Navigation Links
Amsterdam Molecular Therapeutics Initiates Program for Late Stage Liver Cirrhosis and Reports Strong Progress in AMT-011 With Trial Fully Recruited and European and US Submission On Track for First Half of 2008
Date:11/27/2007

Conference Call & Webcast Today at 10:30 CET

AMSTERDAM, November 27 /PRNewswire-FirstCall/ -- Amsterdam Molecular Therapeutics (Euronext: AMT), a leader in the field of human gene therapy, today announced it has signed an agreement with Digna Biotech/CIMA for the development of AAV-mediated insulin-like growth factor I (IGF-I) to treat late stage liver cirrhosis. At 10:30 a.m. CET today, the company's management will hold a conference call to discuss today's announcement and to provide a general business update. Access details can be found at the end of this release.

Liver cirrhosis

Liver cirrhosis is the seventh-leading cause of death in the world and represents a late stage of progressive liver fibrosis. Today, no available treatment can stop or reverse the disease. The only option may be liver transplantation, which still carries a high-risk and, due to the lack of sufficient donors, is not available to many of these patients. More than 27,000 patients die of cirrhosis and chronic liver disease each year in the U.S. alone.

CIMA IGF-I program

The agreement stems from the exclusive license to AMT from Digna Biotech to commercialize all gene therapy products resulting from the R&D activities performed at the Center for the Study of Applied Medicine (CIMA) at the University of Navarra, Spain. Employing more than 400 researchers, CIMA is one of the leading gene therapy research centers in Europe. The IGF-1 program is the first initiated under that agreement.

The group of Professor Prieto at CIMA has established in relevant animal models an extensive Proof of Concept demonstrating that expression of low levels of IGF-I in fibrotic and cirrhotic liver is associated with a favorable outcome of the disease and that gene-therapy-mediated IGF-I expression has promising effects on the progression of the disease as well as its systemic complications. Prieto and his collaborators have demonstrated that even low doses of AAV engineered to carry IGF-1 were sufficient to interfere with, or even reverse fibrosis and achieve a long term effect. AAV vectors constitute the gene therapy platform of choice of Amsterdam Molecular Therapeutics.

A pilot clinical trial conducted by investigators in Pamplona, Spain and Groningen, The Netherlands in a small number of cirrhotic patients supports the importance of IGF-1 in treating cirrhosis - both an increased serum albumin and improved energy metabolism were achieved as a result of (subcutaneous) IGF-I protein administration. Because of the short half-life of IGF-1, a treatment based on the subcutaneous administration of recombinant IGF-I would require almost constant infusion and is not considered practical. The gene-therapy-mediated induction of IGF-I expression bypasses this disadvantage and shows long-term effect, as the animal studies at CIMA have shown. Clinical studies will need to confirm the long-term safety and efficacy in men.

Ronald Lorijn, CEO of AMT, said, "We are very pleased with our agreement with CIMA, which gives us access to programs that are already well-advanced and that have tremendous potential. Our technology platform seems ideally suited to develop IGF-I for the treatment of liver cirrhosis, a very serious disorder, which not only causes great human suffering, but also comes at a very high cost for society. AMT is fully dedicated and equipped to add this new program to its product pipeline and plans to start the necessary pre-clinical studies including a full toxicology program next year. We are confident to continue to leverage our close relationship with Digna and CIMA to fill our pipeline with promising products that address unmet medical needs."

Clinical Program AMT-011

The clinical development of AMT's lead product AMT-011 for the treatment of Lipoprotein Lipase Deficiency is proceeding according to plan. All patients have been recruited in the Canadian study. A total of 6 patients have been injected with AMT-011, completing the first 2 dose cohorts. The remaining 8 patients will be injected before the end of February, allowing the Company to file for registration with the EMEA, FDA and Health Canada before the end of the first half of 2008.

Conference call and webcast presentation

AMT will conduct a conference call open to the public today at 10.30 CET, which will also be webcast. Netherlands dial in: +31(0)800-949-4517 (toll free); US dial in: +1-866-291-4166 (toll free); UK dial in: +44-207-107-0611. The webcast can be accessed on the investors portion of AMT's website at http://www.amtpharma.com. Please go to the website 15 minutes prior to the call to register, download and install the necessary audio software. Playback of the call will be availably for 24 hours after the call. Dial in: +41-91-612-4330; +44-20-7108-6233; or +1-866-416-2558. ID 428#. The archived webcast also will be available for replay shortly after the close of the call.

About Amsterdam Molecular Therapeutics

AMT has a unique gene therapy platform that to date appears to circumvent many if not all of the obstacles that have prevented gene therapy from becoming a mainstay of clinical medicine. Using adeno-associated viral (AAV) vectors as the delivery vehicle of choice for therapeutic genes, the company has been able to design and validate what is probably the first stable and scalable AAV production platform. As such, AMT's proprietary platform holds tremendous promise for thousands of rare (orphan) diseases that are caused by one faulty gene. AMT currently has a product pipeline with six products at different stages of development.

