SAN DIEGO--(BUSINESS WIRE)-- Apricus Biosciences (“Apricus Bio”) (Nasdaq: APRI), backed by a revenue generating CRO business and seeking to leverage its multi-route NexACT® drug delivery technology and internal pipeline through out-licensing partnerships, today announced that the Moores Cancer Center at the University of California San Diego (UCSD) has filed an Investigational New Drug Application (“IND”) with the U.S. Food & Drug Administration (“FDA”) for approval to test Nupen™, Apricus Bio’s proprietary, topical NexACT-based formulation of filgrastim (Neupogen®).
Pending IND approval, Moores UCSD Cancer Center intends to proceed with a Phase 1, single-center, prospective, open-label study assessing topical administration of Nupen in 10 healthy adult subjects. Under the study protocol, the subjects will self-administer Nupen topically once a day for a total of 10 days. Nupen is being developed by Apricus Bio in order to provide easier administration of Neupogen, and potentially improve patient compliance.
The primary objective of the Phase 1 study is to evaluate the safety and tolerability of Nupen in healthy adult subjects. The secondary objectives are to characterize the effect and degree of response by monitoring the levels of neutrophils and platelets in blood following administration of Nupen.
Filgrastim, or Neupogen, is commonly prescribed to speed neutrophil recovery in patients who receive cytotoxic chemotherapy, as well as to mobilize stem cells in patients planning to undergo autologous stem cell transplant or those who are acting as donors for people who will receive allogeneic stem cell transplants. Neupogen is a registered trademark of Amgen Inc., and is available only as an injection.
Commenting on today’s announcement, Bassam Damaj, Ph.D., President and Chief Executive Officer of Apricus Bio, stated, “We are very pleased that our pre-clinical efforts in the transdermal delivery of large molecules are being recognized. The potential ability of the NexACT technology to efficiently deliver large molecules such as filgrastim, could enable us to develop a series of products based on non patient-friendly drugs, such as those that frequently require needles, including vaccines, proteins and bioengineered genetic drugs. We look forward to advancing the development of Nupen, in conjunction with the team at the Moores UCSD Cancer Center.”
About Moores UCSD Cancer Center
Founded in 1978, the Moores UCSD Cancer Center is one of just 40 centers in the United States to hold a National Cancer Institute (NCI) designation as a Comprehensive Cancer Center. As such, it ranks among the top centers in the nation conducting basic and clinical cancer research, providing advanced patient care and serving the community through outreach and education programs.
About Apricus Biosciences
Backed by NexMed, USA and Bio-Quant, Inc., its revenue generating CRO business, Apricus Bio has leveraged the flexibility of its proven NexACT® drug delivery technology to enable multi-route administration of new and improved compounds across numerous therapeutic classes. Future growth is expected to be driven primarily through out-licensing of this technology for the development and commercialization of such compounds to pharmaceutical and biotechnology companies, worldwide. Concurrently, the Company is seeking to monetize its existing product pipeline, including compounds from pre-clinical through Phase 3, currently focused on dermatology, sexual dysfunction and cancer. For further information on Apricus Bio and its subsidiaries, visit http://www.apricusbio.com.
Forward-Looking Statement Safe Harbor
Statements under the Private Securities Litigation Reform Act: with the exception of the historical information contained in this release, the matters described herein contain forward-looking statements that involve risks and uncertainties that may individually or mutually impact the matters herein described for a variety of reasons that are outside the control of the Company, including but not limited to, its ability to replicate pre-clinical results in human clinical trials, the ability to obtain necessary rights to use other parties’ compounds with the NexACT technology and the ability to realize growth plans through the out-licensing of our drug candidates or the NexACT technology. Readers are cautioned not to place undue reliance on these forward-looking statements and are urged to read the Company’s risk factors contained in its most recent annual report on Form 10-K and subsequent quarterly reports on Form 10-Q, as filed with the SEC.
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INDUSTRY KEYWORDS: Health Biotechnology Clinical Trials FDA