Tag Archives: LEXINGTON

Synta Provides Company Updates and Reports Fourth Quarter and Year-End 2012 Financial Results

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Synta Provides Company Updates and Reports Fourth Quarter and Year-End 2012 Financial Results

Expects mid-year overall survival results from the GALAXY-1 trial for ganetespib in second-line non-small cell lung cancer –

— Expects enrollment of the pivotal GALAXY-2 Phase 3 trial to commence this month —

— Announces key addition to executive management team –

LEXINGTON, Mass.–(BUSINESS WIRE)– Synta Pharmaceuticals Corp. (NAS: SNTA) today provided an update on recent progress with its clinical programs and reported financial results for the fourth quarter and year ended December 31, 2012.

“Over the past year, we have made strong progress in the development of ganetespib, our Hsp90 inhibitor,” said Dr. Safi Bahcall, President and CEO of Synta. “Interim results presented last year from our GALAXY-1 trial evaluating ganetespib as second-line treatment of non-small cell lung cancer showed encouraging clinical activity. We look forward to presenting more mature results from the 240-patient target population of this trial mid-year, and enrolling the first patient in our GALAXY-2 Phase 3 trial before the end of this month.”

“Ganetespib represents a distinct cancer treatment paradigm – targeting one protein, the chaperone, which simultaneously destabilizes a broad range of oncogenic pathways,” said Dr. Sumant Ramachandra, President of Research and Development. “This approach is differentiated: existing cancer therapies are generally either non-specific, for example anti-mitotic chemotherapies, or target one particular signaling protein involved in a limited number of cancer signaling pathways, for example tyrosine kinase inhibitors.”

“The clinical evidence to date, together with the preclinical results that show treatment with ganetespib changes the broader biology of cancer cells, reducing tumor aggressiveness, are encouraging,” continued Dr. Ramachandra. “Results expected later this year will be important in confirming the clinical activity and establishing the potential for ganetespib beyond lung cancer.”

The safety profile of ganetespib has been favorable in over 700 patients treated to date in more than 20 clinical trials. Transient, mild or moderate diarrhea has been the most commonly reported adverse event.

Key accomplishments in 2012

1. At the 2012 Congress of the European Society for Medical Oncology (ESMO), investigators …read more
Source: FULL ARTICLE at DailyFinance

Synageva BioPharma™ to Host 2012 Fourth Quarter and Full Year Financial Results Conference Call on M

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Synageva BioPharma™ to Host 2012 Fourth Quarter and Full Year Financial Results Conference Call on March 11

LEXINGTON, Mass.–(BUSINESS WIRE)– Synageva BioPharma Corp. (Synageva) (NAS: GEVA) , a clinical stage biopharmaceutical company developing therapeutic products for rare diseases, will report 2012 fourth quarter and full year financial results after the NASDAQ Market closes on Monday, March 11, 2013. Synageva management will conduct a conference call and audio webcast to discuss these results as well as provide a general business update at 4:30 p.m. EST on the same day.

The dial-in number for the conference call is (877) 312-5514 for U.S. callers, or (970) 315-0452 for international callers, and reference conference ID: 95417172. A live webcast of the call will be available from the “Webcasts & Presentations” section of the Investor Relations tab on the home page of Synageva’s website at www.synageva.com.

About Synageva’s Lead Program

Sebelipase alfa (SBC-102) is a recombinant form of the human LAL enzyme under development by Synageva as an enzyme replacement therapy for LAL Deficiency, a lysosomal storage disorder (LSD). Synageva is currently evaluating sebelipase alfa in global clinical trials for both early and late onset LAL Deficiency. Sebelipase alfa has been granted orphan designations by the U.S. Food and Drug Administration (FDA), the European Medicines Agency, and the Japanese Ministry of Health, Labour and Welfare. Additionally, sebelipase alfa received “fast track” designation by the FDA.

About LAL Deficiency

LAL Deficiency is a rare autosomal recessive LSD caused by a marked decrease in LAL enzyme activity. Late onset LAL Deficiency, sometimes called Cholesteryl Ester Storage Disease (CESD), affects both children and adults. In these patients, the buildup of fatty material in the liver and blood vessel walls may lead to liver cirrhosis, liver failure and accelerated atherosclerotic events. Early onset LAL Deficiency, sometimes called Wolman disease, affects infants and is characterized by severe malabsorption, growth failure and liver failure, and is usually fatal within the first six months of life. There are no approved pharmacological therapies for LAL Deficiency. Success with stem cell and liver transplant appears to be limited by procedure-related morbidity and mortality.

About Synageva BioPharma Corp.
…read more
Source: FULL ARTICLE at DailyFinance