(MENAFN- ProactiveInvestors - UK) TRACON Pharma (NASDAQ:TCON) a clinical stage biopharmaceutical company said the U.S Food and Drug Administration (FDA) has granted TRC105 orphan drug designation for the treatment of patients with soft tissue sarcoma. Shares fluctuated.
TRC105 is a novel clinical stage antibody to endoglin a protein overexpressed on proliferating endothelial cells that is essential for angiogenesis the process of new blood vessel formation.
'Orphan drug designation for TRC105 underscores the high level of unmet medical need in patients with soft tissue sarcomas' CEO Charles Theuer said in a statement on Monday.
'We look forward to the availability of complete results from the Phase 2 portion of the sarcoma trial and initiating a pivotal Phase 3 trial in patients with angiosarcoma in 2016.'
The FDA's Orphan Drug Designation program provides orphan status to drugs and biologics that are being developed to address rare diseases or disorders that affect fewer than 200000 people in the U.S.
With orphan designation TRACON qualifies for various incentives with respect to TRC105 for the treatment of soft tissue sarcoma including tax credits for qualified clinical trials and seven years of market exclusivity upon regulatory approval.
Shares were trading down 0.7% at $8.93 at 9:47 a.m. in New York after advancing to as high as $9.06.
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