The WFH Safety & Supply News is an electronic newsletter on the safety, supply, and availability of hemophilia treatment products.
The publication provides reliable, timely summaries of news and
new developments in products, viral safety, and gene therapy.
To subscribe, email ssnews@wfh.org.
May 2010
Volume 9, Number 1
XMRV donor deferrals
Canadian and Australian authorities have imposed “indefinite” deferrals on potential blood donors who have had a medical diagnosis of chronic fatigue syndrome (CFS). There have been some reports that CFS patients may be infected with xenotropic murine leukemia virus-related virus (XMRV) and the deferrals aim to keep XMRV out of the blood supply as it may be transmitted through blood. At this time, there is no proof that XMRV causes CFS and studies have reached conflicting conclusions regarding XMRV infection in CFS patients. The decisions to defer have been made out of an abundance of caution in a time of uncertainty. An enveloped virus such as XMRV is not a threat to plasma-derived products, such as clotting factor concentrates, as it would be inactivated by current pathogen reduction processes.
Canadian Blood Services statement
Australian Red Cross statement
WFH statement
vCJD test not sufficiently sensitive
Amorfix has announced that its first-generation test for variant Creutzfeldt-Jakob disease (vCJD) failed to detect the disease in three human plasma samples provided by UK health authorities. The company is continuing to develop the test in an effort to improve sensitivity. Amorfix had tested thousands of random samples from blood donors in the UK and elsewhere, but the ability to detect known vCJD samples was a critical hurdle. When a successful vCJD test is developed, its first use will be to screen blood donors. www.amorfix.com/
US ACBSA to hold hearings on MSM donor deferral
At a hearing in June the Advisory Committee on Blood Safety and Availability will be reviewing the policy of permanently deferring as blood donors men who have had sex with men (MSM). The current policy is for a lifetime deferral for MSM if sex occurred even once since 1977. Some groups such as the American Red Cross and American Medical Association have called for the deferral to be reduced to a period of one to five years. The US national member organization of the WFH, the National Hemophilia Foundation, along with other blood product user groups, is urging caution and has called for any decisions to be made in keeping with the precautionary principle and based on science.
www.hemophilia.org/NHFWeb/
WFH statement on MSM donors
China lifts travel ban against people with HIV
In advance of the Shanghai World Expo, China has lifted its 20-year-old travel ban on people with HIV, acknowledging that the ban had no public health benefit. The United States and South Korea also recently lifted HIV travel bans. www.chinadaily.com.cn/
WFH to address World Health Organization’s World Health Assembly
Later this month WFH president Mark Skinner will make a statement to the Sixty-third World Health Assembly concerning Resolution EB126.R14, on the availability, safety and quality of blood products. The WFH statement will be published on our website immediately after the WHA. Resolution EB126.R14
Gene therapy clinical trial for hemophilia B starts
In March, Amsterdam Molecular Therapeutics announced that the first patient has been dosed in the Phase I/II exploratory clinical trial with a gene therapy product for hemophilia B. This gene therapy, administered once, will introduce the functional gene for the Factor IX protein into the patient's liver cells, with the goal to restore blood clotting functionality long-term. http://www.prnewswire.com/
Ipsen and Inspiration enter into partnership
Ipsen and Inspiration Biopharmaceuticals have announced that they have entered into a partnership to develop Ipsen’s recombinant porcine factor VIII, OBI-1(for the treatment of inhibitors), and Inspiration’s recombinant factor IX product, IB1001. The two products are scheduled to begin Phase III clinical testing in 2010. The agreement gives Ipsen the option of acquiring control of Inspiration should product development continue successfully.
http://www.inspirationbio.com
Events
56th Annual SCC Meeting – International Society on Thrombosis and Haemostasis (ISTH)
22–25 May 2010 – Cairo, Egypt
Internet: http://www.ssc2010.org/
IPFA/ PEI 17th Workshop on “Surveillance and Screening of Blood Borne Pathogens”
26-27 May 2010 – Croatia
Internet: http://www.ipfa.nl
PPTA Plasma Forum – Plasma Protein Therapeutics Association
15–16 June 2010 – Reston, Virginia, U.S.A.
Internet: http://www.pptaglobal.org/pptaregistration/home.aspx
XXXI International Congress of the International Society of Blood Transfusion (ISBT)
26 June – 1 July 2010 – Berlin, Germany
Internet: http://www.isbt-web.org/berlin/
Hemophilia 2010 World Congress
10-14 July 2010 – Buenos Aires, Argentina
Internet: http://www.hemophilia2010.org
European Haemophilia Consortium Annual Conference
22-24 October, 2010 – Lisbon, Portugal
Internet: http://www.ehc2010.eu/
WFH Workshop on the Regulation of Plasma-Derived Medicinal Products
15-17 November, 2010 - Rio de Janeiro, Brazil
Safety & Supply News
Published by the World Federation of Hemophilia.
Next issue: September 2010
Editorial Board: Claudia Black, WFH (Canada); Magdy Elekiaby, MD (Egypt); Elizabeth Myles, WFH (Canada); Brian O’Mahony (Ireland); David Page (Canada), Kapil Saxena, MD (U.S.A.); Uwe Schlenkrich, MD (Germany); Mark Skinner (U.S.A.); Mike Soucie, PhD (U.S.A.); Alok Srivastava, MD (India); Alison Street, MD (Australia)
Editor: Mark Brooker, WFH World Federation of Hemophilia
1425 René Lévesque Blvd. West, Suite 1010
Montréal, Québec H3G 1T7 Canada
Tel.: +1 (514) 875-7944 Fax: +1 (514) 875-8916
E-mail: wfh@wfh.org
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Permission to translate and/or reprint all contents of the Safety and Supply News is granted to interested non-profit hemophilia organizations, with prior approval and appropriate acknowledgment of the WFH. Permission does not extend to reproduction, in whole or in part, for sale or use in conjunction with commercial purposes.
Past issues:
Safety & Supply News - November 2009
Safety & Supply News - April 2009
Safety & Supply News - December 2008
Safety & Supply News - July 2008
Safety & Supply News - April 2008
Safety & Supply News - February 2008
Safety & Supply News - Past Issues 2002-2007 |
