Generex Biotechnology Corporation (GNBT)

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Scientus Pharma Provides Update on Buccal Cannabis Development Program

TORONTO,  October 31, 2018 –  HydRx Farms Ltd. (o/a Scientus Pharma) (“Scientus” or the “Company”), a biopharmaceutical company conducting research and product development for extracts and formulations related to medical cannabinoids and their derivatives, today provided an update on its collaboration with Generex Biotechnology Corporation (OTCQB:GNBT) (“Generex”), whereby the companies are co-developing products for the delivery of cannabinoids via the buccal mucosa (the inner lining of the mouth).

 

Having recently received Health Canada authorization to produce cannabis softgel capsules and oils at its state-of-the-art, 45,000 Sq. Ft. commercial production facility in Whitby, Ontario, the Company will turn its focus towards the final development of a buccal cannabis spray using Generex’s RapidMist™ technology.

 

“The ability to produce through our proprietary extraction and activation method an intermediary resin that is >99% activated for THC and CBD allows us to provide cannabis APIs at scale that can be incorporated into a variety of delivery methods, such as buccal spray, that were previously challenged by suboptimal potency and/or bioavailability,” said Har Grover, Chairman and CEO of Scientus. “Our collaboration with Generex provides access to the drug delivery technology that will enable development of an effective cannabis buccal spray. This route of administration is an attractive alternative to patients who have concerns about inhaling or eating medical cannabis, but still want its full therapeutic benefit.”

 

“The RapidMist Buccal Delivery System from Generex is perfectly suited to the formulation and administration of cannabinoids for therapeutic benefit”,  said Joe Moscato, CEO of Generex. “THC and CBD ratios can be formulated specifically for therapeutic indications to achieve optimal benefit, and the device provides a consistent, reliable metered dose to ensure proper use. Patients will be satisfied with the ease of use and reliability of effect of the RapidMist Cannabis product line.”

 

About the Scientus Pharma/Generex Collaboration

In September 2015, CannScience Innovations Inc., one of Scientus’ predecessor companies,  finalized a binding co-development and technology licensing agreement with Generex. Pursuant to the agreement, Generex has licensed its proprietary RapidMist™ drug delivery platform technologies to Scientus for the co-development of products for the buccal delivery of cannabinoids and cannabinoid-derived products. Generex has also granted Scientus an exclusive, worldwide license to commercialize such products in exchange for royalty payments.  Generex and Scientus will co-own the intellectual property created by the co-development effort.

 

About Scientus Pharma’s Production

The cannabis plant is highly complex with more than 500 compounds. Although many growers have developed standardized cultivation methods to reduce variation between harvests, more precision is required to reduce or eliminate this variation and align with the high standards of the pharmaceutical and consumer products industries.

 

Scientus Pharma has developed a proprietary method for the extraction and activation of API from the cannabis plant. This method provides the chemical and biological quality control appropriate for pharmaceutical grade product lines, resulting in an intermediary resin that can be used in a range of dosing forms.

 

About Generex Biotechnology Corporation

Generex is a strategic, diversified healthcare holdings company with offerings in a variety of services, diagnostics, medical devices, and pharmaceutical development. The Company’s direct-to-patient services support its strategy of all-inclusive access to doctors, diagnostics, therapeutics, and additional health-related services to greatly improve the patient experience in receiving care. On the provider side, Generex’s management services remove administrative burdens in multiple provider settings, including private practice and hospital, allowing doctors to devote more time to patient care. Revenue from the Company’s subsidiaries will support clinical advancement of its wholly owned therapeutic products with a focus in immunotherapeutics based on stimulating critical members of the immune response, known as T helper cells, and its proprietary buccal administration of insulin.

 

About Scientus Pharma Inc.

Scientus is a vertically-integrated biopharmaceutical Licensed Producer and Licensed Dealer under the Narcotics Control Regulations of Canada who conducts scientific research on cannabinoids with a focus on developing and commercializing pharmaceutical-grade cannabinoid derivative products. Being one of a limited number of Licensed Dealers in Canada authorized to handle and conduct cannabinoid products, Scientus has the ability to wholesale, buy, process and sell cannabinoid derivatives, from and to other Licensed Producers, as well as international markets. Scientus is also a Licensed Producer under the Access to Cannabis for Medical Purposes Regulations (ACMPR).

