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InCode BioPharmaceutics, Inc. Announces Key Safety Data for rC3-1: A New Treatment of Paroxysmal Nocturnal Hemoglobinuria (PNH)

SAN FRANCISCO, July 28, 2008 /PRNewswire/ -- InCode BioPharmaceutics, Inc. today announced favorable results of its preclinical primate toxicity study demonstrating no adverse events and reduction of key markers of potency for its lead drug candidate, rC3-1.

In the study, escalating doses of rC3-1 were delivered directly to the pulmonary artery of non-human primates. The lung is considered to be the target organ for potential toxicity. All doses recorded no clinically significant changes in direct systemic blood pressure, pulmonary arterial pressure, lung resistance and dynamic compliance, respiratory rate, tidal volume and airway pressure.

"rC3-1 was well tolerated and shows strong indications that it could be a new treatment alternative for complement mediated diseases," commented Bill St. John, CEO of InCode. "The aggressive design of this study supports additional studies of this drug candidate. Complete results will be presented at the XXII International Complement Workshop in Basel, Switzerland, September 28, 2008."

rC3-1 is being developed for the treatment of the rare chronic blood disease Paroxysmal Nocturnal Hemoglobinuria (PNH) and Age-related Macular Degeneration. InCode plans to begin PNH clinical trials in the near future. The only treatment currently available for PNH patients is an anti-C5 antibody Soliris(TM) (eculizumab) sold by Alexion Pharmaceuticals, Inc.

rC3-1 promotes the enzymatic partial depletion of C3, the hub of the complement cascade. Complement protein C3 is the master regulator of complement protein C5 that mediates red blood cell damage in PNH patients and tissue injury in Macular Degeneration animal models.

InCode BioParmaceutics, Inc. is an emerging biotechnology company that is developing a new class of recombinant proteins for the controlled depletion of complement protein C3. The therapeutic potential for C3 depletion has been demonstrated in Macular Degeneration, Asthma, Rheumatoid Arthritis, and autoimmune and inflammatory disease models. C3 depletion has also been demonstrated as a useful adjuvant to surgery, transplantation and cancer therapy. InCode is pursuing a progressive clinical development plan focused on proof of concept trials.

Posted: July 2008