TRACON Pharmaceuticals, Inc. (NASDAQ: TCON) has announced today that it has received Orphan Drug Designation for TRC102 for the treatment of patients suffering from malignant Glioma and glioblastoma (GBM) from the US Food and Drug Administration (FDA). In the Orphan Drug Designation, the drug has been given the Orphan status. This status is given to the companies to provide them with financial benefits for the development of new drugs for the treatment of rare diseases.
TRC102 is being examined in Phase 1 and Phase 2 clinical trials which were sponsored by the National Cancer Institute through a Cooperative Research and Development Agreement (CRADA). In Phase II, TRC102 was analyzed with Temodar chemotherapy. This study has been done on 19 patients who were suffering from progressive or recurrent GBM.
Thes study has shown promising results and increase the time of survival in two patients for more than two years. Both patients have shown the activation of the DNA base excision repair pathway and shown hyperactivation of DNA damage response genes.
Furthermore, TRC102 has also been analyzed in combination with chemotherapy and external beam radiotherapy in a Phase 1 study. 15 patients have participated in this study who have newly diagnosed non-squamous cell non-small cell lung cancer.
TRACON Pharmaceuticals, Inc. (NASDAQ: TCON) shares were trading up 9.29% at $4.94 during the trading session of Friday. TRACON Pharmaceuticals, Inc. (TCON) share price went from a low point around $0.95 to briefly over $6.37 in the past 52 weeks. It has traded up 420.00% from its 52-weeks low and moved down -22.45% from its 52-weeks high. TCON market cap has remained high, hitting $59.58 million at the time of writing.
Orphan Drug Designation status for TRC102 will be helpful in providing the treatment for unmet medical needs of patients who are suffering from malignant glioma. TRACON Pharmaceuticals has committed to developing TRC102 with the help of the National Cancer Institute.