 

Forward-Looking Statements

This new release includes forward-looking statements regarding the Company and its business. Such statements are based on the current expectations and views of future events of the Company’s management. In some cases, the forward-looking statements can be identified by words or phrases such as “may”, “will”, “expect”, “plan”, “anticipate”, “intend”, “potential”, “estimate”, “believe” or the negative of these terms, or other similar expressions intended to identify forward-looking statements. Forward-looking statements in this press release include the Company’s development of a buccal cannabis product.  No forward-looking statement can be guaranteed. In addition, certain information set forth in this news release may contain forward-looking information that involves substantial known and unknown risks and uncertainties. This forward-looking information is subject to numerous risks and uncertainties, certain of which are beyond the control of the Company, including, but not limited to, the impact of general economic conditions, industry conditions, and dependence upon regulatory approvals. Readers are cautioned that the assumptions used in the preparation of such information, although considered reasonable at the time of preparation, may prove to be imprecise and, as such, undue reliance should not be placed on forward looking information or statements. Except as required by applicable securities laws, forward-looking statements or information speak only as of the date on which they are made, and the Company does not undertake any obligation to publicly update or revise any forward-looking statement or information, whether as a result of new information, future events, or otherwise.

 

Contacts:

Corporate:

Har Grover
Chairman and CEO
1-844-493-7922
hgrover@scientuspharma.com

 

Investors:

Stephen Kilmer

1-647-872-4849

skilmer@scientuspharma.com

 

Media:

Sonya Friesen

MSL Group

1-416-847-1343

sonya.friesen@mslgroup.com

Source:  Generex Biotechnology Corporation

Generex Biotechnology Announces IND Filing for a Phase II Clinical Trial of AE37 in Combination with Pembrolizumab (Keytruda®) for the Treatment of Triple-Negative Breast Cancer

MIRAMAR, Fla.- Generex Biotechnology Corporation (www.generex.com) (OTCQB:GNBT) (http://www.otcmarkets.com/stock/GNBT/quote) today announced that the Company filed an investigational new drug application (IND) with the U.S. Food & Drug Administration (FDA) to initiate A Phase II Clinical Trial of Pembrolizumab (Keytruda®) in Combination with the AE37 Peptide Vaccine in Patients with Metastatic Triple Negative Breast Cancer. The trial, sponsored by Generex wholly-owned subsidiary Antigen Express, Inc. (www.antigenexpress.com) and conducted in conjunction with research partners Merck and the NSABP Foundation, Inc. (NSABP), is scheduled to initiate sites in the fourth quarter and to begin enrolling patients in the first quarter of 2019.

 

Dr. Eric von Hofe, President of Antigen Express, commented, “This is an important milestone in the development of AE37. Combining our promising immunotherapeutic with Merck’s checkpoint inhibitor Keytruda® (pembrolizumab) for the treatment of triple-negative breast cancer represents a novel treatment strategy for a cancer of high unmet need. Previous studies with each agent alone showed promising signs of efficacy. Their complementary mechanisms of action are particularly exciting and point to the importance of the current trial.”

 

Richard Purcell, Executive Vice President – Research & Development of Generex, commented, “This IND filing represents the culmination of a committed effort by the team at Antigen Express and our research partners at the NSABP Foundation. Antigen Express has been a pioneer at the forefront of immuno-oncology for over a decade with our Ii-Key platform that ensures CD4 T-cell activation against any tumor antigen to which the Ii-Key is attached. We are advancing this technology with our lead product AE37 for breast cancer, but also for the treatment of prostate and potentially other cancers that express even low levels of HER2/neu. The Ii-Key platform holds great promise, and we plan to explore collaborations and partnerships in the field of personalized immuno-oncology to maximize value for our investors.”

 

About AE37

AE37 is an investigational therapeutic cancer vaccine being developed to treat cancer in women with certain types of breast cancer. It is a combination of portions of two proteins that together stimulate the immune system to fight cancer cells.

 

Up to 80 percent of breast cancers express some level of a protein called HER2. While treatments exist to target HER2 in breast cancer patients with the highest level of HER2 expression (roughly 25%), the majority of patients who have lower levels of expression have more limited treatment options. AE37 consists of a protein derived from the HER2 protein combined with a portion of the MHC class II associated invariant chain which has been termed Ii-Key.

 

AE37 does not directly target HER2, but instead acts as a vaccine to activate the immune system to recognize the HER2 protein that is expressed on cancer cells as foreign.

 

AE37 ensures activation of CD4-positive lymphocytes, immune cells that are important in stimulating both the antibody response (antibodies against HER2) and cellular responses directed against the HER2 protein in breast cancer cells. The Ii-Key peptide is coupled with the HER2 protein to ensure a more robust and long-lasting response.

