Cellceutix Files Amended IND for Novel p53 Anti-Cancer Drug(0)
The countdown has begun for Cellceutix to begin testing their lead compound, anti-cancer drug Kevetrin, at Dana-Farber and Beth Israel Deaconess. After a mild setback with Formatech going bankrupt, the company has completed the necessary changes to the Investigational New Drug application related to Quality Control testing and stability studies through a new supplier and added the data to the IND. This is great news for biotech traders and Cellceutix faithful as investors are eager to see the new drug in humans because Read More
Kevetrin™ Showcased By Toxicon; Cellceutix Update(0)
BEVERLY, MA-(Marketwire - Jun 6, 2011) - Cellceutix Corporation (OTCQB: CTIX) (PINKSHEETS: CTIX), a biopharmaceutical company focused on discovering and developing small molecule drugs to treat unmet medical conditions, is pleased to report that its toxicology vendor, Toxikon Corporation, is currently presenting its poster “Bioanalytical Method for Kevetrin™” at the American Society for Mass Spectrometry (ASMS) meeting in Denver, CO June 5th - 9th. The poster was accepted for presentation by the ASMS and showcases Kevetrin™, the Company’s novel anti-cancer compound.
The poster explains that Kevetrin™ is a unique compound with distinctive chemistry with hydrophilicity and small molecular size. A novel HPLC-MS/MS method was successfully developed and validated for the determination of Kevetrin™ in plasma. This method met the high standards for performance requirements needed to support pre-clinical toxicology studies and IND submission to the FDA.
In Other News:
Cellceutix is pleased to report that Bilcare Global Clinical Supplies, a business unit of industry-leader Bilcare Ltd., has been contracted as a vendor for the planned clinical trials. More information on Bilcare can be found at http://www.bilcare.com/.
Cellceutix Chief Scientific Officer Dr. Krishna Menon is now attending the annual meeting of the American Society of Clinical Oncology (ASCO) for meetings with other pharmaceutical corporations and vendors.
As also announced in a press release on May 23, 2011, Cellceutix is testing Kevetrin™ against an aggressive form of pancreatic cancer before filing of the Investigational New Drug application with the FDA. The Company is pleased to report that testing is near completion.
Leo Ehrlich, CEO of Cellceutix, commented,
Cellceutix CEO States “Full Speed Ahead”(0)
BEVERLY, MA-(Marketwire - May 23, 2011) - Cellceutix Corporation (OTCQB: CTIX), a biopharmaceutical company focused on discovering and developing small molecule drugs to treat unmet medical conditions, announced today that in light of recent exceptional preclinical results regarding Kevetrin™, the Company believes it would be Read More
Cellceutix Cancer Drug Trumps Competitors(0)
Kevetrin™ Stands Out in Its Mechanism of Action by Activating Both Transcription-Dependent and Transcription-Independent Pathways to Promote Apoptosis in a Non-Genotoxic Manner and Targets Both Mutated and Wild Type p53
Cellceutix Corporation, a biopharmaceutical company focused on discovering and developing small molecule drugs to treat unmet medical conditions including drug-resistant cancers, announced that at the 102nd annual American Association for Cancer Research (AACR) meeting held in Orlando, FL, April 2nd to 6th, four posters Read More
Cellceutix Poster Presentation on its p53 Cancer Breakthrough Attracts Wide Interest at 102nd AACR Meeting(0)
Cellceutix Corporation (OTCQB: CTIX), a biopharmaceutical company focused on discovering and developing small molecule drugs to treat severe medical conditions including drug-resistant cancers, is pleased to announce that their recent poster at the 102nd Annual Meeting of the American Association for Cancer Research (AACR) generated significant interest from major Pharmaceutical companies and numerous investigators. The poster, entitled, “Kevetrin™, A Novel Small Molecule, Activates p53, Enhances Expression of p21, Induces Cell Cycle Arrest and Apoptosis in a Human Cancer Cell Line” was showcased by Cellceutix at the AACR Meeting held April 2-6, 2011 in Orlando, FL. The poster is available for viewing on www.cellceutix.com.
Cellceutix was represented by its Chief Scientific Officer, Dr. Krishna Menon, and two of its scientific consultants, Dr. Ashok Kumar and Dr. Sylvia A. Holden. Dr. Holden received her PhD from Boston University followed by an NIH-funded post-doctoral fellowship at Dana-Farber Cancer Institute in the Division of Cancer Pharmacology headed by chemotherapy pioneer and Cellceutix Scientific Advisor, Dr. Emil Frei III. Before joining Cellceutix, Dr. Holden was the Director of Pharmacology at EMD Serono in Billerica, MA (Merck KGaA) and Director of Tumor Biology at Shionogi BioResearch Corp., in Lexington, MA (presently Synta Pharmaceuticals). She was awarded 5 US patents and has published over 100 publications in peer-reviewed journals, including 12 first-authored papers and publications in Science and Nature Medicine.
