BEVERLY, MA–(Marketwired – December 14, 2015) - Cellceutix Corporation (OTC: CTIX) (the “Company”), a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology, anti-inflammatory and antibiotic applications, today reminds shareholders that tomorrow is the first annual Cellceutix shareholder meeting. The meeting will be held at 100 Cummings Center, Suite 221-E, 2nd Floor, Beverly, Massachusetts and will convene at 10:00 a.m. local time. To those attending the shareholder meeting, note that Suite 221-E, 2nd Floor is not attached to our offices, but is on the floor above our offices.
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:
1. Start of Kevetrin advanced study in ovarian cancer.
2. Start of Brilacidin ABSSSI Phase 3
3. Start of Brilacidin for Ulcerative Proctitis proof of concept trial (phase 2)
4. Top line data on Kevetrin Phase 1 trial for advanced solid tumors
5. Top line data on Prurisol Phase 2 trial for chronic plaque psoriasis
6. Interim analysis for Brilacidin Phase 2 trial for Oral Mucositis
7. Start of Retinoblastoma program, formulation and toxicity studies
8. Additional ototoxicity studies with Brilacidin in different concentrations
9. Gram- negative and anti-fungal progress
10. 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.