SAN DIEGO, Nov. 19, 2018 (GLOBE NEWSWIRE) -- TRACON Pharmaceuticals (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, yesterday presented data from the Company’s Phase 2 study of TRC102 and Temodar® (temozolomide) in patients with recurrent glioblastoma at the Society for Neuro-Oncology (SNO) annual meeting, taking place in New Orleans. TRC102 is a small molecule inhibitor of the base excision repair (BER) pathway that causes resistance to Temodar chemotherapy in preclinical tumor models.
In an oral presentation by Dr. Lisa Rogers, Director of Medical Neuro-Oncology at Cleveland Medical Center, entitled, “Phase 2 Trial of Temozolomide and TRC102, Base Excision Repair Inhibitor, in Bevacizumab Naive Glioblastoma at First Recurrence”, safety and efficacy data were presented from patients who received TRC102 and Temodar at the time of recurrence following first line therapy with Temodar chemotherapy and radiation therapy.
The combination of TRC102 and Temodar was tolerable, but did not meet the primary efficacy endpoint of demonstrating objective responses by Response Assessment in Neuro-Oncology criteria in the initial 19 enrolled patients, most of whom were treated at Cleveland Clinic. Two patients (10.5%) demonstrated evidence of clinical benefit and met the secondary endpoint of progression free survival (PFS) beyond 6 months. Both patients who demonstrated PFS for more than 11 months remain alive over 30 months following treatment initiation with TRC102 and Temodar for recurrent glioblastoma. PFS of greater than 11 months was associated with N-methylpurine DNA glycosylase expression, a biomarker that initiates the BER pathway of resistance that is inhibited by TRC102.
“We recognized that the primary endpoint of objective response in the Phase 2 trial of Temodar and TRC102 represented a high efficacy hurdle, that of resensitizing recurrent glioblastoma patients to Temodar treatment. We were encouraged to see certain patients demonstrate prolonged clinical benefit that was associated with evidence of activation of the BER pathway of resistance that is inhibited by TRC102,” said Dr. Charles Theuer, President and CEO of TRACON Pharmaceuticals. “Our efforts will continue to focus on identifying possible biomarkers that are prognostic of response to TRC102 in four ongoing clinical trials supported by the National Cancer Institute.”
TRC102 is a novel, clinical stage small molecule inhibitor of the base excision repair pathway that is implicated in resistance to alkylating and antimetabolite chemotherapy. TRC102 has been combined safely with Temodar, Alimta (pemetrexed) and Fludara (fludarabine) in phase 1 trials and is being studied in a broad program of clinical trials supported by the National Cancer Institute, including a Phase 2 trial of TRC102 and Temodar in patients with solid tumors, a Phase 2 trial of TRC102 and Alimta in patients with non-small cell lung cancer, a Phase 1 trial of TRC102 with chemotherapy and radiation therapy in patients with non-small cell lung cancer, and a Phase 1 trial of TRC102 with Alimta and cisplatin in patients with solid tumors. 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 and ophthalmic 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 solid tumors; and TRC253, a small molecule being developed for the treatment of prostate cancer. TRACON is actively seeking additional corporate partnerships whereby it shares in the cost and risk of clinical development and commercialization of new product candidates. In these partnerships TRACON believes it can serve as a solution for companies without clinical and commercial capabilities in the United States. To learn more about TRACON and its product candidates, visit TRACON's website at www.traconpharma.com.
Statements made in this press release regarding matters that are not historical facts are “forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward‐looking statements. Such statements include, but are not limited to, statements regarding TRACON's plans to further develop its product candidates, plans to identify potential biomarkers released to TRACON’s product candidates, expectations regarding the timing and scope of clinical trials and availability of clinical data, expected development milestones, and potential utility of TRACON’s product candidates. Risks that could cause actual results to differ from those expressed in these forward‐looking statements include: risks associated with clinical development; whether TRACON or others will be able to complete or initiate clinical trials on TRACON’s expected timelines, if at all; the fact that future preclinical studies and clinical trials may not be successful or otherwise consistent with results from prior studies; whether any potential biomarker measurements will ultimately correlate to clinical efficacy; the fact that TRACON has limited control over whether or when third party collaborators complete on-going trials or initiate additional trials of TRACON’s product candidates; the fact that TRACON’s collaboration agreements are subject to early termination; potential changes in regulatory requirements in the United States and foreign countries; TRACON’s reliance on third parties for the development of its product candidates, including the conduct of its clinical trials and manufacture of its product candidates; whether TRACON will be able to obtain additional financing; the possibility of unexpected expenses or other uses of TRACON’s cash resources; and other risks described in TRACON’s filings with the Securities and Exchange Commission under the heading “Risk Factors”. All forward‐looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. TRACON undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
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