Q Therapeutics Receives Orphan Drug Designation From U.S. Food & Drug Administration for Q-Cells(R) for Treatment of ALS

Q Therapeutics Receives Orphan Drug Designation From U.S. Food & Drug 
Administration for Q-Cells(R) for Treatment of ALS 
SALT LAKE CITY, UT -- (Marketwired) -- 11/19/13 --  Q Therapeutics,
Inc. today announced that the U.S. Food & Drug Administration (FDA)
has granted the Company Orphan Drug Designation for its Q-Cells(R)
product (human glial restricted progenitor cells and their progeny),
for the treatment of Amyotrophic Lateral Sclerosis (ALS). Granted to
drug therapies intended to treat diseases or conditions that affect
fewer than 200,000 patients in the United States, Orphan Drug
Designation enables companies to benefit from financial incentives
from the FDA including seven years of market exclusivity after
product marketing clearance, access to federal grant funding
opportunities to defray clinical trial costs, as well as assistance
with clinical protocols and federal tax credits. These incentives are
meant to encourage companies to develop products for treatment of
'orphan diseases.'  
"Designation of Q-Cells as an orphan drug for the treatment of ALS is
a significant milestone for ALS patients, who have few treatment
options, and for our Company as we advance this potentially
life-saving therapeutic," commented Dr. Deborah Eppstein, President
and Chief Executive Officer of Q Therapeutics. "As we move toward our
Phase 1/2a clinical trial with Q-Cells in ALS in 2014, Orphan Drug
Designation opens up new federal grant opportunities to help us
advance our goal of providing efficacious treatment for ALS patients.
Orphan Drug Designation also complements our intellectual property
portfolio. The potential for seven years of market exclusivity
protection after product launch augments Q-Cells proprietary
position. " 
ALS, also known as Lou Gehrig's Disease, occurs throughout the world
with no racial, ethnic or socioeconomic boundaries. According to the
ALS Association, approximately 5,600 people are diagnosed with ALS in
the United States each year. It is estimated that as many as 30,000
Americans may have the disease at any given time. ALS is notoriously
difficult to treat. Most ALS patients die two to five years after
diagnosis, as no effective therapies exist. 
Q Therapeutics is an emerging biotechnology company developing
innovative cell-based therapeutics to treat debilitating diseases of
the central nervous system. In many neurodegenerative conditions,
such as ALS, glial cells in the brain and spine are damaged or
diseased. If untreated, this results in damage to and eventual death
of the neuronal cells that glia are meant to support. Q's approach is
to provide the diseased/damaged central nervous system with healthy
glial cells, trademarked Q-Cells. Q Therapeutics' collaborators at
Johns Hopkins University Medical School have demonstrated doubling of
survival time after ALS disease onset with a single treatment with
the rat homolog of Q-Cells in a rat model of ALS.  
The FDA Office of Orphan Products Development (OOPD) mission is to
advance the evaluation and development of products (drugs, biologics,
devices, or medical foods) that demonstrate promise for the diagnosis
and/or treatment of rare diseases or conditions. In fulfilling that
task, OOPD evaluates scientific and clinical data submissions from
sponsors to identify and designate products as promising for rare
disease and to further advance scientific development of such
promising medical products. The office also works on rare disease
issues with the medical and research communities, professional
organizations, academia, governmental agencies, industry and rare
disease patient groups. 
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(R), 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), spinal cord injury, Parkinson's disease and
Alzheimer's disease. Q Therapeutics' initial clinical target is ALS,
with a first IND submission expected in 2014. 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 quarterly report on Form 10-Q for the period ended
September 30, 2013 and the Company's Annual Report on Form 10-K for
the year ended December 31, 2012. 
FOR MORE INFORMATION:
Hanover|Elite
Kathy Addison 
Chief Operating Officer
407-585-1080 
QCEL@hanoverelite.com 
 
 
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