Jay Pharma to File IND Applications to FDA for a clinical study of proprietary formulations in Radiodermatitis and a combination Therapy in Glioblastoma
On July 29, 2020, AMERI Holdings, Inc. (NASDAQ: AMRH) announced its proposed amalgamation with Jay Pharma Inc. Jay Pharma is set to file two IND applications for treatments aimed at radiodermatitis and glioblastoma multiforme (GBM). Key leadership appointments include Dr. Robert Wilkins as Chief Medical Officer and Dr. Steven Weisman as part of the regulatory team. The GBM clinical trial in Israel will involve 40 participants, assessing a proprietary CBD formulation. The company aims to navigate FDA processes efficiently, marking a significant growth phase for Jay Pharma.
- Appointment of Dr. Robert Wilkins as Chief Medical Officer to enhance IND filing process.
- Plans for IND applications targeting radiodermatitis and GBM treatments.
- Approval for a GBM study in Israel, indicating progress in clinical trial preparations.
- Risks associated with regulatory approval for the IND applications.
- Challenges inherent in conducting human clinical trials, especially for GBM.
ATLANTA, July 29, 2020 /PRNewswire/ -- AMERI Holdings, Inc. (NASDAQ: AMRH) ("Ameri"), announced that its proposed amalgamation partner Jay Pharma Inc. ("Jay Pharma" or "the Company") has announced the addition of new senior staff as the Company prepares to file two new investigational new drug (IND) applications for the treatment of radiodermatitis and glioblastoma multiforme (GBM).
Dr. Robert Wilkins is joining Jay Pharma as Chief Medical Officer. He will begin in the role immediately.
"Jay Pharma is seeking to bring oncology drugs to the market through FDA approval," said Dave Johnson, Jay Pharma's CEO-elect. "With Dr. Wilkins, we are bringing in the skillset necessary to enhance our organization and allow us to navigate the IND process with confidence."
Over the course of a 30-year career, Wilkins has held leadership positions in medical affairs, product development, marketing, commercialization, and business development at leading pharmaceutical companies, such as Abbott, Baxter, and Battelle. Since 2001, Wilkins has consulted with multiple innovators in the medical and pharmaceutical space, such as valve replacement system Endovalve and glucose monitoring equipment GlucoLight.
"Jay Pharma is poised to enter an exciting new stage of growth, and I am delighted to be a part of it," Wilkins said.
Johnson described Wilkins as an "excellent steward" to advance the Company's plans for filing two INDs: a combination therapy drug for the treatment of GBM, and a topical radiodermatitis treatment.
"We recently announced Investigational Review Board (IRB) approval for a GBM study at the Rabin Institute in Israel, and we plan to commence a study for radiodermatitis in the U.S.," Johnson said. "Bob will be crucial to advancing both of these initiatives."
In addition to Dr. Wilkins, Jay Pharma is pleased to announce the signing of Dr. Steven Weisman and Innovative Science Solutions (ISS) Regulatory Services. Steve and the ISS team have decades of experience developing regulatory strategies, product development, preclinical and clinical testing programs, regulatory submissions, and product defense/communication strategies for drugs, foods, cosmetics, and dietary supplements. Weisman also has specialty knowledge in analyzing the scientific and regulatory aspects of potential new products and the development of responses to FDA rule-makings.
"Steve will be an important voice in the preparation of our INDs, and our quality systems," said Wilkins. "We will work closely to ensure Jay Pharma is properly structured to work with the FDA and other regulatory agencies around the world."
The IND program, administered by the U.S. Food and Drug Administration (FDA), is the process through which a Company receives authorization to conduct human clinical trials in the U.S. According to Johnson, the Company plans to enter clinical trials for both its radiodermatitis and GBM formulations upon receipt of FDA clearance.
The radiodermatitis topical formulation has been designed to utilize the Company's proprietary cannabidiol (CBD) formula with the cannabinoid Cannabigerol (CBG) and other ingredients to help alleviate the discomfort caused by radiodermatitis, a skin condition that is a consequence of radiation therapy. It is one of the most common side effects experienced by cancer patients. The topical product is intended to be both preventative and to treat existing radiodermatitis.
A rare and aggressive form of brain cancer, glioblastoma multiforme (GBM) is notoriously resistant to currently available cancer treatments. Phase I/II human clinical trials in Israel will administer the Company's proprietary synthetic CBD formula to 40 enrollees: half of whom will be treated with the CBD formula, and the other half will be treated with the formula in combination with clomiphene, an estrogen binding site inhibitor.
"Our goal is to advance novel treatments that will improve the lives of cancer patients around the world," Johnson said. "With the additions of Dr. Wilkins and Dr. Weisman to the Jay Pharma team, we believe that we have the right individuals to help lead us into this next phase of the Company."
ABOUT JAY PHARMA:
Jay Pharma is dedicated to developing innovative, evidence-based medicines and combination therapies to address unmet needs in cancer care. Our mission is to improve the lives of patients suffering from cancer, initially by developing products for people dealing with the side effects of cancer and cancer treatments, and longer term by advancing a pipeline of novel combination therapies as an adjunct to standard of care cancer treatments.
