Biostage Initiated Study Start-up Activities for Clinical Trial in Severe Esophageal Disease
HOLLISTON, Mass., May 31, 2023 (GLOBE NEWSWIRE) -- Biostage, Inc. (OTCQB: BSTG) (“Biostage” or the “Company”), a clinical-stage biotechnology company developing the technology to regenerate organs inside the body to treat severe diseases, including cancer, trauma and birth defects initially in the esophagus and the airway, today announced that it initiated start-up activities for its first clinical trial.
The Phase 1, first-in-human study approved by the FDA will evaluate both safety and efficacy in up to ten patients requiring the removal of up to 6 cm of their esophagus (including cancer, trauma or birth defects) at up to five hospitals in the U.S. The primary endpoint is the development of a continuous biological neo-conduit at three months following implantation.
Further details of the study are posted on clinicaltrials.gov.
“Every day counts. We have been working at an unprecedented pace together with our partner IQVIA biotech to accelerate the activation of first site for the trial,” said Jerry He, Chairman of the Board and Chief Executive Officer, “We believe our regenerative solution could provide profound benefits for patients in critical need of new treatment options. We look forward to advancing this exciting platform technology and bringing new treatments to the market.”
In April 2023, the Company announced a $6 Million financing to advance the clinical trial and accelerate the development of new pipeline.
We are a clinical-stage biotechnology company developing regenerative-medicine treatments for disorders of the gastro-intestinal system and the airway resulting from cancer, trauma or birth defects. Our technology is based on our proprietary cell-therapy platform that uses a patient’s own stem cells to regenerate and restore function to damaged organs. We believe that our technology represents a next-generation solution for restoring organ function because it allows the patient to regenerate their own organ, thus eiminating the need for human donor or animal transplants, the sacrifice of another of the patient’s own organs or permanent artificial implants.
We conducted the world’s first successful regeneration of the esophagus in a patient with esophageal cancer in August 2017. This surgery was performed by Dr. Denis Wigle, Chair of Thoracic Surgery at the Mayo Clinic. The results were published in the Journal of Thoracic Oncology Clinical and Research Reports in August 2021. The procedure demonstrated that our technology was able to successfully regenerate esophageal tissue, including the mucosal lining, to restore the integrity, continuity and functionality of the esophageal tube.
Biostage has 12 issued U.S. patents, 2 issued in China and 2 orphan-drug designations which can provide seven years of market exclusivity in addition to any exclusivity granted by patents.
Biostage's current goals include raising capital, uplisting from the OTC bulletin board to NASDAQ and beginning its clinical trial for repair of the esophagus.
Some of the statements in this press release are "forward-looking" and are made pursuant to the safe harbor provision of the Private Securities Litigation Reform Act of 1995. These "forward-looking" statements in this press release include, but are not limited to, statements relating to the clinical trials and other development and commercialization efforts of the Company's products, capabilities and performance of our products and product candidates, including as to the Biostage Tissue Patch and our other product candidates; our capital raising plans and expectations, including uplisting to NASDAQ; development expectations and regulatory approval of any of the Company's products, including those utilizing its Biostage Esophageal Implant or Biostage Tissue Patch technologies, by the U.S. Food and Drug Administration, the European Medicines Agency or otherwise, which expectations or approvals may not be achieved or obtained on a timely basis or at all; and success with respect to any collaborations, which such success may not be achieved or obtained on a timely basis or at all. These statements involve risks and uncertainties that may cause results to differ materially from the statements set forth in this press release, including, among other things, the Company's inability to obtain needed funds in the immediate future; the Company's ability to obtain and maintain regulatory approval for its products; plus other factors described under the heading "Item 1A. Risk Factors" in the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 2022 or described in the Company's other public filings. The Company's results may also be affected by factors of which the Company is not currently aware. The forward-looking statements in this press release speak only as of the date of this press release. The Company expressly disclaims any obligation or undertaking to release publicly any updates or revisions to such statements to reflect any change in its expectations with regard thereto or any changes in the events, conditions or circumstances on which any such statement is based.
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