Biotech Values

[DewDiligence]

This Pipex PR regarding dry AMD sounds hyped.

http://biz.yahoo.com/iw/070710/0275735.html

>>
Pipex Pharmaceuticals Acquires Late-Stage Oral Candidate for Dry Age-Related Macular Degeneration (AMD)

Tuesday July 10, 7:30 am ET

80-Patient Double-Blind Clinical Trial Demonstrated Statistically Significant Improvement in Visual Acuity and Other Clinical Parameters of Dry AMD

ANN ARBOR, MI--(MARKET WIRE)--Jul 10, 2007 -- Pipex Pharmaceuticals, Inc. ( PP ), a specialty pharmaceutical company developing innovative late-stage drug candidates for the treatment of neurologic and fibrotic diseases, announced today that it has acquired an exclusive license to patented zinc-monocysteine complexes ("Z-monocys"). Z-monocys is initially being developed as an oral treatment for dry age-related macular degeneration (AMD). According to an article published in the Journal of the American Medical Association, AMD currently affects approximately 10 million people in the U.S. and is the leading cause of blindness in persons over age 65. Oral Z-monocys has successfully completed a six-month, 80-patient, randomized, double-blind clinical trial for the treatment of dry AMD. In this trial, Z-monocys demonstrated statistically significant improvements in the major clinical features of dry AMD, including visual acuity, contrast sensitivity and photorecovery times, as compared to placebo. A manuscript describing the results of this study has been submitted for publication in a leading peer-reviewed ophthalmology journal.

Steve H. Kanzer, Chairman & Chief Executive Officer of Pipex, stated, "Z-monocys not only complements our portfolio of candidates but may be highly synergistic with COPREXA as part of a combined treatment paradigm for neurologically presenting Wilson's disease, in which after initial decoppering with COPREXA, patients are typically transitioned to high dose oral zinc for long term maintenance therapy. The addition of this new late-stage oral candidate for dry AMD further bolsters our leading presence in the research, development and introduction of new oral therapies for important neurological and other indications involving metal dyshomeostasis."

Z-monocys was invented by David A. Newsome, M.D., a retinal disease researcher and board certified ophthalmologist who pioneered the demonstration of decreased amounts of important materials, such as zinc in the maculas of eyes associated with macular degeneration, and the also first to demonstrate the clinical utility of oral high dose zinc for AMD in a controlled clinical trial, the results of which were published in 1988. The clinical utility of oral zinc therapy for AMD was later confirmed in the landmark Age-Related Eye Disease Study (AREDS) sponsored by the National Eye Institute. High dose oral zinc is currently the most widely used and most effective single agent for the treatment of dry AMD. Z-monocys is intended to improve upon and overcome limitations of high dose oral zinc therapy for AMD.

Dr. Newsome commented, "Pipex, together with its research collaborators at the University of Michigan led by George Brewer, M.D., have a substantial depth of experience and appreciation for the utility and limitations of high dose oral zinc therapy currently utilized to treat Wilson's disease and dry AMD. Given the aging baby boomer population in the U.S., there is an urgent need for new and more effective treatments. Dry AMD patients as a group comprise approximately 90% of all AMD patients. My long-standing research interest and clinical experience with high dose oral zinc, when combined with the expertise of Pipex, made Pipex the ideal partner to develop and introduce Z-monocys for the treatment of dry AMD."

Z-monocys is a patented composition of matter protected by U.S. patent 6,586,611, issued Jul. 1, 2003, and U.S. patent 7,164,035, issued Jan. 16, 2007, as well as a pending U.S. patent application which is also exclusively licensed to Pipex. Z-monocys is also the subject of several patents pending worldwide that were filed by and are assigned to Pipex.

About Age-Related Macular Degeneration (AMD)

Macular degeneration is a progressive eye condition affecting approximately 10 million Americans. AMD is associated with tissue deterioration in the center of vision, the macula of the retina, where the sharpest vision occurs in the eye. In its dry form, drusen (deposits of debris) appear in the macula. Vision can be distorted and as the disease progresses, central vision can develop a dark spot of permanently poor sight. Age-Related Macular Degeneration (AMD) is the number one cause of vision loss and legal blindness in adults over age 65. As the U.S. population ages and the "baby boomers" advance into their 60s, the number of AMD patients in the U.S. is expected to increase by 50% by the year 2020. According to the AMD Alliance International, AMD is the leading cause of vision loss for people over the age of 50 in the Western world, affecting approximately 25-30 million people.

About Z-monocys

Non-zinc-salt zinc monocysteine complexes (Z-monocys) are characterized by a strong bond between the zinc atom and the nonessential amino acid cysteine that confers desirable properties that are not found with zinc alone, zinc salts or zinc amino acid chelates. Z-monocys increases the activity of the antioxidant enzyme catalyse and glutathione peroxidase, as well as the antioxidant protein metallothionein, in cultured retinal pigment epithelial cells more efficiently and potently and demonstrates in animals certain other significant pharmacological advantages as compared to zinc, zinc salts and cysteine. We believe that special properties of Z-monocys may help overcome important limitations of existing high dose oral zinc products.

About Pipex Pharmaceuticals, Inc.

Pipex Pharmaceuticals Inc. is a specialty pharmaceutical company that is developing proprietary, late-stage drug candidates for the treatment of neurologic and fibrotic diseases. Pipex's strategy is to exclusively in-license proprietary, clinical-stage drug candidates and complete the further clinical testing, manufacturing and regulatory requirements sufficient to seek marketing authorizations via the filing of New Drug Applications (NDAs) with the FDA in the U.S. and Marketing Application Authorizations (MAAs) with the European Medicines Evaluation Agency (EMEA). For further information please visit www.pipexpharma.com.
<<