 

About Generex Biotechnology Corporation

Generex is a strategic, diversified healthcare holdings company with offerings in a variety of services, diagnostics, medical devices, and pharmaceutical development.

 

The Company’s direct-to-patient services support its strategy of all-inclusive access to doctors, diagnostics, therapeutics, and additional health-related services to greatly improve the patient experience in receiving care.

 

On the provider side, Generex’s management services remove administrative burdens in multiple provider settings, including private practice and hospital, allowing doctors to devote more time to patient care.

 

Revenue from the Company’s subsidiaries will support clinical advancement of its wholly owned therapeutic products with a focus in immunotherapeutics based on stimulating critical members of the immune response, known as T helper cells, and its proprietary buccal administration of insulin.

 

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 Biotechnology Corporation
Joseph Moscato, 646-599-6222
or
Todd Falls, 800-391-6755 Extension 222
investor@generex.com
or
Russo Partners
Investor / Media Contacts:
Alex Fudukidis, 646-942-5632
alex.fudukidis@russopartnersllc.com
or
Caroline Cunningham, 212-845-4292
Caroline.Cunningham@russopartnersllc.com

Source: Generex Biotechnology Corporation

Generex Announces Launch of NuGenerex Distribution Solutions

Company Provides Details on Service Offerings for Doctors, Hospitals, Health Systems and Patients

 

MIRAMAR, Fla.– Generex Biotechnology Corporation (www.generex.com) (OTCQB:GNBT) (http://www.otcmarkets.com/stock/GNBT/quote) is pleased to announce the launch of NuGenerex Distribution Solutions, and the commencement of business operations enabled through the acquisition of certain operating assets of Veneto Holdings, L.L.C., as announced on October 9, 2018.

 

NuGenerex Distribution Solutions (NDS), an affiliate of Generex, has begun implementing its plan to provide essential management services to an extensive network of top-tier ancillary service providers, including pharmacies, laboratories, diagnostic imaging centers, and durable medical equipment manufacturers.

 

Generex Chief Operating Officer, Terry Thompson, stated, “Generex will be providing centralized insurance adjudication, product procurement, and other support services that allow the acquired assets to increase revenue and service quality, decreasing costs, while focusing on providing better patient care. On November 1, 2018, when the anticipated second phase of the acquisition of the Veneto assets is completed, NDS will be able to expand its management services to include legal and regulatory compliance, accounting, HR, IT and other support services to the current and future acquired assets. One of the key benefits of the acquired assets is that they will allow NDS to begin developing its chronic care management and medication therapy management service initiatives by utilizing their dedicated call centers and technology infrastructure in 2019.”

 

Mr. Thompson continued, “NDS benefits the medical community by providing cost effective ancillary services that ultimately deliver better outcomes and enhance the doctor-patient relationship. Utilizing our proprietary pharmacy workflow management systems and dedicated call centers, we will be able help our ancillary service providers, physicians, and patients to better coordinate healthcare services from diagnosis through treatment and follow-up. Over and above the services we provide to pharmacies, one of the keys to the historical success of this model is managing how the pharmacy network provides topical non-opioid treatments that physicians can utilize for their patients for pain management. This helps combat the current opioid epidemic by significantly reducing the risk of addiction to oral pain medications, lowering overall cost to the healthcare system and providing better patient outcomes. We are excited about the repurposing of the Generex family of companies and look forward to growing this proven model that provides compliant operational efficiency for providers, transparency for payers, and convenience that enhances patient satisfaction throughout the continuum of care,” Mr. Thompson concluded.

 

Generex Chief Medical and Scientific Officer, Dr. Jason Terrell, added, “NDS will provide a broad range of outstanding services to benefit patients and physicians alike. The launch of NDS allows us to have an immediate impact on patient care and provides the foundation to support our rapid growth and expansion into other areas in healthcare. NDS represents another successful advancement to our overall goal to improve patient care through innovative products and 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 Biotechnology Corporation
Joseph Moscato, 646-599-6222
or
Todd Falls, 800-391-6755 Extension 222
investor@generex.com

Source: Generex Biotechnology Corporation

About Generex Biotechnology

Generex Biotechnology has been engaged primarily in the research and development of drug delivery systems and technologies. Our primary focus has been our proprietary technology for the administration of formulations of large molecule drugs to the oral (buccal) cavity using a handheld aerosol applicator.

