- This week Cellceutix anticipates enrolling the final subjects for the Brilacidin 42-day UP/UPS clinical study.
- Between patients already enrolled and those presently in screening, Cellceutix has reached over 70 percent of the anticipated number of trial participants in its Phase 2b trial of Prurisol for the treatment of moderate-to-severe chronic plaque psoriasis. Interim analysis top-line results are expected during the third quarter of calendar 2017.
- Interim analysis of patients in the Phase 2 trial of Brilacidin-OM who received at least 55 Gy cumulative units of radiation showed that Brilacidin markedly reduced the rate of Severe OM (WHO Grade = 3): Active Arm (Brilacidin): 2 of 9 patients (22.2 percent); Control Arm (Placebo): 7 of 10 patients (70 percent).
- Concurrent with the Phase 2 clinical trial of intravenous-administered Kevetrin for late-stage ovarian cancer, toxicology studies are ongoing with the purpose of developing an oral formulation of Kevetrin for treating solid tumors. Currently, there are no approved p53-modulating cancer drugs, much less in pill form.
Learn more here: http://www.cellceutix.com/brilacidin-1/Financial Highlights Cash Position—As of March 31, 2017, the Company had approximately $5.6 million in cash and $16 million remaining available for stock sales under the terms of the purchase agreement with Aspire Capital, compared to $6.3 million of cash as of June 30, 2016. Shelf Registration—The Company has in place an effective shelf registration statement on Form S-3, registering the sale of up to $75 million of the Company's securities, with approximately $42.8 million remaining available. Management Discussion—The Company anticipates that future budget expenditures will be approximately $14 million over the next 12 months, including approximately $10 million for clinical trials. Management believes that financing available from Aspire Capital and under the Company's effective Form S-3 shelf registration statement as well as any potential future Form S-1 filing to register the sale of its securities will be sufficient to fund the Company's operations for the next 12 months. "We are extremely proud of our accomplishments to date and are thrilled at the company's prospects going forward into the latter half of 2017," said Leo Ehrlich, Chief Executive Officer of Cellceutix. "Within a matter of months, we anticipate completing multiple mid-phase clinical trials for indications in areas with serious unmet medical needs. Based on highly encouraging clinical data received so far, we look forward to sharing complete clinical results with shareholders, members of the pharmaceutical industry interested in our drug candidates, and the public at large, to further establish the true potential of our clinical pipeline." "Much-needed drugs and tremendous value creation await patients and shareholders alike should we continue to deliver compelling trial results," commented Arthur P. Bertolino, MD, PhD, MBA, President and Chief Medical Officer at Cellceutix. Upcoming Events Cellceutix reminds shareholders and other interested parties of two upcoming events. First, on June 8, 2017, at 11AM EST, the Company will hold a live shareholder and investor conference call. We are fielding questions in advance, which may be submitted by emailing firstname.lastname@example.org and must be received by June 1, 2017 at 5pm EST. Dial-in instructions for participants will be announced one week prior. Second, the Company will be presenting topline findings from the Brilacidin-UP/UPS trial as well as additional interim data from its Phase 2 trial of Brilacidin for Oral Mucositis at Drug Discovery and Therapy World Congress 2017, to be held July 10 - 13, 2017, in Boston. More details to come.
Alerts Sign-up for Cellceutix email alerts is available at: www.cellceutix.com/email-alertsAbout 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 multiple diseases. Cellceutix believes it has a world-class portfolio of first-in-class lead drug candidates and is now advancing them toward market approval, while actively seeking strategic partnerships. Cellceutix's psoriasis drug candidate Prurisol completed a Phase 2 trial and Cellceutix recently launched a Phase 2b study. Prurisol is a small molecule that acts through immune modulation and PRINS reduction. Cellceutix's anti-cancer drug Kevetrin successfully concluded a Phase 1 clinical trial at Harvard Cancer Centers' Dana Farber Cancer Institute and Beth Israel Deaconess Medical Center, and Cellceutix has commenced a Phase 2 study. 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. 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 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; interim results have shown a marked reduction in the incidence of severe oral mucositis (WHO Grade = 3). Cellceutix's lead antibiotic, Brilacidin, has completed a Phase 2b trial for Acute Bacterial Skin and Skin Structure Infection, 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"). In an ongoing Phase 2 open label Proof-of-Concept trial, favorable interim results have been observed in the first two cohorts of patients treated with Brilacidin for Ulcerative Proctitis/Ulcerative Proctosigmoiditis (UP/UPS), two types of Inflammatory Bowel Disease (IBD). 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. Forward-Looking Statements : This press release contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 including statements concerning projected timelines for the initiation and completion of clinical trials, our future drug development plans, other statements regarding future product developments, including with respect to specific indications, and any other statements which are other than statements of historical fact. These statements 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.
INVESTOR AND MEDIA CONTACTCellceutix CorporationLeo Ehrlichinfo@cellceutix.com