Certain statements in this press release are "forward-looking statements" including those that refer to management's plans and expectations for future operations, prospects and financial condition. Words such as "strategy," "expects," "plans," "anticipates," "believes," "will," "continues," "estimates," "intends," "projects," "goals," "targets" and other words of similar meaning are intended to identify such forward-looking statements. Such statements are based on the current expectations of the management of Amsterdam Molecular Therapeutics only. Undue reliance should not be placed on these statements because, by their nature, they are subject to known and unknown risks and can be affected by factors that are beyond the control of AMT. Actual results could differ materially from current expectations due to a number of factors and uncertainties affecting AMT's business, including, but not limited to, the timely commencement and success of AMT's clinical trials and research endeavors, delays in receiving U.S. Food and Drug Administration or other regulatory approvals (i.e. EMEA, Health Canada), market acceptance of AMT's products, effectiveness of AMT's marketing and sales efforts, development of competing therapies and/or technologies, the terms of any future strategic alliances, the need for additional capital, the inability to obtain, or meet, conditions imposed for required governmental and regulatory approvals and consents. AMT expressly disclaims any intent or obligation to update these forward-looking statements except as required by law. For a more detailed description of the risk factors and uncertainties affecting AMT, refer to the prospectus of AMT's initial public offering on June 20, 2007, and AMT's reports filed from time to time with NYSE Euronext (Holding) N.V.


'/>"/>
SOURCE Amsterdam Molecular Therapeutics B.V
Copyright©2007 PR Newswire.
All rights reserved

Related medicine news :

1. Chiltern to Participate at the Partnerships in Clinical Trials Conference in Amsterdam
2. A new molecular zip code, and a new drug target for Huntingtons disease
3. New knock-out gene model provides molecular clues to breast cancer
4. Molecular probe paints cancer cells in living animals, Stanford researchers find
5. Story ideas from molecular & cellular proteomics
6. SNM seeks novel approaches to molecular imaging to showcase at annual meeting
7. SNM seeks novel approaches to molecular imaging to showcase at annual meeting
8. Molecular fingerprint of breast-cancer drug resistance can predict response to treatment
9. Molecular profiling can accurately predict survival in colon cancer patients
10. Xceed Molecular Names Fran Tuttle to Its Board of Trustees
11. Virginia G. Piper Charitable Trust and Flinn Foundation launch molecular diagnostics initiative
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/27/2017)... (PRWEB) , ... February 27, 2017 , ... Elisa Guajardo Carothers is not your typical ... to studying to become a nun. Now, she writes about God, when she isn’t swimming ... Know BC and AD, Here is BS! (Before Satan),” she offers a comedic look at ...
(Date:2/27/2017)... N. Y. (PRWEB) , ... February 27, 2017 , ... ... ( ILADS ) has disclosed that despite scientific studies, the Center for Disease Control ... chronic Lyme disease . Kenneth B. Liegner, M.D. has compiled into a ...
(Date:2/27/2017)... ... February 27, 2017 , ... Silicon Valley Hair Institute, a ... an upgrade to the company's Yelp listing. Bay Area residents struggling from thinning ... as Platelet Rich Plasma (PRP) therapy, hair transplantation techniques such as Follicular Unit ...
(Date:2/26/2017)... ... February 26, 2017 , ... This is an extension of ... to be ISO/IEC 17025:2005 INAB accredited for Der p 1 (house dust mite ... globally recognised standard that sets out requirements for the technical competence of testing ...
(Date:2/26/2017)... (PRWEB) , ... February 26, ... ... sets a new technology standard in staffing, scheduling, and reporting for healthcare ... and predict activity throughout the entire staffing process. StaffBridge technology improves staffing ...
Breaking Medicine News(10 mins):
(Date:2/24/2017)... Research and Markets has announced the addition of the "Hemophilia ... ... Drugs Price Analysis and Strategies - 2016, provides drug pricing data and ... questions: What are the key drugs marketed ... Global Hemophilia market? What are the unit prices and ...
(Date:2/24/2017)... , Feb. 24, 2017 Juan ... & Associates PC , a boutique securities firm headquartered ... York City , announces that a class action ... Massachusetts  against Inotek Pharmaceuticals Corporation (NASDAQ: ... the Company,s securities between July 23, 2015 and December 30, ...
(Date:2/24/2017)... Feb. 23, 2017  Directors from Pharma To Market Pty Ltd ... joined forces, resulting in the founding of Pharma To Market Pte ... To Market are pleased to announce their expansion into ... Singapore . The company are delighted to appoint ... the Singapore based entity. Joelle brings with ...
Breaking Medicine Technology: