Brilacidin Lyophilized as Cellceutix Prepares to Bring First New Class of Antibiotic to Phase 3 Trials in More Than 20 Years
BEVERLY, MA–(Marketwired – January 14, 2016) - Cellceutix Corporation (OTC: CTIX) (the “Company”), a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology, anti-inflammatory and antibiotic applications, is pleased to inform shareholders that manufacturing, lyophilization and filling of vials is now complete in preparation for the planned Phase 3 trials of Brilacidin for Acute Bacterial Skin and Skin Structure (ABSSSI) infections caused by Gram-positive bacteria. The vials of Brilacidin are now in the inspection and quality control (QC) stage. The Company is preparing for submission the final protocol for the trial per guidance from the U.S. Food and Drug Administration (FDA) received at the end-of-phase 2 meeting.
With the vials being filled, a global Contract Research Organization (CRO) selected, and the final protocol nearing completion, the vast majority of the work has been finished in preparation for the pivotal Phase 3 trials of Brilacidin for ABSSSI. Cellceutix is almost ready to make history by becoming the first new class of antibiotic to enter a Phase 3 clinical trial for ABSSSI in more than two decades.
“I’d also like to address the amended complaint by The Rosen Law Firm, pertaining to the ABSSSI Phase 3 trials,” commented Leo Ehrlich, Chief Executive Officer at Cellceutix. ”Using Durata Therapeutics as an example, Rosen alleges that costs for the trial will be a grotesquely over-estimated $145 million. It’s a completely inappropriate example. Investors should remember that we have former Durata executive Dr. Ronald Trust as a consultant for the trial, and our Head of Clinical Operations, Edward Walters, is experienced in taking drugs through Phase 3 and getting drugs FDA approved. Many may be unaware that Cellceutix did not use a full service CRO for our Phase 2 ABSSSI study nor the Phase 2 psoriasis study now nearing completion. This likely saved Cellceutix millions of dollars compared to other companies. For the Phase 3 ABSSSI study we will use a global CRO. To that point, we have completed negotiations with a highly recognized global CRO and have a contractual proposal for costs that are many multiples less than that amount Rosen incredibly asserts. With our cash on hand, our commitment from Aspire Capital, and our shelf registration, we believe we have the funding options subject to market conditions, to not only complete the Phase 3 trial of Brilacidin for ABSSSI, but also continue other clinical trials and pre-clinical research. Investors are encouraged to read Cellceutix budgets as they appear in our filings. We have always operated at a very minimal burn rate compared to peers. I will not go into more detail at this point regarding Rosen’s complaint as it is in litigation, but I assure you that Cellceutix and our counsel consider it extremely frivolous and feel that there is a strong case for dismissal, sanctions and other legal actions against Rosen and the plaintiff for filing this lawsuit.”
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Cellceutix clinical trials on Clinicaltrials.gov:
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 is in a Phase 2 clinical trial with its novel compound Brilacidin-OM for the prevention of Oral Mucositis in patients with head and neck cancer. Brilacidin-OM, a defensin mimetic compound, has shown in an animal model to reduce the occurrence of severe ulcerative oral mucositis by more than 94% compared to placebo. Cellceutix’s anti-psoriasis drug Prurisol is in a Phase 2 trial. Prurisol is a small molecule that acts through immune modulation and PRINS reduction. Cellceutix’s lead antibiotic, Brilacidin, has completed a Phase 2b trial for Acute Bacterial Skin and Skin Structure Infections, or ABSSSI. Top-line data have shown a single dose of Brilacidin to deliver comparable clinical outcomes to the FDA-approved seven-day dosing regimen of daptomycin. Brilacidin has the potential to be a single-dose therapy for certain 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.
This press release contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 that involve risks, uncertainties and assumptions that could cause Cellceutix’s actual results and experience to differ materially from anticipated results and expectations expressed in these forward looking statements. Cellceutix has in some cases identified forward-looking statements by using words such as “anticipates,” “believes,” “hopes,” “estimates,” “looks,” “expects,” “plans,” “intends,” “goal,” “potential,” “may,” “suggest,” and similar expressions. Among other factors that could cause actual results to differ materially from those expressed in forward-looking statements are Cellceutix’s need for, and the availability of, substantial capital in the future to fund its operations and research and development; including the amount and timing of the sale of shares of common stock to Aspire Capital; the fact that Cellceutix’s compounds may not successfully complete pre-clinical or clinical testing, or be granted regulatory approval to be sold and marketed in the United States or elsewhere. A more complete description of these risk factors is included in Cellceutix’s filings with the Securities and Exchange Commission. You should not place undue reliance on any forward-looking statements. Cellceutix undertakes no obligation to release publicly the results of any revisions to any such forward-looking statements that may be made to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events, except as required by applicable law or regulation.