About Prometic
Information of Interest
Pertaining to ProMetic fields of activity
Posted on February 18, 2010
ProMetic Life Sciences Inc. invites you to view the February 16, 2010, Canal Argent interview with its President and Chief Executive Officer, Mr. Pierre Laurin.
In addition, you will find enclosed an article about ProMetic titled “Quand une firme québécoise menace de se développer ailleurs” Click here to access English Translation
Posted on February 5, 2010
ProMetic would like to bring to your attention that, due to a large number of agenda items, today’s second reading in the United Kingdom’s House of Commons for the “Contaminated Blood (Support for Infected and Bereaved Persons) Bill [HL] 2009-10” has been postponed until February 26, 2010.
N.B. the reading has once again been postponed until March 12, 2010.
ProMetic would like to reiterate that what is of utmost importanceis the growing level of awareness for the safety of the UK's blood supply and that it is being recognized and acted upon at the highest levels of government. Whether this Bill is approved or not in the House of Commons, the P-Capt® prion filter will likely be used to improve the safety of blood for children. However, the same governing bodies concur that ensuring blood safety should not be limited to children only but should be extended to all individuals.
Posted on February 3, 2010
ProMetic would like to bring to your attention the following question that was put forward by Sir Paul Beresford to the UK’s Prime Minister Gordon Brown at today’s question session and the Prime Minister’s response.
Q8.[314804] Sir Paul Beresford (Mole Valley) (Con): I am sure that the Prime Minister is aware that in percentage terms the population of the United Kingdom and Ireland is the greatest reservoir of the prion that causes the fatal and incurable human brain disease variant vCJD. One of the means of transmission is blood transfusion. Last October, the Government’s scientific committee that is examining this issue recommended the use of a filter for blood for transfusion for children initially. When are the Government going to react to that recommendation?
The Prime Minister: The hon. Gentleman raises a very serious matter in great detail. That recommendation is obviously very important for the future of the blood transfusion service. I shall look at it very carefully and get back to him.
Furthermore, please find attached letters forwarded to the Guardian under the title “Contaminated blood bill will bring justice”.
Posted on January 29, 2010
ProMetic Life Sciences Inc. would like to bring to your attention an article published recently in the UK’s Business Weekly (January 2010) titled “ Blood boost for Cambridge firm ”.
Posted on January 22, 2010
ProMetic would like to bring to your attention the progression of Lord Morris’ Bill titled “Contaminated Blood (Support for Infected and Bereaved Persons) Bill [HL] 2009-10” though the United Kingdom’s Parliamentary process.
This proposed Bill was passed in the House of Lords on January 21, 2010, and has now moved to the House of Commons.
The Contaminated Blood Bill looks to introduce further protection for the blood given to people with hemophilia. During the third reading, an Amendment was made to the Bill to ensure that prion filtration could also be the method used for protecting blood against variant Creutzfeldt-Jakob Disease.
This Amendment modifies the original Bill as follows (amendment in quotes and highlighted):
Point 2 – subsection (3)
The Secretary of State shall also by regulations establish a system to ensure that “the blood supply is made safe through the implementation of prion filtration and that” all blood donors are routinely tested for the conditions listed in subsection (2)
- Contaminated Blood (Support for Infected and Bereaved Persons) Bill [HL] 2009-10;
- Amendment dated January 21, 2010 to the Contaminated Blood (Support for Infected and Bereaved Persons) Bill [HL] 2009-10; and
- The minutes from the Daily Hansard in which the amendment was proposed.
Posted on January 12, 2010
ProMetic would like to bring to your attention a recently published article in the New England Journal of Medicine (January 6, 2010) titled “Erythropoiesis-Stimulating Agents – Time for a Reevaluation”.
In this article, The Food and Drug Administration (“FDA”) announced that it would review the safety of the widely used anemia drugs (ESAs) after another clinical trial suggested that high doses of one of the drugs might cause strokes.
