Adial Pharmaceuticals Announces Positive Preclinical Data for PNV2 as a Candidate Drug for Triple Negative Breast Cancer

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PNV2 demonstrates reduced metastasis in animal model

CHARLOTTESVILLE, Virginia, November 29, 2021 (GLOBE NEWSWIRE) – Adial Pharmaceuticals, Inc. (NASDAQ: ADIL; ADILW) (“Adial” or the “Company”), a clinical-stage biopharmaceutical company focused on the development of therapies for the treatment and prevention of drug addiction and related disorders, today announced positive preclinical data for PNV2 in an Triple negative breast cancer animal model (TNBC). Based on the strength of this data, Purnovate, Inc., a wholly owned subsidiary of Adial Pharmaceuticals, Inc., plans to make PNV2 the lead compound in its cancer control program.

PNV2 was tested in a model of metastatic breast cancer, the primary endpoint being the amount of cancer metastasis in the lungs 28 days after orthotopic implantation of the breast cancer.

Highlights of the study:

  • Triple negative breast cancer cells (TNBC) modified by luciferase MDA-MB-231 were implanted in the mammary fat pad in female mice.

  • The tumors grew over 28 days and were treated intratumorally three times a week.

  • An active group (n = 10) was treated with PNV2 in solution and a control group (n = 10) was treated with only the solution.

  • Metastasis in the lungs was then determined by measuring the amount of luciferase activity, which indicates the amount of cancer in the lungs.

  • In the control group, 30% of the mice had large, well-established secondary tumors (i.e. secondary tumors in the lungs of any mouse and luciferase activity not exceeding 356 AU in any mouse.

Dr Julien Dimastromatteo, Vice President of Research at Purnovate, commented: “These preclinical data are encouraging, as we appear to have demonstrated a reduction in metastasis and cancer invasion into the lungs following treatment with PNV2. These data confirm previous research on the anticancer properties of adenosine analogues. However, historically, the solubility of these compounds has been an obstacle to the development of effective therapy. This latest research around PNV2 is particularly exciting because we believe we have overcome the challenges of solubility. We plan to conduct additional preclinical research with the goal of advancing PNV2 into clinical trials in 2022. “

William Stilley, CEO of Adial, said: “The adenosine Purnovate platform continues to demonstrate great potential across a wide range of indications and exceeds expectations. We are particularly encouraged by these latest data on triple negative breast cancer following recent data on pain. We look forward to aggressively pursuing the full potential of the Purnovate Adenosine platform and are evaluating the best strategy to achieve the full value of the platform for our shareholders, while we remain focused on Adial on obtaining our data from phase 3 on AD04 for the treatment of alcohol. Use the mess.

PNV2 has been tested to be over 1000 times selective for the adenosine A1 receptor, which is known to have effects on the cardiovascular and central nervous system which have limited the usefulness of adenosine analogues as treatments. . Historically, when selectivity was achieved for the A1 receptor, the solubility in water decreased, making it difficult for the efficient distribution of tissues in the human body (consisting largely of water). However, PNV2 has demonstrated more than 50 times the solubility of other known selective adenosine compounds of the same class. Solubility is often an important characteristic of successful drug candidates, and Purnovate believes that solubility is a particularly important characteristic in determining the drug development potential of molecules of this class.

About Purnovate, Inc.

Purnovate, Inc., a wholly owned subsidiary of Adial Pharmaceuticals, Inc., is a pharmaceutical and chemical development company focused on the invention and development of selective, potent, stable and soluble adenosine analogs for treating diseases and disorders such as pain, cocaine addiction, inflammation, infectious diseases, cancer, asthma and diabetes. Further information is available at www.purnovate.com.

About Adial Pharmaceuticals, Inc.

Adial Pharmaceuticals is a clinical-stage biopharmaceutical company focused on the development of addiction treatments. The Company’s lead new investigational drug, AD04, is a genetically targeted serotonin-3 receptor antagonist, a therapeutic agent for the treatment of alcohol-related disorders (AUD) and is currently under investigation for of the Company’s pivotal phase 3 ONWARD ™ clinical trial for the potential treatment of AUD in subjects with certain target genotypes, which must be identified using the Company’s proprietary companion diagnostic genetic test. A phase 2b clinical trial of AD04 for the treatment of AUD showed promising results in reducing the frequency of drinking, amount of drinking and binge drinking (all with statistical significance) and no obvious safety concerns (no statistically significant serious adverse events were reported). AD04 is also believed to have the potential to treat other addiction disorders such as opioid use disorders, gambling, and obesity. The Company is also developing adenosine analogues for the treatment of pain and other disorders. Further information is available at www.adialpharma.com.

Forward-looking statements

This communication contains certain “forward-looking statements” within the meaning of US federal securities laws. Such statements are based on various facts and derived from many material assumptions and are subject to known and unknown risks, uncertainties and other factors which may cause actual results, performance or achievements to be materially different from any results. , future performances or achievements expressed or implied. by such forward-looking statements. Statements preceded, followed by or which otherwise include the words “believes”, “expects”, “anticipates”, “intends”, “projects”, “estimates”, “plans” and similar expressions or verbs future or conditional such as “” will, “should”, “would”, “could” and “could” are generally forward-looking and not historical facts, although not all forward-looking statements include the foregoing. Forward-looking statements include statements regarding plans to advance PNV2 as a lead compound in our cancer control program, having overcome the solubility challenges of adenosine-selective compounds and solubility being a particularly important characteristic. To determine the drug development potential of molecules in this class, plans to conduct additional preclinical research with the goal of advancing PNV2 into clinical trials in 2022, aggressively pursuing the full potential of the Purnovate platform Adenosine and the potential of AD04 to treat other addiction disorders such as alcohol use disorders, opioid use disorders, gambling, and obesity. All forward-looking statements included in this document reflect our current views and involve certain risks and uncertainties, including, but not limited to, our ability to advance PNV2 in clinical trials and to achieve results similar to those obtained in preclinical studies. , our ability to begin PNV2 clinical trials in 2022, our ability to recruit patients on time and complete clinical trials on time and achieve desired results and benefits as planned, our ability to obtain regulatory approvals for the marketing of product candidates or to comply with current regulatory requirements, regulatory limitations regarding our ability to promote or market our product candidates for specific indications, market acceptance of our product candidates and development, marketing or the successful sale of our products , our ability to maintain our license agreements, the ongoing maintenance and growth of our patent areas, our ability to establish and maintain collaborations, our ability to obtain or maintain the capital or grants necessary to fund our research activities and development, and our ability to retain our key employees or maintain our Nasdaq listing. These risks should not be construed as exhaustive and should be read in conjunction with the other caveat included in our annual report on Form 10-K for the year ended December 31, 2020, subsequent quarterly reports on Form 10-Q and current reports on Form 8-K filed with the Securities and Exchange Commission. Any forward-looking statement speaks only as of the date it was originally made. We assume no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise, except as required by law.

Contact:
Crescendo Communications, LLC
David Waldman / Natalya Rudman
Phone. : 212-671-1021
E-mail: adil@crescendo-ir.com


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