- Company Reaches Agreement with Regulatory Agencies on Key Elements of Phase 3 Program
- Phase 3 Program Expected to Begin by Year-end
San Diego, CA (GLOBE NEWSWIRE) - 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 the successful completion of an End-of-Phase 2 meeting with the United States Food and Drug Administration (FDA) and a Protocol Assistance Meeting with the European Medicines Agency (EMA). TRACON reached agreement with both regulatory agencies regarding key elements of the Phase 3 program for TRC105 in angiosarcoma and expects to initiate enrollment in the Phase 3 study by year-end.
“We appreciate the valuable discussions and guidance from our End-of-Phase 2 discussion with FDA and Protocol Assistance Meeting with EMA, and are confident that we have a robust design for TRC105’s first Phase 3 trial,” said Charles Theuer, M.D., Ph.D., President and CEO. “With the successful completion of the regulatory meetings, we are focused on advancing TRC105 as the first potential therapeutic specifically for the treatment of angiosarcoma, an ultra-orphan indication with a high unmet need. We look forward to initiating our Phase 3 program before the end of the year.”
End-of-Phase 2 Meetings and Phase 3 Study Design
The U.S. and European regulators separately determined the acceptability of the following key aspects of the proposed Phase 3 randomized trial:
- One-to-one randomized trial of TRC105 in combination with Votrient® (pazopanib) versus Votrient alone.
- A planned total enrollment of 124 patients with an adaptive design based on an interim analysis that allows for sample size re-estimation up to a maximum of 200 patients, as well as enrichment of more responsive patients based on the subtype of angiosarcoma, visceral or cutaneous.
- Primary endpoint of progression-free survival (PFS) with overall survival (OS) as a secondary endpoint.
- Open label format with independent blinded assessment of endpoint data.
- Eligible patients will be stratified by treatment naive versus greater than one prior cancer therapy and will not have received a prior VEGF inhibitor.
- The trial will provide at least 80% power to determine an improvement in median PFS from 4.0 to 7.3 months using a two-tailed alpha of 0.05.
TRACON intends to submit the proposed protocol for special protocol assessment to FDA later this year.
About TRC105 (carotuximab)
TRC105 (carotuximab) is a novel, clinical stage antibody to endoglin, a protein overexpressed on proliferating endothelial cells that is essential for angiogenesis, the process of new blood vessel formation, and also expressed on fibroblasts, a cell that causes fibrosis. TRC105 is currently being studied in multiple Phase 2 clinical trials sponsored by TRACON or the National Cancer Institute for the treatment of solid tumor types in combination with VEGF inhibitors. The ophthalmic formulation of TRC105, DE-122, is currently in a Phase 1/2 trial for patients with wet AMD. TRC205, a second generation antibody to endoglin, is undergoing preclinical testing in models of fibrosis. For more information about the clinical trials, please visit TRACON’s website at http://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.; and TRC102, a small molecule that is being developed for the treatment of lung cancer and glioblastoma. 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, including the expected design and implementation of the first Phase 3 trial of TRC105 in angiosarcoma, expectations regarding the initiation and timing of future clinical trials by TRACON or third parties, TRACON’s intention and timing for submitting a special protocol assessment, potential benefits of TRACON’s product candidates, and expected development milestones and availability of additional clinical data. Risks that could cause actual results to differ from those expressed in these forward‐looking statements include: risks associated with clinical development; whether TRACON will be able to complete or initiate clinical trials on TRACON’s expected timelines, if at all; risks that regulatory agencies may change their guidance with respect to acceptable trial designs or may not approve any special protocol assessment; the fact that future preclinical studies and clinical trials may not be successful or otherwise consistent with results from prior studies; 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; 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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