More details on PARD developments:
1) Poinard will present additional data from the company's Phase 2 trial evaluating picoplatin in patients with metastatic colorectal cancer (CRC) on January 24, 2010 at the ASCO 2010 Gastrointestinal Cancers Symposium in Orlando, Fla. This trial is evaluating picoplatin as a neuropathy-sparing agent compared to oxaliplatin (the current standard of care) in the first-line treatment of patients with metastatic colorectal cancer (CRC). The trial is comparing the safety, including the incidence and severity of neuropathy, and efficacy, measured by overall survival, progression-free survival and disease control. Poniard’s inclusion of picoplatin is called the FOLPI regimen, in contrast to the current standard of care regimen called the FOLFOX regimen. Past data already shown at previous conferences have shown a statistically significant reduction in neurotoxicities with the use of picoplatin in Poinard’s FOLPI regimen compared to the standard of care FOLFOX regimen, while maintaining similar anti-tumor activity as assessed by progression-free survival (PFS) and disease control.
2) Poiniard will also present additional data from the company's Phase 2 trial of picoplatin in patients with metastatic hormone-resistant prostate cancer (CRPC) at the ASCO 2010 Genitourinary Cancers Symposium on March 5, 2010 in San Francisco. This study is evaluating the efficacy and safety of picoplatin as a first-line treatment in patients with metastatic CRPC. The primary endpoint of the study is Prostate-specific antigen (PSA) response (defined as a PSA reduction of at least 50 percent from baseline for 4 weeks). Secondary endpoints include safety, disease control, time to progression and overall survival. Past data already shown at previous conferences show that picoplatin, in combination with docetaxel and prednisone, shows promising efficacy and is well tolerated as first-line therapy for metastatic CRPC. This promising efficacy is assessed by several endpoints, including reductions in PSA levels, disease control, and PFS. In addition, no neurotoxicity has been observed.
3) Shortsqueeze.com reports a 24.6% short interest of over 8 million shares of PARD stock (34 million outstanding shares total), with over 4 days to cover at average volume. Interestingly, this is 3 million less short shares than the prior period. This data, combined with the recent 30% increase in share volume and price from its recent lows, suggests that shorts who took advantage of the failed phase III trial results in November are just beginning to cover now. Certainly a continued rally, based on the upcoming PARD events, would cause panic for shorts. With 4 days to cover, this is a set up for a short squeeze which could send the stock soaring.
4) PARD intends to work with the FDA to determine how to use the data from the Phase 3 SPEAR trial. Little progress has been made in advancing therapy for metastatic stage SCLC, with the current standard of care relying on platinum based chemotherapy. The SPEAR evaluated the efficacy and safety of picoplatin as second-line therapy (after patients failed the first therapy) in 401 cancer patients with SCLC. While the study did not meet the primary endpoint of overall survival, PARD states that the data suggests a potential trend toward survival which may yet provide a path forward. The large data set from this phase III study allows for closer examination of its enhanced safety profile (decreased kidney and nerve toxicity with no cardiac toxicity). The results from the ongoing Phase 2 studies in colon and prostate continue to suggest that picoplatin could be superior to existing platinum therapies as a neuropathy-sparing alternative. A closer examination of the SPEAR data may give PARD sufficient evidence to convince the FDA to allow a new Special Protocol Assessment (SPA) for a new trial patients utilizing equivalent efficacy with enhanced safety for picoplatin over existing therapies in SCLC.
5) Existing platinum therapy must be administered intravenously. In addition to considerable difficulty for patients, IV administration causes significant cost burden. Eliminating IV therapies where an oral form of the drug is preferred, especially in light of the considerable cost-cutting efforts being made in health care. Poinard has developed an oral formulation for picoplatin which they have demonstrated to deliver a dose with a sufficient pharmacokinetic profile as IV administration. This oral form opens new doors for picoplatin to be combined with the multiple oral anti-cancer agents coming to market.
6) The current market size for platinum based chemotherapy drugs in the US is about $4 billion. The currently used platinum drugs are Cisplatin (Platinol®) in cancers of the ovaries, bladder, head, and neck; Carboplatin (Paraplatin®) as a second-generation anti-cancer platinum drug; and Oxaliplatin (Eloxatin®), the most recent third generation platinum drug, which was approved by the FDA in August 2002. Picoplatin seeks to replace Oxaliplatin indications. Oxaliplatin is used in combination with other chemotherapy drugs for many indications including small cell lung, colorectal, and prostate cancers. PARD is seeking these indications for picoplatin, but is also seeking to partnerships with other larger pharmaceutical companies who may wish to include platinum drugs with their novel therapies. Indeed, the latest targeted cancer drugs such as Gleevec, Sprycel, Herceptin, Avastin, Tarceva, and others are currently used or are seeking to be used in combination with platinum drugs. With its current cash position, PARD should be able to complete phase III trials for picoplatin in prostate and colorectal cancer. This could be expedited by partnership.
7) With the surprise outcome of the SPEAR trial, PARD dropped from its $8-$9 trading range to a low of $1.60. It bounced back to close to $3 just days later, followed by a slow sell off to the low $2 range. This selloff continued through December into the $1.80 range. When PARD released their corporate outlook the stock saw a modest jump to the low $2 range where However, the TA of PARD is an interesting case. As might be expected, the accum/dist line of PARD dropped significantly upon release of the SPEAR news (-5M shares) on massive (14M) volume, but quickly turned up in the days following (+5M shares) on high volume as traders bought the stock for a quick “bounce play” as the stock rose from its bottom of $1.60 to the $2.80 range. As might also be expected, the accum/dist line dipped again to its lows (-5M shares) on high volume in the days following as the traders exited; but the stock price did not see its lows again and regained much of its accumulation. After some volatility, the stock began to settle back in the $2.25 range, but faced a long slow sell off into years end. We interpret this activity as normal volatility after big news; followed by year-end tax loss selling. As well, apart from the expected shorting and covering, there has been strong overall accumulation of the shares by investors, even in the face of massive short selling, realizing the longer term potential in PARD. Since the beginning of the year, the MACD and accum/dist line have turned positive, with the EMA (30) showing several breakout signals. In the last few days, all of these indicators as well as the MFI and ADI showing a spike into strongly bullish territory; with the ADX rising close to 40, confirming the trend. An ADX value of 50 is a confirmation that would signal another technical breakout of the stock, and we are almost there.
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