American Marconi Wireless News - Vicapsys Life Sciences Provides Shareholder Update on VICAPSYN(TM) Program Advancing Toward Phase 1 Human Clinical Trial, Vertically Integrated With the Company's Indian Health Service Strategy

MIAMI, FL / ACCESS Newswire / November 2, 2026 / Vicapsys Life Sciences, Inc. (OTC PINK:VICP) ("Vicapsys" or the "Company") today provided shareholders with an update on VICAPSYN^™, the Company's immune-isolation technology for the transplantation of insulin-producing islet cells in people with type 1 diabetes. Following the Company's reverse merger with Stateline Distributors of Puerto Rico, Inc. and the build-out of its pharmaceutical distribution platform, Vicapsys confirms that VICAPSYN^™ remains an active asset of the Company and that management is advancing the program toward a Phase 1 human clinical trial.

The problem VICAPSYN^™ addresses

Type 1 diabetes affects roughly two million Americans and more than nine million people worldwide. Transplanting insulin-producing islet cells can restore the body's own insulin production, but the patient's immune system attacks the transplanted cells, so recipients must take immunosuppressive drugs indefinitely. Those drugs carry serious risks of their own, which has kept islet transplantation out of reach for the vast majority of patients.

VICAPSYN^™ takes a different approach. The technology, which originated in research at Massachusetts General Hospital, encloses islet cells in a protective matrix that releases CXCL12, a naturally occurring human protein that repels the immune cells responsible for rejection while recruiting the body's own regulatory cells. The result is a localized zone of immune protection around the transplanted cells-without suppressing the patient's immune system as a whole. Preclinical work, including studies in non-human primates, has been published in peer-reviewed literature. Because the approach is not specific to islet cells, the Company views VICAPSYN^™ as a platform with potential applications across other cell therapies.

What the market has already said about islet cell therapy

In September 2019, Vertex Pharmaceuticals acquired Semma Therapeutics, a privately held developer of stem cell-derived islet cells for type 1 diabetes, for $950 million in cash-before the therapy had entered human clinical trials. The resulting program, zimislecel, has since reported that ten of twelve patients in the Phase 1/2 portion of its study were free of insulin injections at least one year after treatment. Every one of those patients, however, still requires chronic immunosuppression to keep the transplanted cells alive. Vertex's parallel effort to eliminate that requirement by enclosing the cells in an implantable device, VX-264, was discontinued in 2025 after it did not meet its efficacy goals.

Those results establish two things. Islet cell replacement works, and the industry placed a value on it approaching one billion dollars before any human data existed. And the central unsolved problem remains protecting the cells from the immune system without immunosuppressing the patient. That is precisely the problem VICAPSYN^™ was designed to solve.

Vertical integration with the Company's Indian Health Service strategy

Vicapsys is not approaching VICAPSYN^™ as a stand-alone biotech program. The Company's platform is built around underserved markets-Puerto Rico, rural America, and the tribal and federal health systems served by the Indian Health Service, the Department of Veterans Affairs and the Department of Defense-through its licensed wholesale drug distribution subsidiary and its tribal economic-development and federal contracting relationships.

American Indian and Alaska Native communities carry one of the heaviest diabetes burdens of any population in the United States. The Company's strategy is to integrate VICAPSYN^™ into that channel at every stage: pursuing its Phase 1 human trial within an FDA-regulated clinical setting connected to the Indian Health Service network, and, if the program succeeds, manufacturing and delivering the therapy through the same licensed distribution infrastructure the Company is building to supply medicines to those communities. Development, manufacturing and delivery would sit under one company, pointed at the patients who need the therapy most.

A potential international arm: Argentina

The Company is also in exploratory discussions with potential partners in Argentina, a jurisdiction with an established record of conducting human clinical research for major pharmaceutical companies that produced data accepted by the U.S. Food and Drug Administration. During the COVID-19 pandemic, Argentina was one of a handful of countries worldwide selected by Pfizer and BioNTech for the Phase 3 trial of their vaccine, with more than 4,000 volunteers enrolled at a single site in Buenos Aires, and Eli Lilly conducted clinical trials of its COVID-19 antibody therapies at sites across the country. A successful human clinical trial of VICAPSYN^™ in Argentina could support a bifurcated development plan: an international arm, anchored by Argentine clinical data and structured as a Latin American licensing opportunity, running alongside the Company's United States program-with both arms continuing to advance VICAPSYN^™ against its development benchmarks.

Where the program stands

The VICAPSYN^™ program continues under the leadership of Federico Pier, the Company's former Chief Executive Officer, who continues to lead the program, alongside Armando Rubio, Chairman and Chief Executive Officer. The Company is advancing the proof-of-concept work required to moveVICAPSYN^™ into a Phase 1 human clinical trial and is assembling the pre-clinical, regulatory and manufacturing components needed for that trial. Management will update shareholders as milestones are reached.

"VICAPSYN^™ is a core asset of this Company and it is moving forward," said Armando Rubio, Chairman and Chief Executive Officer of Vicapsys. "The reverse merger gave Vicapsys what a development-stage biotech almost never has: a licensed, revenue-generating operating business and a federal channel into the patient populations that need this therapy most. Vertex paid $950 million for islet cell technology before it had been in a human being, and its patients still need immunosuppressants. The industry has already told us what an islet therapy that does not require immunosuppression would be worth. Our job is to carry VICAPSYN^™ from the laboratory to a Phase 1 trial and, ultimately, to deliver it through the same channel we are building to supply medicines to tribal, rural and federal health systems."

About Vicapsys Life Sciences, Inc.

Vicapsys Life Sciences, Inc. (OTC PINK:VICP) is a pharmaceutical platform company focused on underserved markets. Through its subsidiary, Stateline Distributors of Puerto Rico, Inc., a licensed, DSCSA-compliant wholesale drug distributor serving more than 400 healthcare accounts in Puerto Rico, and its mainland and federal channels, the Company targets rural, tribal, Indian Health Service, Department of Veterans Affairs and Department of Defense markets that are structurally underserved by the largest national wholesalers. The Company's platform also includes the NitroMist^® relaunch initiative and the VICAPSYN^™ immune-isolation development program.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements include, without limitation, statements regarding the Company's plans, strategy and expectations for the VICAPSYN^™ program, including the timing and conduct of preclinical and clinical activities, the potential for a Phase 1 human clinical trial, the Company's strategy with respect to the Indian Health Service and other federal and tribal health channels, potential international clinical development and licensing arrangements, including in Argentina, manufacturing arrangements, and the potential applications and value of the Company's technology. These statements are based on current expectations and are subject to risks and uncertainties that could cause actual results to differ materially, including the Company's ability to secure the rights, financing, regulatory authorizations, clinical sites and partners necessary to advance the program, and the outcome of preclinical and clinical studies. The Company undertakes no obligation to update any forward-looking statement except as required by law. VICAPSYN^™ is an investigational technology and has not been approved by the U.S. Food and Drug Administration or any other regulatory authority.

Contact:
Vicapsys Life Sciences, Inc.
Media
[email protected]
(305) 565-8002

SOURCE: Stateline Distributors

View the original press release on ACCESS Newswire

D.Sawyer--AMWN