Recent validation with the FDA that PBI-1402 is a novel, first-in-class drug that differs from existing approved medications (ESAs) for the treatment of anemia, clarifies the regulatory pathway and supports partnering activities.
Given that PBI-1402 reduces tumor growth and does not elevate hemoglobin to potentially dangerous levels, it provides unique positioning strategies that the Company is actively pursuing.
Furthermore, here is an article on this subject written by Mr. Andrew Pollack of the New York Times titled “F.D.A. plans safety check of 3 drugs for anemia”.
Posted January 4, 2010
ProMetic would like to bring to your attention a recently published article in PLoS ONE (January 2010 Volume 5, Issue 1) titled “Human Prion Diseases in the United States”.
Posted December 22, 2009
ProMetic would like to bring to your attention various articles regarding the 30-year old victim of CJD that belonged to a different genetic group as well as the latest Lancet publication titled “Variant CJD in an individual heterozygous for PRNP codon 129”.
Also included is an article published in the Irish Medical Times titled “Department fixed despite new expert advice on vCJD”.
Of importance, the quote from Dr. Willie Murphy, ISBT’s Medical and Scientific Director who: “…told IMT that the blood board would be reconsidering its position in light of the recent SaBTO recommendation, and acknowledged that its previous ‘option appraisal paper’ could be criticised for not taking a more forceful position either way. Our view would be that we should filter everything and test everything as the technology becomes available, and that the Government should pay for it,” he stated, adding that the IBTS would be back in touch with the Department to articulate its position yet again in light of the SaBTO move. “Universal prion filtration is the ideal, but we should certainly begin with children and work from there”.
- CJD victim ‘had different gene’ (BBC)
- More people could have vCJD than previously thought (Guardian)
- Family’s hearbreak over son’s vCJD death (STV)
- 'My son caught human form of mad cow disease from his baby food' (News.Scotsman.com)
- vCJD victim had different gene (Michelmores Medical Negligence News)
- Further concerns over vCJD (Michelmores Medical Negligence News)
- CJD son ‘killed by tainted baby food’ (Sun)
- There may be more vCJD risks than expected (Medpage Today)
- Fears raised over vCJD infection (Press Association)
- CJD death of Scot raises epidemic fears (Herald Scotland)
- Fears Over VCJD Infection (Visit Bulgaria)
- Department fixed despite new expert advice on vCJD (IMT)
- Variant CJD in an individual heterozygous for PRNP codon 129 (Lancet)
Posted November 30, 2009
ProMetic would like to bring to your attention further media pick-up in the United Kingdom on the Advisory Committee for the Safety of Blood, Tissue and Organs’ (“SaBTO”) recommendation that the P-Capt® prion reduction filter be used to protect children 13 and under from vCJD blood transfusion.
Irish Examiner.com (November 30, 2009)
Blood supply “comfortable” as donations increase by 3,000
Business Weekly (November 24, 2009)
Cambridge vCJD technology close to UK roll-out
BioTuesday.ca (November 30, 2009)
British agency recommends ProMetic’s blood filter
Filtration+Separation.com
SaBTO recommends P-Capt® prion reduction filter to remove vCJD prion
Posted November 26, 2009
ProMetic would like to bring to your attention media pick-up in the United Kingdom on the Advisory Committee for the Safety of Blood, Tissue and Organs’ (“SaBTO”) recommendation that the P-Capt® prion reduction filter be used to protect children 13 and under from vCJD blood transfusion.
