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Cellceutix - Durchbruch gegen Krebs?

WKN: A2DTBJ | Symbol: IPIX
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Webseite: http://www.cellceutix.com/

E-mail: info@cellceutix.com

Cellceutix Corp. (OTCBB: CTIX), an emerging bio-pharmaceutical company, is in the early stages of receiving an influx of media attention and widespread notoriety within the pharmaceutical industry due to the promising results shown during the early development of a compound for the treatment of autism, KM-391, and with the imminent start of Phase 1 clinical trials at Dana Farber cancer center for Kevetrin***, the company's compound for the treatment of drug-resistant cancers. In addition to these two, Cellceutix currently manages a portfolio of six other promising compounds.

Kevetrin***, Cellceutix's flagship product, will commence Phase 1 clinical trials on humans with FDA regulated pre-clinical testing completed and the IND application completed and now under review. While most cancer treatments today are derivatives of other compounds, Kevetrin*** is completely unique. Multidrug resistance, the principal mechanism by which strains of cancer develop resistance to chemotherapy drugs, is a major factor in the failure of many forms of chemotherapy today and represents a huge need for novel cancer treatments. Kevetrin has been extensively studied in animal models of lung, breast, and colon cancers, targeting carcinoma strains that have proven resistant to standard therapies available on the market today with the results showing greater tumor growth delay than present therapies and strong efficacy in mouse models with increasing dosages. A successful drug for the treatment of drug-resistant cancers is purported to generate billions of dollars in annual revenues.

KM-133 is a small molecule, acting on the principles of immune stimulation and PRINS reduction, that has been found to be effective against psoriasis in animal models, both in induced psoriasis as well as a xenograft model with human psoriatic tissue. It is easily synthesized and has the potential for oral dosing. KM 133 significantly reduced all psoriatic endpoints measured relative to controls. KM-133 pre-clinical results have been submitted for pre-IND review and advising with the FDA.

KM-391, a 100% novel compound, is revolutionary in that it addresses the core issues of autism, unlike the pharmaceuticals presently on the market which merely treat the symptoms that result from autism. Preliminary testing of KM-391 revealed that test animals showed a significant increase in serotonin uptake compared to controls with noticeable and measurable positive therapeutic changes. Cellceutix is rapidly developing KM-391 in response to the public outcries received by the company since the results of early testing had been made publicly available.

The Company has procured leading figures in the health and science arenas to lead its development efforts. The officers and advisors of Cellceutix include pioneers in the fields of cancer and genetics, as well as those who have been integral to mergers, acquisitions and the generation of exorbitant revenues through ground breaking therapies while holding high-level executive and research positions at industry giants such as Pfizer and Eli Lilly. Holding over a century of highly relevant experience in the pharmaceuticals industry, the team has been assembled with the specific goal of duplicating these past successes while revolutionizing much needed treatments for today's most challenging diseases.

***Kevetrin, a compound that activates p53 "Guardian Angel of the Human Genome" in pre-clinical trials. ALL THINGS P53--http://oregonstate.edu/instruction/bb492/lectures/p53Lecture…

Latest News http://ih.advfn.com/p.php?pid=news&symbol=NB^CTIX
Latest Filings http://sec.gov/cgi-bin/browse-edgar?action=getcompany&CIK=00…

Management Team

Cellceutix has brought together leading figures in the health and science arenas to work toward the goal of developing innovative small molecule therapies for areas of unmet medical need, particularly cancer and inflammatory disease. The officers and advisors of Cellceutix include pioneers in the fields of cancer and genetics, as well as people with wide experience in the pharmaceutical business and their invaluable experiences cover all areas of researching, developing, and marketing ground breaking therapies.

Chief Executive Officer, Chairman of the Board of Directors- Leo Ehrlich, CPA: Served as Chief Financial Officer (CFO) of Cellceutix Pharma since inception in June 2007. Following the acquisition, he was appointed CFO and a director. From October 8, 1999 to the present time, Mr. Ehrlich has been a director at StatSure Diagnostic Systems, Inc. and has held different executive officer positions at that company including CEO, President, and his current title of CFO. Mr. Ehrlich was also CFO and a director of Nanoviricides, Inc. from June 1, 2005. until May 2007. Mr. Ehrlich is a Certified Public Accountant and received his BBA from Bernard Baruch College of the City University of New York.

