Accurexa Enters into Collaboration with The Hebrew University of Jerusalem
NEWWARK, DE / ACCESSWIRE / November 2, 2015 / 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 entered into an agreement with the Yissum Research Development Company of The Hebrew University of Jerusalem Ltd. (“Yissum”) to develop and supply a polymeric formulation of a combination of carmustine and temozolomide for sustained local administration to a solid tumor (the “Services”). The Services will be provided by Yissum under a service agreement under which the Company will retain ownership of all intellectual property rights that are discovered or developed during the course of the provision of the Services. Professor Avi Domb of The Hebrew University of Jerusalem will lead the development efforts provided by Yissum.
“We are excited that Professor Domb will lead the efforts of developing a formulation for our ACX-31 program. He, Professor Brem from Hopkins and Professor Langer at MIT had previously developed Gliadel(R)’s wafer formulation. We believe that our collaboration with them will be exceptionally valuable to the development of our ACX-31 program,” said George Yu, MD, Accurexa’s President & CEO.
Professor Avi Domb was Head of the Department of Biomaterials and Medicinal Chemistry of The Hebrew University of Jerusalem and Director, Division of Identification and Forensic Sciences, with the rank of Brigadier General, of the Israel Police. He is now President of Azrieli, Jerusalem of College of Engineering and Professor at the Faculty of Medicine of the Hebrew University. His research is focused on synthesis, characterization and applications of biopolymers, medicinal and organic chemistry, controlled drug delivery, nanoparticles and nanoformulations, forensic sciences, and biometric analysis. Products that he developed include Gliadel(R)for treating brain tumors (with Langer and Brem); Superfloc – flocculants for water purification; Deximmune(R)- cyclosporin pro-nanodispersion-capsule (Dexcel, Israel); InSpace and OrthoPass(R) – biodegradable balloons for separation of tissues; Cunker Cover(R) – adhesive tablet for treating oral ulcers (Quantum USA); OraMoist(R)-adhesive tablet for treating dry mouth (Quantum, USA) and MAZE – water purification system (Strauss Inc. Israel).
Yissum was founded in 1964 to protect and commercialize the Hebrew University’s intellectual property. Ranked among the top technology transfer companies, Yissum has registered over 8,900 patents covering 2,500 inventions; has licensed out 800 technologies and has spun-off 90 companies. Products that are based on Hebrew University technologies and were commercialized by Yissum generate today over $2 billion in annual sales.
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. 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 $420 million and global sales of $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 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 Yissum Research Development Company of the Hebrew University of Jerusalem Ltd.
Yissum is the technology transfer company of the Hebrew University of Jerusalem. It is responsible for marketing the inventions and know-how generated by the University’s renowned researchers and students. The University’s range of intellectual property includes inventions and know-how in many fields, including nanotechnology, medicine and pharmaceuticals, agriculture and nutrition, water and environmental technologies, computer science, homeland security, and more. Working closely with Hebrew University researchers and staff, Yissum actively focuses on making these technologies commercially viable — and desirable — in the marketplace. Over the past 51 years, Yissum has granted more than 825 technology licenses and is responsible for commercializing an array of successful products that generate over $2 billion in worldwide sales every year. More than 110 spin-off companies, including Mobileye, Collplant, Briefcam, and Santern have had their start at Yissum. Yissum maintains strong relationships with the business community in Israel and abroad to advance the technologies and opportunities coming out of the Hebrew University.
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.
ReleaseID: 433116
Accurexa Enters into Collaboration with The Hebrew University of Jerusalem
NEWWARK, DE / ACCESSWIRE / November 2, 2015 / 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 entered into an agreement with the Yissum Research Development Company of The Hebrew University of Jerusalem Ltd. (“Yissum”) to develop and supply a polymeric formulation of a combination of carmustine and temozolomide for sustained local administration to a solid tumor (the “Services”). The Services will be provided by Yissum under a service agreement under which the Company will retain ownership of all intellectual property rights that are discovered or developed during the course of the provision of the Services. Professor Avi Domb of The Hebrew University of Jerusalem will lead the development efforts provided by Yissum.
“We are excited that Professor Domb will lead the efforts of developing a formulation for our ACX-31 program. He, Professor Brem from Hopkins and Professor Langer at MIT had previously developed Gliadel(R)’s wafer formulation. We believe that our collaboration with them will be exceptionally valuable to the development of our ACX-31 program,” said George Yu, MD, Accurexa’s President & CEO.
Professor Avi Domb was Head of the Department of Biomaterials and Medicinal Chemistry of The Hebrew University of Jerusalem and Director, Division of Identification and Forensic Sciences, with the rank of Brigadier General, of the Israel Police. He is now President of Azrieli, Jerusalem of College of Engineering and Professor at the Faculty of Medicine of the Hebrew University. His research is focused on synthesis, characterization and applications of biopolymers, medicinal and organic chemistry, controlled drug delivery, nanoparticles and nanoformulations, forensic sciences, and biometric analysis. Products that he developed include Gliadel(R)for treating brain tumors (with Langer and Brem); Superfloc – flocculants for water purification; Deximmune(R)- cyclosporin pro-nanodispersion-capsule (Dexcel, Israel); InSpace and OrthoPass(R) – biodegradable balloons for separation of tissues; Cunker Cover(R) – adhesive tablet for treating oral ulcers (Quantum USA); OraMoist(R)-adhesive tablet for treating dry mouth (Quantum, USA) and MAZE – water purification system (Strauss Inc. Israel).
Yissum was founded in 1964 to protect and commercialize the Hebrew University’s intellectual property. Ranked among the top technology transfer companies, Yissum has registered over 8,900 patents covering 2,500 inventions; has licensed out 800 technologies and has spun-off 90 companies. Products that are based on Hebrew University technologies and were commercialized by Yissum generate today over $2 billion in annual sales.
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. 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 $420 million and global sales of $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 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 Yissum Research Development Company of the Hebrew University of Jerusalem Ltd.
Yissum is the technology transfer company of the Hebrew University of Jerusalem. It is responsible for marketing the inventions and know-how generated by the University’s renowned researchers and students. The University’s range of intellectual property includes inventions and know-how in many fields, including nanotechnology, medicine and pharmaceuticals, agriculture and nutrition, water and environmental technologies, computer science, homeland security, and more. Working closely with Hebrew University researchers and staff, Yissum actively focuses on making these technologies commercially viable — and desirable — in the marketplace. Over the past 51 years, Yissum has granted more than 825 technology licenses and is responsible for commercializing an array of successful products that generate over $2 billion in worldwide sales every year. More than 110 spin-off companies, including Mobileye, Collplant, Briefcam, and Santern have had their start at Yissum. Yissum maintains strong relationships with the business community in Israel and abroad to advance the technologies and opportunities coming out of the Hebrew University.
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.
ReleaseID: 433116
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