AXIM Biotech Announces Successful Completion of Pre-IND Meeting with FDA on Comparable Product to Marinol; Green Light from FDA for IND Submission
Ryan Allway
December 12th, 2017
News, Top News
NEW YORK, Dec. 12, 2017 (GLOBE NEWSWIRE) — AXIM® Biotechnologies, Inc. (AXIM), a world leader in cannabinoid research and development, announced today that it has successfully completed a pre-investigational New Drug Application (pre-IND) meeting with the U.S. Food and Drug Administration (FDA) for a dronabinol-based functional, controlled-release chewing gum product it’s developing to help treat patients with chemotherapy-induced nausea and vomiting and HIV/AIDS patients experiencing appetite and weight loss. AXIM will now begin preparing its IND filing to the FDA for this new chewing gum product, referencing Marinol®, one of the FDA-approved, dronabinol-based drugs available in the U.S.
“We are very pleased with the outcome of our pre-IND meeting with the guidance of the FDA, which enabled us now to submit the protocol for clinical development of this dronabinol-based chewing gum that we believe could truly be a breakthrough utilizing Oral Mucosal absorption and those who suffered from the side effects of Marinol,” said George E. Anastassov, MD, DDS, MBA and Chief Executive Officer of AXIM Biotech. “After getting the green light from the FDA, our team will now be working diligently towards the submission of our IND, another major milestone for AXIM Biotech.”
In its current form, Marinol is delivered through a gel capsule where 90% of the dronabinol is metabolized into 11-OH-THC due to the first-pass (liver) metabolism. This may cause significant undesirable side effects for patients including impaired thinking and other adverse reactions. AXIM’s patented controlled-release chewing gum will be designed to largely bypass the first-pass metabolism in the liver with the goal of decreasing side effects for patients.
About AXIM®
AXIM® Biotechnologies, Inc. (AXIM) focuses on the research, development and production of cannabis-based pharmaceutical, nutraceutical and cosmetic products. Our flagship products include CanChew+®, a CBD-based controlled release chewing gum, CanChew+ 50®, containing 50 mg of CBD undergoing clinical trials in patients with IBS and MedChew Rx®, a combination CBD/THC gum that will undergo clinical trials for the treatment of pain and spasticity associated with multiple sclerosis. AXIM has several products developed or in developmental stage for treatment and/ or prevention of multiple conditions and symptoms. We prioritize the well-being of our customers while embracing a solid fiscal strategy. For more information, please visit AXIMBiotech.com.
FORWARD-LOOKING DISCLAIMER
This press release may contain certain forward-looking statements and information, as defined within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, and is subject to the Safe Harbor created by those sections. This material contains statements about expected future events and/or financial results that are forward-looking in nature and subject to risks and uncertainties. Such forward-looking statements by definition involve risks, uncertainties and other factors, which may cause the actual results, performance or achievements of Axim Biotechnologies, Inc. to be materially different from the statements made herein.
LEGAL DISCLOSURE
AXIM® Biotechnologies does not sell or distribute any products that are in violation of the United States Controlled Substances Act (US.CSA).
Public Relations Contact
Andrew Hard
Chief Executive Officer
CMW Media
andrew.hard@cmwmedia.com
P. +1888 829-0070
www.cmwmedia.com
Investor Relations Contact
Shiwei Yin, Grayling
Shiwei.Yin@grayling.com
P. +1646 284-9474
Lucia Domville, Grayling
lucia.domville@grayling.com
P. +1646 284-9416
Corporate Contact Info
North American Address:
18 East 50th Street, 5 Floor
New York, NY 10022
+1 844 294 6246
This article was published by CFN Enterprises Inc. (OTCQB: CNFN), owner and operator of CFN Media, the industry’s leading agency and digital financial media network dedicated to the burgeoning CBD and legal cannabis industries. Call +1 (833) 420-CNFN for more information.
About Ryan Allway
Mr. Allway has over a decade of experience in the financial markets as both a private investor and financial journalist. He has been actively involved in the cannabis industry since its inception, covering public and private companies.
Search CannabisFN
Press Coverage
Psychedelics Index
Top Videos
Watch CFN Media’s exclusive three part interview with Paul Rosen, one of the most active and diversified investors in the emerging cannabis industry. Paul gives his insights on the global cannabis industry and discusses his new endeavors. Become a CFN Media Client Paul Rosen is a noted career entrepreneur and management consultant. Over the last […]
The producers of O’ Cannabiz have decades of experience producing national-profile events and creating global connections between business communities in the arts, broadcasting, media and technology. They have organized trade summit initiatives with governments around the world. And they have worked closely with sponsors in all levels of Canadian government.
