Monday, November 10, 2014 4:54:50 PM
" Presently, we believe we are at the latter stage of the trial as one patient in this cohort experienced a dose limiting toxicity (DLT). After experiencing the DLT, the patient requested to continue on the study and after review by physicians was allowed to, but given a lower dose of Kevetrin in the patient's weekly treatment. The trial protocol requires that we now complete six patients at the current dosing. The Company has received no notice of other events outside of the parameters of the protocol and the trial is progressing."
"In the recent cohorts, results showed significant enhancement of p21 expression in 50% patients and to a greater extent compared to earlier cohorts. This represents a positive signal for the development of Kevetrin."
Prurisol:
"We are meeting with the FDA in December 2014 to present our end of Phase 1 package and discuss our planned Phase 2/ 3 protocol. Upon FDA acceptance of our protocol, we will start the Phase 2/3 study."
Brilacidin-OM:
"On October 13, 2014 Cellceutix announced the acceptance of its IND (Investigational New Drug Application) by the Food and Drug Administration for the treatment of Oral Mucositis with Brilacidin. Presently sites are being set up, supplied, and trained. We expect our first patient to be enrolled in December 2014."
Brilacidin for Diabetic Foot Ulcer, Ophthalmic, and Otitic Infections:
"Further formulation work is needed for each indication. Upon a successful formulation the Company plans to advance these drugs into the clinic. The Company believes this work is challenging and will be completed in the first quarter of 2015."
Finances:
"As of September 30, 2014, a balance of $9.60 million remains and is available under the financing arrangement. From October 1, 2014 to October 27, 2014, the Company has generated additional proceeds of approximately $1,914,000 under the Common Stock Purchase Agreement with Aspire from the sale 800,000 shares of its common stock."
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