“I am proud of the efforts of the TRACON team who made it possible for us to quickly file the IND, open multiple sites, and dose TRC253 in a Phase 1/2 trial following the establishment of our strategic licensing collaboration with Janssen,” said
About the Phase 1/2 TRC253 Clinical Trial in mCRPC
The Phase 1/2 clinical trial is a multicenter, first-in-human, open-label, dose-escalation study in patients with mCRPC. The primary objectives of the Phase 1/2 study are to assess the safety of TRC253, determine its recommended Phase 2 dose and assess response by prostate-specific antigen (
Further details of the study are available on www.clinicaltrials.gov under NCT02987829.
TRC253 is a novel, orally bioavailable small molecule, discovered by
Activation of the AR is crucial for the growth of prostate cancer at all stages of the disease. Therapies targeting the AR have demonstrated clinical efficacy by extending time to disease progression, and in some cases, the survival of patients with mCRPC. However, resistance to these agents is often observed and several molecular mechanisms of resistance have been identified, including gene amplification, overexpression, alternative splicing, and point mutation of the AR.
TRACON develops targeted therapies for cancer, ophthalmic and fibrotic diseases. The Company’s clinical-stage pipeline includes: TRC105, an endoglin antibody being developed for the treatment of multiple cancers, currently in Phase 3 testing; DE-122, the ophthalmic formulation of TRC105 being developed in wet AMD through a collaboration with
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 the potential or TRC253 to be a best-in-class androgen receptor antagonist and address unmet medical needs, the design of the Phase 1/2 clinical trial of TRC253, TRACON's plans to develop TRC253 and expectations regarding the initiation, design and timing of clinical trials by TRACON. 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 preclinical studies and clinical trials may not be successful or otherwise consistent with results from prior studies; potential changes in regulatory requirements in
Casey LoganChief Business Officer (858) 550‐0780 ext. 236 email@example.com Investor Contact: Andrew McDonald LifeSci Advisors LLC646-597-6987 Andrew@lifesciadvisors.com