ABOUT AMERI100:
Ameri is a specialized SAP® cloud, digital and enterprise solutions company that provides SAP® services to customers worldwide. Headquartered in Suwanee, Georgia, Ameri has offices in the U.S. and Canada. The Company also has global delivery centers in India. With its bespoke engagement model, Ameri delivers transformational value to its clients across industry verticals. For further information, visit www.ameri100.com
On January 10, 2020, Ameri entered into an Amalgamation Agreement (the "Merger Agreement") with Jay Pharma, Jay Pharma Merger Sub, Inc., a company organized under the laws of Canada and a wholly-owned subsidiary of Ameri ("Merger Sub"), 1236567 B.C. Unlimited Liability Company, a company organized under the laws of British Columbia and a wholly-owned subsidiary of Ameri ("ExchangeCo"), and Barry Kostiner, as the Ameri representative, pursuant to which, among other matters, and subject to the satisfaction or waiver of the conditions set forth in the Amalgamation Agreement, including, but not limited to, the approval of the proposed transaction by the shareholders of each of Ameri and Jay Pharma, Merger Sub and Jay Pharma will be amalgamated and will continue as one corporation, which shall become a direct wholly-owned subsidiary of ExchangeCo and an indirect wholly-owned subsidiary of Ameri (the "Amalgamation"). In connection with the Amalgamation, Ameri intends to sell substantially all of its current assets, change its name to Jay Pharma and Jay Pharma's business is intended to become the sole business of the combined company following this transaction.
Important Additional Information Will be Filed with the SEC
In connection with the proposed transactions, Ameri has filed with the SEC a registration statement on Form S-4 that includes a preliminary joint proxy statement of Ameri and Jay Pharma that also constitutes a prospectus of Ameri and the definitive joint proxy statement statement/prospectus will be mailed to shareholders of Ameri and Jay Pharma. Ameri and Jay Pharma also plan to file other relevant documents with the SEC regarding the proposed transaction. AMERI URGES INVESTORS AND STOCKHOLDERS TO READ THESE MATERIALS CAREFULLY AND IN THEIR ENTIRETY WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT AMERI, THE PROPOSED TRANSACTIONS AND RELATED MATTERS. Investors and shareholders will be able to obtain free copies of the proxy statement, prospectus and other documents filed by the Company with the SEC (when they become available) through the website maintained by the SEC at www.sec.gov. In addition, investors and shareholders will be able to obtain free copies of the proxy statement, prospectus and other documents filed by Ameri with the SEC by contacting Investor Relations by mail at 4080 McGinnis Ferry Road, Suite 1306, Alpharetta, Georgia. Stockholders are urged to read the proxy statement, prospectus and the other relevant materials when they become available before making any voting or investment decision with respect to the proposed transactions.
Participants in the Solicitation
Ameri and Jay Pharma, as well as each of their respective directors and executive officers and certain of their other members of management and employees, may be deemed to be participants in the solicitation of proxies in connection with the proposed transactions. Additional information regarding these persons and their interests in the transaction will be included in the definitive joint proxy statement/prospectus and other relevant documents filed with the SEC if and when they become available. Investors should read the definitive joint proxy statement/prospectus carefully when it becomes available before making any voting or investment decisions. These documents can be obtained free of charge from the sources indicated above.
No Offer or Solicitation
This press release does not constitute a solicitation of a proxy, consent or authorization with respect to any securities or in respect of the proposed transaction. This press release also does not constitute an offer to sell or the solicitation of an offer to buy any securities, nor will there be any sale of securities in any states or jurisdictions in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offering of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended.
Forward-Looking Statements
This press release contains forward-looking statements and forward-looking information within the meaning of applicable securities laws. These statements relate to future events or future performance. All statements other than statements of historical fact may be forward-looking statements or information. Generally, forward-looking statements and information may be identified by the use of forward-looking terminology such as "plans", " expects" or "does not expect", "proposed", "is expected", "budgets", "scheduled", "estimates", "forecasts", "intends", "anticipates" or "does not anticipate", or "believes", or variations of such words and phrases, or by the use of words or phrases which state that certain actions, events or results may, could, would, or might occur or be achieved. More particularly and without limitation, this news release contains forward-looking statements and information concerning the Amalgamation. Forward-looking statements consist of statements that are not purely historical, including any statements regarding beliefs, plans, expectations or intentions regarding the future. Readers are cautioned not to place undue reliance on forward-looking statements, as there can be no assurance that the Amalgamation will be consummated or that the parties other plans, intentions or expectations upon which they are based will occur. By their nature, forward-looking statements involve numerous assumptions, known and unknown risks and uncertainties, both general and specific that contribute to the possibility that the predictions, estimates, forecasts, projections and other forward-looking statements will not occur.
The forward-looking statements contained in this press release are made as of the date of this press release. Except as required by law, Ameri disclaims any intention and assumes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. Additionally, Ameri undertakes no obligation to comment on the expectations of, or statements made by, third parties in respect of the matters discussed above.
Corporate Contact:
Barry Kostiner, Chief Financial Officer
IR@ameri100.com
Ameri Holdings Investor Relations Contact:
Sanjay M. Hurry
LHA Investor Relations
(212) 838-3777
IR@ameri100.com
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SOURCE Ameri100
FAQ
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