Company Focuses on Clinical Development Path for LCA, HD and ALS; Cuts Costs by Personnel Reductions and Salary Deferrals and Reductions
SEATTLE, WA, Dec 02, 2008 (MARKET WIRE via COMTEX News Network) -- Targeted Genetics Corporation (NASDAQ: TGEN) today announced that it
has realigned its product development priorities to focus on its
ocular and neurological product candidates and its first use of
expressed RNAi. The Company believes these candidates present the
greatest opportunity for creating value in the near term with the
capabilities and resources currently available to the Company and its
collaborators and with the financial resources it believes are
available in today's challenging capital markets. In conjunction
with this pipeline prioritization, the Company has reduced its
payroll costs by 25% and reduced other costs by 15% when compared to
2008.
"We believe this prioritization of our product pipeline and the
resulting changes to our cost structure positions us to advance our
promising candidates while we explore ways to monetize other valuable
assets that the Company has built over the years," said B.G. Susan
Robinson, president and chief executive officer of the Company.
The Company plans to focus its efforts around its clinical stage
AAV-RPE65 product candidate for treatment of severe retinal
dystrophies most commonly diagnosed as Leber's Congenital Amaurosis
(LCA), its preclinical Huntington's Disease (HD) product candidate
and a third product candidate to treat Amyotrophic Lateral Sclerosis
(ALS), also in preclinical development.
Targeted Genetics' LCA program was initiated in 2005 when the Company
entered into a collaboration agreement to develop, manufacture and
commercialize AAV-RPE65 with the University College London and
Moorfield's Hospital. Targeted Genetics manufactured AAV-RPE65 vector
for the ongoing Phase I/II clinical trial initiated in May 2007. In
April 2008, Professor Robin Ali, University College London and
Moorfield's Hospital, reported promising early results at the
Association for Research in Vision and Ophthalmology (ARVO)
conference, which findings were published in the May 2008 issue of
the New England Journal of Medicine. Based on the success seen in
this trial with one of the patients and the possible short time to
market for a potential drug of this type, the Company plans to pursue
commercialization of the AAV-RPE65 product candidate and be in
position as early as 2010 to file regulatory documents seeking
marketing approval for the candidate. If the LCA program is
successful, the Company intends to leverage work on the AAV-RPE65
product and pursue treatment of additional ocular diseases.
Targeted Genetics' HD program, conducted in collaboration with
Beverly Davidson, Ph.D., the Roy J. Carver Professor of Medicine and
Vice Chair of Basic Research in the Department of Internal Medicine
at the University of Iowa, is the Company's prototype program to
utilize the potential of AAV as a delivery mechanism for expressed
RNAi, a potent gene silencing technology. The Company views its
expressed RNAi program for HD as both a promising initial product
opportunity to address neurological disorders and a proof-of-concept
for delivering expressed interfering RNA constructs utilizing an AAV
vector.
Targeted Genetics is conducting its ALS program with John F.
Engelhardt, Ph.D., Director of the Center for Gene Therapy and
Professor, Department of Anatomy and Cell Biology at the University
of Iowa. The program is fully funded for 2009 as a result of a $2.4
million grant from the United States Department of Defense. Targeted
Genetics plans to develop a small-molecule product candidate based on
observations by Dr. Engelhardt which show that over-activation of
NADPH (nicotinamide adenine dinucleotide phosphate) oxidase is
associated with pathogenesis of ALS. The work expected to be
performed under the grant includes formulation development and
preclinical testing. Although not within the Company's general focus
on gene therapy, the Company believes the ability to leverage a
long-standing collaboration and a two-year NADPH sponsored research
agreement with Dr. Engelhardt and its experience with bringing
therapeutics to trial presents a compelling opportunity to expand the
Company's platform. If preclinical results generated in 2009 are
promising, the Company expects to initiate clinical trials of an ALS
drug candidate as early as 2010.
The Company is also evaluating alternatives for the future clinical
development of its inflammatory arthritis product candidate, tgAAC94.
