Biostage Activated Mayo Clinic as The First Site for Clinical Trial in Severe Esophageal Disease

Rhea-AI Summary

Biostage, Inc. (OTCQB: BSTG) has officially activated Mayo Clinic as the first site for its clinical trial in severe esophageal disease. This marks Biostage's first clinical trial in the United States for its esophageal implant technology, which aims to regenerate organs inside the body. 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 due to cancer, trauma, or birth defects.

The study will be conducted at up to five hospitals in the U.S., with the primary endpoint being the development of a continuous biological neo-conduit at three months following implantation. This milestone represents a significant step forward for Biostage in its mission to advance organ regeneration and regenerative medicine.

Positive

• Activation of Mayo Clinic as the first site for clinical trial
• FDA approval for Phase 1 first-in-human study
• Potential to treat severe esophageal diseases including cancer, trauma, and birth defects
• Study to be conducted in up to five hospitals in the U.S.

Negative

• None.

HOLLISTON, Mass., July 18, 2023 /PRNewswire/ -- 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 officially activated the site with Mayo Clinic for its clinical trial as to severe esophageal disease, being its first clinical trial in the United States.

"We are thrilled to announce the initiation of our first clinical study for our esophageal implant, marking an important milestone for Biostage," said Jerry He, Chairman and CEO of Biostage. "Our numerous preclinical studies have demonstrated our technology as an effective platform for tubular organ regeneration. We look forward to testing the esophageal implant in the clinics as we further our understanding of its potential benefits for patients. As a leader in the field of organ regeneration and regenerative medicine, we feel a strong sense of responsibility to act swiftly to bring better treatment for suffering patients as soon as possible," Jerry further emphasized.

Dr. Shunfu Hu, VP of Operations and Business Development, commented with his excitement, "After years of collaboration with the Mayo Clinic, we are thrilled that our innovative organ regeneration platform is undergoing clinical trial evaluation, ready to recruit patients in the US."

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.

About Biostage

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 eliminating 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 13 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.

For more information, please visit www.biostage.com and connect with the Company on Twitter and LinkedIn.

Forward-Looking Statements 

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 capabilities and performance of our products and product candidates; development expectations and regulatory approval of any of the Company's products, 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, clinical trials and other development and commercialization efforts of the Company's products, 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.

Investor Relations Contact

Joseph Damasio
Chief Financial Officer
774-233-7330
jdamasio@biostage.com

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SOURCE Biostage, Inc.

FAQ

What is the purpose of Biostage's (BSTG) clinical trial at Mayo Clinic?

The clinical trial aims to evaluate the safety and efficacy of Biostage's esophageal implant for severe esophageal disease, including cases of cancer, trauma, and birth defects requiring removal of up to 6 cm of the esophagus.

How many patients will be involved in Biostage's (BSTG) Phase 1 clinical trial?

The Phase 1 clinical trial will evaluate up to ten patients requiring the removal of up to 6 cm of their esophagus.

What is the primary endpoint of Biostage's (BSTG) esophageal implant clinical trial?

The primary endpoint of the clinical trial is the development of a continuous biological neo-conduit at three months following implantation of the esophageal implant.

Where can more details about Biostage's (BSTG) clinical trial be found?

Further details of the study are posted on clinicaltrials.gov.