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     324  0 Kommentare Cellceutix First Annual Shareholder Meeting December 15, 2015 - Seite 2

    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. 

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    Cellceutix First Annual Shareholder Meeting December 15, 2015 - Seite 2 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 …