Some more progress re AMD...
Tuesday May 12, 6:59 am Eastern Time
Company Press Release
SOURCE: QLT PhotoTherapeutics Inc.
QLT PhotoTherapeutics Announces Preliminary Data from Pivotal Phase III Trials Demonstrates Safety of Verteporfin as Potential Treatment for AMD
FT. LAUDERDALE, Fla., May 12 /PRNewswire/ -- Data presented last night at the annual meeting of the Association of Research in Vision and Ophthalmics (ARVO) outlined the protocol, preliminary safety data and baseline characteristics of participants in two pivotal Phase III trials of verteporfin (BPD-MA) as a treatment for age-related macular degeneration (AMD), the leading cause of blindness in adults over the age of 50.
Based on an interim review of patient data, no significant safety concerns have been identified to date for the new drug, which is
being co-developed by QLT PhotoTherapeutics Inc. (QLT) (Nasdaq: QLTIF - news) and CIBA Vision Corporation, the eye care unit of Novartis AG.
The randomized, double-masked, placebo-controlled studies -- known as the TAP investigations -- are underway at 22 sites throughout Canada, the U.S., and Europe. The data were presented at ARVO by Dr. Neil Bressler, Professor of Ophthalmology at the Wilmer Ophthalmological Institute, Johns Hopkins Medical Institutions, Baltimore, Md. Dr. Bressler is also Chair of the TAP Study Advisory Group, which advises the sponsors and clinical centers on the scientific aspects of the investigations.
Since the trials are double-masked (that is, neither medical researchers, sponsors, or patients know who is being treated with verteporfin, and who is receiving a placebo), efficacy data from the studies are not yet available. However, patient safety is being closely monitored by an independent Data and Safety Monitoring Committee, appointed specifically for the TAP investigations.
The committee found no safety concerns following its interim review of trial data. The review was based on the experience of 335 patients at 3 months and 122 patients at 6 months.
''These preliminary safety findings are significant and encouraging. They confirm earlier safety data from Phase I/II studies in a larger number of participants who have been followed for a longer period of time,'' said Dr. Bressler. ''The fact that extremely few adverse events have been identified in the TAP trials to date is heartening. More importantly, if the therapy is able to stabilize vision in a greater number of patients than in the control group, then photodynamic therapy with verteporfin could be a significant breakthrough in treating AMD.''
Preliminary analysis of baseline characteristics, based on the first 164 participants, found the average age to be 76 years, with a range of 58 to 93 years. Slightly more than half (54%) of participants were women. A total of 609 patients were recruited for the trials between December 1996 and September 1997.
''The speed with which patients were recruited is indicative of the need for an effective treatment, the integrity of the protocol, the
solid organization of the trials by the co-sponsors, and the active participation of the clinical centers involved,'' said Dr. Bressler.
Patients with the 'wet' form of AMD, which is the form for which verteporfin is being developed, experience a rapid growth of abnormal blood vessels under the central part of the retina, or macula. These abnormal vessels leak fluid, causing scarring and an accelerated loss of central vision over a two-to-three-year period. This form of AMD may be detected by taking a picture of the back of the eye following administration of a fluorescent dye.
A wide variety of angiographic patterns were observed in 146 angiograms reviewed by the Wilmer Photograph Reading Center, Dr. Bressler reported. A mixture of so-called ''classic'' and ''occult'' lesions -- which are defined by the pattern of leakage detected on a fluorescien angiogram -- were found. While 10% of angiograms showed occult-only lesions, 25% had classic-only, and the remainder had a combination of both, he said.
Results of earlier Phase I/II studies of verteporfin suggest that it can selectively affect abnormal blood vessels in the eye associated with the wet form of AMD, thus potentially stopping further growth and destruction by these vessels without causing vision loss, as occurs with currently available treatments.
As previously indicated, QLT and CIBA Vision expect to conclude one-year follow-up evaluations for the TAP trials this fall, Dr. Bressler said. A rigorous assessment process will follow, during which the data will be carefully compiled, audited, unmasked, analyzed and assembled for regulatory review in 1999. Pending approval, the Companies project a commercial launch of verteporfin in 2000.
With worldwide headquarters in Atlanta, Georgia, USA, CIBA Vision is a global leader in research, development and manufacturing of optical and ophthalmic products and services, including contact lenses, lens care products, and ophthalmic pharmaceuticals. CIBA Vision products are available in more than 70 countries.
CIBA Vision is the eye care unit of Novartis AG, a world leader in Life Sciences with core businesses in Healthcare, Agribusiness
and Nutrition. In 1997, Novartis Group sales were 31.2 billion Swiss francs, of which 18.8 billion were in Healthcare, 8.3 billion
in Agribusiness and 4.1 billion in Nutrition. The group annually invests more than 3.6 billion Swiss francs in research and
development. Headquartered in Basel, Switzerland, Novartis employs about 87,000 people and operates in more than 100
countries around the world.
QLT PhotoTherapeutics is a world leader in the development and commercialization of proprietary pharmaceutical products for
use in photodynamic therapy, an emerging field of medicine utilizing light-activated drugs in the treatment of disease. QLT's
innovative science has advanced photodynamic therapy beyond applications in cancer towards potential breakthrough treatments
in ophthalmology and autoimmune disease.
QLT's portfolio of products include PHOTOFRIN(R) (porfimer sodium), the world's only approved photodynamic therapy drug,
used in the treatment of various cancers throughout North America, Japan, and Europe; and verteporfin (BPD-MA), a therapy in
final stages of testing to treat age-related macular degeneration, the leading cause of blindness among adults over age 50.
QLT PhotoTherapeutics Inc. is listed on The Nasdaq Stock Market under the trading symbol ''QLTIF'' and on The Toronto
Stock Exchange under the trading symbol ''QLT''.
The foregoing information contains forward-looking statements which involve known and unknown risks, uncertainties and other
factors which may cause the actual results to be materially different from any future results, performance, or achievements
expressed or implied by such statements. Such factors include: risks associated with the commercialization of PHOTOFRIN(R)
and verteporfin (BPD-MA); uncertainties relating to product development; uncertainty regarding patents and proprietary rights;
product liability claims and insurance; manufacturing uncertainties; uncertainty of pricing and reimbursement; no assurance of
regulatory approval; government regulation; and dependence on corporate relationships; among others, all as described in the
Company's Annual Information Form or Form 10-K.
SOURCE: QLT PhotoTherapeutics Inc. |