BBC Radio Cambridgeshire
Filter to screen vCJD developed by Cambridgeshire company ProMetic BioSciences has been only been recommended for children under 13
Jeremy Sallis
Link to access radio interview with Dr. Steve Burton, ProMetic BioSciences Ltd’s Chief Executive Officer, which starts at point 1:06 10 - http://www.bbc.co.uk/iplayer/episode/p00568dw/Cambridgeshire_Breakfast_with_Jeremy_Sallis_26_11_2009/
BBC News
Calls to filter blood for vCJD
Matthew Hill
Video, including short comment from Dr. Burton, accessible through the following link - http://news.bbc.co.uk/2/hi/health/8380065.stm
BBC West Health Correspondent
CJD blood filter call for under-13s
Matthew Hill
guardian.co.uk
Blood filter to protect patients from vCJD – but only for the young
- Health advisory committee recommends the adoption of a newly developed blood filter for transfusion patients aged under 13
Owen Bowcott
Posted September 17, 2009
ProMetic would like to bring to your attention an article published in the Killer Technologies supplement of the Business Weekly titled "ProMetic pioneers life-saving technology".
Last year, the Business Weekly launched The Killer Technologies Category of the East of England Business Awards which has led to this year’s “new brilliant Killer50 elite”. ProMetic BioSciences Ltd is a recipient of the Killer50 award.
Posted September 15, 2009
ProMetic would like to bring to your attention a news release by Octapharma AG titled "The UK Blood Advisory Group(SaBTO) recommends Variant Creutzfeld Jacob Disease (vCJD) risk-reduction strategy for fresh frozen plasma (FFP) Octapharma develop OctaplasLG® to offer a solution". This is linked to our post dated August 13, 2009 giving a Summary of the Seventh Meeting, 14/15 July 2009 of SaBTO.
Posted September 10, 2009
ProMetic would like to bring to your attention a very interesting recently published article in Transfusion (vol 49, August 2009 supplement) titled "Emerging infectious disease agents and their potential threat to transfusion safety".
This is the result of significant work done by the TTD (Transfusion-Transmitted Disease) task force of the American Association of Blood Banks.
Some of the important messages in the article have been extracted for your convenience:
The intent of this Supplement is to provide a set of tools identifying, describing, and prioritizing those EID agents that have an actual or potential risk of transmission by transfusion and for which there is no currently implemented intervention. (page 3S)
The prioritization effort is intended to suggest where intellect and resources should be spent in planning for the future. This is an especially important message for developers of blood donation screening tests or pathogen reduction methods since the lead time for research and development and clinical trials to bring products to the market place is generally many years. (page 7S)
Each agent was assigned a priority risk level under three different categories: scientific/epidemiologic evidence regarding blood safety, public perception and/or regulatory concern regarding blood safety, and public concern regarding the disease agent. (page 7S)
To note that vCJD has been classed as a red category agent (highest priority).
Red category agents (page 8S)
Human variant Creutzfeldt-Jakob disease (vCJD)
The assignment of the risk of transfusion transmission of vCJD in the US is based on scientific/epidemiologic evidence of transfusion transmissibility and was influenced by several opposing factors.
In favor of a higher risk were:
1) data from the UK indicating that if a donor is incubating vCJD, there appears to be a risk of transfusion transmission and potentially a risk to hemophiliacs who received UK-derived plasma products prior to the implementation of interventions to decrease BSE that were put into effect in 1996 - vCJD abnormal prion protein found in a patient with hemophilia at postmortem, Health Protection Agency, CJD Section, London, UK, and
2) the rapid mortality associated with clinical disease and the lack of effective treatment.
In favor of a lower risk were:
1) the presumed very low to absent rate of carriers of the agent in the general US population and
2) the possibility of an even lower carrier rate in the US blood donor population due to travel deferrals based on time spent in the UK and Europe. These resulted in a priority rating of low for the scientific/ epidemiologic risk category. However, based on high public concern about this agent in the UK and other areas of the world that has influenced public perception in the US about “mad cow disease,” considerable FDA attention to the issue of vCJD transfusion transmission, and the very difficult donor counselling issues and potential for large numbers of donor deferrals attendant on implementation of a test for vCJD, this agent was assigned a high rating with regard to public concern about blood safety.
With all factors taken into account, this led to the assignment of the red priority category for vCJD.
A Fact Sheet on vCJD is found Page 52S of Appendix 2
ProMetic would like to bring to your attention the article published in the Irish Medical Times today titled: "The cost of safe blood".
