BEVERLY, MA–(Marketwired – Sep 24, 2014) – Cellceutix Corporation (OTCQB: CTIX) (the “Company”), a clinical stage biopharmaceutical company developing innovative therapies in oncology, dermatology, and antibiotic applications today has provided an update to its shareholders.
My fellow Cellceutix shareholders,
As I do periodically, I’d like to take a moment to discuss some of our accomplishments over the past year and update everyone on the current position of our company and its portfolio of drugs in development. There is plenty to update as the past twelve months have been a time of substantial growth for Cellceutix and while I am proud of all that we’ve accomplished, I am even more excited about the future.
We are now in the ninth cohort of a Phase 1 trial of Kevetrin for advanced solid tumors that is being hosted at Harvard University’s Dana-Farber Cancer Institute and Beth Israel Deaconess Medical Center. To briefly recap, Kevetrin is a novel compound that acts upon the protein p53, a protein with such an important role in controlling cell cycles that it has been dubbed the “guardian angel gene.” The primary endpoint of the trial is to determine the safety of Kevetrin, but we are also establishing the maximum tolerated dose (MTD) and evaluating Kevetrin’s influence on key biomarkers, as well as looking for signs of effect on tumor size.
Previously in the eighth cohort, patients were treated with 215 mg/m2 of Kevetrin with no drug-related adverse events reported. The present dose for the ninth cohort is 350 mg/m2. We believe that this increased dosage is putting Kevetrin very close to its MTD. Through the first eight cohorts, the preliminary data has been very encouraging, including one ovarian stromal carcinoma patient completing 7 dosing cycles. CA-125, an ovarian cancer marker, was also stabilized in some patients. The biomarker p21 increased in 6 of 14 patients at relatively low doses of Kevetrin and we expect a higher percentage of p21 expression when the data is evaluated from higher doses. Another tumor marker, CEA, was decreased and the tumor size remained stable over 4 months in a pancreatic carcinoma patient.
The trial reaching its late stages and the data that has been collected to date has cleared the path for a new Phase 1b/2 trial of Kevetrin in combination with cytarabine for Acute Myelogenous Leukemia. The protocol has been submitted to the ethics committee and the trial is expected to commence in the fourth quarter 2014. This trial is being sponsored by the University of Bologna in Italy and its partners and hosted at European clinical sites. Our commitment is only to supply the Kevetrin for the study. The protocol for this trial schedules patients to be treated with shorter intervals between doses than the current ongoing trial in the U.S., which will provide vital information going forward with the development of Kevetrin.
Our oncology initiatives are also focused on oral mucositis, a common and often debilitating condition affecting the mouth and pharynx as a side effect of certain cancer treatments, including chemotherapy and radiation therapy given to approximately 500,000 people each year who have head and neck cancer.
Our efforts for this indication are the result of our acquisition of PolyMedix assets in September 2013, which gave us ownership of a promising pipeline of drugs in development, including Brilacidin, the lead drug candidate in a completely novel class of antibiotics called defensin mimetics.
I don’t believe that I can overstate the significance of this new class of drugs and the potential impact defensin mimetics can have for a litany of indications. Defensin mimetics are modeled after host defense proteins, the front line of defense in the innate human immune system, which means that they destroy pathogens just like the body would naturally by penetrating the pathogen’s cell wall, rather than via a biochemical approach like most classes of drugs do today. Evidence suggests that they also have a prophylactic and healing capacities. Importantly, the unique mechanism of action of defensin mimetics to kill pathogens swiftly and thoroughly virtually eliminates the likelihood of drug resistance developing.
On September 8, we submitted an Investigational New Drug application to the U.S. Food and Drug Administration seeking to initiate a Phase 2 clinical trial for Brilacidin-OM, our treatment for oral mucositis. This drug is one of our defensing mimetics and has shown extraordinary results in OM animal models. I am very excited to bring it to the clinic. I personally know many individuals who suffered terribly from this painful condition and the thought that I may be able to help others gives me great personal satisfaction. Shareholders can look forward to helping bring a game changing drug to a clinical trial for an unmet medical need as well as participating in a large market opportunity. We believe the market for an effective drug could be in the hundreds of millions of dollars as the OM gateway can lead this drug to treating oral mucositis associated with stem cell therapies, a huge market as well. As there is no standard-of-care medication, and as discussed in the pre-IND meeting with the FDA, our comparator in this trial is a placebo, which some may consider puts us in an enviable position to begin the trial.