by Dr. Simos Simeonidis
Poniard Pharmaceuticals [1] (PARD Market Outperform) is expected to announce data from the Phase III SPEAR trial of picoplatin [2], its novel platinum compound for the treatment of several solid tumors. The trial is comparing treatment with picoplatin versus best supporting care in 400 small cell lung cancer (SCLC) patients, and we expect data sometime in early fall. We like picoplatin's chances of success in the specific setting and the specific trial, and we believe that following a successful trial, the company will be able to secure a worldwide partnership for picoplatin. In addition, we believe that it is also possible that a pharma partner could decide to acquire the whole company, since in addition to the Phase III trial in SCLC, picoplatin has shown promising results in two additional settings in oncology, with positive Phase II studies in colorectal and prostate cancer. We believe that both the announcement of positive Phase III data later this fall, and the announcement of a partnership for picoplatin, will provide significant upside to the shares from current levels, with the stock trading in the mid to high teens.
GTx [3] (GTXI Market Perform) is developing an oral compound called Toremifene, that has completed Phase III testing for the prevention of bone fractures in men with prostate cancer on androgen deprivation therapy (ADT) and has a PDUFA date of October 30, 2009. We believe there is a lot of risk around this decision, and we believe that the most likely outcome will be an approvable letter, with the requirement for additional data, or even an outright rejection. The reason behind our skepticism around this decision is that despite the fact that Toremifene has shown that it has efficacy in this setting, it does come with two significant safety considerations: the first one is the increased incidence of venous thromboembolic events (VTE), including both deep venous thrombosis and pulmonary embolism, and the second is a significant prolongation of the QT interval, which can lead to heart arrhythmias, and we believe that both safety issues will weigh heavily on reviewers' minds, especially given the fact that this is a drug intended for chronic use by men suffering from prostate cancer.
Links:
[1] http://www.fiercebiotech.com/tags/poniard-0
[2] http://www.fiercebiotech.com/story/poniard-unveils-positive-picoplatin-safety-profile/2009-05-28
[3] http://www.fiercebiotech.com/tags/gtx-0
[4] http://www.fiercebiotech.com/special-reports/five-biotechs-watch-page-2