NEWARK, DE / CRWEPRESSRELEASE / September 3, 2015 /Accurexa Inc. (the “Company”) (OTCMKTS:ACXA), a biotechnology company focused on the development of novel neurological therapies that can deliver therapeutics directly into the brain, announced today that Professor Robert Langer agreed 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.
Professor Robert Langer is the David H. Koch Institute Professor at the Massachusetts Institute of Technology (“MIT”). There are 11 Institute Professors at MIT; being an Institute Professor is the highest honor that can be awarded to a faculty member. Dr. Langer has written over 1,300 articles. He also has over 1,080 patents worldwide. Dr. Langer’s patents have been licensed or sublicensed to over 300 pharmaceutical, chemical, biotechnology and medical device companies. He is the most cited engineer in history (h-index 213).
He served as a member of the United States Food and Drug Administration’s SCIENCE Board, the FDA’s highest advisory board, from 1995â€“2002 and as its Chairman from 1999â€“2002.
“We are thrilled that Professor Langer supports us in the development of our ACX-31 program. We believe that Professor Langer’s world-renowned scientific expertise and prior experience with GliadelÂ® will be exceptionally valuable,” said George Yu, MD, Accurexa’s President & CEO.
“I am excited to collaborate with Dr. Henry Brem at Johns Hopkins and Accurexa in the development of a new therapy to treat brain tumors through local drug delivery. I have known Henry as a clinical innovator for many years,” said Professor Langer.
Dr. Langer has received over 220 major awards. He is one of 4 living individuals to have received both the United States National Medal of Science (2006) and the United States National Medal of Technology and Innovation (2011). He also received the 2002 Charles Stark Draper Prize, considered the equivalent of the Nobel Prize for engineers, the 2008 Millennium Prize, the world’s largest technology prize, the 2012 Priestley Medal, the highest award of the American Chemical Society, the 2013 Wolf Prize in Chemistry, the 2014 Breakthrough Prize in Life Sciences and the 2014 Kyoto Prize. He is also the only engineer to receive the Gairdner Foundation International Award; 82 recipients of this award have subsequently received a Nobel Prize. In 2015, Dr. Langer received the Queen Elizabeth Prize for Engineering. Among numerous other awards Langer has received are the Dickson Prize for Science (2002), Heinz Award for Technology, Economy and Employment (2003), the Harvey Prize (2003), the John Fritz Award (2003) (given previously to inventors such as Thomas Edison and Orville Wright), the General Motors Kettering Prize for Cancer Research (2004), the Dan David Prize in Materials Science (2005), the Albany Medical Center Prize in Medicine and Biomedical Research (2005), the largest prize in the U.S. for medical research, induction into the National Inventors Hall of Fame (2006), the Max Planck Research Award (2008), the Prince of Asturias Award for Technical and Scientific Research (2008), the Warren Alpert Foundation Prize (2011) and the Terumo International Prize (2012). In 1998, he received the Lemelson-MIT prize, the world’s largest prize for invention for being “one of history’s most prolific inventors in medicine.” In 1989 Dr. Langer was elected to the Institute of Medicine of the National Academy of Sciences, and in 1992 he was elected to both the National Academy of Engineering and to the National Academy of Sciences, and in 2012 he was elected to the National Academy of Inventors.
Forbes Magazine (1999) and Bio World (1990) have named Dr. Langer as one of the 25 most important individuals in biotechnology in the world. Discover Magazine (2002) named him as one of the 20 most important people in this area. Forbes Magazine (2002) selected Dr. Langer as one of the 15 innovators worldwide who will reinvent our future. Time Magazine and CNN (2001) named Dr. Langer as one of the 100 most important people in America and one of the 18 top people in science or medicine in America (America’s Best). Parade Magazine (2004) selected Dr. Langer as one of 6 “Heroes whose research may save your life.” Dr. Langer has received honorary doctorates from Harvard University, the Mt. Sinai School of Medicine, Yale University, University of Western Ontario (Canada), the ETH (Switzerland), the Technion (Israel), the Hebrew University of Jerusalem (Israel), the Universite Catholique de Louvain (Belgium), Rensselaer Polytechnic Institute, Willamette University, the University of Liverpool (England), Bates College, the University of Nottingham (England), Albany Medical College, Pennsylvania State University, Northwestern University, Uppsala University (Sweden), Tel Aviv University (Israel), Boston University, Ben Gurion University (Israel), Drexel University, Hanyang University (South Korea), University of New South Wales (Australia) and the University of California â€“ San Francisco Medal. He received his Bachelor’s Degree from Cornell University in 1970 and his Sc.D. from the Massachusetts Institute of Technology in 1974, both in Chemical Engineering.
About Accurexa, Inc.
The Company is focused on developing novel neurological therapies that can deliver therapeutics directly into specific regions of the brain. It is developing its ACX-31 program which could deliver chemotherapy drugs, such as temozolomide in combination with BCNU, directly to brain tumor 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 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.
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. 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.
Additional information about the Company may be found on its website, www.accurexa.com.
* 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.
# 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.
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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SOURCE: Accurexa Inc.