|By Marketwired .||
|December 31, 2012 07:00 AM EST||
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.
Chief Executive Officer, Cellceutix Corporation
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:
Connected devices and the industrial internet are growing exponentially every year with Cisco expecting 50 billion devices to be in operation by 2020. In this period of growth, location-based insights are becoming invaluable to many businesses as they adopt new connected technologies. Knowing when and where these devices connect from is critical for a number of scenarios in supply chain management, disaster management, emergency response, M2M, location marketing and more. In his session at @Th...
Jun. 26, 2016 03:00 PM EDT Reads: 909
It is one thing to build single industrial IoT applications, but what will it take to build the Smart Cities and truly society changing applications of the future? The technology won’t be the problem, it will be the number of parties that need to work together and be aligned in their motivation to succeed. In his Day 2 Keynote at @ThingsExpo, Henrik Kenani Dahlgren, Portfolio Marketing Manager at Ericsson, discussed how to plan to cooperate, partner, and form lasting all-star teams to change t...
Jun. 26, 2016 02:00 PM EDT Reads: 1,108
The cloud market growth today is largely in public clouds. While there is a lot of spend in IT departments in virtualization, these aren’t yet translating into a true “cloud” experience within the enterprise. What is stopping the growth of the “private cloud” market? In his general session at 18th Cloud Expo, Nara Rajagopalan, CEO of Accelerite, explored the challenges in deploying, managing, and getting adoption for a private cloud within an enterprise. What are the key differences between wh...
Jun. 26, 2016 01:00 PM EDT Reads: 721
The 19th International Cloud Expo has announced that its Call for Papers is open. Cloud Expo, to be held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA, brings together Cloud Computing, Big Data, Internet of Things, DevOps, Digital Transformation, Microservices and WebRTC to one location. With cloud computing driving a higher percentage of enterprise IT budgets every year, it becomes increasingly important to plant your flag in this fast-expanding business opportuni...
Jun. 26, 2016 12:00 PM EDT Reads: 1,269
Internet of @ThingsExpo, taking place November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA, is co-located with the 19th International Cloud Expo and will feature technical sessions from a rock star conference faculty and the leading industry players in the world and ThingsExpo Silicon Valley Call for Papers is now open.
Jun. 26, 2016 12:00 PM EDT Reads: 1,095
There is little doubt that Big Data solutions will have an increasing role in the Enterprise IT mainstream over time. Big Data at Cloud Expo - to be held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA - has announced its Call for Papers is open. Cloud computing is being adopted in one form or another by 94% of enterprises today. Tens of billions of new devices are being connected to The Internet of Things. And Big Data is driving this bus. An exponential increase is...
Jun. 26, 2016 12:00 PM EDT Reads: 1,327
In his general session at 18th Cloud Expo, Lee Atchison, Principal Cloud Architect and Advocate at New Relic, discussed cloud as a ‘better data center’ and how it adds new capacity (faster) and improves application availability (redundancy). The cloud is a ‘Dynamic Tool for Dynamic Apps’ and resource allocation is an integral part of your application architecture, so use only the resources you need and allocate /de-allocate resources on the fly.
Jun. 26, 2016 12:00 PM EDT Reads: 1,052
In his keynote at 18th Cloud Expo, Andrew Keys, Co-Founder of ConsenSys Enterprise, provided an overview of the evolution of the Internet and the Database and the future of their combination – the Blockchain. Andrew Keys is Co-Founder of ConsenSys Enterprise. He comes to ConsenSys Enterprise with capital markets, technology and entrepreneurial experience. Previously, he worked for UBS investment bank in equities analysis. Later, he was responsible for the creation and distribution of life sett...
Jun. 26, 2016 11:00 AM EDT Reads: 1,037
Machine Learning helps make complex systems more efficient. By applying advanced Machine Learning techniques such as Cognitive Fingerprinting, wind project operators can utilize these tools to learn from collected data, detect regular patterns, and optimize their own operations. In his session at 18th Cloud Expo, Stuart Gillen, Director of Business Development at SparkCognition, discussed how research has demonstrated the value of Machine Learning in delivering next generation analytics to imp...
Jun. 26, 2016 09:45 AM EDT Reads: 565
There are several IoTs: the Industrial Internet, Consumer Wearables, Wearables and Healthcare, Supply Chains, and the movement toward Smart Grids, Cities, Regions, and Nations. There are competing communications standards every step of the way, a bewildering array of sensors and devices, and an entire world of competing data analytics platforms. To some this appears to be chaos. In this power panel at @ThingsExpo, moderated by Conference Chair Roger Strukhoff, Bradley Holt, Developer Advocate a...
