[ACCESSWIRE]
SAN FRANCISCO,CA / ACCESSWIRE / February 4, 2015 / Accurexa Inc. (the "Company") (OTCQB: ACXA), a biotechnology company focused on developing and commercializing novel neurological therapies, announced today that it initiated the development of ACX-31 for the treatment of glioblastoma multiforme, a malignant primary brain tumor. ACX-31 is a chemotherapy product that delivers temozolomide directly to the tumor site with the Company's BranchPoint device. Temozolomide is a generic, approved chemotherapy drug that is indicated for the treatment of adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy and then as maintenance treatment. The Company's BrainPoint device has been developed for the delivery of therapeutics directly into specific regions of the brain and is expected to obtain FDA regulatory approval through a 510(k) submission process.
"ACX-31 is an important product for Accurexa because it could demonstrate how our BranchPoint device can open up new approaches in the treatment of tumors and other disorders that affect the human brain. We believe that delivering a generic, approved drug with our device can significantly shorten the development timeline of new products and bring novel therapies faster to the patients," said George Yu, the Company's President & CEO.
About Glioblastoma Multiforme
Glioblastoma multiforme (GBM) is the most common and most aggressive malignant primary brain tumor in humans. Approximately 16,000 new patients are diagnosed with GBM in the US each year. Median survival without treatment is 4.5 months. With treatment, concomitant and adjuvant temozolomide chemotherapy with radiation significantly improves, from 12.1 months to 14.6 months, progression free survival and overall survival in GBM patients, as demonstrated in recent randomized clinical trials. Before temozolomide became generic, it generated US sales of $420 million and global sales of $910 million under its brand name Temodar.
About Accurexa, Inc.
The Company is focused on developing and commercializing novel neurological therapies based on its proprietary BranchPoint technology delivering therapeutics directly into specific regions of the brain. The BranchPoint device delivers therapeutics through the radial deployment of a flexible delivery catheter to large and anatomically complex brain targets through a single initial brain penetration. Clinicians can "tailor" therapeutic delivery to individual patient anatomy and specific disease targets, which may enhance the efficacy of therapies. The BranchPoint device also gives physicians more precise control of the volume of therapeutics delivered and ensures that therapeutics delivered into the brain stay in the brain, avoiding the problem of reflux out to the brain surface. This modern and "easy to use" technology allows "real-time" monitoring of therapeutic delivery under interventional MRI guidance (iMRI), which can improve the accuracy of therapeutic delivery, reduce the risk of complications, and increase patient safety.
The BranchPoint device was developed at the University of California, San Francisco (UCSF) with $1.8 million in funding from the California Institute for Regenerative Medicine (CIRM). It is based on a neurosurgical delivery platform which the Company exclusively licensed from UCSF. It can enable new approaches to neurological therapy and be modified for the delivery of a wide range of novel therapeutics, such as stem cells to treat neurodegenerative diseases, chemotherapeutics to brain tumors or gene therapy. Additional information about the Company may be found on its website, www.accurexa.com.
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 ACX-31; the ability of the Company to successfully develop and commercialize novel neurological therapies based on its BranchPoint device 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
Info@accurexa.com
Tel.: 415-494-7850
SOURCE: Accurexa, Inc.