QLT Announces First Patient Dosed in Phase IIa Proof-of-Concept Trial for QLT091001 in Impaired Dark Adaptation
December 09 2013 - 7:00AM
QLT Inc. (Nasdaq:QLTI) (TSX:QLT) ("QLT" or the "Company") today
announced that the first patient has been dosed in the Company's
Phase IIa proof-of-concept trial of QLT091001 in adult subjects
with Impaired Dark Adaptation (IDA), a condition that results in
decreased ability to recover visual sensitivity in the dark after
exposure to bright lights.
The Phase IIa proof-of-concept trial of QLT091001 is a
randomized, multi-center, parallel-group, placebo-controlled study
in adult subjects with IDA. Subjects (age 60 or older) with IDA, or
impaired low luminance low contrast best corrected visual acuity
("LLLC BCVA") in at least one eye and having no known ophthalmic
pathologies to explain their condition other than early age-related
macular degeneration (AMD) will be enrolled at sites in the U.S.
Subjects will be randomized to receive placebo or one of two
different doses (10 or 40 mg/m2) of QLT091001 once per week for
three consecutive weeks with one additional dose the day after the
third dose. The trial is designed to evaluate the safety profile
and effects of QLT091001 on impaired dark adaptation time, glare
recovery time and LLLC BCVA.
"We are pleased that dosing of the first patient has occurred on
schedule, marking another significant milestone for QLT in the
advancement of our synthetic oral retinoid program in multiple
indications," said Mr. Jason M. Aryeh, Chairman of the Board. "This
is an important step outside of rare orphan diseases with
QLT091001, one which is designed to illustrate its potential in a
significantly larger patient population. We are thankful to the
clinical team, investigators, and of course, the patients for their
participation in this study, and look forward to its outcome."
About Impaired Dark Adaptation
Impaired Dark Adaptation (IDA) is a condition that results in
decreased ability of the eye to recover visual sensitivity in the
dark following exposure to bright lights (photobleaching) that gets
worse with age. Profoundly impaired dark adaptation is commonly
associated with inherited retinal degenerations. More recently,
mild to moderate impaired dark adaptation has been associated with
AMD and is proportionate to the severity of the disease. IDA
(and/or impaired low luminance vision) may occur due to age-related
inefficiencies in the retinoid cycle which results in slower
regeneration of the light sensing pigment 11-cis-retinal in the eye
and increased levels of free unbound opsin that lead to delayed
dark adaptation and reduced retinal sensitivity. Ultimately, these
factors impair vision in low light or dark environments. The
kinetics of the rod function have also been reported to be
age-related, with the rod-mediated portion of the dark adaptation
function significantly slower in older patients with normal retinal
function than in younger adults. This rod-mediated dark adaptation
time is further slowed down in patients with early signs of AMD but
with good visual acuity.
IDA in this population causes symptomatic difficulties for
functioning in dim light, especially after exposure to bright
ambient light, and can hamper daily living activities such as
driving, mobility, and workplace tasks. Impaired mobility, in the
form of falling, is one of the most common problems of old
age. IDA is not a disease but a condition that can arise as a
result of a number of pathologic or physiologic
factors. Improving this condition has the potential to not
only improve a subject's quality of life but also delay the
development of degenerative retinal conditions with more severe
visual outcomes.
About QLT
QLT is a biotechnology company dedicated to the development and
commercialization of innovative ocular products that address the
unmet medical needs of patients and clinicians worldwide. We are
focused on developing our synthetic retinoid program for the
treatment of inherited retinal diseases.
QLT is based in Vancouver, Canada and the Company is publicly
traded on NASDAQ (symbol: QLTI) and the Toronto Stock Exchange
(symbol: QLT). For more information about the Company's products
and developments, please visit our web site at www.qltinc.com.
Certain statements in this press release constitute
"forward-looking statements" of QLT within the meaning of the
Private Securities Litigation Reform Act of 1995 and constitute
"forward-looking information" within the meaning of applicable
Canadian securities laws. Forward-looking statements include,
but are not limited to: statements concerning timing and potential
outcomes for the IDA Phase IIa proof-of-concept study; and
statements which contain language such as: "assuming," "prospects,"
"goal," "future" "projects," "potential," "could," "believes,"
"expects"; "hopes" and "outlook." Forward-looking statements are
predictions only which involve known and unknown risks,
uncertainties and other factors that may cause actual results to be
materially different from those expressed in such statements. Many
such risks, uncertainties and other factors are taken into account
as part of our assumptions underlying these forward-looking
statements and include, among others, the risks, uncertainties and
other factors following: the effect that QLT's announcements and
actions will have on the market price of our securities; our
development plans, timing and results of the clinical development
of our synthetic retinoid program; assumptions related to
pre-screening, screening and enrollment of patients, efforts and
success, and the associated costs of our synthetic retinoid
program; outcomes for our clinical trials may not be favorable or
may be less favorable than interim/preliminary results and/or
previous trials; varying interpretations of data produced by one or
more of our clinical trials; the timing, expense and uncertainty
associated with the regulatory approval process for products to
advance through development stages; risks and uncertainties
associated with the safety and effectiveness of our synthetic
retinoid program; risks and uncertainties related to the scope,
validity, and enforceability of our intellectual property rights
and the impact of patents and other intellectual property of third
parties; the Company's future operating results, which are
uncertain and likely to fluctuate; currency fluctuations; and
general economic conditions and other factors described in detail
in QLT's Annual Report on Form 10-K, Quarterly Reports on Form 10-Q
and other filings with the U.S. Securities and Exchange Commission
and Canadian securities regulatory
authorities. Forward-looking statements are based on the
current expectations of QLT and QLT does not assume any obligation
to update such information to reflect later events or developments
except as required by law.
CONTACT: QLT Inc. Contacts:
Investor & Media Relations
Andrea Rabney or David Pitts
Argot Partners
212-600-1902
andrea@argotpartners.com
david@argotpartners.com
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