NEWARK, DE / CRWEPRESSRELEASE / August 12, 2015 / Accurexa Inc. (the “Company”) (OTCMKTS:ACXA), a biotechnology company focused on developing and commercializing novel neurological therapies, announced today that it has entered into an exclusive license agreement (“ACL License”) with Accelerating Combination Therapies LLC (“ACL”) in regards to the exclusive licensing of the issued U.S. Patent No. 8,895,597 B2 Combination of Local Temozolomide with Local BCNU (“Patent Rights”). ACL is beneficially owned by the original Patent Rights holders and Inventors Henry Brem et al. (“Inventors”) who assigned the Patent Rights to ACL. Henry Brem is the Harvey Cushing Professor of Neurosurgery, Director of the Department of Neurosurgery, and Neurosurgeon-in-Chief at The Johns Hopkins University, and invented and developed Gliadel(R) wafers to deliver local chemotherapy to brain tumors.
The Patent Rights relate to formulations for chemotherapy, especially of brain tumors such as gliomas. They claim a composition for treating an individual with a solid tumor comprising a combination of BCNU and temozolomide in a pharmaceutically acceptable polymeric carrier for sustained local administration of an effective amount of BCNU and temozolomide to reduce tumor size or prolong survival of the individual with greater efficacy or reduced systemic side effects as compared to administration of either BCNU or temozolomide systemically (“Invention”). A description of the Patent Rights is available under the following link.
Temozolomide is a generic, approved chemotherapy drug that is indicated for the treatment of glioblastoma multiforme (GBM). Before temozolomide became generic, it generated US sales of $420 million and global sales of $910 million under its brand name Temodar(R) in 2012.
BCNU (carmustine) is another chemotherapy drug that is contained in Gliadel(R), a biodegradable polymer that is implanted locally into the resection cavity after surgical removal of a brain tumor and is indicated for the treatment of newly diagnosed and recurrent GBM.
“This is an important step for our company because this patent license transforms our business model from a drug delivery technology company into a developer of pharmaceutical therapeutics. We are excited that this patent license allows us to collaborate with Prof. Brem’s outstanding team at Johns Hopkins University. His team has demonstrated its expertise in bringing the local delivery of chemotherapy drugs in the treatment of brain cancer into the clinic and to patients as demonstrated with the development of Gliadel(R). Their patent describes the combination and additive effect of the local delivery of the two drugs – temozolomide and BCNU – that define today’s standard of care in the treatment of brain cancer,” said George Yu, the Company’s President & CEO.
Under the ACL License, the Company obtained rights to develop and commercialize the Patent Rights, and has been granted the right to sublicense to third parties. The ACL License requires the Company to initiate a first human clinical trial within 30 months and to pay ACL royalties and other consideration which includes (i) a license issue fee of 1,000,000 shares of the Company’s common stock within 6 months after the effective date of the ACL License; (ii) reimbursement of past patent expenses of $19,392; (iii) license maintenance fees of $8,000 annually until the first commercial sale; (iv) running royalties of 4% of net sales; and (v) certain minimum annual royalties and milestone payments. For a full description of the ACL License, the license agreement is filed and can be reviewed as an exhibit to the Form 8-K as filed on August 12, 2015.
About the Inventors
Henry Brem is the Harvey Cushing Professor of Neurosurgery at The Johns Hopkins University, Director of the Department of Neurosurgery, and Neurosurgeon-in-Chief. He also is a professor of Oncology, Ophthalmology, and Biomedical Engineering. At Hopkins, he has built one of the largest brain tumor research and treatment centers in the world. He has developed new tools and techniques that have changed the field of neurosurgery. His work led to the FDA’s approval of the first image guidance computer system for intraoperative localization of tumors. He has changed the surgical armamentarium against brain tumors by inventing and developing Gliadel(R) wafers to intraoperatively deliver chemotherapy to brain tumors. He designed and led the clinical trials demonstrating safety and efficacy of Gliadel(R) wafers. His work has shown that surgeons can accurately deliver potent therapies directly at the tumor site.
Betty Tyler is an Associate Professor of Neurosurgery at Johns Hopkins University. She runs a highly successful and productive laboratory and has a national reputation for stellar science in the field of translational research and local delivery of chemotherapeutic agents for brain tumor therapy. She assisted in the preclinical studies that led to bringing Gliadel(R) to brain tumor patients as a standard of care.
Violette Renard Recinos is a Neurosurgeon at the Cleveland Clinic.
About Glioblastoma Multiforme
Glioblastoma multiforme (GBM) is the most common and most aggressive malignant primary brain tumor in humans. Approximately 17,500 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.
About Accurexa, Inc.
The Company is focused on developing and commercializing novel neurological therapies that can deliver therapeutics directly into specific regions of the brain. Its BranchPoint device was invented to deliver therapeutics, such as stem cells or gene therapy vectors, through the radial deployment of a flexible catheter to specific brain target areas through a single brain penetration. 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* (University of California, San Francisco) 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 Company is also developing its ACX-31 program which could deliver chemotherapy drugs, such as temozolomide, directly to brain cancer sites. Temozolomide is a generic, 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 temozolomide became generic, it generated US sales of $420 million and global sales of $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 orally administered temozolomide increases patient survival by a significant but modest 2.5 months from a 12.1 months median overall survival.
Animal studies at the Johns Hopkins School of Medicine** have shown that direct 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 far 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.
* 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.
** 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.
# 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 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.
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