Welcome!

Release Management Authors: David H Deans, Liz McMillan, Jnan Dash, Lori MacVittie, Gilad Parann-Nissany

News Feed Item

Cellceutix CEO Discusses Corporate Developments in 2012 and Plans for 2013

BEVERLY, MA -- (Marketwire) -- 12/31/12 -- 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, today provides a letter from the CEO regarding developments of the Company throughout 2012 and expectations for 2013.

My fellow Cellceutix shareholders,

Looking back at the past 12 months, I could not be more pleased with the progression of our Company or more excited about 2013. It has always been our contention that Kevetrin™, our flagship anti-cancer drug, holds a great deal of promise as a potential therapeutic for a wide array of cancers and this past year has provided evidence that many leading institutions also see the potential. I'd like to take a moment and look at the progression of Kevetrin in 2012 and where it stands moving into 2013.

Company-sponsored clinical trials at Harvard University's Dana-Farber Cancer Center and partner Beth Israel Deaconess Medical Center began in November testing Kevetrin for safety against solid tumors. At this time, first cohort patients are about to begin their third cycle of dosing and the second cohort -- in which dosing levels were doubled -- are in their first cycle of dosing. The information that we have received at this early stage of the trial so far has been very encouraging with no data being delivered outside of the parameters of the protocol. We expect some information on pharmacokinetics from the early cohorts in the near term.

European trials that are being sponsored by and hosted at a leading European University (the "University") testing Kevetrin against Acute Myelogenous Leukemia (AML) are scheduled to begin in the first half of 2013. We have been advised that the study, a phase 1b trial, will be titled "A Multi-Center, Open-Labe, Phase 1B Study of Escalating Doses of Kevetrin (Thioureidobutyronitrile) Administered Intravenously, with Cytarabine Adminstered A) Subcutaneously, or B) Intravenously, in Patients with Acute Myelogenous Leukemia (AML)."

The protocol for the clinical trials is completed and undergoing a review process as well as other regulatory preparations progressing smoothly. The University has conducted pre-clinical research that they shared with us but asked that we not disclose the data as they "plan to publish it at a later day." A very brief summary of the data showed Kevetrin causing apoptosis (programmed cell death) in cancerous cells in addition to sensitizing and optimizing the cells to maximize the effectiveness of drugs used in combination with Kevetrin. We will be releasing details about the University very shortly.

The University has indicated they are interested in a second study of Kevetrin in combination with a compound of a major European pharmaceutical company. We will update shareholders as this moves forward in 2013.

Preclinical tests are being performed at Beth Israel Deaconess Medical Center testing Kevetrin in combination with Pfizer, Inc.'s multikinase inhibitor drugs as potential new therapies for renal cancer and melanoma. We have seen the data and it is very exciting to us, but, again, confidentiality agreements prevent us from providing any details at this time. Moreover, data of this nature is generally not discussed so that the institutions may present their findings at industry conferences when they deem appropriate.

We disclosed in an 8-K filing with the Security and Exchange Commission on December 27 that the Company has recently been approached by one of the world's most prominent cancer centers (the "Cancer Center"), located in the Southwest United States. The organization is interested in conducting and sponsoring studies on Kevetrin at their facilities. As stated in the regulatory filing, no assurances are made or implied that an agreement will be executed, but we are optimistic that the relationship will move forward early in 2013. We have now signed a Non-Disclosure Agreement with the Cancer Center and are quickly moving forward with a Material Transfer Agreement. Further details will be provided as permitted, but we are free to say that the Cancer Center is interested in the possibility of Kevetrin as a potential therapy for myeloma. Just like the other institutions, they will perform their own preclinical testing of 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. has condensed the manufacturing process, saving us time and money. Manufacturing of cGMP Prurisol is expected to begin in about a month's 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.

Although many of the expected studies on Kevetrin will be sponsored by outside organizations, financing is still critical to advancing those drugs further into human trials. To achieve this, we are extremely pleased to have received institutional support through a $10 million common stock purchase agreement with Aspire Capital Fund LLC in December. Aspire has committed to purchase up to $10 million of our Company's common stock over the next three years at prices based on the market price at the time of each sale.

2012 has put us at the forefront of some of the leading cancer research centers in the world and I could not be more proud. Kevetrin is an extremely unique drug, actually classified as a new class of chemistry in medicine, and its ability to re-activate p53 could simply be unprecedented if it continues to show low toxicity. There is no comparison of Kevetrin to any other compound. I think that the interest that has been shown by organizations approaching us wishing to conduct and sponsor research speaks for itself as to what some of the brightest minds in oncology see in the data. It has been well publicized what a major impact a p53 drug can have on cancer research and we are excited to be at the forefront of pharmaceutical companies in that space.

