Moores Cancer Center files IND application for topical NexACT-based formulation

Oct 15 2010

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."