Takeda to investigate interactions of anticlotting drugs, PPIs in GERD

   

By Alaric DeArment

DEERFIELD, Ill. (Feb. 9) A research and development arm of Japanese drug maker Takeda has started a clinical trial to investigate potential interactions between a popular cardiovascular drug and drugs used to treat gastroesophageal reflux disease.

Takeda Global Research & Development Center announced Tuesday that it was evaluating published data and communications from the Food and Drug Administration regarding potentially harmful drug interactions associated with use of the anticlotting drug Plavix (clopidogrel), made by Sanofi-Aventis and Bristol-Myers Squibb, and certain proton-pump inhibitors, particularly its drug Kapidex (dexlansoprazole).

The FDA recommended that patients using Plavix avoid taking certain PPIs, especially AstraZeneca’s Prilosec (omeprazole) and Nexium (esomaprazole), after studies showed that the drugs inhibited a certain liver enzyme that Plavix requires to function, thus reducing Plavix’s effectiveness. The effect of other PPIs, such as Kapidex, on the effectiveness of Plavix remains uncertain.

The trial is enrolling patients and is expected to be finished this year, Takeda said.

Amgen's prostate cancer drug more effective than competitor, study concludes

   

By Alaric DeArment

THOUSAND OAKS, Calif. (Feb. 9) An investigational drug made by Amgen for treating prostate cancer that had spread to the bones worked better than an existing drug made by Novartis, according to late-stage clinical trial results that Amgen announced Monday.

Amgen was comparing denosumab with Novartis’ Zometa (zoledronic acid) in a phase 3 trial of 1,901 patients with prostate cancer. The biotech company said the drug, a monoclonal antibody, worked better in delaying the amount of time it took for patients to suffer bone complications, while adverse side effects occurred at similar rates. The trial is one of three involving a total of more than 5,700 cancer patients.

“These phase 3 results demonstrate the ability of denosumab to delay bone complications in patients suffering from metastatic prostate cancer,” Amgen EVP research and development Roger Perlmutter stated. “Denosumab has shown remarkable consistency in reducing the serious complications of bone metastases.”

Cornerstone moves drug testing site for investigational cancer treatment

   

By Alaric DeArment

CRANBURY, N.J. (Feb. 8) Early- and mid-stage clinical trials of an investigational drug for treating cancer have a new testing site, the drug’s developer said Monday.

Privately owned drug maker Cornerstone Pharmaceuticals announced that the phase 1 and phase 2 trials of the drug CPI-613 would include a site owned by Pivotal Research Centers in Peoria, Ariz. CPI-613 is part of a new drug class developed using Cornerstone’s Altered Energy Metabolism Directed technology platform designed to target metabolic changes that may be common to many cancer types. The Food and Drug Administration has given the drug orphan drug status for pancreatic cancer.

“This is a very significant development for our company as we expand the clinical trials of CPI-613 and continue to partner with institutions that share our vision of helping people to better manage their affliction,” Cornerstone CEO Robert Shorr said.