SAN DIEGO - Capricor Therapeutics (NASDAQ: NASDAQ:CAPR), a biotechnology company focused on developing cell and exosome-based therapeutics for rare diseases, announced the expansion of manufacturing capacity for their lead product candidate, CAP-1002. This development comes as part of the company's preparation for potential commercial launch, pending regulatory approval.
The new manufacturing facility in San Diego is designed to meet the anticipated demand for CAP-1002, which is currently undergoing Phase 3 clinical trials for the treatment of Duchenne muscular dystrophy (DMD). The company's CEO, Linda Marbán, Ph.D., expressed satisfaction with the progress, highlighting the facility's role in increasing supply capabilities and improving profit margins.
In addition to the manufacturing scale-up, Capricor reported rapid enrollment for Cohort B of their HOPE-3, Phase 3 clinical study, with expectations to complete enrollment by the second quarter of 2024. Cohort A is already fully enrolled, with top-line data expected in the fourth quarter of 2024. Following these developments, Capricor plans to engage with the U.S. Food & Drug Administration (FDA) to discuss expedited approval pathways.
CAP-1002 is an allogeneic cardiac-derived cell therapy that has shown promise in preclinical and clinical studies for its potential immunomodulatory, antifibrotic, and regenerative actions, particularly for dystrophinopathies and heart disease.
Capricor has also developed a proprietary exosome technology platform, StealthX™, aimed at advancing treatments in vaccinology and targeted delivery of various therapeutics.
The company's forward-looking statements include plans for regulatory filings, research, clinical trials, and manufacturing capabilities, as well as expectations for collaborative activities, commercial rights, and intellectual property rights.
This announcement is based on a press release statement from Capricor Therapeutics. The company has a partnership with Nippon Shinyaku Co., Ltd. for the commercialization and distribution of CAP-1002 in the United States and Japan, subject to regulatory approval. CAP-1002 has not yet been approved for any indications, and Capricor's exosome-based candidates have not received approval for clinical investigation.
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