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
SYS-CON Events announced today that Massive Networks will exhibit at SYS-CON's 21st International Cloud Expo®, which will take place on Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. Massive Networks mission is simple. To help your business operate seamlessly with fast, reliable, and secure internet and network solutions. Improve your customer's experience with outstanding connections to your cloud.
Everything run by electricity will eventually be connected to the Internet. Get ahead of the Internet of Things revolution and join Akvelon expert and IoT industry leader, Sergey Grebnov, in his session at @ThingsExpo, for an educational dive into the world of managing your home, workplace and all the devices they contain with the power of machine-based AI and intelligent Bot services for a completely streamlined experience.
Because IoT devices are deployed in mission-critical environments more than ever before, it’s increasingly imperative they be truly smart. IoT sensors simply stockpiling data isn’t useful. IoT must be artificially and naturally intelligent in order to provide more value In his session at @ThingsExpo, John Crupi, Vice President and Engineering System Architect at Greenwave Systems, will discuss how IoT artificial intelligence (AI) can be carried out via edge analytics and machine learning techn...
SYS-CON Events announced today that Datera, that offers a radically new data management architecture, has been named "Exhibitor" of SYS-CON's 21st International Cloud Expo ®, which will take place on Oct 31 - Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. Datera is transforming the traditional datacenter model through modern cloud simplicity. The technology industry is at another major inflection point. The rise of mobile, the Internet of Things, data storage and Big...
Consumers increasingly expect their electronic "things" to be connected to smart phones, tablets and the Internet. When that thing happens to be a medical device, the risks and benefits of connectivity must be carefully weighed. Once the decision is made that connecting the device is beneficial, medical device manufacturers must design their products to maintain patient safety and prevent compromised personal health information in the face of cybersecurity threats. In his session at @ThingsExpo...
In his session at @ThingsExpo, Arvind Radhakrishnen discussed how IoT offers new business models in banking and financial services organizations with the capability to revolutionize products, payments, channels, business processes and asset management built on strong architectural foundation. The following topics were covered: How IoT stands to impact various business parameters including customer experience, cost and risk management within BFS organizations.
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...
From 2013, NTT Communications has been providing cPaaS service, SkyWay. Its customer’s expectations for leveraging WebRTC technology are not only typical real-time communication use cases such as Web conference, remote education, but also IoT use cases such as remote camera monitoring, smart-glass, and robotic. Because of this, NTT Communications has numerous IoT business use-cases that its customers are developing on top of PaaS. WebRTC will lead IoT businesses to be more innovative and address...
An increasing number of companies are creating products that combine data with analytical capabilities. Running interactive queries on Big Data requires complex architectures to store and query data effectively, typically involving data streams, an choosing efficient file format/database and multiple independent systems that are tied together through custom-engineered pipelines. In his session at @BigDataExpo at @ThingsExpo, Tomer Levi, a senior software engineer at Intel’s Advanced Analytics ...
SYS-CON Events announced today that App2Cloud will exhibit at SYS-CON's 21st International Cloud Expo®, which will take place on Oct. 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. App2Cloud is an online Platform, specializing in migrating legacy applications to any Cloud Providers (AWS, Azure, Google Cloud).
Recently, IoT seems emerging as a solution vehicle for data analytics on real-world scenarios from setting a room temperature setting to predicting a component failure of an aircraft. Compared with developing an application or deploying a cloud service, is an IoT solution unique? If so, how? How does a typical IoT solution architecture consist? And what are the essential components and how are they relevant to each other? How does the security play out? What are the best practices in formulating...
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...
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 Dasher Technologies will exhibit at SYS-CON's 21st International Cloud Expo®, which will take place on Oct 31 - Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. Dasher Technologies, Inc. ® is a premier IT solution provider that delivers expert technical resources along with trusted account executives to architect and deliver complete IT solutions and services to help our clients execute their goals, plans and objectives. Since 1999, we'v...
SYS-CON Events announced today that Ayehu will exhibit at SYS-CON's 21st International Cloud Expo®, which will take place on Oct. 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. 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 infrastructure throu...
SYS-CON Events announced today that Elastifile will exhibit at SYS-CON's 21st International Cloud Expo®, which will take place on Oct 31 - Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. Elastifile Cloud File System (ECFS) is software-defined data infrastructure designed for seamless and efficient management of dynamic workloads across heterogeneous environments. Elastifile provides the architecture needed to optimize your hybrid cloud environment, by facilitating efficient...
SYS-CON Events announced today that Grape Up will exhibit at SYS-CON's 21st International Cloud Expo®, which will take place on Oct. 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. Grape Up is a software company specializing 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 across the U.S. and Europe, Grape Up works with a variety of customers from emergi...
SYS-CON Events announced today that Grape Up will exhibit at SYS-CON's 21st International Cloud Expo®, which will take place on Oct. 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. Grape Up is a software company specializing 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 across the U.S. and Europe, Grape Up works with a variety of customers from emergi...
SYS-CON Events announced today that Golden Gate University will exhibit at SYS-CON's 21st International Cloud Expo®, which will take place on Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. Since 1901, non-profit Golden Gate University (GGU) has been helping adults achieve their professional goals by providing high quality, practice-based undergraduate and graduate educational programs in law, taxation, business and related professions. Many of its courses are taug...
When shopping for a new data processing platform for IoT solutions, many development teams want to be able to test-drive options before making a choice. Yet when evaluating an IoT solution, it’s simply not feasible to do so at scale with physical devices. Building a sensor simulator is the next best choice; however, generating a realistic simulation at very high TPS with ease of configurability is a formidable challenge. When dealing with multiple application or transport protocols, you would be...