President, Chief Scientific Officer, Board of Directors - Dr. Krishna Menon: RCM, PhD, VMD - Dr. Krishna Menon has more than 25 years in drug development for academia and industry. Originally trained as a veterinary surgeon, Menon began his career as the Senior Government Veterinarian for a major Parish in Jamaica. He segued to a two-year stint as Director of Agriculture for the Cayman Islands, in the British Caribbean and, in 1983, moved to the Dana Farber Cancer Research Institute, where he worked under the direction of Dr. Emil Frei. Two years later, he earned his PhD in Pharmacology from Kerala University in 1988. Menon's PhD work focused on anti-folate therapy of various cancers. Menon was a Research Associate Scientist at Dana Farber (Harvard University) from 1988 to 1991 and Research Scientist, In Vivo Research (Cancer & Metabolic Diseases), at Miles Laboratories from 1991 to 1993. After a year operating his own veterinary oncology and drug development consultancy practice, Menon was tapped Group Leader, Cancer In Vivo Research and Clinical Development, for Eli Lilly (1995-2001), where he played a key role in lead selection and pre-clinical development of Gemzar and Alimta which in 2006 had over 2.1 billion dollars ($2,100,000,000) in sales, and is a co-developer of another seven compounds currently in late-stage clinical development. In 1999, Lilly honored Menon with the President's Recognition Award.

Emil Frei III, MD: Dr. Frei is one of the world's leading oncologists, a pioneer of chemotherapy and a leader in medical research, clinical practice and education. His distinguished career includes 40 years in top leadership positions such as Chief of Medicine at National Cancer Institute, Associate Scientific Director at M. D. Anderson, and Director and Physician-in-Chief at the Dana-Farber Cancer Institute. He continues as Physician-in-Chief, Emeritus, at Dana-Farber.

Dr. Samuel Danishefsky, Scientific Advisor: Dr. Samuel Danishefsky is an internationally recognized leader in chemistry, specializing in the synthesis of biologically active organic compounds. He is regarded as one of the world's leading chemists in cancer research. Dr. Danishefsky earned his Ph.D. in chemistry from Harvard. He spent 14 years at Yale University, where he rose to the rank of Sterling Professor of Chemistry, the highest academic rank at Yale University, awarded to a tenured faculty member considered one of the best in his or her field. By 1991, he was also sharing his time with Memorial Sloan-Kettering Cancer Center as director of the Laboratory for Cancer Research Bioorganic Chemistry, becoming chair in 1993. He accepted an appointment as professor at Columbia University in 1993, and now conducts research at both institutions. Further information is available at www.mskcc.org/mskcc/html/64932.cfm

Common Stock 93,124,151 a/o Sep 30, 2012

Authorized Shares: 300M
Insiders Own: 51.9%
Float: ~41M

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Recent News Links:

Cellceutix Informed by FDA That 505(b)(2) Application Would Be an Acceptable Approach for Its Psoriasis Drug

Cellceutix Adds Brain Cancer to Growing List of Indications for Its Novel Cancer Drug

Cellceutix Files Amended IND With FDA for Its Novel p53 "Guardian Angel" Anti-Cancer Drug

Link zum Ihub Forum: http://investorshub.advfn.com/Cellceutix-Corporation-CTIX-12…
BEVERLY, MA., Octoberber 22, 2012–Cellceutix Corporation (OTCBB: CTIX) (the “Company”), a clinical stage biopharmaceutical company focused on discovering small molecule drugs to treat unmet medical conditions, including drug-resistant cancers and autoimmune diseases, announces an update on the status of clinical trials for the Company’s novel anti-cancer drug candidate, Kevetrin™. The Company is very pleased to report that it has been advised by both Harvard University’s Dana-Farber Cancer Institute and Beth Israel Deaconess Medical Center that the trials are now active and that the process of recruitment, enrollment and dosing is set to begin. Clinicaltrials.gov has been notified to change the trial status to active.

About Kevetrin™

As a completely new class of chemistry in medicine, Kevetrin™ has significant potential to be a major breakthrough in the treatment of solid tumors. Mechanism of action studies showed Kevetrin’s unique ability to affect both wild and mutant types of p53 (often referred to as the “Guardian Angel Gene” or the “Guardian Angel of the Human Genome”) and that Kevetrin strongly induced apoptosis (cell death), characterized by activation of Caspase 3 and cleavage of PARP. Activation of p53 also induced apoptosis by inducing the expression of p53 target gene PUMA. p53 is an important tumor suppressor that acts to restrict proliferation by inducing cell cycle checkpoints, apoptosis, or cellular senescence.

