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Biotech / Medical : Synta Pharmaceuticals -- Ignore unavailable to you. Want to Upgrade?

To: tuck who wrote (40)	1/29/2008 12:20:36 PM
From: tuck	Respond to of 112

>>Synta and GlaxoSmithKline Announce Elesclomol Granted Orphan Drug Designation by the FDA Monday January 28, 7:00 am ET LEXINGTON, Mass.--(BUSINESS WIRE)--Synta Pharmaceuticals Corp. (NASDAQ: SNTA - News) and GlaxoSmithKline (GSK) today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to elesclomol (formerly STA-4783) for the treatment of patients with metastatic melanoma. Elesclomol is being developed under a global collaboration agreement between Synta and GSK. Elesclomol is an investigational drug that is not approved for any indication in any market at this time. Orphan drug status is designed to encourage biotechnology and pharmaceutical companies to develop drugs for rare diseases which affect fewer than 200,000 people in the United States. In November 2006 elesclomol received Fast Track designation from the FDA for development in metastatic melanoma. “We are pleased that the FDA granted elesclomol orphan drug status for the treatment of metastatic melanoma,” said Eric Jacobson, M.D., Senior Vice President and Chief Medical Officer, Synta Pharmaceuticals. “With the incidence of melanoma increasing more rapidly than any other cancer during the past ten years, there is a significant need for innovative therapies such as elesclomol.” “Orphan drug status is an acknowledgment of the significant need to develop new therapies for patients with metastatic melanoma, a disease for which there are few treatment options,” said Paolo Paoletti, Senior Vice President of the Oncology Medicine Development Center at GSK. “Through the development of products like elesclomol, GSK Oncology is reaffirming its commitment to address clinical needs in cancer treatment and improve the lives of patients.” About Elesclomol (Formerly STA-4783) Elesclomol is a novel, injectable, investigational drug candidate that is believed to kill cancer cells by elevating oxidative stress levels beyond a breaking point, triggering programmed cell death. This mechanism of action, called oxidative stress induction, represents a novel way of selectively killing cancer cells. A pivotal Phase 3 clinical trial of elesclomol in combination with paclitaxel in metastatic melanoma (the SYMMETRYSM trial) was initiated in October 2007 and Phase 2 trials in other indications, and in combination with other agents, are planned. Information about the SYMMETRY trial can be found at www.clinicaltrials.gov. In a double-blind, randomized, controlled Phase 2b clinical trial in 81 patients with metastatic melanoma, elesclomol in combination with paclitaxel met the primary endpoint, doubling the median time patients survived without their disease progressing, compared to paclitaxel alone (p = 0.035). The most common adverse events in the elesclomol plus paclitaxel group included fatigue, alopecia, constipation, nausea, hypoaesthesia, arthralgia, insomnia, diarrhea, and anemia. About Orphan Drug Status The Orphan Drug Act (ODA) provides economic incentives to encourage biotechnology and pharmaceutical companies to develop drugs for rare diseases which affect fewer than 200,000 people in the United States. Orphan drug designation entitles Synta and GSK to seven years of market exclusivity for elesclomol for the treatment of patients with metastatic melanoma. Additional incentives for orphan drug development include tax credits related to development expenses, reduction in FDA user fees and FDA assistance in clinical trial design. About Metastatic Melanoma The incidence of melanoma has increased more rapidly than any other cancer during the past ten years. According to the American Cancer Society, melanoma accounts for approximately five percent of all skin cancers but causes about 75% of all skin cancer-related deaths. An estimated 60,000 people will be diagnosed and nearly 8,200 people will die from melanoma this year in the U.S. alone. If diagnosed and surgically removed while localized in the outermost skin layer, melanoma is potentially curable; however, for patients with metastatic disease, the prognosis is poor. Treatments are limited and the expected survival for patients with metastatic melanoma is only six to nine months.<< snip Cheers, Tuck

To: tuck who wrote (40)	3/6/2009 11:32:44 AM
From: tuck	Respond to of 112

[The novel HSP90 inhibitor STA-9090 exhibits activity against Kit-dependent and -independent malignant mast cell tumors.] >>Exp Hematol. 2008 Oct;36(10):1266-77. Epub 2008 Jul 26. The novel HSP90 inhibitor STA-9090 exhibits activity against Kit-dependent and -independent malignant mast cell tumors. Lin TY, Bear M, Du Z, Foley KP, Ying W, Barsoum J, London C. Department of Veterinary Biosciences, College of Veterinary Medicine, The Ohio State University, Columbus, Ohio 43210, USA. OBJECTIVE: Mutations of the receptor tyrosine kinase Kit occur in several human and canine cancers. While Kit inhibitors have activity in the clinical setting, they possess variable efficacy against particular forms of mutant Kit and drug resistance often develops over time. Inhibitors of heat shock protein 90 (HSP90), a chaperone for which Kit is a client protein, have demonstrated activity against human cancers and evidence suggests they downregulate several mutated and imatinib-resistant forms of Kit. The purpose of this study was to evaluate a novel HSP90 inhibitor, STA-9090, against wild-type (WT) and mutant Kit in canine bone marrow-derived cultured mast cells (BMCMCs), malignant mast cell lines, and fresh malignant mast cells. MATERIALS AND METHODS: BMCMCs, cell lines, and fresh malignant mast cells were treated with STA-9090, 17-AAG, and SU11654 and evaluated for loss in cell viability, cell death, alterations in HSP90 and Kit expression/signaling, and Kit mutation. STA-9090 activity was tested in a canine mastocytoma xenograft model. RESULTS: Treatment of BMCMCs, cell lines, and fresh malignant cells with STA-9090 induced growth inhibition, apoptosis that was caspase-3/7-dependent, and downregulation of phospho/total Kit and Akt, but not extracellular signal-regulated kinase (ERK) or phosphoinositide-3 kinase (PI-3K). Loss of Kit cell-surface expression was also observed. Furthermore, STA-9090 exhibited superior activity to 17-AAG and SU11654, and was effective against malignant mast cells expressing either WT or mutant Kit. Lastly, STA-9090 inhibited tumor growth in a canine mastocytoma mouse xenograft model. CONCLUSIONS: STA-9090 exhibits broad activity against mast cells expressing WT or mutant Kit, suggesting it may be an effective agent in the clinical setting against mast cell malignancies.<< Here's the protocol for one of the P1s: clinicaltrials.gov Cheers, Tuck