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THROMBOVIEW TRIAL SUCCESS IMPORTANT STEP TO COMMERCIALIZATION.


The recent human trial success of biotechnology company Agenix's blood clot blood clot
n.
A semisolid, gelatinous mass of coagulated blood that consists of red blood cells, white blood cells, and platelets in a fibrin network.
 diagnostic product, ThromboView, takes it one crucial step closer to being registered as a commercial product in the USA, chairman of the company's external Molecular Diagnostic Imaging Scientific Advisory Board, Professor Paul Eisenberg, said.

Professor Eisenberg, vice-president of Global Drug Safety at Eli Lilly Eli Lilly can refer to:
  • Eli Lilly and Company, a global pharmaceutical company
  • Colonel Eli Lilly (1839-1898), founder of Eli Lilly and Company
  • Eli Lilly (industrialist) (1885-1977), former president of Eli Lilly and Company
 Company, based in Indianapolis, USA, made the comments during the board's recent meeting, which was held alongside the International Society of Thrombosis and Haemostasis hemostasis, haemostasis
the stoppage of bleeding or cessation of the circulation of the blood; stagnation of the blood in a part of the body. Also hemostasia, haemostasia.
See also: Blood and Blood Vessels

Noun 1.
 XIX Congress in Birmingham, UK.

Agenix announced recently that ThromboView detected a deep vein thrombosis A blood clot (thrombos) in a vein deep within the muscle, typically in the thigh or calf. It is caused by disease or the lack of activity such as sitting for hours at a computer screen.  in a female student in a phase 1b trial at Royal Brisbane Hospital. This follows phase 1a tests that proved that the agent was safe and well-tolerated.

A second phase 1b patient trial at Sydney's Westmead Hospital Westmead Hospital is a major 975 bed tertiary hospital in Sydney, Australia, Opened in 1978, it is now the major hospital in the Sydney West Area Health Service. It is located on Hawkesbury Road in Westmead, providing a full range of tertiary medical and dental services except for  also successfully located a deep vein thrombosis in a patient.

During the meeting the board reviewed at length the ThromboView project plan and supported the regulatory and clinical strategy that is currently being implemented by the company.

"The results to date have been very encouraging and the board has been delighted with them," said Professor Eisenberg. "The latest results are very consistent with previous ThromboView results. I am pleased with the enthusiasm that this group of international experts has for the value of ThromboView in diagnosing venous thromboembolism thromboembolism /throm·bo·em·bo·lism/ (-em´bo-lizm) obstruction of a blood vessel with thrombotic material carried by the blood from the site of origin to plug another vessel.

throm·bo·em·bo·lism
n.
. Of particular importance to the project is the guidance of this external group of experts in reviewing the clinical data and plan to begin registration trials."

"When successfully commercialized ThromboView will be a valuable diagnostic tool not only for difficult-to-treat patients but more broadly by assisting with a current unmet medical need," said board member Giancarlo Agnelli, professor of Internal Medicine at the University of Perugia The official seal of the university portraits Saint Herculan, one of the saint patrons, and the rampant crowned griffin, which is the city symbol: they represent the ecclesiastical and civil powers, respectively, which gave rise to the university in the Middle Ages.  in Italy.

As a result of the board's meeting and success of the trials to date, Agenix will now make submissions to the US Food & Drug Administration and to the Canadian authorities to begin phase II clinical trials in 2004.

"ThromboView is developing at a rapid pace and continues to meet our expectations as we complete each stage of its development," said Agenix Managing Director Don Home.

The Scientific Advisory Board includes Professor Eisenberg; Dr. Jeff Ginsberg, director, Thromboembolism Unit, McMaster University McMaster University, at Hamilton, Ont., Canada; nondenominational; founded 1887. It has faculties of humanities, science, social sciences, business, engineering, and health sciences, as well as a school of graduate studies and a divinity college.  Medical Centre, Canada; Dr Henry Royal, deputy director, Division of Nuclear Medicine Mallinckrodt Institute of Radiology, St Louis, USA; Dr Philip Wells, chief, Division of Haematology, Ottawa Hospital City Campus, Canada; Dr. Harry Buller, Department of Vascular Medicine, Amsterdam Medical Centre, Netherlands; and Professor Giancarlo Agnelli, professor of Internal Medicine, University of Perugia, Italy.

"It is a world-class independent board, and each is a leader in his field," said Agenix Chairman Ravindran Govindan. "The board members have an intimate understanding of clinical development of imaging agents in thrombosis and are well experienced to guide Agenix. Their positive comments mirror our own internal enthusiasm for ThromboView's progress."

Around 60,000 people die from blood clots Blood Clots Definition

A blood clot is a thickened mass in the blood formed by tiny substances called platelets. Clots form to stop bleeding, such as at the site of cut.
 in both Europe and the United States each year.

The board will meet again once further clinical data is available.

Agenix Limited [ASX ASX

See: Australian Stock Exchange
:AGX, NASDAQ NASDAQ
 in full National Association of Securities Dealers Automated Quotations

U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on
: AGXLY] is a listed company based in Brisbane, Australia, and is part of the Standard & Poor's/ASX 300 index. It manufactures, distributes and markets human and veterinary diagnostic test kits, over-the-counter pharmaceuticals and infant care products via its wholly-owned subsidiaries AGEN Biomedical bi·o·med·i·cal
adj.
1. Of or relating to biomedicine.

2. Of, relating to, or involving biological, medical, and physical sciences.
 and Milton Pharmaceuticals. Agenix focuses on developing a horizontally-integrated product portfolio to service the needs of the acute phase thrombosis market. Agenix's lead candidate is its high-technology ThromboView blood clot-imaging project, which is currently undergoing human trials. ThromboView uses radiolabelled antibodies to locate blood clots in the body. It could revolutionize the US $3 billion global clot diagnostic imaging market. ThromboView is being developed with the assistance of the Federal Government through its START scheme. Agenix employs 190 staff and sells its products to more than 50 countries. ThromboView is a registered trademark of AGEN Biomedical.

For more information, visit http://www.agenix.com.
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Publication:Worldwide Biotech
Geographic Code:8AUST
Date:Sep 1, 2003
Words:652
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