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.

The clinical trial titled, “A Phase 1, Open-Label, Dose-Escalation, Safety, Pharmacokinetic and Pharmacodynamic Study of Kevetrin (Thioureidobutyronitrile) Administered Intravenously, in Patients With Advanced Solid Tumors,” is available at: http://clinicaltrials.gov/ct2/show/NCT01664000?term=cellceutix&rank=1

About Cellceutix

Headquartered in Beverly, Massachusetts, Cellceutix is a publicly traded company under the symbol “CTIX”. It is an emerging bio-pharmaceutical company focused on the development of its pipeline of compounds targeting areas of unmet medical need. Our flagship compound, Kevetrin™, is an anti-cancer drug which has demonstrated the ability in pre-clinical studies to regulate the p53 pathway and attack cancers which have proven resistant to today’s cancer therapies (drug-resistant cancers). Cellceutix also owns the rights to seven other drug compounds, including KM-133, which is in development for psoriasis, and KM-391 for the treatment of the core symptoms of autism. More information is available on the Cellceutix web site at www.cellceutix.com.

Safe Harbor Forward-Looking Statements

To the extent that statements in this press release are not strictly historical, including statements as to revenue projections, business strategy, outlook, objectives, future milestones, plans, intentions, goals, future financial conditions, future collaboration agreements, the success of the Company’s development, events conditioned on stockholder or other approval, or otherwise as to future events, such statements are forward-looking, and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The forward-looking statements contained in this release are subject to certain risks and uncertainties that could cause actual results to differ materially from the statements made. Factors that may impact Cellceutix’s success are more fully disclosed in Cellceutix’s most recent public filings with the U.S. Securities and Exchange Commission.

Cellceutix Corp.

Leo Ehrlich

BEVERLY, MA., Octoberber 22, 2012–

Ein interessanter Artikel über ihr zweites Medikament, Prurisol:

Valeant Is On An Acquisition Spree - Will Prurisol Get Under Big Pharma's Skin?

The dermatological therapeutic business has recently had its landscape rearranged. Valeant Pharmaceuticals (VRX) has vaulted to the No. 1 position with substantial encouragement from its shareholders to continue. GlaxoSmithKline (GSK) attempted to remain in a growth mode, as it acquired a product. However, quietly and inconspicuously, India's second largest pharmaceutical, Dr. Reddy's Lab (RDY), has positioned itself quite smartly to get under the corporate skin of both Valeant and GlaxoSmithKline with regard to the dermatological therapeutic business.

Montreal-based Valeant announced on Sept. 3 a $2.6 billion takeover of Scottsdale, Ariz.-based Medicis (MRX). It was an all-cash offer that advances Valeant as the No. 1 company in the dermatological therapeutics market. If completed, the Medicis transaction will be the fiftieth acquisition that Michael Pearson has made since he became the CEO in 2009. Medicis had $721 million in revenue in 2011. The companies claim that the deal will save $225 million a year (to be recognized in six months) by combining operations. The two figures together approximate a revenue growth plus operational savings benefit of $946 million to Valeant. Wall Street and the up-and-coming Toronto Stock Exchange voted yes on Pearson's move by bidding up the acquiring Valeant's shares by 14.8%, to a NYSE close of $58.36 (as of Sept. 4, 2012).

Pearson sees margin protection and enhancement in the aesthetic dermatological business. Products that prove effective in the removal or delaying the onset of wrinkles or acne like Medicis' Solodyn and Dysport are more apt to be market priced to individuals, as most private and government insurance programs avoid reimbursement for many types of dermatological products -- especially cosmetic ones.

Valeant's acquisition of Medicis might be the largest therapeutic acquisition that a Canadian drug company has ever made of a U.S. pharmaceutical. Quite interestingly, it was driven in large part by a Canadian CEO's desire to better position his company's sails to the accelerating winds of the free market and away from the foundering shoals of government regulation.

Valeant CEO Pearson, however, has transformed the former Biovail, a Canadian company that was substantially shackled by the margin constraints of generic drugs, HMOs, and socialist health care pricing, into an exciting growing international company that has become akin to a Harvard Business School case study on how swiftly a sizable company can grow and transform its image. In doing so, Pearson has become a Maple Leaf Icon of Canadian entrepreneurship and international business.

