Study will be performed under recently opened IND to Evaluate Safety and Efficacy of [18F]-ML-10 in Early Detection of Response of Metastatic Brain Tumors to Radiotherapy -
PETACH-TIKVA, Israel, December 15, 2008 – Aposense Ltd., a leading developer of agents targeting apoptosis (programmed cell death) for molecular imaging and therapy, today announced the initiation of a Phase II, Multi-Center Study of its [18F]-ML-10 compound for molecular imaging of apoptosis at Memorial Sloan-Kettering Cancer Center, following approval by its Institutional Review Board (IRB). This study aims to evaluate the safety and efficacy of [18F]-ML-10 in early assessment of response of metastatic brain tumors to high-dose, single-fraction radiotherapy (also known as stereotactic radiosurgery).
“Early assessment of the effect of therapy is among the major unmet needs in oncology. Taking advantage of new functional imaging tools, oncologists now have the unique opportunity to identify biological changes that occur in a tumor as a result of treatment. These changes may act as early surrogate markers which can significantly improve the way we treat patients. Such information may effectively identify patients early on in their clinical course who are non-responders to a particular therapy and trigger a change in the course of therapy,” said Kathryn Beal, MD, a Radiation Oncologist at Memorial Sloan-Kettering Cancer Center in New York City and the principle investigator of the study. “The early assessment of the treatment response using biological and molecular endpoints could have a profound effect on tailoring a course of cancer therapy for patients in many areas of oncology.”
The study will assess the safety and efficacy of imaging of apoptosis with [18F]-ML-10 to detect response to treatment of brain metastases, within several days after treatment. Apoptosis will be observed by mapping the uptake of [18F]-ML-10 within the tumor by using a PET (positron emission tomography) scan, to be performed prior to treatment and at two other points within one week after treatment. Changes in the [18F]-ML-10 uptake will be compared with changes in tumor size two months after treatment according to MRI. The study end-points include assessment of apoptotic changes occurring within days after treatment, and the accuracy of these changes in predicting treatment results.
“Initiation of this Phase II study is a significant milestone for Aposense and we look forward to collaborating with the scientists and physicians at Memorial Sloan-Kettering,” said Yoram Ashery, CEO of Aposense. “This study marks the expansion of our [18F]-ML-10 program into an area with significant unmet need for real-time information on the biological effect of cancer therapy, and for potentially enabling individualized care for cancer patients using molecular imaging of apoptosis.”
Patient enrollment is scheduled to begin shortly, with target recruitment of 30 to 60 patients. Several other top U.S. cancer centers are also expected to participate.
For more information on the study, visit www.clinicaltrials.gov (identifier NCT00805636).
About Brain Metastases Approximately 170,000 cancer patients develop brain metastases annually, representing approximately 24% of patients who die from cancer. The incidence of brain metastasis is rising with the increase in survival of cancer patients. Metastasis to the brain is the most feared complication of systemic cancer and the most common intracranial tumor in adults. Currently, cancer patients live longer as a result of important advances in cancer diagnosis and management. Early diagnosis and aggressive treatment of brain metastasis may result in remission of brain symptoms and may enhance the quality of the patient's life and prolong survival (http://www.emedicine.com/Radio/topic101.htm).
About Apoptosis Apoptosis is a genetically-controlled program of cell death, inherent in any nucleated cell in the body and therefore often referred to also as “cell suicide”. Upon activation, the apoptotic program executes a well-characterized sequence of events by which the cell undergoes fragmentation and elimination by macrophages, without damaging the surrounding tissue. Apoptosis is a universal process of cell death and it plays a role in most medical disorders, making it one of the important processes of cell biology. For example, apoptosis has important roles in oncology, both in the process of tumor growth, as well as in treatment with most therapies which aim to induce death in cancer cells. Targeting cells undergoing apoptosis, for imaging or delivering therapy, can therefore have broad clinical applications.
About Molecular Imaging Molecular imaging is an emerging field which aims to visualize non-invasively biological processes in-vivo. The ability to image disease-related biological processes may allow physicians to detect disease early, characterize the disease better and to personalize treatment by real-time monitoring of therapeutic effect. Molecular imaging depends on special molecules (probes) that can selectively target these biological processes, while carrying an imaging moiety for visualization, such as 18F or other positron emitting radio-isotopes that can be visualized by positron emission tomography (PET).
About APOSENSE Aposense Ltd. Is a molecular imaging and drug development company, leading the translation of the science of apoptosis (programmed cell death) into clinical practice. Aposense introduces novel imaging and therapeutic agents based on rationally-designed, nano-mechanisms for selective targeting of cells undergoing apoptosis. Aposense technology is based on a new, patented class of small molecular probes that selectively identify and accumulate within apoptotic (dying) cells in vivo. Apoptosis plays a role in many disease areas, including oncology, neurology and cardiology. Aposense probes for Molecular Imaging enables real–time visualization of the biological activity of disease, its onset, change in course and response to therapy, and to personalize treatment for the individual patient in cancer and other diseases. Therapeutic applications of Aposense technology in pre-clinical development include targeted anticancer therapy by using apoptotic cells in tumors as targets for specific delivery and activation of cytotoxic agents in the tumor. For additional information, visit http://www.aposenese.com