Accurexa's BranchPoint Demonstrates Feasibility of Convection-Enhanced Delivery
SAN FRANCISCO, CA / ACCESSWIRE / March 23, 2015 / Accurexa Inc. (the "Company"
(ACXA), a biotechnology company focused on developing and commercializing novel neurological therapies, reported that its BranchPoint technology has been tested for its ability to deploy a Convection-Enhanced Delivery (CED) catheter that is compatible for use with intraoperative Magnetic Resonance Imaging (iMRI) guidance. This feasibility testing of CED with the BranchPoint technology supports the Company's ACX-31 development program which could deliver temozolomide, a chemotherapy drug, 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. Before temozolomide became generic, it generated US sales of $420 million and global sales of $910 million under its brand name Temodar in 2012.
"The testing supports the technical feasibility of Convection-Enhanced Delivery with our BranchPoint device which could facilitate the infusion of therapeutics. We are excited that we continue to make progress with our ACX-31 development program," said Dr. 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 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'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 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. Additional information about the Company may be found on its website, www.accurexa.com.
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.
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
Tel: 415-332-7200
mark@cgcone.com
Mark Gundy
Tel: 972-240-1873
markgundy@gmail.com
Accurexa Inc.
info@accurexa.com
Tel.: 415-494-7850
SAN FRANCISCO, CA / ACCESSWIRE / March 23, 2015 / Accurexa Inc. (the "Company"
(ACXA), a biotechnology company focused on developing and commercializing novel neurological therapies, reported that its BranchPoint technology has been tested for its ability to deploy a Convection-Enhanced Delivery (CED) catheter that is compatible for use with intraoperative Magnetic Resonance Imaging (iMRI) guidance. This feasibility testing of CED with the BranchPoint technology supports the Company's ACX-31 development program which could deliver temozolomide, a chemotherapy drug, 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. Before temozolomide became generic, it generated US sales of $420 million and global sales of $910 million under its brand name Temodar in 2012. "The testing supports the technical feasibility of Convection-Enhanced Delivery with our BranchPoint device which could facilitate the infusion of therapeutics. We are excited that we continue to make progress with our ACX-31 development program," said Dr. 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 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'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 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. Additional information about the Company may be found on its website, www.accurexa.com.
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.
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
Tel: 415-332-7200
mark@cgcone.com
Mark Gundy
Tel: 972-240-1873
markgundy@gmail.com
Accurexa Inc.
info@accurexa.com
Tel.: 415-494-7850
