Jerusalem, May 11, 2008, for immediate release.
TK signal, a subsidiary of Hadasit Bio Holdings Ltd. (TASE: HDST, 28%), received approval from the institutional Helsinki committee of Rambam Medical Center and initiated a preliminary clinical trial to evaluate the efficacy of an existing drug for a new indication of cancer therapy.
TK signal has recently signed a licensing agreement with Dr. Mia Levite for the exclusive rights to develop novel anticancer drug technology. This study was recently granted Helsinki committee's approval as a preliminary ex-vivo clinical trial on blood and bone marrow samples of patients with leukemia and myeloma, to be conducted at the Hematology and Bone Marrow Transplant Institute, Rambam Medical Center (Prof. Jacob M. Rowe, Dr. Irit Avivi, Dr. Tami Katz).
The study, which is expected to take about 6 months to complete, will be conducted on 40 patients' samples. It will investigate the effect of an existing drug, previously authorized for another indication, on cancer cells taken directly from patients with acute and chronic lymphocytic leukemia, acute myeloid leukemia and multiple myeloma.
The studied drug, which is already approved by the FDA for the management of high blood pressure in intensive care units, has been in use for over 15 years and has been shown to be relatively safe and without significant side effects when used for its registered indication. Current therapeutic strategies for malignant tumors are predominantly based on various chemotherapy drugs that unselectively attack and destroy not only cancer cells but also normal cells in the body. This leads to unwanted side effects and organ system dysfunction that weaken the ability of the body to fight the cancer. Furthermore, while available chemotherapy drugs kill most cancer cells, it is often impossible to destroy all cells and cure the cancer completely; instead, these drugs induce only temporary remission, at a high cost of impaired function and quality of life. In some types of cancer, treatment can also consist of additional anticancer therapies, e.g. radiotherapy and bone marrow transplantation
In recent years, "targeted therapy" was added to the cancer therapy toolbox, in order to reduce toxicity and enhance efficacy
Since the studied drug is also considered a targeted therapy, the trial will investigate its selective killing effect on cancer cells only. The current preliminary clinical trial is based on the findings of Dr. Levite that the receptor targeted by the drug is expressed (sometimes very abundantly) on the surface of leukemia and lymphoma cells and that the drug can destroy cancer cells effectively and very rapidly with minimal effect on healthy cells. This anticancer activity of the drug is seen well within the approved dose range for the registered indication (of lowering blood pressure in acute conditions); therefore, TK signal does not foresee safety problems with this novel use of the drug. Dana Cohen, CEO of TK signal, estimates that the duration of the development and completion of the preliminary clinical trial will be relatively short and that, contingent on the successful completion of this trial, the Company will start preparing for a full scale clinical trial in Q4 2008.
Hematologic malignancies, which account for one fifth of all malignant tumors, are the second leading cause of cancer death. 53% of all new patients in 2007 were diagnosed with lymphoma, 33% with leukemia and 15% with myeloma. More than 300,000 new patients are diagnosed with these types of cancer each year, with over 800,000 patients currently diagnosed in the US alone. The global market for hematologic drugs is estimated at over USD 10 billion annually.
In recent years, pharmaceutical companies have taken an increasing interest in drug repositioning, i.e. development of new indications for marketed drugs or modified molecules at their advanced phases of development pipelines.
Drug repositioning allows companies to develop drugs at relatively short time. In general, new indications for previously authorized drugs are approved by the FDA in an expedited regulatory procedure (505(b)(2)). With this expedited approval, pharmaceuticals can skip the safety phase (phase I) and proceed directly into phase II.
TK signal is also looking into the possibility of entering a human clinical trial of solid tumor imaging (PET/CT) in collaboration with the MD Anderson Cancer Center (one of the leading cancer research institutes worldwide). The Company has signed a licensing agreement for patent commercialization (co-owned by Hadassah Medical Center and Prof. Eyal Mishani) for cancer diagnosis and treatment using radio-labeled biomarkers that bind specifically to cancer cells. TK signal also plans to enter the medical imaging market for cancer diagnosis, in particular imaging agents for use in positron emission tomography (PET), one of the most advanced imaging techniques in the field of diagnostics. | 
