BERWYN, Pa. –
Virpax® Pharmaceuticals, Inc. (“Virpax” or the “Company”) (NASDAQ: VRPX), a company specializing in developing non-addictive products for pain management, post-traumatic stress disorder, and central nervous system (CNS) disorders, today announced that it will utilize leading pain expert, Dr. Neil K. Singla, to assist in the design and support of the clinical development strategy for Probudur.
Probudur is Virpax’s post-operative, ultra-long-acting anesthetic injection product candidate for post-operative pain management that is being developed to significantly reduce or eliminate the need for opioids after surgery in approved indications. Probudur’s proprietary formulation is intended for immediate onset and has demonstrated sustained pain control for up to 96 hours in animal studies. The Company entered into a cooperative research and development agreement (CRADA) in May of 2022 with the U.S. Army Institute of Surgical Research, the primary laboratory of the Department of Defense, to evaluate Probudur for trauma and critical care challenges.
Dr. Neil Singla is board certified in Anesthesiology and the Founder and Chief Scientific Officer of Lotus Clinical Research, a leading analgesic clinical research organization (CRO) with extensive analgesic and pain-related expertise. He has interacted frequently with the FDA’s Analgesics Division and is a nationally recognized key opinion leader in analgesic protocol design and implementation. Dr. Singla has published extensively and is a frequent lecturer for physicians, pharmaceutical companies, and medical research institutes throughout the country. He currently chairs the Analgesic Clinical Trials Shared/Special Interest Group at the International Association for the Study of Pain(IASP), chaired the Clinical Trials Shared Interest Group at the American Pain Society (APS) through 2019 and chairs the annual Conference on Analgesic Clinical Trials.
“We expect that Dr. Singla’s knowledge in the analgesic space, especially with liposomal bupivacaine, combined with his experience in regulatory affairs and study design will be of great value to us. I look forward to working with him and his team as we advance this product candidate,” commented Dr. Sheila A. Mathias, Chief Scientific Officer for Virpax.
“Virpax is actively moving its programs forward in anticipation of filing Investigational New Drug applications (INDs) and beginning human clinical trials. We are excited to have leading physicians and researchers who share our enthusiasm for our product candidates partnering with us,” concluded Anthony P. Mack, chairman and CEO of Virpax.
About Virpax Pharmaceuticals
Virpax is developing branded, non-addictive pain management products candidates using its proprietary technologies to optimize and target drug delivery. Virpax is initially seeking FDA approval for two prescription drug candidates that employ two different patented drug delivery platforms. Probudur™ is a single injection liposomal bupivacaine formulation being developed to manage post-operative pain and Envelta™ is an intranasal molecular envelope enkephalin formulation being developed to manage acute and chronic pain, including pain associated with cancer. Virpax is also using its intranasal Molecular Envelope Technology (MET) to develop two other product candidates. PES200 is a product candidate being developed to manage post-traumatic stress disorder (PTSD) and NobrXiol™ is a product candidate being developed for the nasal delivery of a pharmaceutical-grade cannabidiol (CBD) for the management of rare pediatric epilepsy. Virpax acquired global rights to NobrXiol. Virpax is also seeking approval of two nonprescription product candidates: AnQlar, which is being developed to inhibit viral replication caused by influenza or SARS-CoV-2, and Epoladerm™, which is a topical diclofenac spray film formulation being developed to manage pain associated with osteoarthritis. For more information, please visit www.virpaxpharma.com.
This press release contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and Private Securities Litigation Reform Act, as amended, including those relating to the Company’s planned clinical trials, product development, clinical and regulatory timelines, market opportunity, competitive position, possible or assumed future results of operations, business strategies, potential growth opportunities and other statements that are predictive in nature. These forward-looking statements are based on current expectations, estimates, forecasts and projections about the industry and markets in which we operate and management’s current beliefs and assumptions.
These statements may be identified by the use of forward-looking expressions, including, but not limited to, “expect,” “anticipate,” “intend,” “plan,” “believe,” “estimate,” “potential,” “predict,” “project,” “should,” “would” and similar expressions and the negatives of those terms. These statements relate to future events or the Company’s financial performance and involve known and unknown risks, uncertainties, and other factors, including the Company’s ability to successfully complete research and further development and commercialization of Company drug candidates in current or future indications; the uncertainties inherent in clinical testing; our ability to manage and successfully complete clinical trials and the research and development efforts for multiple product candidates at varying stages of development; the effects of the outbreak of COVID-19 on our business and results of operations; the timing, cost and uncertainty of obtaining regulatory approvals for our product candidates; our ability to protect the Company’s intellectual property; the loss of any executive officers or key personnel or consultants; competition; changes in the regulatory landscape or the imposition of regulations that affect the Company’s products; our ability to continue to obtain capital to meet our long-term liquidity needs on acceptable terms, or at all, including the additional capital which will be necessary to complete clinical trials that we plan to initiate; and other factors listed under “Risk Factors” in our annual report on Form 10-K and quarterly reports on Form 10-Q that we file with the U.S. Securities and Exchange Commission.. Prospective investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this press release. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.
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Christopher M. Chipman, CPA
Chief Financial Officer
Affinity Growth Advisors