Posted September 3, 2009
ProMetic would like to bring to your attention the article published in the Irish Medical Times today titled: "HIQA will look at prion test for vCJD".
Posted August 31, 2009
ProMetic would like to bring to your attention the article published in the Irish Medical Times today titled: "Defence options against vCJD".
Posted August 21, 2009
ProMetic would like to bring to your attention the article published in the Irish Medical Times today titled: "DoH rejects call for vCJD group".
The following extract relates interesting comments by Dr. Willie Murphy, Medical and Scientific Director of the Irish Blood Transfusion Service regarding P-Capt® filter technology:
“IBTS Medical and Scientific Director Dr Willie Murphy added that the filter has already been examined in safety studies involving 20 patients from Cork, and a further hundred units are being transfused at Cavan General Hospital. He hopes to extend this to Crumlin Hospital next month.”
“With the UK and France likely to move on the new technologies shortly, Dr Murphy warned that if Ireland was seen to lag on this issue, the pressure on the Government could become ‘unbearable’.”
Posted August 21, 2009
ProMetic would like to bring to your attention the article published in the Irish Medical Times today titled: " DoH goes for 'do nothing' option on tests for vCJD ".
Posted August 20, 2009
ProMetic would like to bring to your attention the following scientific article published involume 2009;19 of Transfusion Medicine (pdf available in August 2009) titled "In vitro assessment of red-cell concentrates in SAG-M filtered through the MacoPharma(TM) P-CAPT prion-reduction filter".
This article relates the data collected by the Irish Blood Transfusion Service for the P-Capt® filter clinical trial. ProMetic is very pleased with the observations made by Drs Murphy et al, in the discussion portion at the end of this article.
Posted August 17, 2009
ProMetic would like to bring to your attention the following translation of an article originally published in French titled “Octapharma: New Developments”.
Translation of an article published on “Pharmaceutiques” site in July 2009 - http://www.pharmaceutiques.com/archive/une/art_1251.html.
Octapharma: New Developments
The European leader in plasma-derived therapeutics expects to invest nearly 45 M Euros in research and development in 2009. Expansion of the Lingolsheim plant will increase its present capacity of 600,000 fractionated litres to more than 1 M litres.
Octapharma, rated third in the world for plasma-derived therapeutics, has announced the commercialisation for the German market of OctaplasLG, the first plasma to be used for transfusion incorporating a technology developed specifically to capture prions, sporadic and variant. The prion capture step is done through a macroporous polymethacrylate-based chromatography column process (>50 nm) saturated with ligands immobilized on beads in a single-use gel medium. This novel prion capture technology allows for a reduction of ≥ 690,000 infectious doses/ml gel (≥ 5.8 log10). This plasma product is awaiting regulatory approval to market for the European Union as a whole. Also, it has received FDA approval for clinical trials in the United States. This affinity chromatography technology for specific capture of prion protein should, in the future, allow for an added security for plasma transfusions.
New Technology
Over the next few months, a new sugar-eliminated IG, incorporating Newgam, a new technology, will enter into clinical trial in the United States and in Europe. This allows for a 1g/litre increase in the amount of immunoglobulin extracted by plasma fractionation, which equals a 20 to 25% increase in product. Presently, only 50% of immunoglobulins contained in plasma are recuperated, the remaining becoming waste. The Switzerland-based group hopes to obtain regulatory approval for Europe within two years.
Octapharma employs more than 350 persons at the Lingolsheim site and thirty others in Boulogne-Billancourt. Octapharma expects to invest nearly 45 M Euros in research and development in 2009 and studies are underway examining prospective facilities in France. By 2012, over 20 M Euros per year will have been invested in the Lingolsheim plant ensuring the increase in capacity from 600,000 fractionated litres to more than 1 M litres.
Posted August 13, 2009
ProMetic would like to bring to your attention the following document titled “Summary of the Seventh Meeting, 14/15 July 2009 of SaBTO”.