We are also very eager to evaluate Prurisol in clinical trials in a matter of months. While not as high-profile as a new cancer drug, psoriasis represents a multi-billion dollar opportunity and an area of great unmet medical need. Soon clinical research on Prurisol will begin which we anticipate will validate our laboratories studies and allow us to have a very promising late-stage clinical trial in the mid-term.

Of course, a big key to this is the new association with Aspire Capital Fund LLC. Their commitment to provide us funding at such favorable terms will prove invaluable to developing our pipeline.

I have stated in the past, "the best is yet to come" and I believe that 2012 was full of our Company meeting milestones that has us firmly moving forward and gaining recognition as an innovative biotechnology company. We have distinguished ourselves through Kevetrin as one of only a handful of companies that is developing a p53 drug, but that is not all that we have to offer. Prurisol is jumping straight into mid-stage trials and we have six other compounds in our pipeline that hold great potential as well. 2012 has seen us transition into a clinical stage company and provided us with the financing to continue to move ahead, but I believe that 2013 will be a bigger year for us with clinical data coming from multiple trials and that the best is still yet to come.

We appreciate the support that we have received from our loyal shareholders throughout the year and pledge to continue to immediately provide as much information as possible through public disclosures as they happen in the coming year.

Thank you.

Leo Ehrlich
Chief Executive Officer, Cellceutix Corporation

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.

INVESTOR AND MEDIA CONTACT:
Cellceutix Corp.
Leo Ehrlich
(978) 236-8717
Email Contact

More Stories By Marketwired .

Copyright © 2009 Marketwired. All rights reserved. All the news releases provided by Marketwired are copyrighted. Any forms of copying other than an individual user's personal reference without express written permission is prohibited. Further distribution of these materials is strictly forbidden, including but not limited to, posting, emailing, faxing, archiving in a public database, redistributing via a computer network or in a printed form.

