Hadasit Bio-Holdings

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Receipt of FDA Approval of the Accelerated Regulator Track for the OpRegenĀ® to Treat Dry Age-Related Macular Degeneration

Sep. 29, 2015

HBL - Hadasit Bio-Holdings Ltd.

(the “Company”)

September 29, 2015

 

To:                                           To:

Israel Securities Authority      Tel Aviv Stock Exchange Ltd. 

www.isa.gov.il                        www.tase.co.il

 

Re: Receipt of FDA Approval of the Accelerated Regulator Track for the OpRegen® to Treat Dry Age-Related Macular Degeneration

The Company is pleased to announce that CellCure Neurosciences Ltd., a company held 21.2% by the Company (hereinafter: “CellCure”) has received approval from the American FDA for an accelerated regulatory track (a fast track) for the development of the OpRegen® product for treating dry age related macular degeneration with geographic atrophy.

  The US Food and Drug Administration, the FDA, grants approval of an accelerated regulatory track (a fast track) after concluding that the drug being developed will provide a solution for a significant medical need for which no treatment exists. A drug that receives fast track approval is entitled to all of part of the following rights:

Holding more frequent meetings with the FDA for discussion the drug’s development plan and the ability to ensure that the clinical data collected meets the requirements for the drug’s approval.

More frequent and ongoing written communication on the part of the FDA with respect to the outline of the clinical trials and use of biomarkers.

Entitled to accelerated approval and priority in terms of submission, in accordance with meeting relevant criteria.

Examination in parts, such that the Company developing the drug can submit in parts results from clinical trials, as they are available, within the submission of the Biologic License Application (BLA) or within the submission of the new drug application (NDA), and without requiring the completion of all of the parts before the full examination of the file. In the regular track, the examination of the BLA or the NDA does not begin until the Company that develops the drug submits all of the requirements for the FDA together.

CellCure is in the midst of a Phase I/II clinical trial of the OpRegen® product of the Company in patients with dry age-related macular degeneration with geographic atrophy and even reported the completion of a transplant in the first patient in the Hadassah Hospital. CellCure expects to publish preliminary interim results from this trial at the beginning of 2016.

The information included in this immediate report regarding the dates expected for the clinical trail is forward looking information, as defined in the Securities Law, 5728-1968, the realization of which depends on various factors, inter alia, the recruitment and location of suitable patients during the clinical trial. The Company also wishes to clarify that there is no certainty that the clinical trial will be completed or that the results of the clinical trial will be positive and/or that the development of the product will be completed by CellCure and that the product will be commercialized.  

 

 

 

 

 

Sincerely,

                                                                                               

HBL - Hadasit Bio-Holdings Ltd.

       By: Ms. Tamar Kfir, CEO

 

 
 

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