Health Boards
Cellceutix Corporation a biopharmaceutical company focused on discovering and developing small molecule drugs to treat unmet medical conditions, is pleased to report that it has filed a pre-IND submission with the U.S. Food and Drug Administration (FDA) on Prurisol™ (also termed "KM-133"), the Company's drug in development as a novel treatment for psoriasis. The Company's submission provides information to the FDA on Prurisol supporting a pre-IND meeting.
Cellceutix is requesting the meeting for guidance to attain approval for a section 505(b)(2) designation for Prurisol from the FDA, allowing its proposed clinical trials to begin in advanced stages. The ultimate goal of the meeting is to gain a full understanding of the studies required to support a New Drug Application (NDA) filing for Prurisol. According to 505(b)(2) guidelines, reliance is placed upon the FDA's findings for a previously approved drug; allowing for a NDA approval to be received for a novel drug with a sponsor forgoing a portion of clinical trials and without a "right of reference" from the original drug maker.
"Prurisol is an ester of a FDA-approved drug that is used for different indications today," commented Dr. Krishna Menon, Chief Scientific Officer at Cellceutix. "Because the safety and tolerability of the active ingredient have already been determined by the FDA, we are hopeful that it will meet the requirements to advance immediately to Phase 2/3 clinical trials, saving considerable time and money. As part of our planned meeting with the FDA, we will also discuss Prurisol's eligibility for 'Fast Track' review, a designation that will further expedite our efforts to bring Prurisol to market."
Cellceutix has previously disclosed images of mice treated with Prurisol demonstrating its effectiveness as compared to methotrexate.
Cellceutix is requesting the meeting for guidance to attain approval for a section 505(b)(2) designation for Prurisol from the FDA, allowing its proposed clinical trials to begin in advanced stages. The ultimate goal of the meeting is to gain a full understanding of the studies required to support a New Drug Application (NDA) filing for Prurisol. According to 505(b)(2) guidelines, reliance is placed upon the FDA's findings for a previously approved drug; allowing for a NDA approval to be received for a novel drug with a sponsor forgoing a portion of clinical trials and without a "right of reference" from the original drug maker.
"Prurisol is an ester of a FDA-approved drug that is used for different indications today," commented Dr. Krishna Menon, Chief Scientific Officer at Cellceutix. "Because the safety and tolerability of the active ingredient have already been determined by the FDA, we are hopeful that it will meet the requirements to advance immediately to Phase 2/3 clinical trials, saving considerable time and money. As part of our planned meeting with the FDA, we will also discuss Prurisol's eligibility for 'Fast Track' review, a designation that will further expedite our efforts to bring Prurisol to market."
Cellceutix has previously disclosed images of mice treated with Prurisol demonstrating its effectiveness as compared to methotrexate.