Preclinical Research
Historical Review of In-Life Data From Studies Utilizing AAVs for Gene Therapy
Intravenous Sampling and Administration in Rodents
Proposed Best Practices for Optimizing the Number of Animals in Toxicology Studies
Drug Development for Cell and Gene Therapy
In this scientific journal, we review considerations for nonclinical cell and gene therapy development, including expert approaches to mitigating complex challenges, improving study efficiency, and maximizing translational opportunities from nonclinical to first-in-human trials.
Learn about:
• the ICH S-12 Guideline on nonclinical biodistribution studies
• species selection criteria per the FDA
• choosing the appropriate vector
• immunogenicity evaluations
• findings from two case studies
Read the issue HERE.
Ready for the next step? Contact one of our experts to discuss your study needs.
You may also be interested in the following:
• Webinar: Cell and Gene Therapy―Enhanced CNS and Ocular Delivery in NHPs
• Poster: Gene Therapy Utilizing Adeno-Associated Viral (AAV) Vectors―Historical Data Review
• Webpage: Preclinical Research Services
Development of a Novel Canine Prostatectomy Model
Mastering Drug Safety: Your Passport to Successful Pharmacology
Navigating the Depths of Safety Pharmacology
Altasciences can help you assess the impact of your therapeutic entity on vital organ systems before first-in-human trials begin. Our experts conduct the core battery of safety pharmacology tests required by international regulatory guidelines, which include cardiovascular function, respiratory function, and central nervous system behavior, as well as combined and supplemental studies, if needed.
You can expect a robust program suited to your unique needs to support your IND submission and minimize potential risks, so you can transition smoothly from preclinical to clinical pharmacology.
Explore our full range of safety pharmacology capabilities here, and read this issue of The Altascientist on Safety Pharmacology Guidelines and Practices to learn more about:
• the benefits of combining safety pharmacology studies (i.e., cardiovascular and
respiratory); and
• safety pharmacology endpoints in general toxicity studies.
QUESTIONS? SUBMIT AN INQUIRY.
You may also be interested in the following:
• Fact Sheet: Safety Pharmacology Studies
• Podcast: Altasciences’ Scientific Experts Discuss Safety Pharmacology
• ICH Guidance for Industry: S7A Safety Pharmacology Studies for Human Pharmaceuticals
Altasciences Chosen by Virpax to Support the Development of a New Drug to Prevent Spread of Flu-like Viruses
Laval, Québec, September 21, 2023 - Altasciences is pleased to have been chosen by Virpax Pharmaceuticals, Inc. (NASDAQ:VRPX) (“Virpax”), a company specializing in developing non-addictive products for pain management, PTSD, central nervous system (CNS) disorders, and viral barrier indications, to conduct preclinical studies in support of their development of quaternary ammonium palmitoyl glycol chitosan (GCPQ, under the trade name of AnQlar™). AnQlar is a nanoparticle intended to help prevent the spread of negatively charged viruses such as COVID-19 and influenza via intranasal spray, and has been shown to inhibit the ability of the virus to replicate at non-toxic concentrations.
In development since 2022, the project has so far seen the completion of safety assessment utilizing intranasal administration at Altasciences’ preclinical site in Columbia, MO. A cardiovascular study was also completed at Altasciences’ preclinical facility in Scranton, PA.
Bioanalytical sample analysis for the GLP studies is currently ongoing. “We are very pleased to be working with Virpax again and are satisfied with the trajectory our studies have taken. The final step for this program will be a bioanalytical sample analysis. Once samples are validated, this will conclude the IND package” said Kyle Klepner, Senior Scientist, Study Director, Safety Assessment, at Altasciences.
Steve Mason, Co-Chief Operating Officer, Altasciences, added: “The creation of AnQlar as a treatment, if successful, could be a huge leap forward in preventing the spread of influenza and similar viruses. We look forward to further collaboration with Virpax in the near-future.”
Sheila Mathias PhD, Chief Scientific Officer, Virpax, also said of the project: “Our work with Altasciences over the last year has been both exceedingly productive and rewarding demonstrating tangible results, and the preclinical support provided has been vital in ensuring the progress of this project."
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. To learn more about Altasciences, visit altasciences.com.
About Virpax
Virpax is developing branded, non-addictive pain management product 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™, a single injection liposomal bupivacaine formulation being developed to manage post-operative pain, and Envelta™, 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 PTSD, and NobrXiol™, a product candidate being developed for the nasal delivery of a pharmaceutical-grade cannabidiol (CBD), for the management of rare pediatric epilepsy.
Having recently acquired global rights to NobrXiol, Virpax has competitive cooperative research and development agreements (CRADAs) for all three of its prescription drug candidates, two with the National Institutes of Health (NIH) and one with the Department of Defense (DOD).
Virpax is currently 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™, a topical diclofenac spray film formulation being developed to manage pain associated with osteoarthritis.
For more information, please visit virpaxpharma.com or follow on Twitter, LinkedIn, and YouTube.
Virpax Media Contact:
Robert Cavosi
RooneyPartners
+1 646 638-9891
rcavosi@rooneypartners.com
Julie-Ann Cabana
Altasciences
+1 514 601-9763
jcabana@altasciences.com
Altasciences' Facilities: Moving in Unison
Ensuring Nonhuman Primate Availability for Your Studies
Altasciences Ensures Nonhuman Primate Availability
Several preclinical CROs are expecting an impact on study start dates due to nonhuman primate (NHP) supply constraints. NOT Altasciences. We ensure NHP availability! We have the capacity at our four preclinical sites to start your studies six to eight weeks following contracting, thanks to our steady supply of NHPs.
SCHEDULE YOUR NHP STUDIES TODAY!
At Altasciences, we remove the stress of sourcing research animals so that you can start your studies when you need to, with:
• dedicated and diversified cynomolgus monkey supply agreements in place to allow for faster start-up timelines;
• a continuously maintained and backfilled population of hundreds of naïve NHPs at our preclinical facilities.
You can schedule newly contracted NHP studies to start immediately.
Have five minutes? Discover our extensive site capabilities:
Webpage: Full Range of Preclinical Drug Development Solutions
Fact Sheet: Preclinical Services Capabilities
The Altascientist: Planning Your Preclinical Assessment
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.