FDA Approves Accurexa's Small Business Qualificati
Post# of 579
Posted On: 03/19/2015 10:45:32 AM
FDA Approves Accurexa's Small Business Qualification
2015-03-16 08:03 ET - News Release
SAN FRANCISCO, CA / ACCESSWIRE / March 16, 2015 / Accurexa Inc. (the "Company"
(OTCQB:ACXA), a biotechnology company focused on developing and commercializing novel neurological therapies, announced today that the U.S. FDA (Food and Drug Administration) informed the Company that it qualifies under MDUFA (Medical Device User Fee Amendment) as a Small Business for a reduced or waived fee for medical device submissions made during fiscal year 2015. The Company's Small Business status expires at the close of business September 30, 2015. "We submitted our application for Small Business qualification to the FDA in preparation of the filing of our 510(k) marketing clearance application. We are pleased that the development of our BranchPoint device is advancing towards a regulatory submission," said Dr. George Yu, the Company's President & CEO. The Company's 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 temozolomide, a chemotherapy drug, directly to brain cancer sites with its BranchPoint device. 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 only 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.
Notes: * 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. 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, median 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 based on its proprietary BranchPoint device delivering therapeutics directly into specific regions of the brain . The BranchPoint device can deliver 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 may also give physicians more precise control of the volume of therapeutics delivered and could ensure that therapeutics delivered into the brain would stay in the brain, avoiding the problem of reflux out to the brain surface. This modern and "easy to use" technology may allow "real-time" monitoring of therapeutic delivery under interventional MRI guidance (iMRI), which could 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 that the Company has exclusively licensed from UCSF. It can potentially enable new approaches to neurological therapy and be modified for the delivery of a broad range of novel therapeutics, such as stem cells to treat neurodegenerative diseases, chemotherapeutics to brain tumors and gene therapy vectors. 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 novel neurological therapies based on its BranchPoint device, ACX-31 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: Capital Group Communications 575 Bridgeway, Sausalito CA 94965 Mark Bernhard 415-332-7200 mark@cgcone.com Mark Gundy 972-240-1873 markgundy@gmail.com Accurexa Inc. info@accurexa.com 415-494-7850 SOURCE: Accurexa, Inc.
© 2015 Canjex Publishing Ltd. All rights reserved.
2015-03-16 08:03 ET - News Release
SAN FRANCISCO, CA / ACCESSWIRE / March 16, 2015 / Accurexa Inc. (the "Company"
(OTCQB:ACXA), a biotechnology company focused on developing and commercializing novel neurological therapies, announced today that the U.S. FDA (Food and Drug Administration) informed the Company that it qualifies under MDUFA (Medical Device User Fee Amendment) as a Small Business for a reduced or waived fee for medical device submissions made during fiscal year 2015. The Company's Small Business status expires at the close of business September 30, 2015. "We submitted our application for Small Business qualification to the FDA in preparation of the filing of our 510(k) marketing clearance application. We are pleased that the development of our BranchPoint device is advancing towards a regulatory submission," said Dr. George Yu, the Company's President & CEO. The Company's 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 temozolomide, a chemotherapy drug, directly to brain cancer sites with its BranchPoint device. 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 only 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.
Notes: * 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. 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, median 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 based on its proprietary BranchPoint device delivering therapeutics directly into specific regions of the brain . The BranchPoint device can deliver 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 may also give physicians more precise control of the volume of therapeutics delivered and could ensure that therapeutics delivered into the brain would stay in the brain, avoiding the problem of reflux out to the brain surface. This modern and "easy to use" technology may allow "real-time" monitoring of therapeutic delivery under interventional MRI guidance (iMRI), which could 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 that the Company has exclusively licensed from UCSF. It can potentially enable new approaches to neurological therapy and be modified for the delivery of a broad range of novel therapeutics, such as stem cells to treat neurodegenerative diseases, chemotherapeutics to brain tumors and gene therapy vectors. 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 novel neurological therapies based on its BranchPoint device, ACX-31 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: Capital Group Communications 575 Bridgeway, Sausalito CA 94965 Mark Bernhard 415-332-7200 mark@cgcone.com Mark Gundy 972-240-1873 markgundy@gmail.com Accurexa Inc. info@accurexa.com 415-494-7850 SOURCE: Accurexa, Inc.
© 2015 Canjex Publishing Ltd. All rights reserved.
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