Shares of a cash-strapped Poniard Pharmaceuticals (PARD) took a pounding this morning as investors reacted to the news that its cancer therapy picoplatin demonstrated a lower overall survival rate for colorectal cancer patients when compared to a standard combination treatment in a mid-stage trial. And the 21 percent share price slip occurred despite the fact that the therapy hit its primary endpoint in the clinical trial.
Researchers said that picoplatin combined with 5-fluorouracil and leucovorin demonstrated a statistically significant reduction of neurotoxicity when compared with oxaliplatin and the same combo drugs. The problem, from investors' perspective, was that picoplatin showed overall survival of 13.6 months compared to 15.6 months for the comparison therapy. And that set off a number of alarm bells among analysts tracking the company.
"While it is a small study and data are clearly not conclusive, we believe it does increase the risk of a non-inferiority late-stage trial," Leerink Swann analyst Howard Liang said in a note to clients. "Continued development of picoplatin is dependent on successfully finding a partner as Poniard only has cash through mid-2010 and appears unlikely to be able to obtain financing to fund what could be expensive late-stage development."
The company, though, concentrated on the positive.
"We believe that these Phase II data confirm picoplatin's potential as an alternative to oxaliplatin in the first-line treatment of metastatic CRC and will support the design of a Phase III study," said Jerry McMahon, Ph.D., chairman and CEO of Poniard. "We plan to schedule an end of Phase II meeting with the U.S. Food and Drug Administration to discuss these data and a potential registration strategy for picoplatin in CRC. Our ultimate goal is to secure a strategic partnership to support further development of picoplatin in CRC and other solid tumor indications, including prostate and ovarian cancers."
- here's the press release on the study
- check out the Reuters story