Cellceutix (OTCQB: CTIX) CEO Leo Ehrlich in September issued a fiscal year-end business statement recapping the company’s ability to usher its three unique compounds through various stages of clinical trials to successfully meet primary endpoints and drop anchors in several key markets. Advancements of its current pipeline – spanning dermatology, cancer, infectious disease and gastrointestinal indications – also set the company on course to achieve another season of remarkable progress.
Cellceutix’s lead cancer drug candidate is Kevetrin™, an Orphan Drug anti-cancer agent entering phase 2a clinical trials for the treatment of ovarian cancer. Upon commercialization, Kevetrin would be the world’s first p53-modulating drug. The company is also conducting research to develop an oral formulation of Kevetrin, taking advantage of the drug’s short half-life of roughly two hours.
“If we can develop an oral Kevetrin dosing possibilities are numerous. Perhaps two times or three times a day and seven days a week. Now you know why we are excited. A drug activating p53 and dosed orally, we think would have blockbuster potential. More research needs to be done to validate the clinical effectiveness of Kevetrin as well as developing an oral formulation. But I’d hope investors now understand why we get excited about the possibility of developing both the world’s first safe p53 modulating drug and an oral formulation,” Ehrlich stated in the company’s fiscal Q1 2017 earnings call in September (http://dtn.fm/2l0JR).
Another propellant of progress is an anti-psoriasis drug candidate the company once called a “dark horse” or “long shot.” Advancing through two successful clinical trials, however, the potential of Cellceutix’s Prurisol™, now in phase 2b trials, is starting to take shape.
“We believe that the potential safety profile of Prurisol may make this an attractive alternative to Celgene’s (NYSE: CELG) OTEZLA, which is on its way to achieving $1 billion in sales within just three years of its launch,” Arthur P. Bertolino, MD, PhD, MBA, president and chief medical officer at Cellceutix, stated in a recent news release.
In the previously mentioned September business update, Ehlrich also noted Allergan’s (NYSE: AGN) $639 million acquisition of Vitae Pharmaceuticals’ (NASDAQ: VTAE) two clinical drug candidates, one of which is an oral therapy for psoriasis (http://dtn.fm/JJ3mQ).
“I share this with you because it exemplifies the premium that the industry is placing on new, oral psoriasis drugs, even those in mid-stage development. I’m not in the business of analysis, but it seems to me that Allergan values VTP-43742 at more than our total market capitalization. As such, we see a tremendous market opportunity with Prurisol and greatly look forward to initiating our Phase 2b trial in patients with moderate to severe psoriasis with emphasis on the Psoriasis Area and Severity Index (PASI). We’ve just advanced substantial start-up payments to vendors towards the trial, an action that we feel will continue to grow shareholder value.
“I wish to point out that Dr. Bertolino is now introducing Prurisol to large pharmas, most of which are embracing it for the first time. We believe that the path to a large financial deal is generation of comparably encouraging data in Phase 2b as recently seen in our completed Phase 2a trial,” he said.
Interim analysis of top-line phase 2b results of Cellceutix’s study is expected in the second quarter of 2017.
The third candidate in the pipeline is Brilacidin, which has shown antibacterial, anti-biofilm and anti-inflammatory properties in various pre-clinical studies. Currently underway is a phase 2 trial evaluating the oral rinse Brilacidin-OM for the treatment of chemoradiation-induced oral muscositis (OM), an inflammatory condition, in head and neck cancer patients.
“Having data, demonstrating Brilacidin can fight inflammation and doesn’t accumulate in the blood is a major benefit for what can be a painful and expensive condition that doesn’t have any FDA approved treatments. We greatly look forward to additional data from this trial expected in the first half of 2017,” said Ehrlich.
Cellceutix’s pursuit of FDA approval for the products in its pipeline is piquing the interest of larger peers, according to Ehrlich, which in recent months has resulted in more “high-level” business development meetings than at any other time in the company’s history.
“Over the years we have gone from a company with only a single lead drug candidate in an early clinical study to a company that has effectively has three lead drug candidates at mid-state trials targeting multiple indications with new possibilities cropping up regularly underscored by our robust pipeline. We’re having success at targeting multi-billion dollar opportunities with new drugs that can provide relief for millions of people worldwide suffering from hard-to-treat maladies. I believe that is more than ample reason to be excited about all that we have accomplished our future and the litany of catalyst expected in 2017,” said Ehrlich.
For more information, visit the company’s website at www.cellceutix.com
