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Sigma-Tau Pharmaceuticals, Inc. Announces First Patient Dosed in Phase I/II Clinical Trial of STP206 for Prevention of Necrotizing Enterocolitis in Very Low Birth Weight Premature Infants

STP206 is a Live-Biotherapeutic Being Developed in the U.S. Under an FDA Investigational New Drug Application

February 4, 2014 7:00 AM EST Send to a Friend

GAITHERSBURG, Md., Feb. 4, 2014 (GLOBE NEWSWIRE) -- Sigma-Tau Pharmaceuticals, Inc. (Sigma-Tau) today announced that the first patient has been dosed as part of the Company's Phase I/II multi-center, double-blind, randomized, placebo-controlled clinical trial for STP206, in development for the prevention of necrotizing enterocolitis (NEC) in very low birth weight premature infants. STP206 is a live biotherapeutic being developed in the United States, under an FDA investigational new drug application (IND).

NEC is the most common serious acquired disease of the gastrointestinal tract in preterm infants, most often affecting infants under 1,500 g (3 lbs, 5 oz). The disease is characterized by signs of abdominal distension, intra-abdominal inflammation, and radiologic presence of pneumatosis intestinalis (gas in the bowel wall) and/or portal venous air or free air indicating perforation of the bowel, which in the most severe cases, can be life threatening. The disease has been reported to occur in approximately 10% of very low birth weight (≤1500 g) infants and about 1 in every 2,000-4,000 births. There is presently no FDA approved treatment for NEC, resulting in an urgent, unmet medical need.

Dave Lemus, Chief Executive Officer of Sigma-Tau, noted, "Sigma-Tau remains committed to serving those affected by rare diseases. Dosing of the first patient in our Phase I/II trial for STP206 represents an important milestone in the continued development of this novel therapy for the prevention of NEC in premature infants with a very low birth weight, a life threatening disease with no currently FDA approved treatment. Additionally, we are also pleased that this program has played a central role in helping advance the further development of live biotherapeutics, and in that vein, aspire to become the first FDA approved live biotherapeutic on the market."

About Live Biotherapeutics

A live biotherapeutic is a biological product that (1) contains live microorganisms, such as bacteria or yeast, that are naturally occurring, recombinant, or clonally selected; (2) is applicable to the prevention, treatment, or cure of a disease or condition of human beings; and (3) is not an immunogen-specific vaccine. As the characterization of the human microbiome and its link to human health has become better understood, the use of live biotherapeutic products in clinical application has shown promise for reducing infection, stimulating innate immune responses, and modulating gastrointestinal metabolism.

About Sigma-Tau Pharmaceuticals, Inc.

Sigma-Tau Pharmaceuticals, Inc. is a U.S.-based, wholly owned subsidiary of the sigma-tau Group, and is dedicated to the global development and commercialization of medicines for patients with rare diseases. Sigma-Tau Pharmaceuticals, Inc. is based in Gaithersburg, Maryland, and the company's marketed products are focused on cancer, kidney disease, gastrointestinal and genetic related disorders. The company also has clinical development programs focused on transplant, hematological cancer, malaria, and other areas of unmet medical need. For more information about Sigma-Tau Pharmaceuticals, Inc., visit www.sigmatau.com.

CONTACT: For Sigma-Tau:
         Eric Goldman
         Rx Communications Group, LLC
         917-322-2563
         egoldman@RxIR.com

Source: Sigma-Tau Pharmaceuticals



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