Recommendations made by SaBTO in their summary state that the use of UK-derived fresh frozen plasma (“FFP”) should be ceased and replaced by imported FFP for all recipients. Furthermore, recommendation is made for the use of commercially available pooled FFP that is pathogen-inactivated to further reduce the risk of vCJD transmission.
This announcement is of direct and positive impact to ProMetic Life Sciences Inc. and Octapharma AG. ProMetic collaborated with Octapharma AG on Octaplas® LG, a pooled virally-inactivated and prion-reduced plasma product. In addition, Octaplas® LG meets the required specifications recommended by SaBTO, i.e., >5 logs of prion safety compared to UK-sourced FFP. Octaplas® LG is presently undergoing regulatory approval for use in various countries.
The SaBTO recommendations could open up the market for Octaplas® LG in the UK. That prion-reduced products have the potential to take market share bodes well for ProMetic and is a strong indicator of the true value of PRDT’s prion-reduction technology.
ProMetic is now looking forward to the next SaBTO meeting in October when it anticipates more news on P-CAPT® filter adoption.
Posted April 23, 2009
ProMetic Life Sciences Inc. would like to bring to your attention the following release by MacoPharma regarding the first formal meeting of the Coalition on Blood Safety, addressed by Lord Archer of Sandwell, which took place in Parliament earlier in April. The complete article can be accessed through MacoPharma’s website: http://www.macopharma.com/com/index.php?option=com_content&task=view&id=105&Itemid=35
Additionally, This link http://phx.corporate-ir.net/phoenix.zhtml?c=175436&p=irol-newsArticle&ID=1277960&highlight= will direct you to a Halozyme news release dated April 20, 2009, titled “Halozyme Studies Target Hyaluronan Surrounding Solid Tumors, May Offer New Approach to Cancer Treatment” which announced that PEGPH20 produces anti-cancer activity in models of breast, prostate, and brain metastases that produce hyaluronan. Halozyme has commenced a Phase 1 clinical trial for a bisphosphonate administered with Halozyme's recombinant human hyaluronidase enzyme (rHuPH20) (see links posted on this page on December 15, 2008).
Posted February 16, 2009
Article titled: Scientists warn of first ever case of human mad cow disease from blood plasma - http://www.telegraph.co.uk/health/4624348/Scientists-warn-of-first-ever-case-of-human-mad-cow-disease-from-blood-plasma.html.
The first case of a person being infected with the human form of mad cow disease after receiving contaminated plasma derived coagulating factor has been identified by scientists (as reported by the Telegraph on February 15, 2009).
Although vCJD (variant Creutzfeldt-Jakob Disease) has been transmitted by blood donations in the past, leading to three deaths, no cases of infection had ever been linked to plasma (or plasma derived product), which is used to clot blood (e.g. Factor VIII). Scientists had believed the processing and dilution of the product before it is injected into patients significantly reduced the risks.
Scientists fear there could be a second wave of the human variant of mad cow disease, which was caused by cattle being fed the remains of other cattle in the 1980s
The man was one of thousands of haemophiliacs who received blood plasma transfusions in the years before strict controls were brought in to eliminate the spread of vCJD. Until now, scientists had maintained that the 4,000 people who may have received plasma from infected donors were at very low risk of developing the fatal brain disease.
Warnings were issued to them as a "highly precautionary measure". But the Health Protection Agency is expected to announce on Tuesday that an elderly man, who died from other causes, contracted vCJD from plasma.
BSE expert Professor Hugh Pennington, Emeritus Professor of Bacteriology at Aberdeen University said the findings would have "significant implications" for thousands of people who had been given plasma before the dangers were suspected. "This looks like pretty grim news for a group of people who have been through fire and water for so long; they have already had increased exposure to hepatitis B and HIV," he said.
