Excellagen Clinical Trial Analysis: Rapid Healing of Diabetic Neuropathic Foot Ulcers

Presentation on Friday Evening April 5, 2019 at the JW Marriott Hotel in Washington, DC

MIRAMAR, FL, March 26, 2019 (GLOBE NEWSWIRE) -- via NEWMEDIAWIRE – Generex Biotechnology Corporation (OTCMKTS: GNBT) today announced that its subsidiary, Olaregen Therapeutix, Inc., has been selected to present clinical data and a subset analysis of the Excellagen clinical trial dataset in a formal poster presentation. Dr. Lois Chandler, inventor of Excellagen and an advisor to Olaregen, will be presenting the poster, Wound Conforming Matrix (WCM) Promotes Rapid Healing of Diabetic Neuropathic Foot Ulcers: Subset Analysis of Randomized Controlled Trial on Friday evening, April 5th in a special poster session at the JW Marriott Hotel in Washington DC, the official site of the DLS Meeting. The poster will present clinical data demonstrating acceleration in wound healing for Olaregen’s Excellagen (formulated fibrillar collagen 2.6%) as compared with Standard of Care (SOC) in patients with diabetic neuropathic foot ulcers. 

Dr. Chandler’s co-authors on the manuscript include Robert Kirsner, MD, PhD (University of Miami), Oscar Alvarez, PhD (Rutgers University), Peter Blume, DPM, (Yale University), John Lantis, MD (Mount Sinai Hospital – NY), Paul Kim, DPM (Georgetown University), and William Marston, MD (University of North Carolina).

The Diabetic Limb Salvage meeting will be attended by approximately 500 wound care clinicians and researchers from around the world dedicated to treating diabetes-related foot complications, including diabetic foot ulcers (DFUs), which are leading causes of non-traumatic lower extremity amputation. In the United States, a total of $176 billion is spent annually on direct costs for diabetes, and as much as one third of that (>$50 billion) is spent on lower extremity complications (Driver et al, J Vasc Surg 2010).

Olaregen Therapeutix is preparing for the impending launch of Excellagen, an FDA 510K cleared device for a broad array of dermal wounds, including diabetic foot ulcers. “This is a very exciting opportunity for Olaregen to have our clinical research on Excellagen selected for presentation at one of the most preeminent wound care events in the world, providing us with a highly visible platform to highlight the benefits of Excellagen for the treatment of diabetic foot ulcers,” said Anthony Dolisi, CEO & President of Olaregen. “As we are introducing Excellagen to the market next month, the DLS meeting serves as an invaluable launching pad to reach the experts in diabetes care.”

Joe Moscato, CEO of Generex, commented, "We are excited at Generex to have our subsidiary Olaregen launch Generex’ first U.S. commercial product, Excellagen wound conforming matrix that is FDA-cleared for 17 wound healing indications, including diabetic foot ulcers. The performance of the Olaregen management team in launching Excellagen demonstrates our strategy to acquire great companies with innovative, FDA approved products, guided by exceptional management teams that can execute on strategic and commercial plans. We wish Dr. Chandler the best in her poster presentation.”

About Generex Biotechnology

Generex Biotechnology is a strategic, diversified healthcare holdings company with offerings in a variety of services, diagnostics, medical devices, and pharmaceutical development. The mission of the company is to provide physicians, hospitals, and all healthcare providers with an end-to-end solution for patient centric care from rapid diagnosis through delivery of personalized therapies, streamlining care processes, minimizing expenses, and delivering transparency for payers.

About Olaregen Therapeutics

Olaregen Therapeutix, Inc. is a regenerative medicine company focused on the development, manufacturing and commercialization of products that fill unmet needs in the current wound care market. The company aims to provide advanced healing solutions that substantially improve medical outcomes while lowering the overall cost of care. Olaregen's first product introduction, Excellagen (flowable dermal matrix) is a topically applied product for dermal wounds and other indications. Excellagen is an FDA 510K cleared device for a broad array of dermal wounds, including partial and full thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (donor sites/ grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns and skin tears) and draining wounds, enabling Olaregen to market Excellagen in multiple vertical markets. Additionally, Excellagen can serve as an Enabling Delivery Platform for pluripotent stem cells, antimicrobial agents, small molecule drugs, DNA-Based Biologics, conditioned cell media and peptides. Olaregen's initial focus will be in advanced wound care including diabetic foot ulcers (DFU), venous leg ulcers and pressure ulcers. Future products focusing on innovative therapies in bone and joint regeneration comprise the current pipeline. The company's mission is to become a significant force in regenerative medicine and advance the science of healing.

About our Service-Disabled Veteran-Owned Small Business (SDVOSB)

This a Service-Disabled Veteran-Owned Small Business (SDVOSB) that specializes in the sale, marketing, and distribution of innovative medical products through a nationwide network of veteran owned distribution services.

Cautionary Note Regarding Forward-Looking Statements

This release and oral statements made from time to time by Generex representatives in respect of the same subject matter may contain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements can be identified by introductory words such as "expects," "plan," "believes," "will," "achieve," "anticipate," "would," "should," "subject to" or words of similar meaning, and by the fact that they do not relate strictly to historical or current facts. Forward-looking statements frequently are used in discussing potential product applications, potential collaborations, product development activities, clinical studies, regulatory submissions and approvals, and similar operating matters. Many factors may cause actual results to differ from forward-looking statements, including inaccurate assumptions and a broad variety of risks and uncertainties, some of which are known and others of which are not. Known risks and uncertainties include those identified from time to time in the reports filed by Generex with the Securities and Exchange Commission, which should be considered together with any forward-looking statement. No forward-looking statement is a guarantee of future results or events, and one should avoid placing undue reliance on such statements. Generex undertakes no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.  Generex claims the protection of the safe harbor for forward-looking statements that is contained in the Private Securities Litigation Reform Act.

Generex Contact:
Generex Biotechnology Corporation
Joseph Moscato

Todd Falls
1-800-391-6755 Extension 222

Olaregen Contact:
Anthony Dolisi, CEO