NEWARK, DE / ACCESSWIRE / July 5, 2016 / Accurexa Inc. (the "Company") (ACXA), a biotechnology company focused on the development of novel neurological therapies to be directly delivered into the brain, announced today that the U.S. FDA (Food and Drug Administration) has granted Accurexa a pre-IND (Investigational New Drug) meeting requested to discuss the CMC (Chemistry, Manufacturing and Controls), nonclinical and clinical development of its ACX-31 program, and to confirm the acceptability of a 505b2 application pathway. The FDA's stated goal date for providing its written response is August 19, 2016, provided that the background information submitted to the FDA by Accurexa is adequate. Accurexa is developing its ACX-31 program for the local delivery of temozolomide as adjunctive therapy to BCNU, both chemotherapeutics, in the treatment of brain tumors.
"We are pleased with this timely response from the FDA to our pre-IND meeting request. This is a positive step forward in the development of our ACX-31 program in collaboration with Professor Brem's brain tumor research and clinical team at Johns Hopkins University. We are looking forward to the FDA's written responses," said Dr. George Yu, Accurexa's President & CEO.
About Accurexa, Inc.
The Company is focused on developing novel neurological therapies to be directly delivered into specific regions of the brain. It is developing its ACX-31 program for the local delivery of temozolomide as adjunctive therapy to BCNU, both chemotherapeutics, to brain tumor sites. The ACX-31 program is based on an issued patent licensed from Accelerating Combination Therapies LLC which is co-owned by Prof. Henry Brem, Director of the Neurosurgery Department at Johns Hopkins University. The Company is collaborating in the development of its ACX-31 program with Prof. Henry Brem who built one of the largest brain tumor research and treatment centers in the world at Johns Hopkins University. Prof. Robert Langer, who is the David H. Koch Institute Professor at MIT and the most cited engineer in history, has also advised the Company in the development of its ACX-31 program. The Company engaged the Yissum Research Development Company of The Hebrew University of Jerusalem Ltd. ("Yissum") to develop and supply polymeric formulations of a combination of temozolomide and BCNU. Professor Avi Domb leads the development efforts provided by Yissum. Prof. Brem, Prof. Langer and Prof. Domb are pioneers in the development of local drug delivery treatments, and invented and developed Gliadel® (carmustine implant) which is a FDA approved, local chemotherapy for the treatment of glioblastoma multiforme.
Oral temozolomide is a generic, FDA approved, first-line chemotherapy drug that is indicated for the treatment of adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy and then as maintenance treatment. Before oral temozolomide became generic, it generated US sales of approximately $420 million and global sales of approximately $910 million under its brand name Temodar® in 2012. However, current standard of care of delivering temozolomide to tumor sites through oral administration is limited by the blood-brain-barrier and oral temozolomide increases patient survival by 2.5 months from a 12.1 months median overall survival.
Animal studies at the Johns Hopkins School of Medicine have shown that local delivery of temozolomide increased concentrations of the drug in the brain threefold and increased survival up to fourfold compared with oral administration. The percentage of long-term survivors for groups receiving local delivery of temozolomide ranged from 25% to 37.5% while there were no long-term survivors with orally administered temozolomide. Further animal studies at the Johns Hopkins School of Medicine have shown that the additive effect of combined delivery of local temozolomide with local BCNU, especially in combination with radiotherapy, was significantly more effective than delivery of either drug alone or one systemically and one locally, either with or without radiation. Groups treated with combination of local temozolomide, local BCNU and radiation therapy had 75% long-term survivors.
Additional information about the Company may be found on its website, www.accurexa.com.
1 Brem S, Tyler BM, Li K, Pradilla G, Legnani F, Caplan J, et al. Local delivery of temozolomide by biodegradable polymers is superior to oral administration in a rodent glioma model. Cancer Chemother Pharmacol 2007; 60:643-50.
2 Renard Recinos V, Tyler BM, Brem H, et al. Combination of intracranial temozolomide with intracranial carmustine improves survival when compared with either treatment alone in a rodent glioma model. Neurosurgery 2010; 66:530-537.
Safe Harbor Statement
This release contains certain "forward-looking statements" relating to the business of the Company. All statements, other than statements of historical fact included herein are "forward-looking statements" including statements regarding: the ability of the Company to successfully submit an IND application and conduct clinical trials, develop and commercialize novel neurological therapies based on U.S. Patent No. 8,895,597 B2, or its ACX-31 program and execute its business plan; the business strategy, plans, and objectives of the Company; and any other statements of non-historical information. These forward-looking statements are often identified by the use of forward-looking terminology such as "believes," "expects" or similar expressions and involve known and unknown risks and uncertainties. Although the Company believes that the expectations reflected in these forward-looking statements are reasonable, they do involve assumptions, risks, and uncertainties, and these expectations may prove to be incorrect. Investors should not place undue reliance on these forward-looking statements, which speak only as of the date of this news release. The Company's actual results could differ materially from those anticipated in these forward-looking statements as a result of a variety of factors, including those discussed in the Company's periodic reports that are filed with the Securities and Exchange Commission and available on its website (http://www.sec.gov). All forward-looking statements attributable to the Company or persons acting on its behalf are expressly qualified in their entirety by these factors. Other than as required under the securities laws, the Company does not assume any duty to update these forward-looking statements.
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SOURCE: Accurexa Inc.