I thought it prudent to share with the broader investment community an exciting pharmaceutical stock that I have been following for some time, and that recently has had several noteworthy developments that confirm inter alia its potential to revolutionize the cancer drug industry.
Cellceutix Corp. (OBB: CTIX, Stock Forum) has made what appears to be a breakthrough in oncology with its Kevetrin compound. Kevetrin's in vitro antitumor potency was confirmed in a study that pitted it against pulmonary adenocarcinoma, a recalcitrant cancer of the lungs that begins in the organs epithelial cells. Kevetrin's effects on this particularly drug-resistant malignancy were arresting, literally and figuratively. This novel, tiny antitumor molecule stymied cancer cell progression and induced apoptosis (malignant cell suicide).
The compounds mechanism of action works by exploiting the tumor protein 53. This p53 is a tumor suppressor protein encoded by a gene whose disruption is associated with 55% of all human cancers. For lung carcinomas in particular, the p53 tumor suppressor gene, located on chromosome 17p, is affected in 60-75% of cases. Remarkably, Kevetrin does this all with no genotoxicity. This sets it uniquely apart from all other chemotherapeutic based treatments which inevitably damage the DNA of the patient.
All this scientific argot might not mean much to you, but the eyes and ears of the scientific cognoscenti were acutely attending to Cellceutix' recent presentation at the 102nd Annual Meeting of the American Association for Cancer Research (AARC). By all accounts, it was an unqualified success. Commenting on the interest generated by the Kevetrin presentation, Dr. Sylvia Holden, a scientific consultant for Cellceutix who presented the poster at the AACR gathering, said "I have been participating in the AACR annual meeting for more than twenty years and I can't recall a poster session ever being as active as Cellceutix's was this year.
There were people waiting at our poster before we had arrived and a steady flow of elite scientists at all times up to and through the closing of the session...The manner in which people gravitated to Cellceutix to learn about Kevetrin and its p53 breakthroughs attests to the value of Kevetrin as a novel cancer therapy. We were approached for in-depth conversations by representatives of the world's largest pharmaceutical companies and most prestigious universities in the United States. Moreover, we held a meeting with the National Cancer Institute to discuss the future for Kevetrin development as well. Now that people have gotten a first-hand look at our research explaining the mechanism of action for Kevetrin, the interest that was starting to brew is truly intensifying as organizations of all sizes want to continue discussions back at our offices and lab."
Those in-the-know know the p53 is often referred to as the “Guardian Angel Gene” because of its crucial role in controlling cell mutations. The potential market for Kevetrin is huge. Currently, there are more than 10 million people with tumors that contain inactivated p53, while a similar number have tumors in which the p53 gene is partially inactivated. Kevetrin's activation of p53 functions in tumor cells makes it a promising anticancer drug. Based on the exciting results of the recent studies, Cellceutix plans to commence Phase 1 clinical trials in 2011.
What's more, and strikingly improbable, is that they've already secured a CDA (confidential disclosure agreement) for the compound with a major pharma. On September 26, it was announced that Harvard Medical School's Dana-Farber Cancer Institute, perhaps the most prestigious such center in the world, signed a Laboratory Services Research Support Agreement with Cellceutix. Obviously, the fact that these Harvard white coats have done their own due diligence and have concluded that they want to perform Cellceutix' trials is especially significant. These guys are no dummies; and this ain't their first rodeo. Cellceutix currently trades at $0.35 a share—a 65% reduction from its 52 week high. Considering Kevetrin alone, this is an attractive entry point for a biopharma investor looking for a rare growth opportunity. But Cellceutix has more--much more.
The company has 8 different pharmaceutical compound candidates in the wings. Their proprietary anti-autism compound KM-391 has also received a great deal of press when news of its promising preclinical research was promulgated. Autism is a socially salient disorder, and the parents of sufferers are vocal and keen for a solution. Another, KM-133, also known as Purisol, has been shown to be quite effective against psoriasis in animal studies. In fact, mice treated with Purisol were completely cured of the disease. Check out the astonishing before-and-after photos at the company website. Because the active moiety of the drug is already FDA approved, the company has issued a 505(b)(2) application which will hopefully win it expedited approval.
The company has a seasoned and perspicacious management team at the helm, led by Leo Ehrlich CPA, Chief Executive Officer of the firm. Leo Ehrlich has smartly mitigated risk by growing and diversifying the pipeline of the company, all the while keeping focus on therapeutics with substantial profit potential and broad application (especially in the emerging markets, where a more favorable regulatory market often makes for swifter approval).
The company's president and Chief Scientific Officer, Dr. Krishna Menon, previously developed two drugs for Eli Lilly that have proved massively profitable with present sales in excess of $3 billion. A fortiori, Messrs. Ehrlich and Menon are evidently so convinced of the company's prospects that they are refusing any compensation and are self-funding the entire operation. Not only does this evince complete confidence in the company, it shows a rare and refreshing concern for the dilution of Cellceutix's equity investors. And by all lights the management team has cobbled together a top-shelf scientific research coterie. Emil Frei, a senior member of the company's scientific advisory board, received a lifetime award for his contributions to cancer research at the 2009 AARC convention. And he was again feted at this year’s gathering.
"What Cellceutix is doing with Kevetrin™ can lead to a groundbreaking moment in the world of oncology," commented Cellceutix Scientific Advisor Dr. Emil Frei III, M.D. "In my career, including my tenure as Chief of Medicine at National Cancer Institute, I have seen countless companies throughout the world striving to bridge the gap between damaged or mutated p53 and carcinomas with little to no success. p53 can hold a vital key to the next generation of chemotherapy. Cellceutix's discovery of Kevetrin™, which has been shown to reactivate p53 in a non-genotoxic manner, is a very promising advance in the fight against cancer."