Cellceutix Corp (CTIX.OB) is based in Beverly, Massachusetts and is a clinical stage biotech company. The product pipeline includes eight drugs. Kevetrin and Prurisol are two of their drugs that should be watched closely for potential events in 2013. The big question is which one comes to market first. Either one should be a blockbuster.
A Phase I trial of Kevetrin is being conducted by Harvard University's Dana Farber Cancer Institute and partner Beth Israel Deaconess Medical Center. Kevetrin is a revolutionary new drug in the treatment of cancer. The first cohort in this trial has already completed two cycles. While the second cohort has already started, it's not clear which cycle each cohort is actually on. The commonly associated toxic side effects in cancer therapies haven't shown up thus far. The longer the trial goes on without news, the better, since the trial would be halted if there were problems.
The Kevetrin trial at Dana Farber is still recruiting subjects for future cohorts per the FDA clinical trials site. Most investors are excited about Kevetrin. It's also billed as the lead compound on the Cellceutix website. Kevetrin has caused excitement with its ability to activate p53 in animals without toxic side effects normally associated with chemotherapy drugs.
With changing technology and upcoming regulation changes you may miss the early boat if you are waiting on PDUFA dates. Many investors have become accustomed to waiting for later stage trials to get involved in biotech stocks. That is changing as the regulatory landscape changes with the adoption of new breakthrough therapies standards by the FDA. If Kevetrin is shown to work in humans it may be one of the first to come to market using these new regulations.
Reading about Kevetrin from the Cellceutix website is actually exciting. No wonder most focus on it. It may end up being used to fight 50% of all cancers. And, it has multiple mechanisms of action.
» has demonstrated the potential for a major breakthrough in cancer research by inducing activation of p53. p53, often referred to as the "Guardian Angel Gene" or the "Guardian Angel of the Human Genome" due to its crucial role in controlling cell mutations, is a tumor suppressor protein that is encoded by the TP53 gene in humans and has been widely regarded as possibly holding a key to the future of cancer therapies. p53 has been shown to play critical roles in the homeostatic health of the human body by activating proteins required to repair DNA and plays a major role in the life cycle of cells by inducing cell cycle arrest and apoptosis to maintain cellular and genetic stability.
» In more than 50 percent of all human carcinomas, p53 is limited in its anti-tumor activities by mutations in the protein itself. Currently, there are greater than 10 million people with tumors that contain inactivated p53, while a similar number have tumors in which the p53 pathway is partially abrogated by inactivation of other signaling components. This has left cancer researchers with the grand challenge of searching for therapies that could restore the protein's protective function, which Kevetrin appears to be doing the majority of the time.
» Mechanism of action studies showed that Kevetrin strongly induced apoptosis by activation of Caspase 3 and cleavage of PARP. Kevetrin induced phosphorylation of p53 at Ser15 leading to a reduced interaction between p53 and MDM2, an ubiquitin ligase for p53 that plays a central role in p53 stability. Phosphorylation of p53 induced apoptosis by inducing the expression of PUMA. In addition, Kevetrin increased expression of p53 target genes such as p21 (Waf1), an inhibitor of cell cycle progression.
» Kevetrin also induced transcription-independent p53 mediated apoptosis. Kevetrin enhanced the phosphorylation of MDM2. Phosphorylation of MDM2 alters the E3 ligase processivity. Stable monoubiquitinated form of p53, induced by Kevetrin, accumulates in the cytoplasm and mitochondria and interacts with BAK or BAX proteins in mitochondria to induce apoptosis.
» Since Kevetrin activates both transcription-dependent and transcription-independent pathways to promote apoptosis through p53 activation, Kevetrin can function as a major inducer of apoptosis in many types of tumors independent of p53 mutation status.
» Excellent results in animal model experiments in drug-resistant cancers.
Results received from in vivo studies conducted at Beth Israel Deaconess Medical Center ("BIDMC") indicate that the Kevetrin/sunitinib combination is the first they have tested where tumor shrinkage is noted. The combination was tested on cell line 786, a drug-resistant renal cancer. Renal cancer is very difficult to treat. Sunitinib is marketed as Sutent by Pfizer, Inc. (PFE) and there has been a lot of speculation as to whether or not Pfizer makes a buyout offer to Cellceutix.
As great as Kevetrin sounds, Prurisol is being underestimated by most investors. Prurisol is a psoriasis drug and that problem is much worse than most realize. Results from Prurisol may come sooner than from Kevetrin.
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. (NYSE: RDY) 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.
With only 30 days of treatment and 30 days follow up the Prurisol results will come in very quickly from the Phase II/III Proof of Concept trial. Prurisol may make it to market faster than Kevetrin.
Cancer may be on the minds of most, but, psoriasis may be causing greater distress than most realize. It is believed to affect about 3% of the population.
Psoriasis is a chronic inflammatory disease that effects many parts of the body. It isn't limited to just the skin since chronic inflammation causes systemic problems. Psoriasis affects the skin, joints and nails. Depending on where the outbreaks present themselves it can cause victims of this disease to avoid leaving home. Quality of life can be severely reduced due to issues including social isolation, stigmatization, and depression.
There are different types of psoriasis. People usually just have one type at a time. As one type disappears a triggering event tends to start up another type.
The most prevalent form is psoriasis vulgaris and this is what 80% of psoriasis sufferers have. It's usually on the elbows, knees, scalp and lower back. It presents itself as raised, red and inflamed lesions covered by silver white scales.
The link shows the various other types of psoriasis along with photos. This disease can be quite debilitating and it is believed that it can lead to other diseases such as arthritis, diabetes, cardiovascular disease and cancer.
Psoriasis covering more than 10% of the body is considered severe. However, a mild case covering the palm of the hand, which is only 1%, or the sole of a foot can impact quality of life severely.
The market for psoriasis is quite large, and Prurisol could end up being quite the revenue maker if it works for humans as it does on animals. Current treatments come with too many side effects.
Dr. Reddy's Laboratories Ltd. (RDY) shareholders would also benefit greatly from the arrangement with Cellceutix. The manufacturing of Prurisol will bring Dr Reddy's Labs an additional revenue stream.
There is risk in buying a stock whose trials on humans aren't completed yet. The drugs may not work the same on humans as they do on animals. If either Kevetrin or Prurisol are shown to work in humans it will be a life changer for early investors. The safest way to invest is to wait until the trials prove the drugs work, even though that will mean a much higher entry price.
The end of year recap of the company is quite enlightening. Cellceutix may end up being partnered up or bought out by a large pharmaceutical company once either Kevetrin or Prurisol are shown to work on humans. Both drugs will have a huge market.
Disclosure: I am long CTIX.OB.