TRACON Pharmaceuticals (NASDAQ:TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted therapeutics for cancer, wet age-related macular degeneration and fibrotic diseases, today announced that positive results from a Phase 1 clinical trial of TRC102 (methoxyamine) and Fludara® (fludarabine) in patients with advanced hematologic malignancies were published in the journal Oncotarget (Volume 8, Number 45, pages 79864-79875).
The Phase 1 trial enrolled a total of 20 patients, of whom 17 had measurable disease, with chronic lymphocytic leukemia (n=10), follicular lymphoma (n=3), diffuse large B cell lymphoma (n=3), plasma cell myeloma (n=2), mantle cell lymphoma (n=1), or anaplastic large cell lymphoma (n=1). Patients received one of five levels of TRC102 (15, 30, 60, 90, or 120 mg/m2) dosed intravenously on the initial day of recurring three week cycles in combination with Fludara dosed per label at 25 mg/m2 intravenously on days 1 through 5. Dose limiting toxicity was not observed. The most frequent toxicities were hematologic and were reversible when managed with supportive care. Four of the 17 patients (24%) experienced a partial response to treatment, and eight additional patients (8/17, 47%) had stable disease. The combination of TRC102 and Fludara produced evidence of tumor DNA damage that appeared to correlate with antitumor activity.
“We have now observed TRC102 to be well-tolerated in combination with three separate chemotherapeutics, Alimta®, Temodar® and Fludara, and we are encouraged by the responses seen to date,” said Charles Theuer, M.D., Ph.D., President and CEO of TRACON. “We continue to make strong progress on the program and expect to report data from multiple National Cancer Institute-sponsored Phase 2 trials of TRC102 in 2018.”
TRC102 (methoxyamine) is a novel, clinical-stage small molecule inhibitor of the DNA base excision repair pathway, which is a pathway that causes resistance to alkylating and antimetabolite chemotherapeutics. TRC102 is currently being studied in multiple Phase 1 and Phase 2 clinical trials sponsored by the National Cancer Institute or Case Comprehensive Cancer Center. For more information about the clinical trials, please visit TRACON’s website at www.traconpharma.com/clinical_trials.php
TRACON develops targeted therapies for cancer, ophthalmic and fibrotic diseases. The Company’s clinical-stage pipeline includes: TRC105, an endoglin antibody that is being developed for the treatment of multiple cancers; DE-122, the ophthalmic formulation of TRC105 that is being developed in wet AMD through a collaboration with Santen Pharmaceutical Company Ltd.; TRC102, a small molecule being developed for the treatment of lung cancer and glioblastoma; and TRC253, a small molecule being developed for the treatment of prostate cancer. To learn more about TRACON and its product candidates, visit TRACON’s website at www.traconpharma.com
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