Thema: Presse: Fluorescence Guided Resection Of Brain Cancer
Presse: Fluorescence Guided Resection Of Brain Cancer
Sabi[a]
16.01.2003 19:38:50
Press Release Source: DUSA Pharmaceuticals, Inc.
Jan. 14, 2003
Signs In-Licensing Agreement For Fluorescence Guided Resection Of Brain Cancer
DUSA Pharmaceuticals, Inc. reported today the signing of a License and Development Agreement with Photonamic GmbH & Co. KG, a recently formed subsidiary of medac GmbH, a German pharmaceutical company, and a Supply Agreement with medac. These agreements provide for the licensing to DUSA of Photonamic´s proprietary technology related to aminolevulinic acid (ALA), the compound used in DUSA´s Levulan® Photodynamic Therapy (PDT) and Photodetection (PD) for particular indications.
Under the terms of the License and Development Agreement, DUSA receives a license for the United States and several other countries, to use Photonamic´s technology and data related to ALA for systemic dosing in the field of brain cancer and other indications which the parties may jointly develop during the term of their collaboration. Photonamic is currently conducting a European Phase III clinical trial in which ALA-induced fluorescence is used to guide surgical tumor resection in patients suffering from the most aggressive form of adult brain tumor, glioblastoma multiforme (GBM). Completion of these trials is expected within two years. DUSA´s license covers both this primary clinical indication as well as other brain cancers. DUSA is also entitled to use the licensed technology including pre-clinical data in connection with other additional indications DUSA is developing on its own.
The Supply Agreement with medac covers medac´s current systemic dosage formulation for use in brain cancer, Barrett´s esophagus, if DUSA requires it, as well as other potential formulations which the parties may jointly develop.
DUSA paid an up-front license fee, and will be obligated to pay certain regulatory milestones and royalties on net sales of a brain cancer product under the terms of the License and Development Agreement. DUSA will also purchase product under the Supply Agreement for mutually agreed upon indications. Should Photonamic´s clinical studies be successful, DUSA will be obligated to proceed with development of the product in the U.S. in order to retain the license for the use of the technology to treat brain cancer.
The estimated global annual incidence of newly diagnosed brain tumors in adults ranges from 7 to 17 cases per 100,000 people per year. Gliomas are the largest group of primary adult brain tumors, and GBM accounts for approximately 80% of adult malignant gliomas. The median survival of patients with GBM after surgery is approximately one year. The addition of radiation therapy can improve survival by 16-18 weeks. Complete surgical removal of GBM provides optimal survival, but visual detection of the complete tumor during surgery using current techniques can be difficult.
In an independent European investigator study on 52 patients with GBM, using oral ALA, 20 mg/kg body weight, and a modified operating microscope, selective ALA-induced fluorescence was observed only in GBM tumor tissue during surgery. Biopsies showed that normal white matter of the brain did not show fluorescence. The study also showed that when all fluorescent areas could be removed, post-operative MRI showed no residual tumor. (Stummer et al, Fluorescence-guided resection of glioblastoma multiforme by using 5-aminolevulinic acid-induced porphyrins, J Neurosurg 93; 1003- 1013, 2000).
In the multi-center registration study currently being sponsored by Photonamic, patients with resectable GBM are randomized to standard or fluorescence-guided resection. The study is examining the safety and efficacy of fluorescence-guided resection as compared with standard therapy. The study is designed to detect whether use of ALA fluorescence-guided resection of GBM results in a 15% increase in tumor progression-free status 6 months after surgery and will also follow patients to assess the impact on survival rates. The study is expected to accrue more than 320 patients.
Jan. 14, 2003
Signs In-Licensing Agreement For Fluorescence Guided Resection Of Brain Cancer
DUSA Pharmaceuticals, Inc. reported today the signing of a License and Development Agreement with Photonamic GmbH & Co. KG, a recently formed subsidiary of medac GmbH, a German pharmaceutical company, and a Supply Agreement with medac. These agreements provide for the licensing to DUSA of Photonamic´s proprietary technology related to aminolevulinic acid (ALA), the compound used in DUSA´s Levulan® Photodynamic Therapy (PDT) and Photodetection (PD) for particular indications.
Under the terms of the License and Development Agreement, DUSA receives a license for the United States and several other countries, to use Photonamic´s technology and data related to ALA for systemic dosing in the field of brain cancer and other indications which the parties may jointly develop during the term of their collaboration. Photonamic is currently conducting a European Phase III clinical trial in which ALA-induced fluorescence is used to guide surgical tumor resection in patients suffering from the most aggressive form of adult brain tumor, glioblastoma multiforme (GBM). Completion of these trials is expected within two years. DUSA´s license covers both this primary clinical indication as well as other brain cancers. DUSA is also entitled to use the licensed technology including pre-clinical data in connection with other additional indications DUSA is developing on its own.
The Supply Agreement with medac covers medac´s current systemic dosage formulation for use in brain cancer, Barrett´s esophagus, if DUSA requires it, as well as other potential formulations which the parties may jointly develop.
DUSA paid an up-front license fee, and will be obligated to pay certain regulatory milestones and royalties on net sales of a brain cancer product under the terms of the License and Development Agreement. DUSA will also purchase product under the Supply Agreement for mutually agreed upon indications. Should Photonamic´s clinical studies be successful, DUSA will be obligated to proceed with development of the product in the U.S. in order to retain the license for the use of the technology to treat brain cancer.
The estimated global annual incidence of newly diagnosed brain tumors in adults ranges from 7 to 17 cases per 100,000 people per year. Gliomas are the largest group of primary adult brain tumors, and GBM accounts for approximately 80% of adult malignant gliomas. The median survival of patients with GBM after surgery is approximately one year. The addition of radiation therapy can improve survival by 16-18 weeks. Complete surgical removal of GBM provides optimal survival, but visual detection of the complete tumor during surgery using current techniques can be difficult.
In an independent European investigator study on 52 patients with GBM, using oral ALA, 20 mg/kg body weight, and a modified operating microscope, selective ALA-induced fluorescence was observed only in GBM tumor tissue during surgery. Biopsies showed that normal white matter of the brain did not show fluorescence. The study also showed that when all fluorescent areas could be removed, post-operative MRI showed no residual tumor. (Stummer et al, Fluorescence-guided resection of glioblastoma multiforme by using 5-aminolevulinic acid-induced porphyrins, J Neurosurg 93; 1003- 1013, 2000).
In the multi-center registration study currently being sponsored by Photonamic, patients with resectable GBM are randomized to standard or fluorescence-guided resection. The study is examining the safety and efficacy of fluorescence-guided resection as compared with standard therapy. The study is designed to detect whether use of ALA fluorescence-guided resection of GBM results in a 15% increase in tumor progression-free status 6 months after surgery and will also follow patients to assess the impact on survival rates. The study is expected to accrue more than 320 patients.
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