Jun. 26, 2016 08:45 AM EDT Reads: 706
Cognitive Computing is becoming the foundation for a new generation of solutions that have the potential to transform business. Unlike traditional approaches to building solutions, a cognitive computing approach allows the data to help determine the way applications are designed. This contrasts with conventional software development that begins with defining logic based on the current way a business operates. In her session at 18th Cloud Expo, Judith S. Hurwitz, President and CEO of Hurwitz & ...
Jun. 25, 2016 03:00 PM EDT Reads: 1,562
A strange thing is happening along the way to the Internet of Things, namely far too many devices to work with and manage. It has become clear that we'll need much higher efficiency user experiences that can allow us to more easily and scalably work with the thousands of devices that will soon be in each of our lives. Enter the conversational interface revolution, combining bots we can literally talk with, gesture to, and even direct with our thoughts, with embedded artificial intelligence, wh...
Jun. 25, 2016 01:45 PM EDT Reads: 902
19th Cloud Expo, taking place November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA, will feature technical sessions from a rock star conference faculty and the leading industry players in the world. Cloud computing is now being embraced by a majority of enterprises of all sizes. Yesterday's debate about public vs. private has transformed into the reality of hybrid cloud: a recent survey shows that 74% of enterprises have a hybrid cloud strategy. Meanwhile, 94% of enterpri...
Jun. 25, 2016 01:15 PM EDT Reads: 1,237
SYS-CON Events announced today that Bsquare has been named “Silver Sponsor” of SYS-CON's @ThingsExpo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. For more than two decades, Bsquare has helped its customers extract business value from a broad array of physical assets by making them intelligent, connecting them, and using the data they generate to optimize business processes.
Jun. 25, 2016 11:45 AM EDT Reads: 1,186
Internet of @ThingsExpo, taking place November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA, is co-located with 19th 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 devices - comp...
Jun. 25, 2016 11:15 AM EDT Reads: 1,211
Cloud computing is being adopted in one form or another by 94% of enterprises today. Tens of billions of new devices are being connected to The Internet of Things. And Big Data is driving this bus. An exponential increase is expected in the amount of information being processed, managed, analyzed, and acted upon by enterprise IT. This amazing is not part of some distant future - it is happening today. One report shows a 650% increase in enterprise data by 2020. Other estimates are even higher....
Jun. 25, 2016 10:15 AM EDT Reads: 1,270
SYS-CON Events announced today that ReadyTalk, a leading provider of online conferencing and webinar services, has been named Vendor Presentation Sponsor at the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. ReadyTalk delivers audio and web conferencing services that inspire collaboration and enable the Future of Work for today’s increasingly digital and mobile workforce. By combining intuitive, innovative tec...
Jun. 24, 2016 01:00 PM EDT Reads: 1,341
Amazon has gradually rolled out parts of its IoT offerings, but these are just the tip of the iceberg. In addition to optimizing their backend AWS offerings, Amazon is laying the ground work to be a major force in IoT - especially in the connected home and office. In his session at @ThingsExpo, Chris Kocher, founder and managing director of Grey Heron, explained how Amazon is extending its reach to become a major force in IoT by building on its dominant cloud IoT platform, its Dash Button strat...
Jun. 24, 2016 12:00 PM EDT Reads: 1,616
industrial company for a multi-year contract initially valued at over $4.0 million. In addition to DataV software, Bsquare will also provide comprehensive systems integration, support and maintenance services. DataV leverages advanced data analytics, predictive reasoning, data-driven diagnostics, and automated orchestration of remediation actions in order to improve asset uptime while reducing service and warranty costs.
Jun. 22, 2016 11:00 AM EDT Reads: 1,361
Vidyo, Inc., has joined the Alliance for Open Media. The Alliance for Open Media is a non-profit organization working to define and develop media technologies that address the need for an open standard for video compression and delivery over the web. As a member of the Alliance, Vidyo will collaborate with industry leaders in pursuit of an open and royalty-free AOMedia Video codec, AV1. Vidyo’s contributions to the organization will bring to bear its long history of expertise in codec technolo...
Jun. 19, 2016 12:45 PM EDT Reads: 1,257