JB3729
Sunday, February 24, 2013 5:56:01 PM
Trust JB doesn't mind, wanted to share and keep this gem
Post # of 25238
Leo (CEO) on Dr. Menon (CSO) - "This Company was always built around the capabilities of Dr. Menon in developing and sourcing compounds. Dr. Menon is the bedrock of Cellceutix. Over the past three years I’ve attended many industry meetings with Dr. Menon. We’ve met with leading scientists and pharma industry executives. The feedback to me was always about the depth of knowledge and brilliance of Dr. Menon. I have never met anyone like Dr. Menon and he will continue to be the key to Cellceutix achieving its goals.”
Additionally, when a drug shows this sort of activity across a wide sampling of tumor lines in animals, it greatly increases the odds of efficacy in humans. It is for these reasons that Dr. Menon, our Chief Scientific Officer, is so excited about Kevetrin. Dr. Menon, the inventor of Kevetrin, is considered an expert in reviewing animal data and is often consulted by small and large pharma corporations and universities. Never before has he seen a drug as robust as Kevetrin against cancers. He believes that Kevetrin is outperforming other drugs he had worked on at similar points in development, which eventually became multi-billion dollar blockbusters.
I have a great deal of admiration for Dr. Menon and went back and reviewed and copied his PR statements from the Cellceutix website. If interested, Dr. Menon's escalating excitement can be captured by reading from the bottom up -
February 25, 2013 “We are excited by the advancement of the clinical trials of Kevetrin as we move toward finding the MTD (maximum tolerated dose),” said Dr. Krishna Menon, Chief Scientific Officer of Cellceutix. “While we are still early in the trials, we are eager to receive information on the p21 biomarker as it could represent a major breakthrough in cancer research. There has been no shortage of commentary and discussions in the scientific community recently about the latest initiatives of the U.S. Food and Drug Administration to further expedite novel drugs to market for areas of great unmet medical need. Obviously, we will be exploring this option for Kevetrin, however an application for this type of rapid movement through the regulatory process can only be made after the completion of the phase 1 clinical study.”
February 4, 2013 Dr. Krishna Menon, Chief Scientific Officer at Cellceutix, commented, “We are still at the early stages of the clinical trial. To date, we have not observed any dose limiting toxicities. Initial pharmacokinetic (PK) data from the clinical trial has been received and is consistent with the animal data, which is a very optimistic sign moving forward . Additional information on these PK studies will be forthcoming at ASCO. We are now looking forward to receiving data from the p21 biomarker studies which is expected in March 2013.”
January 7, 2013 “Kevetrin has garnered the attention of some of the world’s foremost authorities in oncology,” commented Dr. Krishna Menon, Chief Scientific Officer of Cellceutix. “The University of Bologna has a distinguished history as a European leader in cancer research with a particular expertise in the field of hematological cancers. We could not be more pleased that this institution sees the potential for Kevetrin as a new drug candidate for AML and look we forward to building upon this special relationship with this esteemed institution.”
December 24, 2012 “As we stated in a press release on April 25, 2011 discussing our poster presentation at last year’s annual meeting of the American Association for Cancer Research, Kevetrin was a standout then amongst any other p53 drug in development,” added Dr. Krishna Menon, Chief Scientific Officer of Cellceutix. “Nothing has fundamentally changed since that day. In fact, the additional laboratory data that we have collected on Kevetrin, reinforces the novel drug’s ability to re-activate p53 to its role as a potent anti-proliferative and pro-apoptotic protein and holds a great deal of promise as a new therapeutic for treating cancer including some of the most difficult to treat types of the disease. The New York Times may have overlooked Cellceutix and Kevetrin, but the organizations that are contacting us to host and sponsor clinical trials certainly have not.”
December 14, 2012 “We are very encouraged with the way the Kevetrin trials are progressing,” said Dr. Krishna Menon, Chief Scientific Officer at Cellceutix. “At this time, we are eagerly awaiting the pharmacokinetics analysis of the first dosing.”
