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Synta - Exploring Galaxy And Beyond


Shares of Synta Pharmaceuticals Corp. (SNTA) have lost more than 14 percent of their value year-to-date and hover around $4. The company's lead drug candidate is Ganetespib, an Hsp90 inhibitor, which is currently being studied in over 20 cancer trials. As Synta continues to move forward with the clinical development of its pipeline, a number of milestones are in the offing, making this stock worth keeping on the watch list.

For readers who are new to the Lexington, Massachusetts-based Synta, here's what to expect in the coming months...

The lead drug candidate Ganetespib has demonstrated clear evidence of clinical activity, including prolonged tumor shrinkage in patients, according to Synta. The most advanced trial with Ganetespib, dubbed GALAXY, is evaluating the compound's potential in the treatment of advanced non small cell lung cancer.

The GALAXY is a phase 2b/3 study of Ganetespib in combination with chemotherapy drug Docetaxel versus Docetaxel alone in patients with stage IIIb or IV non-small cell lung cancer. The trial, designed to enroll 240 patients, was initiated last July.

The phase 2b portion of the trial will assess efficacy as measured by progression-free survival with co-primary endpoints for the ITT (intent to treat) population and the subpopulation with a mutation in the KRAS gene. The interim results from the phase 2b portion of the trial, including landmark progression-free survival, response rate, and disease control rates are expected this quarter (2Q). The final progression-free survival results, as well as overall survival results from the phase 2b part, are expected in the second half of 2012.

The phase 3 portion of the GALAXY trial is expected to be initiated in the second half of 2012.

Earlier in the month, with funding from Multiple Myeloma Research Foundation, Synta initiated a phase I trial of Ganetespib as a single agent and in combination with Takeda Pharma's chemotherapy drug Velcade for the treatment of relapsed multiple myeloma.

Synta is currently initiating a global clinical trial with Ganetespib as monotherapy in patients with advanced non-small cell lung cancer whose tumors show an ALK gene rearrangement, previously untreated with ALK inhibitors, and a global clinical trial in patients with breast cancer whose tumors show either a HER2+ or triple-negative genetic profile.

The preliminary results from the two trials are expected by this year-end.

In addition, a number of phase 2 trials evaluating Ganetespib as a potential treatment for ocular melanoma, gastric cancer, pancreatic cancer, prostate cancer and melanoma are ongoing.

The other investigational compounds of Synta include, Elesclomol under a phase 2 study for ovarian cancer and under a phase I trial for acute myeloid leukemia; STA-9584 under preclinical development for prostate cancer and CRACM channel inhibitors, also under preclinical testing for chronic inflammatory diseases and transplant rejection.

A quick look at the company's balance sheet...

Since commencing operations in July 2001, the company has incurred significant operating losses and, as of December 31, 2011, had an accumulated deficit of $398.4 million.

The company earlier had collaborative research and development agreements with Roche for its CRACM inhibitor program, and with GlaxoSmithKline for Elesclomol. While the agreement with GlaxoSmithKline was terminated in September 2009, the collaboration with Roche was terminated in February 16, 2012. Now, all the clinical and preclinical programs of Synta are 100% self-owned, and the company is engaged in multiple preliminary partnership discussions for the development of its compounds.

In 2011, Synta's annual loss widened to $47.4 million or $1.00 per share from $37.5 million or $0.93 per share for in 2010. Total revenue in 2011 was $7.6 million compared to $14.8 million for the same period in 2010.

The company ended 2011 with $39.7 million in cash on hand.

Synta went public in February 2007, offering its shares at $10 each. Earlier this year, the company made a public offering of its stock at $4.40 each. Over the past 1 year, the stock has traded in a range of $3.02 and $6.27.

by RTTNews Staff Writer

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