After Valeant's $2.6 billion acquisition of dermatological company, Medicis, and GlaxoSmithKline's (Steifel Labs) $350 million June 12 acquisition of Basilea's (SIX) Toctino (alitretinoin), an FDA Phase III product for exzema, another event took place in conjunction with Dr. Reddy's Lab.

On June 13, 2012, Cellceutix (CTIX.OB) announced that after meeting with the FDA, it will be applying for Phase II trials for its anti-psoriasis compound, Prurisol (KM-133). Please note that Cellceutix's flagship compound Kevetrin has three separate trials planned for 2012-2013, with one beginning shortly. Two other Phase I trials are being funded by other entities, one at Harvard Beth Israel with Pfizer's multikinase inhibitors and an as-yet-unnamed large European pharmaceutical in tandem with a top 10 European university. Cellceutix's first FDA Phase 1 trial is at Harvard's Dana Farber. For a company with a capitalization of less than $125 million, Cellceutix is exceptionally rare (see "Pfizer Eyes Kevetrin" and Lynn Zehr's Seeking Alpha piece). Cellceutix is the smallest cap company to enter trials at the prestigious Dana Farber.

On Sept. 3, 2012, Dr. Reddy's Lab and Cellceutix announced a manufacturing agreement whereby Dr. Reddy's Lab would manufacturer Prurisol for Cellceutix' s clinical trials for KM-133. The announcement as it rippled through the blogs sounded very basic and matter of fact. Dr Reddy's Lab, a $5.4 billion cap international pharma performs this function not only for clinical trial compounds but also generic drug tablets and prescription compounds the world over. So the announcement appeared on the surface to deliver a small amount of high-margin business for Dr. Reddy's without reason for further excitement. However, as I researched Dr Reddy's, I stumbled upon a very interesting fact about Dr. Reddy's Lab that bears mentioning. Neatly tucked away within Dr. Reddy's high profile image as a contract drug manufacturer is a wholly owned subsidiary, Promius, that focuses exclusively on the "Development of Dermatological Drugs and Compounds."

If you know about Prurisol (KM-133) and study Promius you can certainly see that there is more than one reason why they would want to own all or the lion's share of Prurisol. Prurisol is described in this quote from Cellceutix's web site:

Prurisol was studied in SCID mice that were irradiated then grafted with human psoriatic tissue by inserting human psoriatic tissue under the skin using a trocar. Groups of ten mice were treated with Prurisol orally for 21 days with either 10 mg/kg Prurisol once/day or 10 mg/kg Prurisol twice/day, or with 7.5 mg/kg methotrexate IP once/day for five days. The mice were followed for 180 days. Endpoints were skin appearance, histological observations, PRINS expression, and blood levels of IL-20. For these parameters, Prurisol was compared to controls and methotrexate. In a second experiment, groups of 10 immunocompetent CD-1 mice were treated with one or two doses of 10 mg/kg Prurisol daily or 3 mg/kg efalizumab SC once per week for three weeks. CD4+ and CD8+ lymphocyte counts were also measured and compared to efalizumab. Result: Prurisol significantly reduced all psoriatic endpoints measured relative to control. The FDA has informed the Company that a 505(b)(2) application would be an acceptable approach for Prurisol™. Cellceutix has begun the preparatory work necessary for a Phase 2 clinical trial application for Prurisol™ based upon the FDA guidance.

After the Dr. Reddy's engagement was sealed, Cellceutix CEO Leo Ehrlich said in an Aug. 30, 2012, press release:

We have great expectations for this drug because it performed amazingly in lab studies. Our research showed Prurisol to be much more effective than methotrexate, a standard of care treatment for advanced psoriasis, as there was no recurrence of psoriasis on the animals. Visually, it eliminated all indications of psoriasis. We wanted to use only a world class manufacturer and Dr. Reddy's is internationally-renowned for their excellence in research, manufacturing and distribution.

As we continue to emerge as a leading drug developer, we are committed to working with companies and organizations that have high standards and a strong reputation. Dr. Reddy's is a perfect fit for Prurisol. Prurisol has a complex process for synthesizing and manufacturing in oral form and we are very pleased to have Dr. Reddy's handling those for Cellceutix.

