SAN DIEGO, CA, USA I November 19, 2018 I 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, 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.”
About TRC102
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.
About TRACON
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.
SOURCE: TRACON Pharmaceuticals
Post Views: 103
SAN DIEGO, CA, USA I November 19, 2018 I 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, 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.”
About TRC102
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.
About TRACON
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.
SOURCE: TRACON Pharmaceuticals
Post Views: 103
