The single-patient compassionate-use Phase 2 clinical trial enrolled a 37-year old woman with persistent and unresectable metastatic choriocarcinoma. This is an aggressive form of gestational trophoblastic neoplasia (GTN). Prior to entry into the trial, this patient received multiple treatments, including laparoscopic hysterectomy, five prior chemotherapy regimens and a stem cell transplant.
The patient was treated with TRC105 weekly in combination with Avastin (bevacizumab) dosed every other week. As of the time of the presentation, the patient had completed seven cycles (28 weeks) of treatment.
According to the trial:
Beta human chorionic gonadotropin (β-hCG), a known, reliable marker of disease burden in choriocarcinoma, normalized during the fourth cycle of treatment, decreasing from greater than 3,000 IU/L at treatment initiation to less than 1 IU/L from cycles 4 through 7, indicating an ongoing complete response.
Charles P. Theuer, M.D., Ph.D., president and CEO of TRACON, commented on the results:
We have now seen complete responses in two orphan tumor types that overexpress endoglin, choriocarcinoma and angiosarcoma. There are currently limited treatment options for patients with either of these cancers who progress on first-line chemotherapy,” “We intend to treat additional patients with GTN in a Phase 2 multicenter trial that we expect to initiate in the fourth quarter of 2015, and to apply for orphan drug status for TRC105 in GTN, as well as soft tissue sarcoma, by the end of the year.
Shares of Tracon closed Thursday down 0.9%, at $11.73 in its post-IPO trading range of $9.02 to $21.00. In early trading indications Friday, shares were up over 78% at $20.89. The stock has a consensus analyst price target of $20.75.
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