Interesting tidbit about Brilacidin "agreement" with "large" US pharma:
Cellceutix: December to Be Momentous Month in Company's History
Mon November 24, 2014 7:00 AM|Marketwire | About: CTIX
BEVERLY, MA -- (Marketwired) -- 11/24/14 -- Cellceutix Corporation (OTCQB: CTIX) (the "Company"), a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology, and antimicrobial applications, is pleased to announce the completion of the ninth cohort in the Company's Phase 1 clinical trial of Kevetrin for advanced solid tumors being conducted at Harvard University's Dana-Farber Cancer Institute and Beth Israel Deaconess Medical Center. The safety committee overseeing the clinical trial will be meeting in the first week of December to review safety data and discuss a possible dose escalation for the tenth cohort.
Cellceutix (CTIX) expects December to be a momentous month in its history. The Company anticipates that the Kevetrin trial is nearing its conclusion with the start of the tenth cohort next month. Cellceutix looks forward to additional data from the trial to add to current information that has been used to form decisions for planned Phase 2/3 trials of Kevetrin. Elsewhere, a meeting has been scheduled in December between Cellceutix and the University of Bologna to discuss the status of commencing the Phase 1/2 trial of Kevetrin in combination with cytarabine in patients with Acute Myelogenous Leukemia (AML). The Company will update shareholders on this European trial as available.
Looking to Brilacidin, the lead drug candidate in the Company's definsin-mimetic platform, Cellceutix has signed an agreement with a division of one of the largest U.S. pharmaceutical companies for testing Brilacidin as a component of certain implanted devices as a means to prevent infection. This potential prophylactic use was not part of Cellceutix's strategic plans for Brilacidin, but given the compilation of clinical and laboratory data, it is a logical application that could potentially add millions of dollars of revenue to the Company. The material transfer does not cover the pharmaceutical use of Brilacidin for treatment of infections or other diseases. A final contract can only be entered into if and when Brilacidin receives Food and Drug Administration (FDA) approval.
The Phase 2 clinical trial of Brilacidin-OM for oral mucositis, an often debilitating effect of certain cancer therapies, is on target to commence in the second week of December. Cellceutix anticipates that www.ClinicalTrials.gov should be updated at the start of the trial.
As disclosed in a November 11 press release, Cellceutix will be meeting with the FDA in December to discuss advancing the clinical development of Brilacidin for Acute Bacterial Skin and Skin Structure Infections (ABSSSI) and Prurisol for treatment of psoriasis.
Cellceutix is also focused on IND-enabling studies and planning the first clinical trial of a defensin-mimetic for ulcerative colitis, a gastrointestinal disorder. Cellceutix management will be meeting with key opinion leaders at the 2014 Advances in Inflammatory Bowel Diseases, Crohn's & Colitis Foundation's Clinical & Research Conference on December 4-6, 2014 in Orlando, Florida.
"From the lab to the clinic, we have an awful lot to look forward to in December. We're excited about enrolling the tenth cohort in the Kevetrin trial, and the possibility of increasing the dose," stated Leo Ehrlich, Chief Executive Officer of Cellceutix. "We think that the material transfer of Brilacidin to a major pharma company for investigation in prevention of infection in implanted devices showcases the vast potential of this remarkable compound in multiple applications. We believe we are on track with Brilacidin to become the first in a new class of antibiotics to be approved in over 20 years."
About Cellceutix:
Headquartered in Beverly, Massachusetts, Cellceutix is a publicly traded company under the symbol "CTIX". Cellceutix is a clinical stage biopharmaceutical company developing innovative therapies in oncology, dermatology and antimicrobial applications. Cellceutix believes it has a world-class portfolio of compounds and is now engaged in advancing its compounds and seeking strategic partnerships. Cellceutix's anti-cancer drug Kevetrin is currently in a Phase 1 clinical trial at Harvard Cancer Centers' Dana Farber Cancer Institute and Beth Israel Deaconess Medical Center. In the laboratory Kevetrin has shown to induce activation of p53, often referred to as the "Guardian Angel Gene" due to its crucial role in controlling cell mutations. Cellceutix will soon begin a Phase 2 clinical trial with its novel compound Brilacidin-OM for the prevention and treatment of Oral Mucositis. Brilacidin-OM, a defensin mimetic compound, has shown in the laboratory to reduce the occurrence of severe ulcerative oral mucositis by more than 94% compared to placebo. Cellceutix's anti-psoriasis drug Prurisol has recently completed a Phase 1 clinical trial and is being readied for a Phase 2 trial. Prurisol is a small molecule that acts through immune modulation and PRINS reduction. Cellceutix's key antibiotic, Brilacidin, has completed a Phase 2b trial for Acute Bacterial Skin and Skin Structure Infections, or ABSSSI. Top-line data has shown a single dose of Brilacidin to deliver statistically comparable clinical outcomes to the FDA-approved seven-day dosing regimen of daptomycin. Brilacidin has the potential to be a single-dose therapy for multi-drug resistant bacteria (Superbugs). Cellceutix has formed research collaborations with world-renowned research institutions in the United States and Europe, including MD Anderson Cancer Center, Beth Israel Deaconess Medical Center, and the University of Bologna. More information is available on the Cellceutix web site at www.cellceutix.com.
