- Thinly traded micro cap Tracon Pharmaceuticals (NASDAQ:TCON) is up 70% premarket on average volume in response to its announcement that a patient with an aggressive form of uterine cancer is experiencing an ongoing complete response after being treated with the company's investigational TRC105 in combination with Roche's (OTCQX:RHHBY) Avastin (bevacizumab). The results were presented at the 18th World Congress on Gestational Trophoblastic Diseases in Bali, Indonesia.
- The single patient was suffering from persistent and unresectable metastatic choriocarcinoma which is an aggressive form of gestational trophoblastic neoplasia (GTN), a rare form of uterine cancer. Under a compassionate use protocol, she was dosed with TRC105 10 mg/kg weekly, in combination with Avastin 10 mg/kg every other week. After 28 weeks of treatment (seven cycles), her beta human chorionic gonadotropin (bHCG), a reliable biomarker in choriocarcinoma, decreased from more than 3,000 IU/L to less than 1 IU/L from cycles four through seven, indicating a complete response.
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Choriocarcinoma is the second tumor type known to express high levels of a protein called endoglin, which plays a key role in angiogenesis (development of new blood vessels that "feed a tumor"). The other, angiosarcoma, also responds well to treatment with TRC105 and a VEGF inhibitor like Avastin.
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TRC105 is a novel antibody to endoglin.
- The company plans to initiate a Phase 2 study in GTN in Q4 and apply to the FDA for Orphan Drug status in GTN and soft tissue sarcoma by the end of the year.