Commenting on the poster session, Dr. Holden stated, “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.” Dr. Holden continued, “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.”
Additionally, the Cellceutix team was proud that once again during this year’s convention, Cellceutix Scientific Advisor, Dr. Emil Frei III, was honored by the AACR. Dr. Frei was a previous recipient of accolades from the AACR as the inaugural AACR Award for Lifetime Achievement in Cancer Research was given to him in 2004. In 2009, the AACR recognized Cellceutix cancer drug Kevetrin, as an elite drug in development due to promising potency during its first “Frontiers in Basic Cancer Research Meeting.”
Cellceutix Corporation (CTIX) Stock Quote and News:
Cellceutix (CTIX) p21 Biomarker Breakthrough(0)
Cellceutix Cancer Drug, Kevetrin™, Shows Increased Levels of p21; Biomarker for Cancer Trials
Cellceutix Corporation (OTCQB:CTIX), a biopharmaceutical company focused on discovering and developing small molecule drugs to treat severe medical conditions including drug-resistant cancers, is pleased to announce that additional research has been concluded on Kevetrin™, the Company’s flagship cancer compound. Kevetrin was shown to increase levels of p21, a key protein responsible for cell cycle arrest, in the lymphocytes of mice. Cellceutix will be incorporating the p21 assay into its Investigational New Drug application scheduled to be filed with the Food and Drug Administration in approximately six weeks. If the data are duplicated in human studies, p21 as a biomarker will be another major step forward in cancer research for Kevetrin™, which has already been shown to be a non-genotoxic drug that reactivates p53; a major development of its own.
Dr. Krishna Menon, Chief Scientific Officer for Cellceutix, commented, “There has been a big movement in the oncology industry to establish new biomarkers as they are an earlier measure of activity in the body’s cells. p21 has been proven to play a critical role in cell cycle arrest leading to cell death. No one has been able to validate it as a biomarker, to the best of our knowledge, so this will be a major event not only for Cellceutix, but for the cancer clinical trials.” Dr. Menon continued, “Increased levels of p21 are not only a predictor of cell death, but a benchmark in judging effectiveness of Kevetrin™. Our pre-clinical research on p21 has met its endpoints and we are optimistic that the upcoming human trials will yield similar results.”
Cellceutix Corporation (CTIX) Stock Quote and News:
Cellceutix Cancer Drug Shown to be Non-Genotoxic(0)
Cellceutix released additional news on Kevetrin™ that continues to impress. This simple compound proved to reactivate p53, the “Guardian Angel of the Human Genome” as announced on Monday and today the news reports that Kevetrin is non-genotoxic. Genotoxic drugs (which are the majority of chemotherapy drugs used today) destroy the cancer cell, but do damage to the surrounding area as well. It could be somewhat likened to the idea of napalming a field to kill one plant in the middle. While effective, it is not the ideal method of action to treat a disease. Dr. Menon states in the press release that “the best is yet to come” and this could very well be true considering the promising path that Kevetrin™ is on presently. Dr. Menon has a history of being behind blockbuster cancer drugs and it looks like he may be onto another one that appears to be even bigger.
The Press Release:
Cellceutix Cancer Drug Kevetrin Shows No Genotoxicity in Study
Cellceutix Corporation today announced that it has received more data on Kevetrin™, the Company’s flagship compound for the treatment of cancers. Analysis of the latest research shows Kevetrin™ is non-genotoxic, contrary to the majority of currently available chemotherapeutic drugs. Genotoxic drugs affect nucleic acids and alter their function. These drugs may directly bind with DNA or may indirectly lead to DNA damage by affecting enzymes involved in DNA replication. A DNA damaging drug results in rapid phosphorylation of H2A.X at Ser 139 by PI3K-like kinases. Kevetrin™ did not induce phosphorylation of H2A.X protein; whereas, other chemotherapy drugs, such as Adriamycin, did induce the phosphorylation of H2A.X as shown by Western blot assay.
Research data announced earlier this week showed that Kevetrin™ reactivates p53, a key protein which plays a critical role in mediating cellular stress responses such as that brought about by DNA-damage. It is therefore vital in regulating a vast array of proteins involved in cell cycle progression, DNA repair, and apoptosis.
Dr. Krishna Menon, Chief Scientific Officer at Cellceutix, commented,
“This is another major breakthrough for Kevetrin. p53 activation is considered among the critical molecular events for cancer therapy. The fact that Kevetrin™ reactivated p53 and resulted in tumor suppression in animals with drug resistant cancers was a milestone in oncology on its own, but with Kevetrin™ now proven to be non-genotoxic, we believe this has set the compound at the forefront of developmental cancer therapies.”
