Welcome!

News Feed Item

Q Therapeutics Issues Formal Corporate Update

SALT LAKE CITY, UT -- (Marketwired) -- 04/21/14 -- Q Therapeutics, Inc. ("Q"), an emerging biotechnology company developing innovative cell therapy products for the treatment of neurodegenerative diseases, today issued a formal corporate update relating to the Company's progress on advancing its pre-clinical research and development efforts. Q's President and Chief Executive Officer, Deborah Eppstein, PhD, stated:

"2013 was a productive year for Q Therapeutics on many fronts -- and we've continued to gain momentum in 2014. Of particular note is the progress we're making in moving towards the IND filing and clinical studies using our proprietary, patented Q-Cells® as a potential therapy for Amyotrophic Lateral Sclerosis (ALS, or Lou Gehrig's disease). In late 2012, we commenced formal GLP animal safety studies at MPI Research, and recently completed the in-life portion of those safety, biodistribution and tumorigenicity studies. We expect to complete the full data analysis of this study within the next six months. The interim data show no safety concerns attributed to Q-Cells, thereby meeting the safety milestone for the multi-year National Institutes of Health (NIH) grant that supports this work. We are optimistic that the fourth and final tranche of funding of this milestone-driven grant will be awarded to support completion of IND-enabling studies required by the FDA for clearance to begin clinical trials.

"Late in the third quarter of 2013, the FDA granted Orphan Drug Designation to Q-Cells for the treatment of ALS. This designation, given to drug therapies intended to treat diseases or conditions that affect fewer than 200,000 patients in the United States, enables companies to benefit from certain financial incentives, including seven years of market exclusivity after product marketing clearance, access to federal grant funding opportunities to defray clinical trial costs, and assistance with clinical protocols and federal tax credits. Orphan Drug Designation represents a significant milestone for ALS patients and for our Company as we advance this potentially life-saving therapeutic. We plan to apply for similar available designations in Europe and Japan.

"We have advanced our cell manufacturing efforts in partnership with the University of Utah's Cell Therapy and Regenerative Medicine Facility, focused on documenting Q-Cells' manufacturing platform in accordance with FDA guidelines -- documentation that also will support IND filing and clinical trials.

"We continue to work closely with our academic collaborators. For our initial clinical trials in ALS, these include Nicholas Maragakis, MD at The Johns Hopkins University School of Medicine and Jonathan Glass, MD, and Nicholas Boulis, MD at Emory University School of Medicine, who are all working to further define and develop clinical protocols for the ALS trials. Dr. Boulis is also working with us to design and conduct a short-term safety study of Q-Cells in mini-pigs, using the injection platform for cell delivery that we intend to employ in clinical trials. This important safety study is being conducted by MPI Research to document compatibility between Q-Cells and the injection platform, and its effectiveness in implanting those cells. Studies led by Dr. Piotr Walczak at The Johns Hopkins University continue to demonstrate and validate the benefits of Q-Cells in myelination deficiency models. We expect Dr. Walczak's work to support our future studies in other indications, including transverse myelitis, multiple sclerosis and stroke.

"I'm pleased to report that we have also advanced the preclinical study of Q-Cells as a regenerative therapy for the treatment of traumatic spinal cord injuries. Dr. Itzhak Fischer's laboratory at Drexel University is engaged in demonstrating the benefits of Q-Cells for this therapeutic application, and in June 2013 published positive study results in the peer-reviewed Journal of Neurotrauma.

"We also formed exciting new scientific collaborations with XCell Science, Inc. to develop manufacturing technologies for new neural cell products derived from induced pluripotent stem cell (iPSC) lines. We expect that will enhance our proprietary product portfolio with new tissue sources and allow us to identify novel and impactful new therapeutic targets in the neurodegeneration area.

"Finally, we continued to prosecute our intellectual property portfolio, bringing the number of issued patents to 18 covering neural lineage cells, in addition to two in-licensed patents concerning the spinal injection platform.

"On the corporate side of our business, we have continued to dedicate effort to securing growth capital necessary to fund Q's ongoing R&D efforts. Since March 7, 2014, we have closed on $4.4 million with several strategic and financial investors. We expect to seek additional funding to support further development of our product candidates, including initiation of our clinical trial plans for those candidates.

"In closing, I'd like to acknowledge that our leadership team has been enhanced notably with the return of Q's Scientific Founder, Mahendra Rao, MD, PhD, in the roles of Chief Strategy Officer and Scientific Advisory Board Chair. Q Therapeutics remains committed to optimizing and realizing the value we have created -- and continue to enhance -- in our Company and in our Q-Cells platform. We are highly optimistic about being in position to submit an IND to the FDA later this year and proceeding to clinical trials in relatively short order," concluded Dr. Eppstein.

About Q Therapeutics, Inc.
Headquartered in Salt Lake City, Utah, Q Therapeutics, Inc. is a fully reporting, non-trading company engaged in developing adult stem cell therapies to treat debilitating diseases of the central nervous system. The Company's first product, Q-Cells®, is a cell-based therapeutic intended to restore or preserve normal activity of neurons by providing essential support functions that occur in healthy central nervous system tissues. Q-Cells may be applicable to a wide range of central nervous system diseases, including demyelinating conditions such as multiple sclerosis, transverse myelitis, cerebral palsy and stroke; as well as other neurodegenerative diseases and injuries, such as ALS (Lou Gehrig's disease), Huntington's disease, spinal cord injury, traumatic brain injury, Parkinson's disease and Alzheimer's disease. Q Therapeutics' initial clinical target is ALS, with a first IND submission expected in 2014. The Company's proprietary product pipeline also encompasses neural cell products derived from induced pluripotent stem cells (iPSC). For more information, visit www.qthera.com.

