DelMar Pharmaceuticals and Accurexa to Collaborate in the Development of a Novel Combination Chemotherapy for the Local Treatment of Brain Cancer

PRNewswire: September 7, 2016 – VANCOUVER, British Columbia, Canada, and WALNUT CREEK, CA, U.S.A. – DelMar Pharmaceuticals, Inc. (NASDAQ: DMPI) (“DelMar”), a company focused on developing and commercializing proven cancer therapies in new orphan drug indications, and Accurexa Inc. (OTCQB: ACXA) (“Accurexa”), a company focused on the development of novel neurological therapies to be directly delivered into the brain, announced today a collaboration to develop a novel formulation for the local delivery of combination chemotherapy for the treatment of brain cancer and other solid tumors.

Under the terms of the collaboration agreement DelMar will supply VAL-083 (dianhydrogalactitol) to be formulated within Accurexa’s proprietary ACX-31 implantable polymer wafer to locally deliver VAL-083 in combination with temozolomide and/or BCNU for the treatment of brain cancer. DelMar has been granted an exclusive option to license or acquire and commercialize product candidates and intellectual property resulting from the research.

Accurexa’s ACX-31 program has been developed in collaboration with Prof. Henry Brem, who built one of the largest brain tumor research and treatment centers in the world at Johns Hopkins University, and Prof. Robert Langer, who is the David H. Koch Institute Professor at MIT and the most cited engineer in history. Prof. Avi Domb at the Hebrew University of Jerusalem will lead the formulation development efforts for the collaboration. Profs. Brem, Langer, and Domb are pioneers in the development of local drug delivery treatments, and invented and developed Gliadel® (carmustine implant) which is an FDA-approved, local chemotherapy for the treatment of GBM. Drs. Brem and Langer will serve as advisors for the collaboration.

“Working together with Accurexa will allow DelMar to explore a promising new product opportunity that is complementary to our existing portfolio of systemic drug development programs established around VAL-083 without significant cash outlay or impact on our near-term cash burn rate,” said Jeffrey Bacha, chairman and CEO of DelMar Pharmaceuticals. “This research collaboration will take advantage of our knowledge regarding the unique cytotoxic mechanism of VAL-083 to deliver combination chemotherapy directly to patients’ cancer. Combining drugs with distinct mechanisms for local delivery provides an opportunity to overcome chemoresistance while minimizing potential systemic toxicity.”

“We are very pleased to collaborate with DelMar’s experienced team, allowing us to leverage their strong development capabilities. They have recently completed a phase I/II clinical trial of VAL-083 in brain cancer patients and had a successful end-of-phase II meeting with the FDA, while we recently had a positive pre-IND meeting with the FDA for our ACX-31 wafer program. Looking forward to the future development pathway, we believe that the local delivery of VAL-083 as a component of our ACX-31 wafer could potentially provide a new and exciting treatment option for brain cancer patients,” said George Yu, MD, Accurexa’s president and CEO.

DelMar and Accurexa believe that combining VAL-083 with temozolomide and/or BCNU within Accurexa’s proprietary drug delivery system may provide treatment advantages while limiting systemic toxicity.

VAL-083 is a first-in-class, small-molecule chemotherapeutic. In more than 40 phase I and II clinical studies sponsored by the U.S. National Cancer Institute, VAL-083 demonstrated safety and efficacy in treating a number of cancers including lung, brain, cervical and ovarian tumors and leukemia. VAL-083 is approved in China for the treatment of chronic myelogenous leukemia and lung cancer and has received orphan drug designation in the United States for the treatment of gliomas, medulloblastoma, and ovarian cancer as well as in Europe for the treatment of glioma.

VAL-083 exhibits its antitumor affect by forming DNA cross-links at the N7 position of guanine, whereas temozolomide and BCNU primarily target the O6 position of guanine as their site of anticancer function.

VAL-083’s mechanism of action appears to be unaffected by the expression of MGMT, a DNA repair enzyme that causes chemotherapy resistance to chemotherapies targeting the O6 position of guanine. DelMar has also demonstrated that the combination of VAL-083 and temozolomide was highly effective against brain tumor stem cells in vitro.

DelMar and Accurexa will seek to establish a novel formulation that incorporates VAL-083 into the ACX-31 polymer wafer and to establish nonclinical proof of concept regarding the proposed advantages of the combination therapy. DelMar will supply Accurexa with VAL-083, and the companies will share certain limited costs associated with the research. DelMar has been granted an exclusive option to license or acquire and commercialize product candidates and intellectual property resulting from the research for a defined period after the completion of the research. DelMar’s option to negotiate a license or acquire the technology includes any and all results, research materials, related information, and product candidates, including without limitation ACX-31 and related intellectual property and all rights thereto on an exclusive worldwide basis or other such terms as the parties may agree, in order to further develop and commercialize products based on the research project.

“Both of our companies have already made significant investments into the IP, mechanism of action, and formulation of VAL-083 and ACX-31, respectively. Therefore, developing a combined formulation is not expected to require significant cash expenditures. This collaboration is a highly cost-effective approach to expand our product development portfolio by leveraging our companies’ respective capabilities and assets,” stated Mr. Bacha.

DelMar Pharmaceuticals, Inc., was founded to develop and commercialize proven cancer therapies in new orphan drug indications where patients are failing or have become intolerant to modern targeted or biologic treatments. The company’s drug in development, VAL-083, is currently undergoing clinical trials in the United States as a potential treatment for refractory glioblastoma multiforme. VAL-083 has been extensively studied by U.S. National Cancer Institute and is currently approved for the treatment of chronic myelogenous leukemia (CML) and lung cancer in China. Published preclinical and clinical data suggest that VAL-083 may be active against a range of tumor types via a novel mechanism of action that could provide improved treatment options for patients. For further information, please visit http://delmarpharma.com.