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
The vast majority of businesses now use cloud services, yet many still struggle with realizing the full potential of their IT investments. In particular, small and medium-sized businesses (SMBs) lack the internal IT staff and expertise to fully move to and manage workloads in public cloud environments. Speaker Todd Schwartz will help session attendees better navigate the complex cloud market and maximize their technical investments. The SkyKick co-founder and co-CEO will share the biggest challe...
When applications are hosted on servers, they produce immense quantities of logging data. Quality engineers should verify that apps are producing log data that is existent, correct, consumable, and complete. Otherwise, apps in production are not easily monitored, have issues that are difficult to detect, and cannot be corrected quickly. Tom Chavez presents the four steps that quality engineers should include in every test plan for apps that produce log output or other machine data. Learn the ste...
With more than 30 Kubernetes solutions in the marketplace, it's tempting to think Kubernetes and the vendor ecosystem has solved the problem of operationalizing containers at scale or of automatically managing the elasticity of the underlying infrastructure that these solutions need to be truly scalable. Far from it. There are at least six major pain points that companies experience when they try to deploy and run Kubernetes in their complex environments. In this presentation, the speaker will d...
While some developers care passionately about how data centers and clouds are architected, for most, it is only the end result that matters. To the majority of companies, technology exists to solve a business problem, and only delivers value when it is solving that problem. 2017 brings the mainstream adoption of containers for production workloads. In his session at 21st Cloud Expo, Ben McCormack, VP of Operations at Evernote, discussed how data centers of the future will be managed, how the p...
Predicting the future has never been more challenging - not because of the lack of data but because of the flood of ungoverned and risk laden information. Microsoft states that 2.5 exabytes of data are created every day. Expectations and reliance on data are being pushed to the limits, as demands around hybrid options continue to grow.
Machine learning provides predictive models which a business can apply in countless ways to better understand its customers and operations. Since machine learning was first developed with flat, tabular data in mind, it is still not widely understood: when does it make sense to use graph databases and machine learning in combination? This talk tackles the question from two ends: classifying predictive analytics methods and assessing graph database attributes. It also examines the ongoing lifecycl...
Enterprises are striving to become digital businesses for differentiated innovation and customer-centricity. Traditionally, they focused on digitizing processes and paper workflow. To be a disruptor and compete against new players, they need to gain insight into business data and innovate at scale. Cloud and cognitive technologies can help them leverage hidden data in SAP/ERP systems to fuel their businesses to accelerate digital transformation success.
Wooed by the promise of faster innovation, lower TCO, and greater agility, businesses of every shape and size have embraced the cloud at every layer of the IT stack – from apps to file sharing to infrastructure. The typical organization currently uses more than a dozen sanctioned cloud apps and will shift more than half of all workloads to the cloud by 2018. Such cloud investments have delivered measurable benefits. But they’ve also resulted in some unintended side-effects: complexity and risk. ...
Everyone wants the rainbow - reduced IT costs, scalability, continuity, flexibility, manageability, and innovation. But in order to get to that collaboration rainbow, you need the cloud! In this presentation, we'll cover three areas: First - the rainbow of benefits from cloud collaboration. There are many different reasons why more and more companies and institutions are moving to the cloud. Benefits include: cost savings (reducing on-prem infrastructure, reducing data center foot print, r...
Daniel Jones is CTO of EngineerBetter, helping enterprises deliver value faster. Previously he was an IT consultant, indie video games developer, head of web development in the finance sector, and an award-winning martial artist. Continuous Delivery makes it possible to exploit findings of cognitive psychology and neuroscience to increase the productivity and happiness of our teams.
Excitement and interest in APIs has skyrocketed in recent years. However, if you ask a room full of IT professionals "What is an API", you will get a wide array of answers. There exists a wide knowledge gap between API experts and those that have a general idea of what they are, but are unsure of what they have been for in the past, what they look like now, and how they can be used to expand your business in the future. In this session John will cover what the history of APIs, what an API looks ...
JETRO showcased Japan Digital Transformation Pavilion at SYS-CON's 21st International Cloud Expo® at the Santa Clara Convention Center in Santa Clara, CA. The Japan External Trade Organization (JETRO) is a non-profit organization that provides business support services to companies expanding to Japan. With the support of JETRO's dedicated staff, clients can incorporate their business; receive visa, immigration, and HR support; find dedicated office space; identify local government subsidies; get...
Digital Transformation is well underway with many applications already on the cloud utilizing agile and devops methodologies. Unfortunately, application security has been an afterthought and data breaches have become a daily occurrence. Security is not one individual or one's team responsibility. Raphael Reich will introduce you to DevSecOps concepts and outline how to seamlessly interweave security principles across your software development lifecycle and application lifecycle management. With ...
Bill Schmarzo, author of "Big Data: Understanding How Data Powers Big Business" and "Big Data MBA: Driving Business Strategies with Data Science" is responsible for guiding the technology strategy within Hitachi Vantara for IoT and Analytics. Bill brings a balanced business-technology approach that focuses on business outcomes to drive data, analytics and technology decisions that underpin an organization's digital transformation strategy.
With 10 simultaneous tracks, keynotes, general sessions and targeted breakout classes, @CloudEXPO and DXWorldEXPO are two of the most important technology events of the year. Since its launch over eight years ago, @CloudEXPO and DXWorldEXPO have presented a rock star faculty as well as showcased hundreds of sponsors and exhibitors! In this blog post, we provide 7 tips on how, as part of our world-class faculty, you can deliver one of the most popular sessions at our events. But before reading...