BEVERLY, MA – December 31, 2012– Cellceutix Corporation (OTCBB : CTIX ) (the “Company”), a clinical stage biopharmaceutical company focused on discovering small molecule drugs to treat unmet medical conditions, including drug-resistant cancers and autoimmune diseases, today provides a letter from the CEO regarding developments of the Company throughout 2012 and expectations for 2013.
My fellow Cellceutix shareholders,
Looking back at the past 12 months, I could not be more pleased with the progression of our Company or more excited about 2013. It has always been our contention that Kevetrin™, our flagship anti-cancer drug, holds a great deal of promise as a potential therapeutic for a wide array of cancers and this past year has provided evidence that many leading institutions also see the potential. I’d like to take a moment and look at the progression of Kevetrin in 2012 and where it stands moving into 2013.
Company-sponsored clinical trials at Harvard University’s Dana-Farber Cancer Center and partner Beth Israel Deaconess Medical Center began in November testing Kevetrin for safety against solid tumors. At this time, first cohort patients are about to begin their third cycle of dosing and the second cohort – in which dosing levels were doubled – are in their first cycle of dosing. The information that we have received at this early stage of the trial so far has been very encouraging with no data being delivered outside of the parameters of the protocol. We expect some information on pharmacokinetics from the early cohorts in the near term.
European trials that are being sponsored by and hosted at a leading European University (the “University”) testing Kevetrin against Acute Myelogenous Leukemia (AML) are scheduled to begin in the first half of 2013. We have been advised that the study, a phase 1b trial, will be titled “A Multi-Center, Open-Labe, Phase 1B Study of Escalating Doses of Kevetrin (Thioureidobutyronitrile) Administered Intravenously, with Cytarabine Adminstered A) Subcutaneously, or B) Intravenously, in Patients with Acute Myelogenous Leukemia (AML).”
The protocol for the clinical trials is completed and undergoing a review process as well as other regulatory preparations progressing smoothly. The University has conducted pre-clinical research that they shared with us but asked that we not disclose the data as they “plan to publish it at a later day.” A very brief summary of the data showed Kevetrin causing apoptosis (programmed cell death) in cancerous cells in addition to sensitizing and optimizing the cells to maximize the effectiveness of drugs used in combination with Kevetrin. We will be releasing details about the University very shortly.
The University has indicated they are interested in a second study of Kevetrin in combination with a compound of a major European pharmaceutical company. We will update shareholders as this moves forward in 2013.
Preclinical tests are being performed at Beth Israel Deaconess Medical Center testing Kevetrin in combination with Pfizer, Inc.’s multikinase inhibitor drugs as potential new therapies for renal cancer and melanoma. We have seen the data and it is very exciting to us, but, again, confidentiality agreements prevent us from providing any details at this time. Moreover, data of this nature is generally not discussed so that the institutions may present their findings at industry conferences when they deem appropriate.
We disclosed in an 8-K filing with the Security and Exchange Commission on December 27 that the Company has recently been approached by one of the world’s most prominent cancer centers (the “Cancer Center”), located in the Southwest United States. The organization is interested in conducting and sponsoring studies on Kevetrin at their facilities. As stated in the regulatory filing, no assurances are made or implied that an agreement will be executed, but we are optimistic that the relationship will move forward early in 2013. We have now signed a Non-Disclosure Agreement with the Cancer Center and are quickly moving forward with a Material Transfer Agreement. Further details will be provided as permitted, but we are free to say that the Cancer Center is interested in the possibility of Kevetrin as a potential therapy for myeloma. Just like the other institutions, they will perform their own preclinical testing of
Regarding Prurisol™, our leading anti-psoriasis drug candidate, a Company-sponsored Phase II/III Proof of Concept trial is on target to begin late first quarter/early second quarter 2013. This will be a relatively short trial with only 30 days of treatment and 30 days of follow-up to evaluate the efficacy and safety of Prurisol. Dr. Reddy’s Laboratories Ltd. has condensed the manufacturing process, saving us time and money. Manufacturing of cGMP Prurisol is expected to begin in about a months time. Given the outstanding data from our laboratory studies and the guidance from the Food and Drug Administration that a 505(b)(2) pathway is acceptable, we have high expectations for these trials to support a larger scale, late stage clinical trial. I believe updates on these trials will be quite frequent.
Although many of the expected studies on Kevetrin will be sponsored by outside organizations, financing is still critical to advancing those drugs further into human trials. To achieve this, we are extremely pleased to have received institutional support through a $10 million common stock purchase agreement with Aspire Capital Fund LLC in December. Aspire has committed to purchase up to $10 million of our Company’s common stock over the next three years at prices based on the market price at the time of each sale.
2012 has put us at the forefront of some of the leading cancer research centers in the world and I could not be more proud. Kevetrin is an extremely unique drug, actually classified as a new class of chemistry in medicine, and its ability to re-activate p53 could simply be unprecedented if it continues to show low toxicity. There is no comparison of Kevetrin to any other compound. I think that the interest that has been shown by organizations approaching us wishing to conduct and sponsor research speaks for itself as to what some of the brightest minds in oncology see in the data. It has been well publicized what a major impact a p53 drug can have on cancer research and we are excited to be at the forefront of pharmaceutical companies in that space.
We are also very eager to evaluate Prurisol in clinical trials in a matter of months. While not as high-profile as a new cancer drug, psoriasis represents a multi-billion dollar opportunity and an area of great unmet medical need. Soon clinical research on
Prurisol will begin which we anticipate will validate our laboratories studies and allow us to have a very promising late-stage clinical trial in the mid-term.
Of course, a big key to this is the new association with Aspire Capital Fund LLC. Their commitment to provide us funding at such favorable terms will prove invaluable to developing our pipeline.
I have stated in the past, “the best is yet to come” and I believe that 2012 was full of our Company meeting milestones that has us firmly moving forward and gaining recognition as an innovative biotechnology company. We have distinguished ourselves through Kevetrin as one of only a handful of companies that is developing a p53 drug, but that is not all that we have to offer. Prurisol is jumping straight into mid-stage trials and we have six other compounds in our pipeline that hold great potential as well. 2012 has seen us transition into a clinical stage company and provided us with the financing to continue to move ahead, but I believe that 2013 will be a bigger year for us with clinical data coming from multiple trials and that the best is still yet to come.
We appreciate the support that we have received from our loyal shareholders throughout the year and pledge to continue to immediately provide as much information as possible through public disclosures as they happen in the coming year.
Chief Executive Officer, Cellceutix Corporation