December 3, 2012 “The clinical trials are progressing extremely well and right on schedule,” commented Dr. Krishna Menon, Chief Scientific Officer at Cellceutix. “As we await the lab reports, it’s very encouraging that we have not seen any of the toxic side effects that are commonly associated with chemotherapy at this point. Many new drugs demonstrate toxicity immediately, so I interpret the information on Kevetrin™ with a great deal of optimism. We are excited for the upcoming weeks when the next cohort, in which dosing levels will be doubled, may provide us even greater insight on what we believe is the most exciting oncologic drug in development today.”
November 8, 2012 “These advancements for a small biotech company could not have been possible without the dedication and passion our whole team demonstrated working on Kevetrin,” commented Dr. Krishna Menon, Chief Scientific Officer at Cellceutix. “Kevetrin has shown in laboratory studies to activate p53, ‘the Guardian Angel Gene,’ to reduce tumor volume and slow tumor progression in cancers which other drugs were ineffective in doing so. A completely new class in chemistry, we believe that our novel drug is something that the cancer industry has been in search of for decades. We have extremely high expectations for Kevetrin.”
October 29, 2012 “We are extremely pleased to hear that the first patients will begin therapy with Kevetrin™ in a matter of days,” said Dr. Krishna Menon, Chief Scientific Officer at Cellceutix. “Not only is this is a substantial milestone for Cellceutix and its shareholders, but we feel it is important to the field of oncology. As a novel compound that directly impacts p53, the “Guardian Angel of the Human Genome,” we look forward to a steady patient enrollment and future outcomes that potentially could change the landscape of cancer therapeutics.
September 24, 2012 “This is a unique clinical trial and institutions such as Dana-Farber and Beth Israel Deaconess are extremely meticulous in their protocol. It is this level of excellence that compelled us to sponsor the trials at these clinical sites,” commented Dr. Krishna Menon, President and Chief Scientific Officer at Cellceutix.
September 10, 2012 “It seems that the potential of Kevetrin is starting to circle the globe. This University has a distinguished reputation in hematological diseases,” commented Dr. Krishna Menon, Chief Scientific Officer at Cellceutix. “Our patent has been published. Only when a compound looks extremely promising do major pharmaceutical companies and universities approach a smaller company like Cellceutix. This gives us a great sense of confirmation as to the potential of Kevetrin and validation in our beliefs about the possible robust number of indications where it could provide a therapeutic benefit.”
(Marketwire – Aug 6, 2012) “To date, everything is completed and we are waiting for the host hospitals to begin dosing patients, which we anticipate will happen shortly, but it is in the hospitals’ hands at this point,” commented Dr. Krishna Menon, Chief Scientific Officer at Cellceutix. ”Throughout my career, I have evaluated and seen many new drug candidates go from start to finish through the regulatory pathway and I am extremely optimistic and excited about the potential of Kevetrin™ because of our data collected during extensive studies and the p53 connection as the Mechanism of Action. I’m not aware of any other anti-cancer compound at this stage of development that could have such a dramatic impact in the field of oncology. Dana-Farber is one of the few hospitals in the world that collects data ‘mapping’ the human genome as related to tumor profiling and the information that will be collected from our clinical trials of Kevetrin™ could prove an invaluable asset to those suffering from cancer and to Cellceutix.”
(Marketwire – Jul 16, 2012) “We have conducted multiple meetings with companies to manufacture Prurisol™ and are aligning our strategies to advance the drug candidate into human trials as expeditiously and efficiently as possible,” commented Dr. Krishna Menon, Chief Scientific Officer at Cellceutix. ”Our confidence is high for Prurisol™ and we are systematically deciding the best procedures going forward with it to maximize outcomes and shareholder value.”
(Marketwire – Jun 26, 2012) “In many, if not the majority, of instances, approval from the IRB and SRC can take months to receive. For us to be notified the same day as the FDA clearance that the protocol has been approved by the hospital is extremely rare and I believe that shows the commitment to commence the human trials as quickly as possible,” commented Dr. Krishna Menon, Chief Scientific Officer at Cellceutix. “Everything is coming together very nicely and we will now be meeting with the host hospitals regarding the scheduling of patient enrollment and the first doses of Kevetrin™ to be administered.”
