BEVERLY, MA--(Marketwired - December 14, 2015) - Cellceutix Corporation (
The Company is extremely proud to see Cellceutix grow from a tiny biotech with only a handful of shareholders just a few years ago into a company with a robust pipeline and thousands of passionate shareholders.
It has been a year of milestones and important developments at Cellceutix. On the corporate level, we signed a $30 million share purchase agreement with Aspire Capital, giving us the financial strength for our R&D efforts. We strengthened our board with new independent directors and added several seasoned consultants with broad experience in getting drugs FDA approved.
The dynamics of Cellceutix are in the novelty of our compounds and the diseases we are addressing with our clinical trials. We seek markets with unmet medical needs where we would have the potential to be a market leader. We consider generic competition as well as potential insurance reimbursement coverage for the end user before engaging in a project or clinical trial. Innovation and solution is how we will achieve our goals to reward our stockholders.
Clinically, we're proud to have initiated two new Phase 2 trials during 2015. The first was in Brilacidin-OM, which received an FDA Fast Track designation for the treatment of oral mucositis, and the other trial was in Prurisol for chronic mild-to-moderate plaque psoriasis.
Across 2015, we released and presented data from the Phase 2b trial of Brilacidin for Acute Bacterial Skin and Skin Structure Infections, or ABSSSI, that showed a single dose of our novel compound delivers comparable results against 7 days of infusions of daptomycin, the blockbuster drug marketed as Cubicin. We have worked vigilantly on a new formulation of Brilacidin to maximize purity of the compound and have completed the development process of lyophilization so it can be safely stored at room temperature or simply refrigeration, rather than freezing. Production is scheduled this month for use in the upcoming planned Phase 3 trials. It's much behind the scenes work, but very important work we do to de-risk development, and assuming FDA approval, plan for commercialization.
We are heading into a pivotal phase of Brilacidin, which will be distinguished as the first new class of antibiotic to enter a Phase 3 program for ABSSSI in more than 20 years. As we've said, ABSSSI is a tremendous market opportunity and a gateway indication for our platform technology. I know people wonder about competition from other drugs that have been approved for ABSSSI. We believe that Brilacidin has so many distinct advantages that it could be the go-to drug of choice if FDA approved and marketed.
Regarding Kevetrin as an anti-cancer drug, we continued to produce promising results. The FDA has granted not one or two, but three important designations for Kevetrin. Those being Orphan Drug designations for ovarian cancer and retinoblastoma, and a Pediatric Rare Disease designation for retinoblastoma.
We really like what we see in Kevetrin. For ovarian cancer we look forward to initiating an advanced trial in the first half of 2016 under the Orphan Drug designation. Of course, if the data is compelling as we hope it will be, we will pursue expedited pathways of the FDA to hasten development. As far as the current Phase 1 trial of Kevetrin for advanced solid tumors at Dana-Farber Cancer Institute, we will be making a decision in the coming weeks about concluding the trial. We have ample data, and very compelling data for that matter, to end the trial, but we don't want to miss any opportunity for expanded research by an exceptional PI (Principal Investigator) team, so we have some important decisions to make. The important thing to note is that all the data from the trial has provided the foundation to move forward immediately with additional trials with Kevetrin, so whether we extend the work at Dana-Farber or not, it has no influence on commencing these new studies.
We believe Pediatric Rare Disease designations by the FDA are scarcely given and are extremely proud to have received this designation for Kevetrin. Now the work begins. We are in early stage discussions regarding Kevetrin's use in eye diseases in a joint venture (JV) with another company, which has a unique technology for eye cancer treatments.
We are looking forward (See Forward-Looking Statements Below) to our fiscal year end of June 30, 2016 and we hope to announce/have announced:
- Start of Kevetrin advanced study in ovarian cancer.
- Start of Brilacidin ABSSSI Phase 3
- Start of Brilacidin for Ulcerative Proctitis proof of concept trial (phase 2)
- Top line data on Kevetrin Phase 1 trial for advanced solid tumors
- Top line data on Prurisol Phase 2 trial for chronic plaque psoriasis
- Interim analysis for Brilacidin Phase 2 trial for Oral Mucositis
- Start of Retinoblastoma program, formulation and toxicity studies
- Additional ototoxicity studies with Brilacidin in different concentrations
- Gram- negative and anti-fungal progress
- Submission of grant application for study of Kevetrin in Pancreatic cancer with renowned hospital.
There are many developments in progress and, as we have historically done, will keep our shareholders closely informed as that can be disclosed. We'd like to thank everyone for the constant support and look forward to meeting with shareholders tomorrow.
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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 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.
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 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.
Contact Information:
INVESTOR AND MEDIA CONTACT:
Cellceutix Corporation
Leo Ehrlich