Cautionary Statement Regarding Forward Looking Information
This news release may contain forward-looking statements made pursuant to the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that such forward-looking statements in this press release regarding potential applications of Q Therapeutics' technologies constitute forward-looking statements that involve risks and uncertainties, including, without limitation, risks inherent in the development and commercialization of potential products, uncertainty of clinical trial results or regulatory approvals or clearances, need for future capital, dependence upon collaborators and maintenance of its intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements. Additional information on potential factors that could affect results and other risks and uncertainties are detailed from time to time in Q Therapeutics' periodic reports, including the Company's Annual Report on Form 10-K for the year ended December 31, 2013.

Add to Digg Bookmark with del.icio.us Add to Newsvine

FOR MORE INFORMATION:
Hanover|Elite
Erin Palmer
Director of Client Relations
407-585-1080
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.

Latest Stories
SYS-CON Events announced today that Secure Channels will exhibit 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. The bedrock of Secure Channels Technology is a uniquely modified and enhanced process based on superencipherment. Superencipherment is the process of encrypting an already encrypted message one or more times, either using the same or a different algorithm.
Traditional on-premises data centers have long been the domain of modern data platforms like Apache Hadoop, meaning companies who build their business on public cloud were challenged to run Big Data processing and analytics at scale. But recent advancements in Hadoop performance, security, and most importantly cloud-native integrations, are giving organizations the ability to truly gain value from all their data. In his session at 19th Cloud Expo, David Tishgart, Director of Product Marketing ...
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.
SYS-CON Events announced today that Commvault, a global leader in enterprise data protection and information management, has been named “Bronze Sponsor” of SYS-CON's 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Commvault is a leading provider of data protection and information management solutions, helping companies worldwide activate their data to drive more value and business insight and to transform moder...
DevOps at Cloud Expo – being held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA – announces that its Call for Papers is open. Born out of proven success in agile development, cloud computing, and process automation, DevOps is a macro trend you cannot afford to miss. From showcase success stories from early adopters and web-scale businesses, DevOps is expanding to organizations of all sizes, including the world's largest enterprises – and delivering real results. Am...
Almost two-thirds of companies either have or soon will have IoT as the backbone of their business in 2016. However, IoT is far more complex than most firms expected. How can you not get trapped in the pitfalls? In his session at @ThingsExpo, Tony Shan, a renowned visionary and thought leader, will introduce a holistic method of IoTification, which is the process of IoTifying the existing technology and business models to adopt and leverage IoT. He will drill down to the components in this fra...
The vision of a connected smart home is becoming reality with the application of integrated wireless technologies in devices and appliances. The use of standardized and TCP/IP networked wireless technologies in line-powered and battery operated sensors and controls has led to the adoption of radios in the 2.4GHz band, including Wi-Fi, BT/BLE and 802.15.4 applied ZigBee and Thread. This is driving the need for robust wireless coexistence for multiple radios to ensure throughput performance and th...
SYS-CON Events announced today that Pulzze Systems will exhibit 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. Pulzze Systems, Inc. provides infrastructure products for the Internet of Things to enable any connected device and system to carry out matched operations without programming. For more information, visit http://www.pulzzesystems.com.
Enterprise IT has been in the era of Hybrid Cloud for some time now. But it seems most conversations about Hybrid are focused on integrating AWS, Microsoft Azure, or Google ECM into existing on-premises systems. Where is all the Private Cloud? What do technology providers need to do to make their offerings more compelling? How should enterprise IT executives and buyers define their focus, needs, and roadmap, and communicate that clearly to the providers?
SYS-CON Events announced today the Kubernetes and Google Container Engine Workshop, being held November 3, 2016, in conjunction with @DevOpsSummit at 19th Cloud Expo at the Santa Clara Convention Center in Santa Clara, CA. This workshop led by Sebastian Scheele introduces participants to Kubernetes and Google Container Engine (GKE). Through a combination of instructor-led presentations, demonstrations, and hands-on labs, students learn the key concepts and practices for deploying and maintainin...
SYS-CON Events announced today that SoftLayer, an IBM Company, has been named “Gold Sponsor” of SYS-CON's 18th Cloud Expo, which will take place on June 7-9, 2016, at the Javits Center in New York, New York. SoftLayer, an IBM Company, provides cloud infrastructure as a service from a growing number of data centers and network points of presence around the world. SoftLayer’s customers range from Web startups to global enterprises.
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...
DevOps at Cloud Expo, taking place Nov 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 widespread success of cloud computing is driving the DevOps revolution in enterprise IT. Now as never before, development teams must communicate and collaborate in a dynamic, 24/7/365 environment. There is no time to wait for long dev...
Digital innovation is the next big wave of business transformation based on digital technologies of which IoT and Big Data are key components, For example: Business boundary innovation is a challenge to excavate third-party business value using IoT and BigData, like Nest Business structure innovation may propose re-building business structure from scratch, as Uber does in the taxicab industry The social model innovation is also a big challenge to the new social architecture with the design fr...
Data is an unusual currency; it is not restricted by the same transactional limitations as money or people. In fact, the more that you leverage your data across multiple business use cases, the more valuable it becomes to the organization. And the same can be said about the organization’s analytics. In his session at 19th Cloud Expo, Bill Schmarzo, CTO for the Big Data Practice at EMC, will introduce a methodology for capturing, enriching and sharing data (and analytics) across the organizati...