Cellceutix, a clinical stage biopharmaceutical company developing innovative therapies in oncology, dermatology, and antibiotic applications, today provides shareholders with an update on the current status of the Company’s compounds in development.
Kevetrin, anti-cancer compound in a Phase 1 clinical trial for solid tumors being hosted at Dana-Farber Cancer Institute and Beth Israel Deaconess Medical Center:
To date, six cohorts have completed enrollment, with the sixth cohort receiving infusions at 110 mg/m2. Maximum Tolerated Dose (“MTD”) has still not been reached. To date, one patient has competed 7 dosing cycles; 2 patients have completed 5 dosing cycles; 1 patient has completed 4 dosing cycles; 1 patient has completed 3 dosing cycles; 8 patients have completed 2 dosing cycles; and 7 patients have completed 1 dosing cycle. A dosing cycle is 28 days.
As disclosed in December (See press release dated December 9, 2013), the Company had filed an amendment with the U.S. Food and Drug Administration (“FDA”) to modify the trial protocol to limit the dosing infusion timeframe to a maximum of six hours, versus the current protocol of 30 mg/m2 without a maximum infusion timeframe.
As dosing continued to increase without yet reaching a MTD, the infusion duration became a concern as it could become quite lengthy. We are pleased to report that yesterday the FDA accepted our amendment. The FDA approval now allows for enrollment to begin of the seventh cohort under the amended protocol. The safety committee overseeing the trial has approved dosing to be increased to 165 mg/m2 with a 6-hour maximum infusion timeframe for the seventh cohort.
Cellceutix has been advised that requisite documentation is prepared for the planned Phase 1b/2 clinical trial of Kevetrin in combination with Cytarabine for Acute Myelogenous Leukemia to be sponsored by the University of Bologna in Italy, The Italian Cooperative Study Group on Chronic Myeloid Leukemia (ICSG on CML) and Acute Leukemia (GIMEMA Group) and hosted at European clinical sites. We are now in the process of manufacturing a formulation of Kevetrin for this trial.
Prurisol, anti-psoriasis compound being developed under FDA guidance that a 505(b)(2) designation is an appropriate developmental pathway:
Recently, the Company submitted the application to the Institutional Review Board (“IRB”) responsible for the planned Phase 1 clinical trial of Prurisol. Upon IRB approval, the Company will immediately file the Investigational New Drug (“IND”) application with the FDA to initiate a brief Phase 1 crossover study to confirm that Prurisol converts into abacivir in the human body, as it has been shown to do in animal models.
The Phase 1 trial is expected to take approximately 45 days to complete. Following successful completion of the crossover study, Cellceutix will move forward with initiation of a larger Phase 2/3 clinical trial under the pathway of a 505(b)(2), which permits research to immediately move to advanced stages because Prurisol is an ester of an drug already approved by the FDA.
Dr. Reddy’s Laboratories has already manufactured sufficient quantities of Prurisol for both the Phase 1 and Phase 2/3 trials.
Brilacidin, lead compound in a novel class of synthetic immunomodulatory antimicrobials known as defensin-mimetics:
ABSSSI (Acute Bacterial Skin and Skin Structure Infections). On January 10, 2014, Cellceutix received IRB approval for a U.S.-based phase 2b clinical trial in ABSSSI. In this 200-patient study, three brilacidin dosing regimens (two single-dose regimens and one 3-day regimen) will be compared to a standard 7-day regimen of daptomycin.Site initiation visits are planned, after which enrollment will begin.
Oral mucositis (OM): As disclosed in December (See press release dated December 20, 2013), the Company filed an application with the U.S. Food and Drug Administration requesting Orphan Drug designation for its oral rinse formulation Brilacidin-OM as a drug candidate for the prevention of radiation or chemotherapy-induced oral mucositis in patients with head and neck cancer. The company is awaiting a response from the Agency.
The company is planning a U.S.-based Phase II trial of Brilacidin-OM for this indication and plans an IRB submission at the end of 1Q 2014.
Ophthalmic infections: As disclosed in November (See press release dated November 4, 2013) 2013), the company has identified ocular infections, such as keratitis, as an area of unmet medical need and significant commercial potential, based on positive preclinical data supporting safety, antimicrobial efficacy, and prolonged residence time on the ocular surface with minimal systemic exposure. The Company has received proposals for the necessary formulation and will shortly select a manufacturer.
Otitis media/externa: Preclinical studies in animals have begun and formulation development is in progress.
“We are extremely pleased with the advancements of Kevetrin, Brilacidin, and Prurisol; their developments as a testament to the dedication and hard work of our team,” comments Leo Ehrlich, Chief Executive Officer of Cellceutix. “Looking back at 2013, our Company has experienced tremendous growth, moving forward in clinical trials, adding very promising compounds to our portfolio with the acquisition of PolyMedix assets, doubling the size of our laboratory and strengthening our financial position. As satisfied as we are with the accomplishments of 2013, we have higher expectations for 2014 and again are striving to be an even better, more formidable company at this time next year.”