The Company continues to see value in the inflammatory arthritis
program. It believes, however, that the most prudent and efficient
way to advance this program will be through collaboration with a
corporate partner that has the resources to take the product into
phase II development and, if successful, onto commercialization. In
the near term, the Company plans to continue its collaborations with
the National Institutes of Health and Children's Hospital of
Philadelphia to support the initiation of clinical trials by its
collaborators of an HIV-vaccine product candidate.
In addition, the Company plans to maintain its manufacturing
collaboration with Celladon Corporation in support of their clinical
study in congestive heart failure. Finally, the Company plans to
continue to explore opportunities to monetize its other assets,
including ways to capitalize on its industry pioneering work and
strength as a leader in the development of commercially scalable AAV
manufacturing processes.
The Company's cost cutting measures included a reduction of seven
employees and salary deferrals or reductions to half-time status for
the seven most senior Company executives. These changes, along with
the previously announced resignations of the Company's former chief
executive officer and chief scientific officer, collectively reduce
the Company's current cash outflow for employee compensation by
approximately 25%. As a result of these staffing changes, the
Company currently employs 56 full-time equivalent employees.
As reported in the Company's Form 10Q filed November 5, 2008, the
Company only has cash and short term investments to support its
ongoing activities into the first quarter of 2009. As a result, the
Company is aggressively pursuing access to additional capital from a
wide variety of potential sources, including strategic transactions,
licensing or selling technology, additional product development
collaborations, sales of stock or placement of debt, additional
revenue from expanding or augmenting current collaborations and
initiatives to capitalize on the Company's intellectual property,
manufacturing capabilities and product development expertise.
About Targeted Genetics Corporation
Targeted Genetics Corporation is a biotechnology company committed to
the development of innovative therapies for the prevention and
treatment of diseases with significant unmet medical need. A key
area of focus for Targeted Genetics is applying its proprietary
Adeno-Associated Virus (AAV) technology platform to deliver genetic
constructs to increase gene function or silence gene function.
Targeted Genetics' lead product development efforts target ocular and
neurological indications, two therapeutic areas where AAV delivery
may have competitive advantages over other therapeutic modalities.
To learn more about Targeted Genetics, visit its website at
www.targetedgenetics.com.
Safe Harbor Statement under the Private Securities Litigation Reform
Act of 1995:
This release contains forward-looking statements regarding the
Company's liquidity and financial resources, its ability to fund
ongoing and future operations and its business strategy and product
development, including statements regarding the Company's ability to
raise capital or secure other financial resources in the near term,
the extent of the Company's cash horizon, the timing, nature and
results of the Company's research and development programs and the
potential impact of the results of such programs on the Company's
operations, the Company's ability to monetize assets and other
statements about the Company's plans, objectives, intentions and
expectations. These statements involve current expectations,
forecasts of future events and other statements that are not
historical facts. Inaccurate assumptions and known and unknown risks
and uncertainties can affect the accuracy of forward-looking
statements and cause actual results to differ materially from those
expected or implied by the forward-looking statements. Factors that
could affect actual future events or results include, but are not
limited to, the risk that the Company will run out of cash earlier
than expected, the risk that the Company will not be able to raise
capital or secure other financial resources in the near term, the
risk that the Company's research and development programs are not
successful or are delayed or terminated, the risk that payments
anticipated by the Company under product development collaborations,
contracts and its grant are not earned or received when expected or
at all, the risk that the Company will not be able to monetize its
assets as expected or at all and the risk that the Company will not
be able to maintain its listing on the NASDAQ Capital Market as well
as other risk factors described in "Item 1A. Risk Factors" in the
Company's most recent quarterly report on Form 10-Q for the period
ended September 30, 2008 filed with the SEC. You should not rely
unduly on these forward-looking statements, which apply only as of
the date of this release. The Company undertakes no duty to publicly
announce or report revisions to these statements as new information
becomes available that may change the Company's expectations.
Media Contact:
Stacie D. Byars
WeissComm Partners
206.660.2588
Email Contact
SOURCE: Targeted Genetics
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