Warnings were sent to 4,000 haemophiliacs, and patients suffering from other rare blood conditions in 2004 to warn them that they had had received transfusions from 200 batches of blood products at risk of contamination with vCJD.
The plasma was collected from nine people who went on to develop the brain-wasting disease. All 4,000 were advised not to give blood or donate organs and to warn doctors and dentists that they had been put at risk by the use of plasma.
Posted February 5, 2009
ProMetic scientific article article that was featured as headline article of the on-line version of Lead Discovery titled “2,6,9 - Trisubstituted purine derivatives as protein A mimetics for the treatment of autoimmune diseases” published in the Bioorganic & Medicinal Chemistry Letters 19 (B. Zacharie et al. / Bioorg. Med. Chem. Lett. 19 (2009) 242–246) - http://www.leaddiscovery.co.uk/admin/dailyUpdate/today/trial/?ch=3.
The complete article can be accessed through our Scientific Library web page: http://www.prometic.com/en/therapeutics/scientific-library.php.
Posted February 3, 2009
Article titled "Netherlands reports third human death from mad cow disease".
Posted December 18, 2008
Articles of interest regarding a new strain of vCJD as well as an article from "quotimed.com" on the P-Capt® filter
- Hundreds could die as scientists identify first case of 'second wave' vCJD
- Return of mad cow disease - warning
- New genetic group 'could be at risk from vCJD'
- Fears raised over new vCJD wave
- Un filtre transfusionnel pour éliminer les prions (in french only)
Posted December 15, 2008
- The following link phx.corporate-ir.net/phoenix.zhtml?c=175436&p=irol-newsArticle&ID=1233454&highlight= will direct you to a Halozyme news release dated December 8, 2008, titled Halozyme Therapeutics Announces Roche Begins Phase 1 Clinical Trial and Selects Fourth Exclusive Biologic Target which states that under an existing license and collaboration agreement Roche has selected an additional exclusive fourth biological target for its hyalurondiase enzyme, rHuPH20. Under the terms of the agreement, Roche will pay Halozyme for exclusive, global rights for the application of its hyaluronidase enzyme, rHuPH20, to a fourth biologic target selected by Roche.
- This link http://phx.corporate-ir.net/phoenix.zhtml?c=175436&p=irol-newsArticle&ID=1234643&highlight= will direct you to a Halozyme news release dated December 10, 2008, titled Halozyme Therapeutics Begins Phase 1 Clinical Trial of Bisphosphonate Administered With rHuPH20 Enzyme in which they announced the commencement of patient dosing for a Phase 1 clinical trial for a bisphosphonate administered with Halozyme's recombinant human hyaluronidase enzyme (rHuPH20) as a subcutaneous (SC) injection. This study will explore the safety, tolerability and pharmacokinetics of SC administration of a bisphosphonate plus rHuPH20. Currently, injectable bisphosphonates must be administered intravenously (IV).
Posted October 20, 2008
Posted on October 16, 2008
Posted September 19, 2008
- Takeda and Affymax Provide Clinical Development Update for Hematide™ in Chemotherapy-induced Anemia – Companies Decide to Suspend Co-Development of Hematide™ in CIA and Focuses all Efforts on Late Stage Co-Development in Chronic Renal Failure Related Anemia
- Ranbaxy Laboratories Ltd., retains former New York City Mayor Rudy Giuliani to lead team in resolution of issues raised by U.S. Food & Drug Administration
- Preliminary Data from Experimental Study Demonstrate Increased Mortality in Stroke Patients Treated With Epoetin Alfa
- Blood article "Prion diseases are efficiently transmitted by blood transfusion in sheep"
Posted May 12, 2008
Articles of interest regarding the trial initiated by the Scottish Blood Transfusion Service using the P-Capt® filter and the " U.S. wants to stop increased testing for mad cow".
- Scots launch trial for removal of vCJD
- Scots pioneer trial to remove "mad cow disease" from donated blood
- Scot medics hail advance in mad cow disease fight
- U.S. wants to stop increased testing for mad cow
