Synta Pharmaceuticals Corp. (NASDAQ: SNTA), a biopharmaceutical company focused on discovering, developing, and commercializing small molecule drugs to treat severe medical conditions, today reported financial results for the quarter ended June 30, 2010.
“We are now in discussions with a number of investigators and cooperative groups, based on the recent data, regarding additional elesclomol trials. We expect to initiate at least one additional trial in a solid tumor cancer by the first half of 2011.”
The Company reported a net loss of $9.1 million or $0.22 per basic and diluted share for the second quarter in 2010, compared to a net loss of $8.5 million, or $0.25 per basic and diluted share for the same period in 2009. Total collaboration revenue was $3.4 million for the second quarter in 2010 compared to total collaboration revenue of $4.7 million for the same period in 2009. Research and development expenses were $9.7 million for the second quarter in 2010 compared to $10.1 million for the same period in 2009. General and administrative expenses were $2.7 million for the second quarter in 2010 compared to $3.0 million for the same period in 2009. As of June 30, 2010, the Company had $48.7 million in cash, cash equivalents and marketable securities compared to $44.2 million as of December 31, 2009.
More detailed financial information and analysis may be found in the Company’s Quarterly Report on Form 10-Q, which was filed with the Securities and Exchange Commission on August 9, 2010.
“We have made strong progress with STA-9090, our potent, second-generation, small-molecule Hsp90 inhibitor,” said Safi R. Bahcall, Ph.D., President and Chief Executive Officer, Synta Pharmaceuticals. “Over 200 patients have been treated across our eight ongoing trials and three recently initiated trials. STA-9090 has been well-tolerated, without the serious liver toxicities seen with first-generation Hsp90 inhibitors or the commonly occurring ocular toxicities seen with certain second-generation compounds. At these dose levels, we have seen encouraging signs of single-agent activity, including confirmed responses and tumor shrinkage with durable disease control.”
“The differentiated safety and activity profile, and broad potential application of Hsp90 inhibition, have generated a high level of interest in our program,” said Dr. Bahcall. “Investigator-sponsored trials have recently been initiated in hepatocellular carcinoma (HCC) and small cell lung cancer (SCLC). In addition, in July we initiated a Phase 1 trial of STA-9090 in combination with docetaxel in tumors where docetaxel is commonly used, including breast cancer, prostate cancer, and lung cancer. The new and ongoing trials form a thorough clinical development program that will provide a strong indication of the activity profile of STA-9090, as results from these trials are presented over the coming year.”
STA-9090 is currently being studied in 11 clinical trials with an additional four or more trials expected to be announced in the coming months. The ongoing studies include four Phase 1 trials, three in solid tumors (once- and twice-weekly dosing and docetaxel combination) and one in hematologic cancers (once-weekly); a Phase 1/2 trial in acute myeloid leukemia (AML) and other hematologic cancers; and six Phase 2 trials in a range of solid tumor malignancies.
Dr. Bahcall also announced that two clinical trials of elesclomol, a first-in-class, investigational drug candidate that triggers apoptosis (programmed cell death) in cancer cells, are expected to be initiated, one in Q4 2010 and one by the first half of 2011.
“Recent progress by Synta and our collaborators have led to further understanding of elesclomol’s unique mechanism of action – targeting mitochondrial energy production – and its dependence on tumor oxygen conditions, including the importance of serum level of lactate dehydrogenase (LDH) as a predictive marker for activity,” said Dr. Bahcall.
Anti-cancer activity of elesclomol in patients with low to normal level of LDH has been observed in three blinded, randomized trials: a Phase 3 melanoma trial, a Phase 2b lung cancer trial, and a Phase 2b melanoma trial. Preclinical data have shown that elesclomol kills cancer cells under normal oxygen (normoxic) conditions, in which energy production occurs primarily through the mitochondria. Under low oxygen (hypoxic) conditions, which are associated with elevated levels of LDH, elesclomol loses anti-cancer activity.
“The consistency of the preclinical and clinical findings with elesclomol; the pattern observed across three blinded, randomized, controlled trials; and additional recent evidence that LDH may play an important predictive role for drugs acting through metabolic pathways, as seen with Avastin and Torisel, are encouraging evidence that elesclomol can provide clinical benefit in patients with low to normal levels of LDH, and that future clinical trials in these patient populations are warranted,” said Dr. Bahcall.
“We previously announced we expect to initiate a trial in acute myeloid leukemia by the end of 2010,” said Dr. Bahcall. “We are now in discussions with a number of investigators and cooperative groups, based on the recent data, regarding additional elesclomol trials. We expect to initiate at least one additional trial in a solid tumor cancer by the first half of 2011.”
Additional development for elesclomol is expected to be supported or sponsored by third parties, including cooperative groups or individual investigators.