Additional results for Picoplatin’s Phase 2 trial anticipated (Nasdaq:PARD)

Picoplatin is a type of cancer drug developed by Poniard Pharmaceuticals, Inc. (Nasdaq:PARD). On January 7, 2010, the company announced that it wanted to form a strategic partnership so that it could continue develop picoplatin for treating “solid tumor malignancies”. It also listed a series of its plans and its objectives for the year 2010. Among these, the notable plan was to show the extra data from its Phase 2 trial of the picoplatin drug on the upcoming Sunday (January 24, 2010). The presentation was held at ASCO 2010 Gastrointestinal Cancers Symposium which took place in Orlando, Fla. The Phase 2 trial was conducted to measure the effectiveness of the picoplation drug in treating patients who have been diagnosed with metastatic colorectal cancer (CRC). The trial also compared the effectiveness with that of oxaliplatin which is the drug that is presently used for first-line treatment of CRC. Overall, the trial results were very satisfactory. More information of the trial would be disclosed on or around March 5, at the ASCO GU Cancer Conference.

Earlier, in September 15, 2009, the company announced that 320 patient deaths –called “evaluable events” – have taken place in the very important Phase 3 SPEAR. The trial of SPEAR, which is the abbreviated form of “Study of Picoplatin Efficacy After Relapse” trial is done taking into account the Special Protocol Assessment (SPA) made by the United Nations of America’s one of the toughest regulators, the Food and Drug Administration (FDA). The SPEAR trial was done to measure the effectiveness of picoplatin for the second-line treatment of SCLC (i.e. small cell lung cancer).

The 320^th patient death allowed Poniard Pharmaceuticals, Inc. to start the analyzing the Phase 3 trial data for the final time. The company intended to finish analyzing the data from October to December 2009. It hoped to get favorable results from the analysis since such results would allow Poniard to submit the NDA (New Drug Application) to the FDA by 2009.

However, on November 16, 2009, the company announced that the results of the analysis of Phase 3 SPEAR trial were not satisfactory. The analysis found that an unsafe ratio of 0.82 with a p value of 0.089 was associated with picoplatin. However, Poniard did not leave its hopes after that. It contacted the FDA so that they could still find a way to develop picoplatin. And its efforts were successful – as shown by the Phase 2 trial results.

After the results were announced, Poniard’s Chief Executive Officer and also Chairman, Jerry McMahon, Ph.D. said:

“We believe that these Phase 2 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 3 study. We plan to schedule an end of Phase 2 meeting with the U.S. Food and Drug Administration to discuss these data and a potential registration strategy for picoplatin in CRC.”