Cellceutix Files with FDA for Phase 2b Clinical Tr
Post# of 72445
Posted On: 02/03/2014 8:01:30 AM
Cellceutix Files with FDA for Phase 2b Clinical Trial of Novel Antibiotic Brilacidin; Enrollment of Patients Expected to Start Mid-February
BEVERLY, MA—February 3, 2014 –Cellceutix Corporation (OTCQB: CTIX) (the "Company"), a clinical stage biopharmaceutical company developing innovative therapies in oncology, dermatology, and antibiotic applications, announces today that the protocol for the Phase 2b trial of Brilacidin, Cellceutix’s lead compound in a novel class of synthetic immunomodulatory antimicrobials known as defensin-mimetics, was sent to the U.S. Food and Drug Administration.
Also, the Company’s submission to ClinicalTrials.gov for this upcoming Phase 2b clinical trial of Brilacidin for Acute Bacterial Skin and Skin Structure Infections (ABSSSI) has been accepted. Cellceutix has been advised that the Brilacidin for ABSSSI trial will appear on www.ClinicalTrials.gov within two business days.
Cellceutix anticipates that trial recruitment of patients will begin mid-February.
The Phase 2b clinical trial will be evaluating Brilacidin as compared to the FDA-approved drug daptomycin in patients with ABSSSI caused by S. aureus and Strep pyogenes. Brilacidin will be administered in one-day and three-day dosing regimens, dosing schedules that are shorter than those of currently marketed antibiotics.
“We are within a few weeks of a milestone moment for our Company with the commencement of the Brilacidin trial for ABSSSI,” comments Leo Ehrlich, Chief Executive Officer at Cellceutix. “We have made it very clear that we have high expectations for Brilacidin ever since we acquired it in September. I am very proud of the commitment and efficiency of our team, which in less than five months, completed requisite lab work and regulatory filings to have this important clinical trial ready to begin. With optimized dosing, we believe that Brilacidin can represent a major breakthrough in the field of antibiotics. ”
I too am proud of the CTIX team for moving Brilacidin forward so quickly and aggressively. Can't wait for this trial to get rolling!
BEVERLY, MA—February 3, 2014 –Cellceutix Corporation (OTCQB: CTIX) (the "Company"), a clinical stage biopharmaceutical company developing innovative therapies in oncology, dermatology, and antibiotic applications, announces today that the protocol for the Phase 2b trial of Brilacidin, Cellceutix’s lead compound in a novel class of synthetic immunomodulatory antimicrobials known as defensin-mimetics, was sent to the U.S. Food and Drug Administration.
Also, the Company’s submission to ClinicalTrials.gov for this upcoming Phase 2b clinical trial of Brilacidin for Acute Bacterial Skin and Skin Structure Infections (ABSSSI) has been accepted. Cellceutix has been advised that the Brilacidin for ABSSSI trial will appear on www.ClinicalTrials.gov within two business days.
Cellceutix anticipates that trial recruitment of patients will begin mid-February.
The Phase 2b clinical trial will be evaluating Brilacidin as compared to the FDA-approved drug daptomycin in patients with ABSSSI caused by S. aureus and Strep pyogenes. Brilacidin will be administered in one-day and three-day dosing regimens, dosing schedules that are shorter than those of currently marketed antibiotics.
“We are within a few weeks of a milestone moment for our Company with the commencement of the Brilacidin trial for ABSSSI,” comments Leo Ehrlich, Chief Executive Officer at Cellceutix. “We have made it very clear that we have high expectations for Brilacidin ever since we acquired it in September. I am very proud of the commitment and efficiency of our team, which in less than five months, completed requisite lab work and regulatory filings to have this important clinical trial ready to begin. With optimized dosing, we believe that Brilacidin can represent a major breakthrough in the field of antibiotics. ”
I too am proud of the CTIX team for moving Brilacidin forward so quickly and aggressively. Can't wait for this trial to get rolling!
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