CytRx Technical Breakout on Pending News (NASDAQ:CYTR)
Miv Investments Inc. has initiated an independent bullish technical trading alert for 11/23/09 on CytRx Corporation (NASDAQ:CYTR). Shares of the company finished trading during 11/20/09 at $1.14 per share. As of 11/18/09, the biopharmaceutical company announced plans to initiate an open-label, multinational Phase 2 clinical trial with its doxorubicin prodrug INNO-206 as a second-line treatment in patients with advanced gastric (stomach) cancer.
CytRx President and CEO Steven A. Kriegsman said, “This planned clinical trial is a key step forward in our plans to build a commercial oncology franchise for CytRx. We have studied the oncology market in solid tumors and believe that stomach cancer represents a major market and an unmet medical problem worldwide. We have also been encouraged by exciting animal data for INNO-206 in a broad array of cancer indications, and are hopeful that this carefully-designed study will bring hope to the sufferers of advanced gastric cancer.”Rumours are also swirling that a biopharma news-portal contacted the company, and news is pending on what could be a turning point for shareholders. An announcement could come as early as this week, many investors have long been awaiting news on the Tamibarotene, Acute Promyelocytic Leukemia pivotal phase II trial.
About CytRx Corporation
Product Pipeline
CytRx Corporation’s oncology pipeline includes three clinical-stage drug candidates in various stages of development, including:
Tamibarotene (formerly known as TM-411, TOS-80T, Am-80, and INNO-507) is an orally available, rationally designed, synthetic retinoid compound which was designed to potentially avoid toxic side effects by binding to its molecular target more selectively than all trans-retinoic acid (ATRA), the current first line treatment for APL. There is a Special Protocol Assessment (SPA) in place with the FDA for a Phase 2 registration clinical trial, known as STAR-1, which is evaluating the efficacy and safety of tamibarotene as a third-line treatment for APL. The STAR-1 trial is ongoing and currently includes seven clinical sites in the U.S. CytRx recently reported that, of the 11 patients enrolled in the STAR-1 trial to date, 5 patients, or 45%, achieved a morphologic leukemia-free state, or MLFS. Of those, two patients have achieved durable complete response and one has achieved morphologic leukemia-free state, or MLFS, but withdrew from the trial to receive a bone marrow transplant before the durable complete response could be confirmed. One patient achieved a complete response, but did not maintain MLFS for the required 28 days to be considered a durable complete response. Another patient achieved a durable MLFS, but did not have the necessary increases in blood cells to be considered a durable complete response. CytRx holds the North American and European rights to tamibarotene as a treatment for APL.
The FDA has granted Orphan Drug Designation for APL and Fast Track Designation for the use of tamibarotene in patients with relapsed or refractory APL following treatment with all-trans retinoic acid (ATRA) and arsenic trioxide. In addition, tamibarotene has been granted orphan medicinal product status by the European Medicines Agency for the treatment of APL. The efficacy of orally-administered tamibarotene was demonstrated in two Phase 2 studies conducted in Japan in a total of 63 Japanese subjects with APL. The overall complete response rate in these subjects was 60%. In subjects experiencing their first relapse, the overall complete response rate was 81%.
APL is diagnosed in approximately 1,500 new patients in the United States annually. The near-term market opportunity for CytRx’s tamibarotene in refractory APL in the U.S. alone is estimated to approach $20 million per year – with the market opportunity for an expanded label including refractory, maintenance and front-line therapy increasing to $150 million in potential recurring revenue in the U.S. and Europe. There are currently no approved third-line treatment options for refractory APL patients.
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