Walter Reed Army Medical Center Seeks Palatin Technologies' LeuTech for Potential Early Detection of
Inhaled Anthrax Infection
PRINCETON, N.J.--(BW HealthWire)--Nov. 5, 2001--Palatin Technologies, Inc. (AMEX: PTN - news) announced today that it has teamed with the Walter Reed Army Medical Center, Washington, D.C. to evaluate the clinical utility of Palatin's investigational infection imaging and diagnostic product, LeuTech®, for the early detection of inhalation anthrax.
Under the agreement, made through The Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc., study patients exposed to anthrax will begin receiving LeuTech® scans this week. LeuTech® is a radiolabeled monoclonal antibody that binds to white blood cells that collect at sites of infection, thus enabling the infection to be easily and rapidly imaged and detected with a gamma camera.
Carl Spana, Ph.D., president and chief executive officer of Palatin said, ``We are excited to be collaborating with Walter Reed Army Medical Center in this clinical evaluation of LeuTech®, and consider it a privilege to assist the U.S. government in the fight against bioterrorism. Historically, inhalation anthrax infection has been almost uniformly fatal because of the difficulty in recognizing the disease early and its rapidly progressive clinical course. We believe the diagnostic quality, speed, and the ease of use of LeuTech® represent key advantages over other technologies for the imaging and diagnosis of infection. Based on these advantages, we are optimistic that LeuTech® has the potential to diagnose infection with inhalation anthrax in the early stages of the disease process, when it is most likely to be treatable.''
In the early stages of infection with inhalation anthrax, bacteria multiply in the lymph nodes in and around the lungs. White blood cells migrate to these localized areas of bacterial growth to fight the invading organisms, thus offering the opportunity for LeuTech® to bind to these cells and detect the bacterial infection at an earlier stage. Diagnosing inhalation anthrax infection in its early stages, before the bacteria can poison the body with its toxins, allows patients to receive aggressive antibiotic therapy at a time when it is most effective, potentially avoiding the later-stage complications of the disease.
The initial study is being conducted at the Walter Reed Army Medical Center and will enroll up to 500 individuals believed to be at risk of having inhaled anthrax spores. ``We are excited to have LeuTech® as part of our anthrax prophylaxis study, a key objective of which is to define and validate a logical imaging protocol for the detection of early acute pulmonary anthrax infection in patients with a credible exposure to anthrax who are asymptomatic,'' said Dr. Robert Bridwell of the Walter Reed Army Medical Center.
Should the initial results of this clinical trial demonstrate LeuTech's® utility in the diagnosis of inhalation anthrax, Palatin will initiate discussions with the FDA to provide LeuTech® to other medical institutions under the regulatory provision of a Treatment IND (Investigational New Drug Application). Treatment INDs permit unapproved products to be made available to patients before general marketing begins to treat serious or life-threatening diseases or infections.
``Anthrax infection is now the latest addition to our clinical development plan for LeuTech® which targets the medical need for improved diagnosis of acute and chronic infections, including appendicitis, osteomyelitis (bone infection), post-surgical infections and bowel infections/inflammation,'' said Perry Molinoff, MD, executive vice-president of Research and Development at Palatin Technologies. ``We received a unanimous vote from the FDA Medical Imaging Drugs Advisory Committee's (MIDAC) that LeuTech® is safe and effective for the diagnosis of equivocal appendicitis, and recently reported positive interim Phase 2 clinical trial results for LeuTech® in the diagnosis of osteomyelitis. At the request of the FDA and in order to resolve manufacturing and process validation issues, we are working very closely with our manufacturer and Mallinckrodt, a subsidiary of Tyco Healthcare, to gain marketing approval of LeuTech® as expeditiously as possible.''
Hey Claud...you still there...been a LONG time.
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