@ThingsExpo Stories
The current age of digital transformation means that IT organizations must adapt their toolset to cover all digital experiences, beyond just the end users’. Today’s businesses can no longer focus solely on the digital interactions they manage with employees or customers; they must now contend with non-traditional factors. Whether it's the power of brand to make or break a company, the need to monitor across all locations 24/7, or the ability to proactively resolve issues, companies must adapt to...
Artificial intelligence, machine learning, neural networks. We’re in the midst of a wave of excitement around AI such as hasn’t been seen for a few decades. But those previous periods of inflated expectations led to troughs of disappointment. Will this time be different? Most likely. Applications of AI such as predictive analytics are already decreasing costs and improving reliability of industrial machinery. Furthermore, the funding and research going into AI now comes from a wide range of com...
In this presentation, Striim CTO and founder Steve Wilkes will discuss practical strategies for counteracting fraud and cyberattacks by leveraging real-time streaming analytics. In his session at @ThingsExpo, Steve Wilkes, Founder and Chief Technology Officer at Striim, will provide a detailed look into leveraging streaming data management to correlate events in real time, and identify potential breaches across IoT and non-IoT systems throughout the enterprise. Strategies for processing massive ...
SYS-CON Events announced today that GrapeUp, the leading provider of rapid product development at the speed of business, will exhibit at SYS-CON's 21st International Cloud Expo®, which will take place October 31-November 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. Grape Up is a software company, specialized in cloud native application development and professional services related to Cloud Foundry PaaS. With five expert teams that operate in various sectors of the market acr...
Internet of @ThingsExpo, taking place October 31 - November 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA, is co-located with 21st Cloud Expo and will feature technical sessions from a rock star conference faculty and the leading industry players in the world. The Internet of Things (IoT) is the most profound change in personal and enterprise IT since the creation of the Worldwide Web more than 20 years ago. All major researchers estimate there will be tens of billions devic...
SYS-CON Events announced today that Ayehu will exhibit at SYS-CON's 21st International Cloud Expo®, which will take place on October 31 - November 2, 2017 at the Santa Clara Convention Center in Santa Clara California. Ayehu provides IT Process Automation & Orchestration solutions for IT and Security professionals to identify and resolve critical incidents and enable rapid containment, eradication, and recovery from cyber security breaches. Ayehu provides customers greater control over IT infras...
SYS-CON Events announced today that MobiDev, a client-oriented software development company, will exhibit at SYS-CON's 21st International Cloud Expo®, which will take place October 31-November 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. MobiDev is a software company that develops and delivers turn-key mobile apps, websites, web services, and complex software systems for startups and enterprises. Since 2009 it has grown from a small group of passionate engineers and business...
SYS-CON Events announced today that Cloud Academy named "Bronze Sponsor" of 21st International Cloud Expo which will take place October 31 - November 2, 2017 at the Santa Clara Convention Center in Santa Clara, CA. Cloud Academy is the industry’s most innovative, vendor-neutral cloud technology training platform. Cloud Academy provides continuous learning solutions for individuals and enterprise teams for Amazon Web Services, Microsoft Azure, Google Cloud Platform, and the most popular cloud com...
The current age of digital transformation means that IT organizations must adapt their toolset to cover all digital experiences, beyond just the end users’. Today’s businesses can no longer focus solely on the digital interactions they manage with employees or customers; they must now contend with non-traditional factors. Whether it's the power of brand to make or break a company, the need to monitor across all locations 24/7, or the ability to proactively resolve issues, companies must adapt to...
SYS-CON Events announced today that CA Technologies has been named "Platinum Sponsor" of SYS-CON's 21st International Cloud Expo®, which will take place October 31-November 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. CA Technologies helps customers succeed in a future where every business - from apparel to energy - is being rewritten by software. From planning to development to management to security, CA creates software that fuels transformation for companies in the applic...
We build IoT infrastructure products - when you have to integrate different devices, different systems and cloud you have to build an application to do that but we eliminate the need to build an application. Our products can integrate any device, any system, any cloud regardless of protocol," explained Peter Jung, Chief Product Officer at Pulzze Systems, in this SYS-CON.tv interview at @ThingsExpo, held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA
SYS-CON Events announced today that IBM has been named “Diamond Sponsor” of SYS-CON's 21st Cloud Expo, which will take place on October 31 through November 2nd 2017 at the Santa Clara Convention Center in Santa Clara, California.
Amazon started as an online bookseller 20 years ago. Since then, it has evolved into a technology juggernaut that has disrupted multiple markets and industries and touches many aspects of our lives. It is a relentless technology and business model innovator driving disruption throughout numerous ecosystems. Amazon’s AWS revenues alone are approaching $16B a year making it one of the largest IT companies in the world. With dominant offerings in Cloud, IoT, eCommerce, Big Data, AI, Digital Assista...
SYS-CON Events announced today that Enzu will exhibit at SYS-CON's 21st Int\ernational Cloud Expo®, which will take place October 31-November 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. Enzu’s mission is to be the leading provider of enterprise cloud solutions worldwide. Enzu enables online businesses to use its IT infrastructure to their competitive advantage. By offering a suite of proven hosting and management services, Enzu wants companies to focus on the core of their ...
Multiple data types are pouring into IoT deployments. Data is coming in small packages as well as enormous files and data streams of many sizes. Widespread use of mobile devices adds to the total. In this power panel at @ThingsExpo, moderated by Conference Chair Roger Strukhoff, panelists looked at the tools and environments that are being put to use in IoT deployments, as well as the team skills a modern enterprise IT shop needs to keep things running, get a handle on all this data, and deliver...
In his session at @ThingsExpo, Eric Lachapelle, CEO of the Professional Evaluation and Certification Board (PECB), provided an overview of various initiatives to certify the security of connected devices and future trends in ensuring public trust of IoT. Eric Lachapelle is the Chief Executive Officer of the Professional Evaluation and Certification Board (PECB), an international certification body. His role is to help companies and individuals to achieve professional, accredited and worldwide re...
IoT solutions exploit operational data generated by Internet-connected smart “things” for the purpose of gaining operational insight and producing “better outcomes” (for example, create new business models, eliminate unscheduled maintenance, etc.). The explosive proliferation of IoT solutions will result in an exponential growth in the volume of IoT data, precipitating significant Information Governance issues: who owns the IoT data, what are the rights/duties of IoT solutions adopters towards t...
With the introduction of IoT and Smart Living in every aspect of our lives, one question has become relevant: What are the security implications? To answer this, first we have to look and explore the security models of the technologies that IoT is founded upon. In his session at @ThingsExpo, Nevi Kaja, a Research Engineer at Ford Motor Company, discussed some of the security challenges of the IoT infrastructure and related how these aspects impact Smart Living. The material was delivered interac...
With major technology companies and startups seriously embracing Cloud strategies, now is the perfect time to attend 21st Cloud Expo October 31 - November 2, 2017, at the Santa Clara Convention Center, CA, and June 12-14, 2018, at the Javits Center in New York City, NY, and learn what is going on, contribute to the discussions, and ensure that your enterprise is on the right path to Digital Transformation.
No hype cycles or predictions of zillions of things here. IoT is big. You get it. You know your business and have great ideas for a business transformation strategy. What comes next? Time to make it happen. In his session at @ThingsExpo, Jay Mason, Associate Partner at M&S Consulting, presented a step-by-step plan to develop your technology implementation strategy. He discussed the evaluation of communication standards and IoT messaging protocols, data analytics considerations, edge-to-cloud tec...