About Immunovative Therapies, Ltd. and Dr. Michael Har-Noy
For the official Immunovative Therapies, Ltd. corporate website, please visit www.immunovative.com
Immunovative Therapies, Ltd. is a private Israeli company founded in May 2004 by Dr Michael Har-Noy. Dr. Har-Noy immigrated to Israel in February 2004 to accept an appointment as a researcher at Hadassah-Hebrew University Medical School. The University provided Dr. Michael Har-Noy a laboratory and a position in the Department of Bone Marrow Transplant and Cancer Immunotherapy.
In May 2004, Dr. Michael Har-Noy applied for a competitive grant from the Israel Office of the Chief Scientist (OCS) through the Misgav Venture Accelerator technology incubator to develop a concept he called the “Mirror EffectTM”. The Mirror EffectTM was designed to initiate the same immune effect that occurs in allogeneic stem cell transplant procedures (“Mini-Transplants”) without the associated lethal graft-vs.-host disease side effect and without the need for a matched tissue donor. Dr. Michael Har-Noy has published the scientific hypothesis behind the development of this technology.
After a rigorous evaluation of the Mirror EffectTM’s technology and potential commercialization, Immunovative Therapies, Ltd. won this prestigious competitive support from the OCS and Immunovative Therapies, Ltd. was officially founded by Dr. Michael Har-Noy in May 2004 to begin work to provide proof-of-principle” for the Mirror Effect. In order to conduct this research, Immunovative Therapies, Ltd. entered into a collaboration agreement with the business unit of the Hadassah-Hebrew University Medical School known as “Hadasit”. The agreement with Hadasit enabled Dr. Michael Har-Noy to work in the Bone Marrow Transplant Department and be assigned a laboratory and support personnel in exchange Hadasit received a 3% interest in Immunovative Therapies, Ltd.. As part of this agreement, Hadasit agreed that any current or future intellectual property developed by Immunovative Therapies, Ltd. or Dr. Michael Har-Noy would belong to Immunovative Therapies, Ltd.
Immunovative Therapies, Ltd. is now a successful graduate of the Misgav Venture Accelerator, a division of the internationally respected Israel technological incubator program. Immunovative Therapies, Ltd., under the guidance of Dr. Michael Har-Noy, was the Misgav Venture Accelerator’s candidate for the prize for the Office of the Chief Scientist’s outstanding incubator project of 2006.
Incredibly, in just five short years and less than $10 million, under the direction of Dr. Michael Har-Noy, Immunovative Therapies, Ltd. was able to complete pre-clinical development of two products related to the Mirror Effect, including animal efficacy studies, pharmacology, toxicology, dose and frequency studies and Good Manufacturing Process (GMP) compliant production with in-process and final release criteria for safety, function and identity. At Immunovative Therapies, Ltd., Dr. Michael Har-Noy also conducted toxicity studies in monkeys and a toxicity study in humans under a compassionate Investigational New Drug (IND) permit granted by the Thailand Food and Drug Administration (FDA). These data led to the United States FDA approval of a Phase I/II clinical study in Carlsbad, California.
Dr. Michael Har-Noy and Immunovative Therapies achieved remarkable results in their Phase I/II United States FDA-approved trial in which their proprietary drug AlloStimTM was used to treat 42 patients with different types of advanced metastatic tumors. All patients had failed conventional therapy and had a maximum life expectancy of 60 days. After AlloStimTM was administered using the protocol developed by Dr. Michael Har-Noy at Immunovative Therapies, the mean survival of the entire group of patients was 163 days – almost triple the predicted survival time in untreated patients with similar tumors. Additionally, 20% of the study patients were still in remission one year after treatment! Some of the patients went on to live for several years after the conclusion of the study. Dr. Michael Har-Noy is preparing to publish the study data in a peer-reviewed journal.
Immunovative Therapies, Ltd. has raised approximately $16 million to date over a 9 year period, has 14 issued and over 100 pending patents and Dr. Michael Har-Noy has currently obtained full regulatory approval to commence a pivotal Phase II/III, double-blind, placebo controlled study in metastatic breast cancer. This is believed to be the final study necessary to support applications to obtain marketing approval in US, EU and other countries in the world.
Immunovative Therapies, Ltd. remains under the guidance of Dr. Michael Har-Noy, its current Chief Executive Officer. Immunovative Therapies, Ltd. has 18 employees and is located in Jerusalem, Israel at the Malcha Technology Park. The employees of Immunovative Therapies, Ltd. focus on product research and development, GMP manufacturing, and quality control laboratory and immunological monitoring. Immunovative Therapies, Ltd. also operates a wholly-owned subsidiary in Carlsbad, California which coordinates the conduction of worldwide clinical trials. Dr. Michael Har-Noy works closely with consultants in radiology and pathology as well as with a Data Safety Monitoring Board. Immunovative Therapies, Ltd. continuously tracks a variety of independent clinical monitors and uses an electronic database system for real-time evaluation of clinical data. Immunovative Therapies, Ltd also has operations in Bangkok, Thailand and collaborates closely with the National Cancer Institute of Thailand.