(RTTNews) - Poniard Pharmaceuticals Inc. (PARD) is only days away from announcing the much-awaited late-stage trial results of its experimental drug Picoplatin in small cell lung cancer. The top-line results of the study dubbed SPEAR are expected to be released this month.
If trial results pan out the way they are expected, Poniard will initiate a rolling submission of a New Drug Application with the FDA for Picoplatin as a treatment for refractory or recurrent small cell lung cancer this year. The primary efficacy endpoint of the trial is overall survival. The company will also explore a potential development and commercialization partnership for Picoplatin to maximize shareholder value.
In a phase II trial of Picoplatin in small cell lung cancer, the median overall survival was 27 weeks in patients who received Picoplatin and median progression-free survival was 9 weeks. The six-month and one-year survival rates in patients administered Picoplatin were 51% and 17%, respectively.
The current medical treatments for refractory and resistant small cell lung cancer patients often include palliative best supportive care and there is no approved therapy in the U.S. for this patient population. Best supportive care has been shown previously to have a median overall survival of 14 weeks.
Picoplatin is a new generation platinum chemotherapy agent that is being studied in a variety of cancers, treatment combinations and by two routes of administration -- intravenous and capsule formulation. Picoplatin was licensed to Poniard in April 2004 by Canada-based *AnorMed. (*AnorMed was acquired by Genzyme Inc. in 2006).
The clinical trials of intravenous Picoplatin include the SPEAR trial in small cell lung cancer and two phase II trials in metastatic colorectal and hormone-refractory prostate cancers. A phase 1 clinical trial of oral Picoplatin in patients with solid tumors is also currently underway.
Poniard will also be submitting updated data from the phase II trial in colorectal cancer and the final phase I cardiac safety trial results at the AACR - NCI - EORTC Symposium to be held in Boston, November 15-19.
The upcoming phase III study of Picoplatin is a major binary event for Poniard Pharma and though investing in this stock is risky, it could be lucrative, should the trial prove successful.
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