Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA; TASE: TEVA) and OncoGenex Pharmaceuticals, Inc. (Nasdaq: OGXI) have expanded their Phase III clinical trial of Custirsen for the treatment for castrate-resistant prostate cancer. The trial will now examine whether the drug can improve survival rates for prostate cancer patients when combined with the recently-approved, second-line chemotherapy drug Jevtana.
The new trial will enroll 630 men and is due to begin later this year. It will replace the Prostate Cancer Saturn Study, whose primary endpoint was to measure the easing of durable pain of custirsen in second-line treatment of castrate-resistant prostate cancer. The companies changed the focus of the trial to evaluate overall survival in second-line prostate cancer after the approval of several new drugs that have redefined the standard of care for the disease.
Teva Global Branded Products SVP Lesley Russell said, “The amendments made to the Phase 3 program reflect the rapidly-evolving castrate-resistant prostate cancer landscape and our commitment to ensure custirsen data are aligned with requirements to demonstrate improvements in survival across the treatment continuum. Developing custirsen for patients suffering from advanced prostate cancer remains a top priority within the Teva Oncology product-line and we believe this new trial is a reflection of that commitment."
Teva and OncoGenex are continuing the Phase III trial of Custirsen as a first-line treatment for castrate-resistant prostate cancer to test the survival of patients. They have increased the number of patients in the trial from 800 to 1,000 in order to optimize the potential to be submitted to regulatory agencies independent of additional Phase III studies.
In a separate development Teva Respiratory has obtained US Food and Drug Administration (FDA) for ProAir HFA with a dose counter for use in patients aged four and older for the treatment or prevention of bronchospasm with reversible obstructive airway disease and for the prevention of exercise-induced bronchospasm (EIB). The dose counter is designed to help patients and their caregivers keep track of the number of doses remaining in the canister. The new product will be commercially available later in the year.
The FDA approved ProAir HFA in October 2004 for adults and children older than 12 years, and extended approval for patients aged four and up in September 2008.
Teva's share price fell 0.4% in morning trading on the TASE today to NIS 170.80, after rising 0.3% on Nasdaq on Friday to $44.92, giving a market cap of $42.3 billion.
Published by Globes [online], Israel business news - www.globes-online.com - on March 11, 2012
© Copyright of Globes Publisher Itonut (1983) Ltd. 2012