Valeant, GlaxoSmithKline, and Dr. Reddy's are all moving with various strategies to either become or remain major players in the dermatology drug market. Whereas Valeant's and Glaxo's strategies have been synthetic and hence more observable, Dr. Reddy's appears slower and internally R&D driven, tucked away under it's primary pharmaceutical manufacturing business. In an NFL game we call Dr Reddy's Prurisol strategy a counterplay. However, all of us football fans know that a well timed counterplay can be one of the most exciting actions to view because suddenly, contrary to perceived expectation, a big play materializes and perhaps a touchdown is scored. Should Dr. Reddy's Lab's dermatology arm (Promius) capitalize on the informational advantage of their manufacturing business, Valeant and Mr. Pearson might have a very significant competitor in the dermatological therapeutic business that it currently dominates.

The psoriasis afflicted population in the U.S. alone is 7.5 million persons, with a U.S. treatment market value of approximately $2.5 billion a year. Remember that the Prurisol inventor, Dr. Krishna Menon, is not a marginal inventor. He was a distinguished Presidential Award winner at Eli Lilly, having had an illustrious career there. He assisted in the development of two oncolytic blockbusters that together produced billions in revenue in 2011.

At least as far as mice are concerned, Prurisol is the most effective psoriasis compound in the world today. Its invitation to proceed immediately into an advanced FDA Phase II trial is certainly validating. Fred Zucker in SEC Fillings.com on Sept. 10, 2012, said:

A good benchmark for the value of Prurisol can be gauged by the recent activity of Steifel Labs, a GlaxoSmithKline company. Steifel said it will be spending approximately $350 million to acquire rights to skin treatment drugs still in development from Welichem Biotech and Basilea Pharmaceutica"... It is noteworthy that Steifel's acquisition is for topical eczema treatments. Prurisol has been synthesized into an oral medication which should give it a value many multiples of the Steifel compound if a therapeutic benefit can be observed in humans. Steifel paid this price for a phase 3 dermatology drug that analysts expect will generate about 250 million dollars a year in revenue to GlaxoSmithKline.

I find Zucker's comparison to be yet below my best guess. One reason is because the topical treatments for Basilea's eczema drugs are expected to generate $250 million in revenue a year at best.
The current $2.6 billion a year U.S. psoriasis market is predicted to grow to be a $5.6 billion a year market come 2020. The Global market for psoriasis treatment is predicted to grow to 7.4 billion by 2020. Speculatively visualizing Prurisol as a drug that could command 15% of the global market, Prurisol could become a billion dollar annual revenue generator. However, assuming data similar to that of the animal preclinicals of Prurisol would be seen in humans, I believe that Prurisol's annual revenue expectancy would be multiples more than that of GlaxoSmithKline's Toctino (FDA Phase III), which is projected to be $250 million annually. Therefore, I would anticipate that as soon as FDA trials for Prurisol begin, a Glaxo/Toctino type structured deal would be the minimum for Prurisol. Prurisol could attract a suitor for multiples of what Glaxo offered for Toctino.

For those readers who follow Cellceutix and have been enthusiastic about Kevetrin, this article should help you to see that an acquisition and/or licensing valuation for Cellceutix that is based solely on Prurisol and using Zuckers conservative Prurisol valuation, could be upward of $2.00 per share. Therefore, in my opinion, everyone who buys Cellceutix under $2.00 will have obtained Kevetrin and Dr. Krishna Menon's six other preclinical drugs free. According to the end of the first quarter 2012 10Q, CTIX has approximately 133 million shares fully diluted. All this leaves in place Zucker's restrained comparison of Prurisol with a $350 million eczema product acquisition, when in fact the relevant market is far larger. And, of course, my assessment assumes positive Phase II data from Prurisol trials.

Dr. Reddy's potential counterplay with Prurisol, though it appears much less dramatic and sensational than either Valeants' bold acquisition or GlaxoSmithKline's hot product grab could, over the-intermediate term rival and or surpass either transaction. Indeed it's also possible that another pharmaceutical could step in and acquire Prurisol. In short, anyone who pays for Prurisol may just get a drug with multibillion-dollar potential (Kevetrin) for nothing.

