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The Company completed recruitment of the initial 150 patients in the Phase III Clinical Trial for KIT-302
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Upon completion of treatment of patient tratment and analysis of the data, it will be determined whether additional patients are to be recruited in order to demonstrate statistical validity and to meet the primary end-point of the trial
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The primary end-point of the trial is to demonstrate that the reduction in blood pressure observed in the arm treated with KIT-302, which combines a drug that treats pain and a drug that lowers blood pressure, is at least 50% of the reduction in blood pressure observed in the arm that was treated only with the blood pressure drug
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Analysis of the data by an independent committee and publication of the interim results is expected to take up to eight weeks
TEL AVIV, Israel I October 21, 2015 I Kitov Pharma (TASE: KTOV) announced today that it has completed recruitment of the initial 150 patients in the Phase III Clinical Trial for KIT-302.
Upon completion of the treatment of these 150 patients, the trial data will be disclosed to an external, independent Data Monitoring Committee, which will analyze the data’s standard deviations and determine whether additional patients are to be recruited in order to demonstrate statistical validity and to meet the primary end-point of the trial (the “Interim Results”), and if so, the number of such additional patients. The Committee’s analysis and the publication of the Interim Results are expected to take up to eight weeks.
Should the Committee recommend treatment of up to 200 additional patients, the Company will continue recruiting patients until reaching statistical validity and achievement of the primary end-point of the trial.
In accordance with the written recommendation of the FDA in their Special Protocol Assessment (SPA) response, there will be no statistical penalty resulting from the analysis of the data by the Committee following the initial stage of the trial.
The primary end-point of the trial, as agreed in writing with the FDA, is to demonstrate that the reduction in blood pressure observed in the arm treated with KIT-302, which combines a drug that treats pain and a drug that lowers blood pressure, is at least 50% of the reduction in blood pressure observed in the arm that was treated only with the blood pressure drug. Isaac Israel, CEO of the Company, stated, “Completion of the recruitment of the initial 150 patients in the trial is an important milestone in Kitov Pharma’s business development and is additional evidence of the capabilities of the clinical development team, led by Dr. J. Paul Waymack. We are anxiously awaiting the Interim Results and are preparing for the continuation of our work plan in anticipation of submitting a New Drug Application for our lead drug in 2016.
About Kitov Pharmaceuticals and KIT-302:
Kitov Pharma is a biopharmaceutical company focused on the development of therapeutic candidates for the simultaneous treatment of two clinical conditions: pain caused by osteoarthritis; and hypertension (high blood pressure), which can be pre-existing or caused by the treatment for osteoarthritis.
In particular, Kitov Pharma focuses on developing combinations of existing drugs in advanced stages of development.
Kitov Pharma’s lead drug, KIT-302, is based on celecoxib and the generic drug amlodipine. Celecoxib is the active ingredient of a known and approved-for-use drug designed primarily to relieve pain caused by osteoarthritis.
SOURCE: Kitov Pharmaceuticals
Post Views: 122
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The Company completed recruitment of the initial 150 patients in the Phase III Clinical Trial for KIT-302
-
Upon completion of treatment of patient tratment and analysis of the data, it will be determined whether additional patients are to be recruited in order to demonstrate statistical validity and to meet the primary end-point of the trial
-
The primary end-point of the trial is to demonstrate that the reduction in blood pressure observed in the arm treated with KIT-302, which combines a drug that treats pain and a drug that lowers blood pressure, is at least 50% of the reduction in blood pressure observed in the arm that was treated only with the blood pressure drug
-
Analysis of the data by an independent committee and publication of the interim results is expected to take up to eight weeks
TEL AVIV, Israel I October 21, 2015 I Kitov Pharma (TASE: KTOV) announced today that it has completed recruitment of the initial 150 patients in the Phase III Clinical Trial for KIT-302.
Upon completion of the treatment of these 150 patients, the trial data will be disclosed to an external, independent Data Monitoring Committee, which will analyze the data’s standard deviations and determine whether additional patients are to be recruited in order to demonstrate statistical validity and to meet the primary end-point of the trial (the “Interim Results”), and if so, the number of such additional patients. The Committee’s analysis and the publication of the Interim Results are expected to take up to eight weeks.
Should the Committee recommend treatment of up to 200 additional patients, the Company will continue recruiting patients until reaching statistical validity and achievement of the primary end-point of the trial.
In accordance with the written recommendation of the FDA in their Special Protocol Assessment (SPA) response, there will be no statistical penalty resulting from the analysis of the data by the Committee following the initial stage of the trial.
The primary end-point of the trial, as agreed in writing with the FDA, is to demonstrate that the reduction in blood pressure observed in the arm treated with KIT-302, which combines a drug that treats pain and a drug that lowers blood pressure, is at least 50% of the reduction in blood pressure observed in the arm that was treated only with the blood pressure drug. Isaac Israel, CEO of the Company, stated, “Completion of the recruitment of the initial 150 patients in the trial is an important milestone in Kitov Pharma’s business development and is additional evidence of the capabilities of the clinical development team, led by Dr. J. Paul Waymack. We are anxiously awaiting the Interim Results and are preparing for the continuation of our work plan in anticipation of submitting a New Drug Application for our lead drug in 2016.
About Kitov Pharmaceuticals and KIT-302:
Kitov Pharma is a biopharmaceutical company focused on the development of therapeutic candidates for the simultaneous treatment of two clinical conditions: pain caused by osteoarthritis; and hypertension (high blood pressure), which can be pre-existing or caused by the treatment for osteoarthritis.
In particular, Kitov Pharma focuses on developing combinations of existing drugs in advanced stages of development.
Kitov Pharma’s lead drug, KIT-302, is based on celecoxib and the generic drug amlodipine. Celecoxib is the active ingredient of a known and approved-for-use drug designed primarily to relieve pain caused by osteoarthritis.
SOURCE: Kitov Pharmaceuticals
Post Views: 122
