RxTrials Institute Drug Pipeline Alert

Pharmaxis’ Bronchitol, in late-stage development for bronchiectasis and cystic fibrosis, is safe and well tolerated after 12 months of use, according to recent Phase III study results.

Bayer HealthCare and Onyx Pharmaceuticals are enrolling patients in a Phase III trial of Nexavar for people with hepatocellular carcinoma.

NovaRx has begun its pivotal Phase III clinical trial of Lucanix for the treatment of advanced nonsmall cell lung cancer (NSCLC).

Patients taking Eli Lilly and Daiichi Sankyo’s anti-platelet drug prasugrel were 35 percent less likely to have a second cardiovascular event than those who took Bristol-Myers Squibb and Sanofi-Aventis’ blockbuster Plavix, according to Phase III data published in advance online in the European Heart Journal.

Biogen has started a Phase III clinical trial of intravenous Adentri, an adenosine A1 receptor antagonist, for acute decompensated heart failure (ADHF) patients with renal insufficiency.

OncoGenex Pharmaceuticals’ OGX-011 in combination with docetaxel has received fast-track designation from the FDA for progressive metastatic prostate cancer.

The Hong Kong Department of Health cleared Chemokine Therapeutics to begin a Phase II trial in liver cancer with its lead drug candidate, CTCE-9908.

Despite its early termination, a Phase IIb study yielded positive outcomes in studying ARYx Therapeutics’ prokinetic agent ATI-7505 in patients with chronic idiopathic constipation.

A Phase II trial from Pfizer and its partner NicOx failed to meet its primary endpoint in studying PF‑03187207 in patients with primary open-angle glaucoma or ocular hypertension.

Oxygen Biotherapeutics will meet with the FDA to discuss two remaining issues about the use of Oxycyte in a proposed Phase IIb clinical trial in traumatic brain injury.

Resverlogix has begun its Phase Ib/IIa trial with RVX-208 for the treatment of atherosclerosis.

Using its cancer treatment ofatumumab, Genmab will start a Phase I trial in Japan for patients with follicular non-Hodgkin’s lymphoma (NHL) and chronic lymphocytic leukemia (CLL).

Aveo Pharmaceuticals is initiating a Phase Ib clinical trial of AV-951 for the treatment of gastrointestinal cancers.

The Multiple Myeloma Research Consortium and its partner Celgene have begun a Phase I/II trial with CC-4047 in patients who have received at least two prior therapies, including treatments with Revlimid and Velcade.

The nonprofit Academy of Pharmaceutical Physicians and Investigators has joined the Clinical Trials Transformation Initiative (CTTI), a partnership between the FDA and Duke University established last year to modernize clinical trials.