Altasciences Chosen by Virpax Pharmaceuticals, Inc. to Conduct First-in-Human Study of Epoladerm™ for Chronic Pain Associated with Osteoarthritis of the Knee
Laval, Quebec, January 21, 2021 – Altasciences is pleased to have been chosen by Virpax Pharmaceuticals, Inc. (NASDAQ:VRPX) to conduct a first-in-human study of Epoladerm™ (diclofenac epolamine) for chronic pain associated with osteoarthritis of the knee. This treatment is supplied in a pre-filled device for administration as a topical spray film.
The study will be conducted in Q2 2022 at Altasciences’ clinical pharmacology unit in Montreal, Canada. “We look forward to working with Altasciences to accelerate the development of this analgesic treatment and provide robust data in support of the 505(b)(2) FDA approval pathway,” stated Virpax’s Chairman & CEO, Anthony P. Mack.
Virpax’s proprietary technology provides a pre-filled canister for the therapeutic application of a clear, fast-drying spray film that is thinner than a standard liquid bandage. This technology offers convenience and eliminates the need for messy creams or gels.
Altasciences leverages decades of experience conducting first-in-human clinical trials, a vast database of study participants, and state-of-the-art bioanalytical facilities to provide expert guidance and personalized solutions. Ingrid Holmes, Altasciences’ Vice President, Global Clinical Operations, says, “We are proud to partner with Virpax to help move this important therapeutic further along the path to regulatory approval.”
Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining drug development solutions, whether for a single service or a synchronized approach to CRO and CDMO services, from lead candidate selection to clinical proof of concept, and beyond.
More information on Virpax Pharmaceuticals, Inc.’s program can be found here.
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About Altasciences
Altasciences is an integrated drug development solution company offering pharmaceutical and biotechnology companies a proven, flexible approach to preclinical and clinical pharmacology studies, including formulation, manufacturing, and analytical services. For over 25 years, Altasciences has been partnering with sponsors to help support educated, faster, and more complete early drug development decisions. Altasciences’ integrated, full-service solutions include preclinical safety testing, clinical pharmacology and proof of concept, bioanalysis, program management, medical writing, biostatistics, clinical monitoring, and data management, all customizable to specific sponsor requirements. Altasciences helps sponsors get better drugs to the people who need them, faster.
Julie-Ann Cabana
Altasciences
+1 514 601-9763
jcabana@altasciences.com
Industry Expert Talks Human Abuse Liability
A Chat with Dr. Kelsh, Sr. Principal Investigator
In the past decade alone, Altasciences has conducted 50+ human abuse potential, abuse-deterrent formulation, or substance abuse studies, including through repeated multi-year clinical research contracts with the National Institutes of Health (NIH) and the U.S. Food and Drug Administration (FDA).
Watch as Dr. Kelsh, Senior Principal Investigator at our Kansas City clinical facility, discusses why Altasciences is a leader in the conduct of human abuse liability trials.
Want to know more? Speak with an expert about your CNS clinical research needs.
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Webinar: Navigating the Abuse Potential Evaluation of CNS-Active Drugs for EU and U.S. Submissions
Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining drug development solutions, whether for a single study or multiple programs, to offer an integrated/synchronized approach to CRO and CDMO services from lead candidate selection to clinical proof of concept, and beyond.
A Step-by-step Guide for Meeting Your Safety Assessment Start Dates
Careful planning and financial commitment can make the difference between starting your safety testing studies on time or experiencing significant delays.
Once you have determined your desired safety assessment start date, we recommend taking the following steps to ensure you start your studies on time, and on your terms.
- 12-18 months before:
- Schedule a meeting with the FDA to go over your safety assessment plan.
- 9-12 months before:
- Get quotations from your preferred CRO partners.
- After receiving the proposals, discuss your program with an expert toxicologist to ensure you captured all the required studies.
- 6-12 months before (depending on research animal species and study type):
- Choose a CRO partner and sign a contract.
Reach out to us today so we can go over these steps together and ensure your study starts on time.
Bioanalytical Scientific Guidance from Discovery to Preclinical to Phase IV
From discovery to preclinical to Phase IV, Altasciences’ bioanalytical team of over 260 scientific experts specialized in bioanalysis, ligand binding assays (LBA), mass spectrometry, immunology, biomarkers, flow cytometry, and PCR, operates in three strategic locations in proximity to our preclinical and clinical sites. We aim to provide top quality data for TK, PK, and PD determinations to support your preclinical and clinical studies.
At Altasciences, One Laboratory Sciences moves in unison for the success and acceleration of drug development.
Let’s schedule time to discuss your bioanalytical needs.
You may also be interested in the following:
- Podcast — Three Laboratories - One Vision, with Dr. Lynne Le Sauteur
- Webinar — Managing Challenging Bioanalysis for PK/PD Assessments for Phase I Biologics
- Video — Take a Look Inside our PCR Lab
- Press Release — Altasciences Expands Ligand Binding Laboratory to Meet High Demand for Bioanalytical Solutions
Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining drug development solutions, whether for a single study or multiple programs, to offer an integrated/synchronized approach to CRO and CDMO services from lead candidate selection to clinical proof of concept, and beyond.