Hadasit Bio-Holdings

Press Releases

IND Submission to the FDA of Cell Cure Neuroscience Ltd.

Oct. 6, 2014

HBL – Hadasit Bio-Holdings Ltd.

(The Company)

October 5, 2014

 

To:

Tel-Aviv Stock Exchange Ltd.

www.tase.co.il

 

To:

ISA

www.isa.gov.il

 

 

 

 

Subject: IND Submission to the FDA of Cell Cure Neuroscience Ltd.

 

The Company is happy to announce that Cell Cure Neuroscience Ltd. (hereinafter: “Cell Cure”) has submitted a request of the IND type (Investigational New Drug) to the Food and Drug Administration (“FDA”), in order to conduct a clinical trial  Phase I/IIa on dry age-related macula degeneration patients (“Dry-AMD”) using the Company’s product, OpRegen®.

The purpose of the clinical trial is to prove safety and efficiency of OpRegen®, that is the derivation of pigment cells of the retina (RPE cells) from the embryonic stem cells after subretinal implantation in the advanced Dry-AMD patients with the “geographic atrophy”, as well as to prove longevity of the OpRegen® product. Secondary purpose of the trial is to test the ability of OpRegen® to stop the progression of the disease. In accordance with the IND protocol, patients must stay under supervision for 12 months in order to evaluate the safety and the tolerability of the OpRegen® product.

In parallel with the IND submission, Cell Cure, in collaboration with Hadassa Ein Karem Hospital clinical personnel, has submitted a request to the Helsinki Committee and to the Ministry of Health for a permit to conduct clinical trials in Hadassa.

Along with the IND permit issued by the FDA and the final permit for clinical trials on humans from the Ministry of Health, and subject to the issue of the above permits, the Company shall start conducting the clinical trial Phase I/IIa in Hadassa Hospital.

Said notification is a continuation of Cell Cure’s note, as published on September 17, 2014 (Reference number: 2014-01-159270), regarding obtained results that demonstrate safety and efficacy of the OpRegen® product after the completion of series of pre-clinical trials on animals.

According to the Company's knowledge, the Dry-AMD disease is one of the most common diseases among the elderly population in the United States, Europe and Australia. The number of Dry-AMD patients grows by 1.6 million each year. Total annual economic loss in the domestic product in the USA as a result of the Dry-AMD disease is estimated at 24.4 billion dollars.

The global market potential of the treatment Cell Cure is developing for its advanced Dry-AMD patients with "geographic atrophy" (Geographic atrophy) is estimated at about 5 billion dollars.

The company holds 21.2% of the share capital of Cell Cure engaged in research and development in the field of cell treatment of neurodegeneration diseases, while its main goal is to develop a product for the treatment of dry age-related macula degeneration.

The information contained in this immediate report regarding the beginning of the clinical trial at Hadassah Hospital, is forward-looking, as defined in the Securities Law, 5728 - 1968, which realization depends on various factors, including final approval of the Helsinki Committee.

 

Best regards,

HBL – Hadasit Bio-Holdings Ltd.

By: Ms. Tamar Kafir, CEO

 
 

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