Cellceutix is completing formulation production, scheduled for early March 2011, which would produce Kevetrin™ in the dosage form for planned clinical trials. The Company plans to file an Investigational New Drug (IND) application with the U.S. Food and Drug Administration in May 2011 with human trials to begin thereafter.
Cellceutix Corporation is a preclinical cancer, anti-inflammatory and autism drug developer. Cellceutix owns the rights to eight drug compounds, including Kevetrin, which it is developing as a treatment for certain cancers, KM-133, for the treatment of psoriasis, and KM-391, for the treatment of autism. More information is available on the Cellceutix web site at www.cellceutix.com.
This Press Release contains forward-looking statements that are based on our current expectations, beliefs and assumptions about the industry and markets in which Cellceutix Corporation operates. Such forward-looking statements involve known and unknown risks, uncertainties, and other factors that may cause Cellceutix’s actual results to be materially different from any future results expressed or implied by these statements. Actual results may differ materially from what is expressed in these statements, and no assurance can be given that Cellceutix can successfully implement its core business strategy and improve future earnings.
Cellceutix Corporation (CTIX) Stock Quote and News:
Cellceutix Lead Compound Makes Historic Breakthrough in Cancer Research(0)
Cellceutix Makes Breakthrough in Cancer Research; Reactivates p53, the “Guardian Angel” Protein
Cellceutix Corporation (Pinksheets:CTIX) announced a major breakthrough this morning with its flagship compound, Kevetrin for the treatment of drug resistant cancers, in stating that the drug is demonstrating the reactivation on p53, the protein commonly referred to as the “Guardian Angel Protein” because of its crucial role in maintaining healthy human cells. Major pharma have been striving to achieve some success with bringing p53 back to normal “cell protection” status, but have come up empty-handed to this point. This little pharma has been quiet for a few months, but appears that they have not been inactive, just in a normal quiet time as most pharmas go through while compounds continued to be developed. This is not all that this company has to offer as their pipeline rivals many biotechs trading on the big boards.
Today’s press release:
Cellceutix Makes Breakthrough in Cancer Research by Activating p53, the “Guardian Angel of the Human Genome”
Cellceutix Corporation (Pinksheets:CTIX – News) 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. p53, often referred to as the “Guardian Angel Gene” or the “Guardian Angel of the Human Genome” due 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.
Dr. Ashok Kumar, a consultant to Cellceutix, discovered this function while researching Kevetrin’s Method of Action (MOA). Dr. Kumar is a highly regarded Molecular Biologist who received his Ph.D. from Jawaharlal Nehru University, one of the most prestigious schools in India. He has been awarded a Japan Society of Promotion of Sciences fellowship from the Government of Japan and has been published extensively in top scientific journals in the area of Immunology and Molecular Biology. From 2001-2010 he was a faculty member in the Dept. of Immunology, Mayo Clinic, Rochester, MN. Dr. Kumar commented, “The research began with trying to understand why Kevetrin™ was so effective against certain resistant cancers that other drugs can’t treat. After a period of extensive testing, the results showed that Kevetrin activates p53 which induces the expression of p21 and acts as inhibitor of cell cycle progression. Activated p53 induces expression of PUMA and initiates apoptosis. In addition to activation of p53, Kevetrin also induces G2 / M phase of the cell cycle arrest by decreasing CDK1 and cdc25 and increasing Wee1 regulatory proteins in the cell.” Dr. Kumar continued, “Kevetrin can become the ideal drug against many cancers.”
Leo Ehrlich, Chief Executive Officer of Cellceutix, stated, “This is a potentially astounding breakthrough in cancer research and greatly increases the hope that pharmacological activation of p53 will provide a clinical benefit for a wide array of malignancies. Significant resources have been expended by the largest pharmaceutical companies in an attempt to develop an effective drug to activate p53, but to date, it seems, none have succeeded. An approved drug that has the ability to treat drug-resistant lung, breast and colon cancers would be expected to generate billions of dollars in sales. Thus far, Kevetrin has demonstrated that ability in animals and we are eager for human trials to begin.” Mr. Ehrlich continued, “While we are expected to maintain calm and composure, the excitement is clearly evident as to what kind of an impact Kevetrin™ might have on the world of oncology.”
Cellceutix is completing formulation production, scheduled for early March 2011, which would produce Kevetrin™ in the dosage form for planned clinical trials. The Company plans to file an Investigational New Drug (IND) application with the U.S. Food and Drug Administration in May 2011 with human trials to begin shortly thereafter.
Cellceutix Corporation is a preclinical cancer, anti-inflammatory and autism drug developer. Cellceutix owns the rights to eight drug compounds, including Kevetrin, which it is developing as a treatment for certain cancers, KM-133, which it is developing for the treatment of psoriasis, and KM-391, which it is developing for the treatment of autism. More information is available on the Cellceutix web site at www.cellceutix.com.
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