Send to printer »

GEN News Highlights : Nov 16, 2009

Poniard’s Stock Drops Over 75% with Failed Small-Cell Lung Cancer Phase III Trial

Firm believes that drug still has partnering potential based on positive results from earlier clinical trials in other cancers.

Poniard Pharmaceuticals is reporting that picoplatin did not meet its primary endpoint of overall survival in a Phase III study as a second-line treatment of small-cell lung cancer (SCLC). The firm went from $7.58 at Friday’s close to open today at $1.86, a 75.42% fall.

The international, multicenter, randomized, controlled late-stage SPEAR study was conducted with 401 patients who were refractory to or who progressed within six months of first-line platinum-based therapy. Picoplatin administered as an intravenous infusion once every three weeks plus best supportive care (BSC) was compared to BSC alone. Other endpoints besides overall survival included overall response rate, progression-free survival, disease control rate, and duration of response.

“The data indicates that more patients on the best supportive care arm received chemotherapy following progression than those on the picoplatin arm, and we believe that this may have been a significant factor contributing to the trial outcome, as picoplatin appeared to demonstrate a trend toward a survival advantage,” according to Jerry McMahon, Ph.D., chairman and CEO of Poniard.

Picoplatin is a differentiated platinum-based chemotherapeutic agent designed to overcome platinum resistance associated with chemotherapy in solid tumors. While SCLC is the company’s lead program, Poniard is also evaluating intravenous picoplatin in Phase II trials in colorectal cancer and castration-resistant prostate cancer as well as in a Phase I cardiac safety assessment.

“We believe that the SPEAR data, coupled with efficacy and safety data from more than 1,100 cancer patients treated with picoplatin, and the proof-of-concept data from our trials in colorectal, prostate and ovarian cancers, support our continued partnering effort,” Dr. McMahon adds. “Our focus will be on the regulatory pathway for picoplatin, partnering activities, and realigning the use of resources for these objectives.”