Poniard Rally To Continue: Strong Efficacy And Safety Data From Picoplatin

Main Category: Cancer / Oncology
Also Included In: Clinical Trials / Drug Trials
Article Date: 02 Jun 2009 - 1:00 PDT

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Poniard announced positive Phase II data from its two trials in CRC and CRPC with picoplatin this morning, including efficacy that was comparable to the current standard of care, with a significantly improved safety profile. We believe that these data provide further evidence of picoplatin's favorable efficacy and safety profile in two more large oncology markets, in addition to SCLC, and position picoplatin as a platform treatment that can provide solutions in multiple oncology settings. We believe that given these data from CRC and CRPC, in addition to the anticipated Phase III SPEAR data in SCLC, will attract the interest of multiple players and we expect that Poniard will be able to at least secure a large pharma partnership sometime this summer, unless a company like Sanofi (SNY Not Rated), Takeda (TKD Not rated), or Bristol-Myers Squibb (BMY Not Rated) decide to step in and acquire the whole company, for rights to both the IV and oral version of picoplatin.

The CRC Phase II trial data.

In this randomized Phase II trial, 101 chemo-naive metastatic CRC patients treated with picoplatin in the FOLPI regimen demonstrated median PFS of 6.8 months, versus 7.0 months in patients treated with the current standard of care, oxaliplatin-containing, FOLFOX-6 regimen, while exhibiting very similar disease control (75% vs. 76% respectively). The main differentiating factor between the two treatment regimens was the reduced occurrence of neuropathy (29% in FOLPI vs. 60% in FOLFOX6), including a statistically significant difference in Grade ¾ neuropathy (0% vs. in FOLPI vs. 16% in FOLFOX6, p-value< 0.0019). We believe that these data, if they were to be replicated in a Phase III setting would make a strong case for the use of picoplatin as the preferred therapy in the front-line metastatic CRC setting, and could get significant market share away from the currently used platinum therapy, oxaliplatin. (See page 2 for a table describing these data)

The CRPC Phase II trial data.

In this Phase II trial, 32 chemo-naïve CRPC patients treated with picoplatin in combination with docetaxel and prednisone, showed a 78% rate of PSA response, versus the 45% observed in the TAX-327 arm of q3w docetaxel. In addition, median PFS was 8.5 months, and 58% of the patients achieved disease control. On the safety front, there was no neurotoxicity observed, in contrast to what was observed in TAX-327, with 30% neuropathy, including 2% severe neuropathy. (See page 3 for a table describing these data)

When and where can investors see these data?

Poniard will present data at ASCO from these two Phase II trials testing A) picoplatin plus docetaxel/prednisone in patients with metastatic castration-resistant (hormone-refractory) prostate cancer (CRPC) (Abstract # 5140) on Sunday, May 31st (2-6pm ET, Level 2, West Hall C) and B) picoplatin plus 5-FU/leucovorin in patients with metastatic colorectal cancer (CRC) (Abstract # 4026) on Monday, June 1 (Poster session 8am-12pm ET, Level 2, W240A, with a discussion of the poster scheduled from 11:30 a.m. to 11:45 a.m. in West Hall E1, Level 2).

Source
Poniard

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