WestCann Holdings Ltd. is bringing the industrial and commercial benefits of tobacco processing technologies to the emerging international marijuana and hemp markets.
Tryp Therapeutics is a pharmaceutical company focused on developing compounds with known activity and/or safety profiles for the treatment of rare diseases and other diseases with high unmet medical needs.
Network Partners
About CFN Media Group
CFN Enterprises Inc. (OTCQB: CNFN) owns and operates CFN Media Group, the premier agency and financial media network reaching executives, entrepreneurs and consumers worldwide. Through its proprietary content creation, video library, and distribution via www.CannabisFN.com, CFN has built an extensive database of cannabis interest, assisting many of the world’s largest cannabis firms and CBD brands to build awareness and thrive. For more information, please visit www.cfnenterprisesinc.com.
Disclaimer: Matters discussed on this website contain forward-looking statements that are subject to certain risks and uncertainties that could cause actual results to differ materially from any future results, performance or achievements expressed or implied by such statements. CFN Media Group, which owns CannabisFN, is not registered with any financial or securities regulatory authority and does not provide nor claims to provide investment advice or recommendations to readers of this release. CFN Media Group, which owns CannabisFN, may from time-to-time have a position in the securities mentioned herein and will increase or decrease such positions without notice. The Information contains forward-looking statements, i.e. statements or discussions that constitute predictions, expectations, beliefs, plans, estimates, or projections as indicated by such words as "expects", "will", "anticipates", and "estimates"; therefore, you should proceed with extreme caution in relying upon such statements and conduct a full investigation of the Information and the Profiled Issuer as well as any such forward-looking statements. Any forward looking statements we make in the Information are limited to the time period in which they are made, and we do not undertake to update forward looking statements that may change at any time; The Information is presented only as a brief "snapshot" of the Profiled Issuer and should only be used, at most, and if at all, as a starting point for you to conduct a thorough investigation of the Profiled Issuer and its securities and to consult your financial, legal or other adviser(s) and avail yourself of the filings and information that may be accessed at www.sec.gov, www.pinksheets.com, www.otcmarkets.com or other electronic sources, including: (a) reviewing SEC periodic reports (Forms 10-Q and 10-K), reports of material events (Form 8-K), insider reports (Forms 3, 4, 5 and Schedule 13D); (b) reviewing Information and Disclosure Statements and unaudited financial reports filed with the Pink Sheets or www.otcmarkets.com; (c) obtaining and reviewing publicly available information contained in commonlyknown search engines such as Google; and (d) consulting investment guides at www.sec.gov and www.finra.com. You should always be cognizant that the Profiled Issuers may not be current in their reporting obligations with the SEC and OTCMarkets and/or have negative signs at www.otcmarkets.com (See section below titled "Risks Related to the Profiled Issuers, which provides additional information pertaining thereto). For making specific investment decisions, readers should seek their own advice and that of their own professional advisers. CFN Media Group, which owns CannabisFN, may be compensated for its Services in the form of cash-based and/or equity-based compensation in the companies it writes about, or a combination of the two. For full disclosure, please visit: https://www.cannabisfn.com/legal-disclaimer/. A short time after we acquire the securities of the foregoing company, we may publish the (favorable) information about the issuer referenced above advising others, including you, to purchase; and while doing so, we may sell the securities we acquired. In addition, a third-party shareholder compensating us may sell his or her shares of the issuer while we are publishing favorable information about the issuer. Except for the historical information presented herein, matters discussed in this article contain forward-looking statements that are subject to certain risks and uncertainties that could cause actual results to differ materially from any future results, performance or achievements expressed or implied by such statements. CFN Media Group, which owns CannabisFN, is not registered with any financial or securities regulatory authority, and does not provide nor claims to provide investment advice or recommendations to readers of this release. CFN Media Group, which owns CannabisFN, may from time to time have a position in the securities mentioned herein and will increase or decrease such positions without notice. For making specific investment decisions, readers should seek their own advice and that of their own professional advisers. CFN Media Group, which owns CannabisFN, may be compensated for its Services in the form of cash-based and/or equity- based compensation in the companies it writes about, or a combination of the two. For full disclosure please visit: https://www.cannabisfn.com/legal-disclaimer/.
Copyright © Accelerize Inc. · All Rights Reserved · Privacy Policy · Legal Disclaimer