 

Generex Biotechnology has a two business focuses: 1) implementing an acquisition strategy and 2) financing sponsored clinical trials. We are positioning ourselves as a diversified holding company involved in increasing our “pipeline” of compounds, therapies, treatments, diagnostics, and technologies in all stages in the FDA process through accretive acquisitions. We are also strategically aligning ourselves with the global biopharmaceutical companies by providing a financing solution to them as sponsors of clinical trials, which are conducted by patient care providers (PCPs) such as hospitals, medical research institutes, centers, and clinics.

 

We are Dedicated to Biopharmaceutical Research & Advancement

 

Generex Biotechnology Corp., is a biopharmaceutical company that is actively involved in discovery, research, development, and financing of new compounds, therapies, diagnostics, delivery systems, and medical technologies.

 

Technology

 

Generex Biotechnology Corp. is developing innovative technologies for reliable, convenient, pain-free delivery of both small and large-molecule drugs. To date we have focused on creating a unique liquid formulation that can be administered directly into the mouth as an aerosol spray for absorption through the buccal mucosa, the mucous membranes that line the inner walls of the cheek.

 

The buccal mucosa offers a near ideal, non-invasive portal through which large-molecule drugs might enter the body. The large surface area of the buccal mucosa provides direct access to a rich network of blood vessels, offering the potential of rapid absorption of medications into the circulatory system. Using this route, drugs avoid the gastrointestinal system and other hostile environments.

 

Medications based on large molecules (also called macromolecules) are increasingly crucial to the treatment of many diseases and conditions. In fact, large-molecule biopharmaceutical products – including proteins, peptides, and nucleic acids-are sometimes referred to as “next generation” medicines. Unfortunately, large molecules have some challenging properties. They are:

 

  • Poorly absorbed through the epithelial membrane
  • Easily destroyed by gastrointestinal acids and enzymes
  • Relatively insoluble

 

Large-molecule drugs are therefore usually introduced into the body via injection and that is a problem. Injections are painful, inconvenient, and often must be delivered by trained medical staff. For these reasons, injection is not a user-friendly drug delivery system.

 

The discomfort of a daily regimen of injections increases patient anxiety, which clearly is an undesirable outcome in itself. Moreover, as anxiety increases, compliance decreases, and that has serious repercussions. For the individual patient, decreased compliance with a medication schedule often leads to a serious deterioration in health. For the health care system as a whole, decreased compliance is extremely costly – in the US alone, hospital and physician visits attributable to noncompliance have an estimated price tag of $8.5 billion.

 

Scientists in academic and commercial laboratories have attempted to find less invasive alternatives to injection of large-molecule drugs, but so far most of the results have not been useful. That is why the preliminary success of the Generex approach – buccal delivery of large-molecule drugs – is so exciting.

 

Generex ​Oral-lyn

 

Generex Oral-lyn, is an insulin spray for the treatment of Type I and Type II diabetes. Generex Oral-lyn; is a safe, simple, fast, effective, and pain-free alternative to subcutaneous injections of prandial insulin and is conveniently delivered to the membranes of the oral cavity by a simple asthma-like device with no pulmonary (lung) deposition.

 

As a pain-free and convenient method of insulin delivery, Generex Oral-lyn will allow individual patients to “fine tune” and then maintain their metabolism resulting in an improved quality of life. Accordingly, Generex Oral-lyn provides the opportunity for the establishment of a new and more effective diabetes treatment paradigm.

 

RapidMist an advanced buccal drug delivery technology, is comprised of a proprietary formulation and a proprietary device design that is able to deliver drugs through the buccal mucosa safely, thereby eliminating the pain from and need for multiple injections. RapidMist has been shown to have a rapid onset of action with no lung deposition, precise dosage control, easy use and handling, and improved patient compliance.

 

The formulation involves the preparation of a proprietary process in which an active pharmaceutical agent is placed in a solution with a combination of absorption enhancers and other excipients classified generally recognized as safe (“GRAS”) by the Food and Drug Administration (“FDA”) when used in accordance with specified quantity and other limitations. The formulation is a liquid that contains a medication plus a number of enhancers. The enhancers are the key. They help the medication penetrate the epithelial membrane of the buccal mucosa, and they also promote rapid absorption of the drug into the circulatory system.

 

Enhancers are surface-active compounds, called surfactants. A surfactant is an organic chemical that contains both hydrophilic and hydrophobic ends. Because one end of a surfactant resists water and the other end embraces it, a surfactant has some unique characteristics. For example, under certain conditions, a surfactant assumes a micelle structure. In a micelle, the ‘water-loving’ ends of the surfactant form a protective shell around the ‘water-hating’ ends. Micelles are critical to drug delivery, because the protective shell of a micelle can be used to surround a large molecule. The micelle then carries the target molecule through cell membranes and even through cell walls.

