NEWARK, DE / ACCESSWIRE / February 10, 2016 / Accurexa Inc. (the "Company") (OTCQB: ACXA), a biotechnology company focused on the development of novel neurological therapies to be directly delivered into the brain, announced today that it has engaged PharmaLex Development Services, LLC ("PharmaLex") to advise the Company in the development of its ACX-31 program for the local delivery of temozolomide in combination with BCNU, both chemotherapeutics, in the treatment of brain tumors.
"We are looking forward to working with Tom Fritz and Agnes Cobbum at PharmaLex to advance our ACX-31 program towards a regulatory path with the FDA. Tom has over 25 years of experience in pharmaceutical drug development in emerging biotech and larger pharmaceutical companies. He has deep expertise in operations, clinical, regulatory and manufacturing in regards to combination products and controlled-release formulations. Agnes has over 15 years of experience in pharmaceutical regulatory affairs. Agnes formerly worked at MGI Pharma (formerly Guilford Pharmaceuticals) where she worked on regulatory approvals of Gliadel(R). Gliadel(R) contains BCNU and is a local chemotherapy approved for the treatment of glioblastoma," 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 to deliver two chemotherapy drugs, temozolomide in combination with BCNU, locally 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, is also advising 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 a polymeric formulation 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(R) (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(R) 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[1] 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[2] 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.
The Company's BranchPoint device was invented to deliver multiple therapeutics, such as stem cells, chemotherapy or gene therapy vectors, through the radial deployment of a flexible catheter to specific brain target areas through a single brain penetration, and was licensed from UCSF (University of California, San Francisco). The current standard of care is the use of straight, rigid needles, often requiring surgeons to penetrate the brain multiple times for delivering therapeutics, which in turn may increase the risk of bleeding, stroke and reflux of therapeutics back out to the brain surface. An animal study at UCSF[3] demonstrated that the use of a straight needle was associated with reflux of at least 75% of the infusion while no reflux was found with the BranchPoint device. The development of the BranchPoint device was originally funded with $1.8 million by California's Stem Cell Agency CIRM (California Institute of Regenerative Medicine). A 510(k) application was submitted to the FDA in June 2015.
Additional information about the Company may be found on its website, www.accurexa.com.
Notes:
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.
3 Silvestrini MT, Yin D, Coppes VG, Mann P, Martin AJ, Larson PS, Starr PA, Gupta N, Panter SS, Desai TA, Lim DA. Radially branched deployment for more efficient cell transplantation at the scale of the human brain. Stereotact Funct Neurosurg. 2013;91(2):92-103.
About PharmaLex
PharmaLex provides expert guidance to companies looking for FDA regulatory affairs assistance at all stages during the drug development process. Providing a custom service model adaptable for any size client, PharmaLex regulatory advisors provide a full spectrum of services from the pre-IND stage to post-marketing lifecycle management, and can help clients navigate FDA requirements, provide efficient FDA communications, prepare for and conduct FDA meetings, electronically submit documents, and build a constructive relationship with the FDA. PharmaLex has extensive regulatory and scientific experience in most therapeutic areas, including small molecules and biologicals, and has a proven track record of success with more than 10,000 successfully completed projects for over 500 clients from around the globe and of all sizes, including over half of the top 20 global pharma companies.
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 develop and commercialize novel neurological therapies based on its BranchPoint device or 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.
Contact Investor Relations:
David Burke
The Ruth Group
Tel.: 646-536-7009
dburke@theruthgroup.com
Accurexa Inc.
info@accurexa.com
Tel.: 302-709-1822
SOURCE: Accurexa Inc.
