Company: Pharmasset, Inc.
Initiated Phase 2b Clinical Trial of R7128, April 24, 2009
Company Comments: The trial will evaluate the dose and duration of treatment of R7128 in combination with Roche’s PEGASYS (peginterferon alfa-2a) and COPEGUS (ribavirin) – in HCV patients who have not been treated previously. The goal of adding R7128 to the existing standard therapy is to improve rates of sustained virological response (SVR) and to shorten the length of treatment for patients.
Company: TOPICA Pharmaceuticals
Begab Phase 2 Clinical Trial of Potent Antifungal, Luliconazole, in Athlete’s Foot, April 22, 2009
Company Comments: The Phase 2, multi-center, randomized, double blind, trial is evaluating the safety and optimal duration of one percent luliconazole cream administered once daily for 14 or 28 days in patients with tinea pedis.
Company: Watson Pharmaceuticals, Inc.
Watson Filed FDA Applications for Generic Mucinex, April 22, 2009
Company Comments: Watson Pharmaceuticals, Inc. confirmed that it has filed two Abbreviated New Drug Applications (ANDAs) with the U.S. Food and Drug Administration seeking approval to market its guaifenesin extended-release 600mg and 1200mg tablets and its dextromethorphan HBr/guaifenesin extended-release 30mg/600mg and 60mg/1200mg tablets prior to the expiration of patents owned by Reckitt Benckiser Inc.
Company: AcelRx Pharmaceuticals, Inc.
Initiated Phase 2 Cancer Breakthrough Pain Program, April 22, 2009
Company Comments: The primary objective of this multicenter, randomized, placebo-controlled, crossover study is assessment of safety, tolerability, and efficacy of ARX-02 relative to placebo in cancer patients experiencing episodic breakthrough pain.
BMN-110 or N-acetylgalactosamine 6-sulfatase (GALNS)
Company: BioMarin Pharmaceutical Inc.
Initiated Phase 1/2 Clinical Trial for GALNS for Morquio A Syndrome, April 21, 2009
Company Comments: The Phase 1/2 study is designed as an open-label, within-patient dose escalation trial in approximately 20 patients followed by a treatment continuation phase.
Arikace (liposomal amikacin for inhalation)
Company: Transave, Inc.
Completed Enrollment in Arikace Phase 2 Bronchiectasis Study, April 21, 2009
Company Comments: The double-blind, placebo-controlled study is designed to evaluate Arikace in non-CF patients who have bronchiectasis with Pseudomonas lung infections.
Company: Dendreon Corporation
Initiated Phase 1 Clinical Trial of Small Molecule Targeting TRPM8 in Cancer, April 21, 2009
Company Comments: The trial is an open-label, dose-escalation study evaluating the safety and pharmacokinetics of orally-administered D3263 in patients with solid tumors that are refractory to standard therapies.
Company: Circassia Ltd
Began Phase 2 Clinical Trial in Asthma Patients, April 21, 2009
Company Comments: The study will enroll 48 patients with confirmed cat allergies and cat-allergen induced asthma. The randomized, double-blind, placebo-controlled trial will study the use of a standard dose of ToleroMune administered over a number of weeks.
Company: Elusys Therapeutics, Inc.
Anthrax Anti-Toxin, Anthim, Enters Second Phase 1 Clinical Study, April 20, 2009
Company Comments: The Phase 1 dose-escalation trial is planned to enroll 45 healthy volunteers and is designed to expand the human safety database.
Company: Amira Pharmaceuticals, Inc.
Initiated Phase 1 Clinical Trial of Novel DP2 Antagonist, April 20, 2009
Company Comments: AM211 is an oral, selective antagonist of the receptor DP2, which recent studies have shown to be a potential target for the treatment of asthma, chronic obstructive pulmonary disease (COPD), and allergic rhinitis. The Phase 1 study is designed to obtain safety and proof of mechanism data for AM211.
Company: Biolex Therapeutics, Inc.
Commenced Phase 2B Trial of Locteron in Chronic Hepatitis C, April 20, 2009
Company Comments: The Phase 2b trial is being conducted in the United States and Europe in 100 treatment-naive, genotype-1, chronic hepatitis C patients. Patients will be randomized into one of four dosing cohorts, the 320, 480, or 640 g dose of Locteron (administered once every two weeks) or a control arm consisting of PEG-Intron@ (administered every week), with all patients receiving weight-based ribavirin. Patients will be treated for 48 weeks and will be followed for an additional 24 weeks to determine the sustained virologic response (SVR) rate. The interim results after 12 weeks of treatment are expected to be used as the basis for the selection of the Locteron dose(s) for Phase 3 trials.
Company: Psylin Neurosciences Inc.
Commenced Development of Compound for Depression, April 20, 2009
Company Comments: Not only has PSN0041 shown effects in multiple preclinical tests of depression, but also in preclinical tests of anxiety. The peptide has several anticipated advantages over current antidepressant medications including cognitive enhancement, weight loss, a lack of sexual side effects, and an enhanced safety and side effect profile. Psylin’s primary aim is to advance PSN0041 rapidly through early clinical development.
Company: NanoBio Corp.
Initiated FDA Approved Clinical Trial for Adjuvanted Intranasal Influenza Vaccine, April 20, 2009
Company Comments: The Phase 1 trial is a randomized, controlled study in the United States involving 120 healthy human volunteers. The primary endpoints are safety and immunogenicity as determined by neutralizing serum antibodies.
Filed Under: Drug Discovery