 

A relatively small concentration of surfactant not only allows a drug to traverse mucous membranes rapidly, but it also increases both the solubility and the stability of the drug, which makes it possible to achieve therapeutic levels of the drug in blood plasma. After years of research and tests, our scientists have succeeded in identifying a unique combination of enhancers that makes it possible to deliver a large-molecule drug – insulin – as an oral spray that is absorbed through the buccal mucosa.

 

Management ​& Directors

 

Joseph Moscato – President & Chief Executive Officer
Mr. Moscato over 30 years of experience in healthcare, sales, marketing, and finance.

 

Terry Thompson  – Chief Operating Officer
Mr. Thompson brings a wealth of experience and expertise in healthcare, providing executive leadership in pharmacy benefits management, network administration, claims processing, and distribution & logistics for drugs, durable medical equipment (DME), and infusion therapy, as illustrated by his impressive 35-year career.

 

Mark Fletcher, Esq. – Company’s Executive Vice-President,
​General Counsel, and Secretary

Mr. Fletcher served as the Company’s President & Chief Executive Officer from September 2010 through January 2017 and as a member of the Board of Directors from March 2011 through January 2017.  He served as the Company’s Executive Vice-President and General Counsel from April 2003 through September 2010.   Prior to joining Generex, Mr. Fletcher was engaged in the private practice of corporate/commercial and securities law as a partner at Goodman and Carr LLP, a leading Toronto law firm.  Mr. Fletcher received his LL.B. from the University of Western Ontario and is a member of the Law Society of Upper Canada, the Canadian Bar Association, and the Association of Corporate Counsel.

 

Andrew Ro – Chief Investment Officer, Senior VP of Investments, Director
Mr. Ro over 20 years of experience in the financial markets. He is a partner with an investment fund.

 

Mark Corrao – Chief Financial Officer, Treasurer

Mr. Corrao over 20 years of experience in financial management. He is also involved in the initial registration of numerous public companies and subsequent SEC quarterly and annual reporting. He is the CFO and a Director for a pharmaceutical company specializing in research and development, as well as novel and new therapeutic agents as immune modulators and neuroprotectants.

Jacob Dagan, Ph.D. – VP Business Development, Director

Dr. Dagan over 25 years of proven success in healthcare management, corporate and product development, operations, marketing, sales, and hospital management. He also has strong biomedical scientific skills.

 

 Craig Eagle, MD – Director

Dr. Eagle Head of Pfizer European, Head of Pfizer Canada, and Senior Director, Global Oncology Pfizer Global Pharmaceuticals.

 

Gary Lyman, MD, MPH -Director

Dr. Lyman is co-director of the Fred Hutchinson Institute for Cancer Outcomes Research, as well as Professor of Medicine and Professor in the Schools of Public Health & Pharmacy at the University of Washington.

 

Jason B. Terrell, MD – Director, Chief Medical and Scientific Officer

Dr. Terrell is currently Chief Medical Officer and Head of U.S. Operations for a NYSE-traded international medical diagnostic company.

 

Richard Purcell – Senior Vice President Research & New Drug Development, Director

Mr. Purcell is a consultant and advisor for emerging biopharmaceutical and technology companies on new business strategy, operations management, clinical development of novel compounds, data solutions for clinical and medical applications, and patient engagement and communication, as well as medical education for professionals, consumers, and data analytics for outcomes research.

Lawrence Salvo – Director

Mr. Salvo is the founder of rapid diagnostic tests for infectious diseases. He is involved in the management of international distribution, sales, and design and has developed and maintained substantial and long-term relationships within China, South and Central America, and the African Continent.

 

Investor ​Relations

 

Generex Biotechnology Corp. (OTCMKTS:GNBT) is a biopharmaceutical company focused on developing or acquiring technologies that help pharmaceutical companies discover and develop medicines.  Our company creates value for stockholders by providing a diversified portfolio of biotech and pharmaceutical product revenue streams that are supported by an efficient and low corporate cost structure.

 

The company goal is to offer investors an opportunity to participate in the promise of the biotech industry in a profitable, diversified and lower-risk business than a typical biotech company. Our business model is based on doing what we do best: drug discovery, early-stage drug development, product reformulation and partnering.  We partner with other pharmaceutical companies to leverage what they do best (late-stage development, regulatory management and commercialization) to ultimately generate our revenue.

 

SOURCE:  http://www.generex.com/

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