(Marketwire -06/04/12) The Cellceutix team is also pleased to report from the Annual ASCO (American Society for Clinical Oncology) Meeting, which is being held in Chicago from June 1st to June 5th, 2012. The leading industry event features clinicians, researchers and pharmaceutical companies in the cancer arena presenting their achievements, new treatments and other innovations.
“From all the materials presented, we cannot find any compound in development focused on p53 at a stage remotely comparable to Kevetrin™. p53 is an important tumor suppressor that acts to restrict proliferation by inducing cell cycle checkpoints, apoptosis, or cellular senescence. If any mention is given to a new compound targeting p53, we learned that they are very early in development,” said Dr. Krishna Menon, Chief Scientific Officer at Cellceutix. “We have been in discussions with leading firms and pioneers in oncology throughout the conference. Appropriately, there is great enthusiasm surrounding vaccines and antibodies in oncology, especially the news about the experimental drugs by Bristol Myers Squibb (‘BMY’), but their limitations always surface in conversation because they have a narrow target of specific cancer lines. Researchers know that harnessing the power of p53, the ‘Guardian Angel of the Human Genome,’ can be a game changer because it is present in either ‘wild,’ ‘mutant’ or ‘null’ form in every type of cancer. Kevetrin™ is the only compound that affects all three forms, meaning that as a cancer therapy, it could have no bounds as to what cancer it treats . A drug of that prowess would represent one of the biggest breakthroughs in modern oncology and illustrates the scope and hope with Kevetrin™; explaining why it is garnering so much attention.”
“Awareness about Kevetrin™ and Cellceutix continues to grow,” commented Dr. Menon. “We are very proud of the recognition we are receiving for our company, our compounds and new cancer treatments that could potentially change the dynamics of chemotherapy as we know it today.”
“The passing of the legislation in the U.S. House of Representatives and the Senate recently, which includes a section on accelerating the review of new drugs for life-threatening diseases, has us even more eager for the commencement of clinical trials for Kevetrin™,” Dr. Menon continued. “Due to its unique Mechanism of Action to re-activate p53 in the destruction of cancer cells, we feel that this new mandate bodes especially well for us in expediting the development of this novel compound.”
(Marketwire – May 21, 2012) Dr. Krishna Menon, Chief Scientific Officer at Cellceutix commented, “I will be attending the American Society of Clinical Oncology (“ASCO”) Meeting in June to continue discussions regarding Kevetrin™. We anticipate that next year we will be presenting data from this year’s planned clinical trials.”
(Marketwire – Apr 16, 2012) Dr. Krishna Menon, Chief Scientific Officer at Cellceutix, added, “For most developmental companies, Prurisol™ would be a lead drug candidate based on its composition, the strong research data that we have collected and the great need for a new drug for psoriasis. Our research of human xenografts in mouse models shows the type of stark differences in treatment with Prurisol™ as compared to standard treatments that are rarely demonstrated by a new drug. While we believe our flagship drug, Kevetrin™, which has attracted so much attention by showing it can re-activate p53 to destroy cancer cells, has greater market potential, Prurisol should not be underestimated as in preclinical studies it too has shown significant qualities that can make it an important drug for Cellceutix. Cellceutix is in a very fortunate position now with two breakthrough drugs in the regulatory process. By advancing Prurisol™ to this stage, we are increasing our leverage in the industry as we continue to strive to make Cellceutix the most exciting pharmaceutical company today.”
(Marketwire – Apr 4, 2012) “Many of the representatives of major pharma companies that have spoken with us previously came to visit with us and get updated on Kevetrin’s status,” said Dr. Menon. “Others seemed surprised to find a small molecule with such multi-faceted effects on cancers of various types. I was enthused to have engaged with so many bright minds from such diverse backgrounds and to have the opportunity to present our new findings on Kevetrin™ at the AACR meeting again.”