Hi Loserin, die Firma veröffentlicht häufig Freitag nachbörslich news, die erst am Montag regulär veröffentlicht werden.
Antwort auf Beitrag Nr.: 43.733.897 von Nikkitawin am 20.10.12 16:22:31Auf der Webseite sind die news seit gestern nachbörslich zu sehen. Wird Montag vorbörslich dann regulär veröffentlicht.
Antwort auf Beitrag Nr.: 43.733.908 von Nikkitawin am 20.10.12 16:28:57Pipeline, from website

Kevetrin Cancer Phase 1
Prurisol Psoriasis Phase 2/3 505(b)(2)
KM 391 Autism Preclinical
KM 227 Arthritis Preclinical
KM 278 Arthritis/Asthma Preclinical
KM 3174 Cancer Early R&D
KM 362 MS/ALS/Park Early R&D
KM 732 Hypertensive emergency Early R&D

*** Cellceutix filed Phase 1 for Kevetrin @ ClinicalTrials.gov.

*** Kevetrin™ Phase 1

*** 8/6/2012 Dana-Farber Cancer Institute received Kevetrin™, the Company's flagship anti-cancer drug, for the commencement of hospital funded clinical trials.

*** 9/24/2012- Cellceutix expects the process of activation, recruitment, enrolling and first dosing to take approximately 3 weeks.

*Prurisol™ (psoriasis) the path to phase 2:

* 1/3/2012--The Company will be interacting with the FDA regarding obtaining 505(b)(2) designation for KM-133 (psoriasis) so it may be advanced immediately to Phase II clinical trials.

* 6/13/2012--Cellceutix is extremely pleased to announce that the FDA has informed the Company that a 505(b)(2) application would be an acceptable approach for Prurisol™ (psoriasis)

* 7/16/2012--"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"

* 9/4/2012--"Cellceutrix announces the selection of Dr. Reddy's Laboratories Ltd., a New York Stock Exchange-listed company traded under the ticker "RDY," for the manufacturing of Prurisol™, the Company's new drug candidate for the treatment of psoriasis.

* Kevetrin™ Leukemia the path to Phase 1

* 9/10/2012--Cellceutix in discussions with top 10 European University wishing to fund clinical trials on Kevetrin™

Antwort auf Beitrag Nr.: 43.734.064 von Nikkitawin am 20.10.12 17:44:41Quote:
KevetrinTM a compound that activates p53 "Guardian Angel of the Human Genome". P53 activates proteins required to repair DNA.
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.

In the laboratory, Kevetrin activates p53, a tumor suppressor protein that has an important role in protecting the body. p53 functions by activating proteins that repair DNA and kill cells that have genetic mutations such as in cancers. Research experiments showed that when cancer cells were treated with Kevetrin, it activated p53 which induced p21, a protein that inhibits cancer cell growth. p53 also induced PUMA (p53 up-regulated modulator of apoptosis), a protein that causes tumor cell death. Because of these activities, slowing cancer cell growth and causing cancer cell death, Kevetrin may help to treat tumors.

Cellceutix consultant Dr. Sylvia Holden commented, "I have been researching new drugs for nearly 30 years. Cellceutix is now a true pioneer in oncology discovery with this very special compound, Kevetrin. The Mechanism of Action of Kevetrin™, impacting both wild and mutant types of p53 to induce apoptosis and cell cycle arrest through multiple pathways while being well-tolerated, is what sets it apart from other chemotherapies today. Rather than being a traditional drug that targets and attempts to seek and destroy cancer cells independently, Kevetrin™ revitalizes p53 so that the body's natural defense system eliminates the tumor on its own. As a stand-alone or combination front-line therapy, the magnitude of the potential of Kevetrin™ is simply unparalleled by anything that I have ever seen in the laboratory before."

To determine the maximum tolerated dose (MTD) of Kevetrin.
To determine the dose limiting toxicities (DLT) of Kevetrin.
To establish a safe dose level of Kevetrin that can be used for future studies.

The secondary objectives are to determine the following:

The pharmacokinetics of Kevetrin in humans.
Observe for evidence of antitumor activity following administration of Kevetrin.
If there is a pharmacodynamic relationship between the plasma concentrations of Kevetrin and a clinical/cellular effect.
If Kevetrin induces changes in the biomarker p21 in peripheral blood lymphocytes.

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." commented Dr. Krishna Menon, Chief Scientific Officer at Cellceutix.
Natürlich ist es ein sehr spekulativer Wert in diesem frühen Stadium, aber wer auf Sicherheiten wartet, dem sollte bei solchen Medikamenten bewusst sein welchen Aufpreis man für Sicherheiten zahlt. :-)
Hier noch der wichtigste link um die Studie zu verfolgen: http://clinicaltrials.gov/ct2/show/NCT01664000?term=Kevetrin…
Status sollte in kürze geupdatet werden.

Ich rechne mit sehr vielen news, Firma ist sehr kommunikativ und wird vermutlich für jeden einzelnen Test eine PR veröffentlichen.

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