovance
Summary: BERKELEY, Calif. – Aerovance Inc. today announced that it has secured $38 million in additional equity financing. In previous transactions since formation in 2004, the company has raised $92 million in equity financing and $10 million in debt financing. This financing round, which consists of two tranches, was led by new investor ProQuest Investments and includes the full pro rata participation of existing investors Apax Partners, Clarus Ventures, Alta Partners, Lehman Brothers, NGN Capital and Burrill & Co., as well as that of new investor BB Biotech Ventures. Aerovance closed on $20 million and has the right to call the remaining $18 million after six months.
|
|
|
|
|
