Generex Biotechnology Announces Plans to Establish the NuGenerex Diabetes Research Center in Collaboration With Arizona Endocrinology Group & Paradise Valley Medical Family Medicine

• Integrated, collaborative data systems enable population analytics
  
  
• Generex plans to accelerate the clinical development of Oral-Lyn-2 for Type-2 diabetes and Altsulin^® for Type-1 diabetes

MIRAMAR, Fla., Sept. 27, 2019 (GLOBE NEWSWIRE) -- Generex Biotechnology Corporation (OTCQB:GNBT) is pleased to announce plans to establish the NuGenerex Diabetes Research Center in collaboration with Arizona Endocrinology Group and Paradise Valley Family Medicine, P.C., our partners in our previously announced MSO, NuGenerex Health, LLC. Together, the collaborative medical practices provide integrated primary and specialty care, as well as pharmacy services to a patient population of roughly 65,000 patients, 25,000 of whom are insulin-dependent diabetes patients.

The NuGenerex Diabetes Research Center (NDRC) will focus on data analytics and clinical trial management to promote the clinical development of innovative medicines and therapeutic strategies for the benefit of patients.  The NuGenerex Health partners utilize a common electronic medical record to facilitate both prospective and retrospective analyses, and with an integrated pharmacy record, enabling virtual clinical research studies that can be used to evaluate compliance and predict outcomes. Also, NDRC plans to evaluate the impact of various educational initiatives to improve patient health.  

Another goal of the NDRC will be to accelerate the development of the Generex clinical pipeline, including the reformulated Oral-Lyn-2 for Type-2 diabetes and Altsulin^® from our soon to be subsidiary ALTuCELL for the treatment of Type-1 diabetes. Both clinical development programs are expected to initiate in the first quarter of 2020.

Richard Purcell, Generex Executive Vice President of Research and Development said, “By establishing NuGenerex Diabetes Research Center with our partners at Arizona Endocrinology Group and Paradise Valley Family Medicine, we have a platform to relaunch the Oral-Lyn-2 clinical development program and to evaluate the safety and efficacy of ALTuCELL’s amazing microencapsulation technology and cellular implantation therapy that may have the potential to actually cure Type-1 diabetes. Furthermore, we have made a corporate commitment to data analytics, and the opportunities to utilize the real-world real-time, deidentified data sets from a large population of complex diabetes patients will enable us to identify best practices for patient-centric therapy that will improve outcomes and reduce the costs of diabetes care.”

Joe Moscato, President & Chief Executive Officer of Generex commented, “Once we establish the NDRC with our partners, and implement the research platform for our own products, Oral-Lyn-2 and AltsulinÒ, we will open up our diabetes research center of excellence to diabetes drug developers for clinical trials of promising new therapies. It is rare to have a clinical research team with twelve (12) endocrinologists, four (4) internal medicine physicians, and six (6) primary care providers, and a population of about 40,000 patients with diabetes. Plus, we are in discussions with several additional primary care practices with over fifty (50) providers that will provide access to an additional 150,000 patients who may benefit from clinical research opportunities. This powerful NDRC research engine will be very attractive to large pharmaceutical companies with diabetic platforms as we strive to accelerate the development of new medicines.”

About Generex Biotechnology Corp.

Generex Biotechnology is an integrated healthcare holding company with end-to-end solutions for patient centric care from rapid diagnosis through delivery of personalized therapies. Generex is building a new kind of healthcare company that extends beyond traditional models providing support to physicians in an MSO network, and ongoing relationships with patients to improve the patient experience and access to optimal care.

In addition to advancing a legacy portfolio of immune-oncology assets, medical devices, and diagnostics, the Company is focused on an acquisition strategy of strategic businesses that complement existing assets and provide immediate sources of revenue and working capital. Recent acquisitions include a management services organization, a network of pharmacies, clinical laboratory, and medical device companies with new and approved products. 

Our newly formed, wholly-owned subsidiary, NuGenerex Distribution Solutions (NDS), integrates our MSO network with a pharmacy network, clinical diagnostic lab, durable medical equipment company (DME-IQ) and dedicated call center.

About Olaregen Therapeutix

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. Generex 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 a 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. Generex's mission is to become a significant force in regenerative medicine and advance the science of healing.

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

646-599-6222

Todd Falls

1-800-391-6755 Extension 222