(Marketwire – Mar 12, 2012 “Prurisol is an ester of a FDA-approved drug that is used for different indications today,” commented Dr. Krishna Menon, Chief Scientific Officer at Cellceutix. “Because the safety and tolerability of the active ingredient have already been determined by the FDA, we are hopeful that it will meet the requirements to advance immediately to Phase 2/3 clinical trials, saving considerable time and money. As part of our planned meeting with the FDA, we will also discuss Prurisol’s eligibility for ‘Fast Track’ review, a designation that will further expedite our efforts to bring Prurisol to market.”
(Marketwire – Jan 17, 2012) “We believe we have identified the Mechanism of Action of Kevetrin which explains why Kevetrin™ is so effective in a broad spectrum of cancers,” says Dr. Krishna Menon, Chief Scientific Officer at Cellceutix. “Downregulation of HDAC2 also explains why Kevetrin™ is so effective in drug resistant tumors. Furthermore, since Kevetrin™ acts in a non-genotoxic manner and induces potent antitumor activity, we feel that Kevetrin™ is a clear standout from all other anticancer drugs. In all my years as a cancer researcher, I haven’t seen a drug act like Kevetrin™ which is targeting and reacting with virtually every type of cancer.”
(Marketwire – Jan 3, 2012) “We are very excited about 2012 as the year that we make our mark in the biotechnology world,” stated Dr. Krishna Menon, Chief Scientific Officer of Cellceutix. “The bankruptcy of Formatech, the drug formulation manufacturer for Kevetrin™, is a bit of a set-back, but the reality of drug development is that sometimes these things happen and it will only cost us a couple of months in the grand scheme of things. Ultimately, we are in an envious position with Kevetrin™ and are using the time now to move KM-133 quickly forward. Our pre-clinical data gives us confidence that we have developed the absolute best drugs that can trump all competitors for their respective indications and are confident that we will have our compounds for both drug-resistant cancers and psoriasis in human trials in 2012. Many eyes are upon us and they all want to see the stellar pre-clinical data validated with clinical trials. If the compounds produce like we think that they are going to, the value of Cellceutix should increase exponentially for our company and shareholders, making 2012 a banner year.”
(Marketwire – Oct 3, 2011) Cellceutix Chief Scientific Officer Dr. Krishna Menon said, “Each research center has its own drug delivery device that must be tested with a new drug to ensure stability, according to FDA protocol.” Dr. Menon continued, “It has been an extremely gratifying process working with Kevetrin™ and we are close to beginning the process of validating our contentions about the potency of our drug. The drug in studies to date has proven to be a major leap forward in the fight against cancer. We have reviewed our research on Kevetrin™ with the hospital, major pharmaceutical companies and some of the brightest minds in oncology today with very encouraging responses. As professionals, we are expected to remain subdued, but, honestly, it is a bit difficult as Kevetrin™ is showing characteristics that could make it one of the most innovative drugs in cancer research."
(Marketwire – Jun 20, 2011) “Kevetrin™ simply continues to impress,” stated Dr. Krishna Menon, CSO of Cellceutix. “In reality, the nearly 100% tumor growth delay was underestimated as the tumors in one of the Kevetrin treated mice never reached 500mm3. Therefore, it had to be omitted from that set of data; otherwise the figure would have been even higher. Preliminary data from the second cycle of dosing, initiated when tumors had reached 2200mm3, is again showing reduction of tumor growth, reinforcing the idea of no resistance towards Kevetrin™ developing and the sheer potency of our compound. In all my years as a researcher, I have never seen anything like Kevetrin™.”
(Marketwire – May 16, 2011) Dr. Krishna Menon, Chief Scientific Officer of Cellceutix, commented, “Our research to date has shown the potential of Kevetrin™ as a stand-alone therapy. This additional data demonstrates its value as a combination therapy. We believe the radiosensitizer capacity of Kevetrin™ is once again attributable to its interaction with p53. The data that we have collected in our pre-clinical studies on Kevetrin™ gives me great hope that Cellceutix is developing a drug that one day will have a major impact on cancer treatments.”
(Marketwire – February 28, 2011) – Cellceutix Corporation (PINKSHEETS: CTIX) announced today that data from research on Kevetrin™, the Company’s flagship compound against cancers, has demonstrated the potential for a major breakthrough in cancer research by exhibiting an activation of p53.
