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What about the launch ATryn, are here already revenues, why this silence?
For now, only UK?
Please G. Cox, a little bit more information.
Advances in Transgenic Animal Research
January 11-13
2008
http://www.isb.vt.edu/CFDOCS/resourcemeetingslevel2.cfm
http://www.mdanderson.org/prof_education/cmecs/display.cfm?id=50b75852-e4d9-4edf-a868b0f73bbbdf1d&am....
PRODUCTS IN DEVELOPMENT
INTERNAL PRODUCT PIPELINE
http://www.gtc-bio.com/products/prod.html
Pharming Receives Orphan Drug Designation For Recombinant Fibrinogen From FDA
Pharmaceutical development for fibrinogen deficiencies initiated
LEIDEN, NETHERLANDS--
(Marketwire - October 11, 2007) -
http://www.marketwire.com/mw/release.do?id=779601
Leiden, The Netherlands, October 11, 2007. Biotech company Pharming Group N.V. (“Pharming” or “the Company”) (NYSE Euronext: PHARM) announced today that it has received Orphan Drug designation for recombinant human fibrinogen (rhFIB) from the US Food and Drug Administration (FDA) for the treatment of bleeding in patients deficient in fibrinogen. Pharming has initiated development of recombinant human fibrinogen as a pharmaceutical product for genetic and acquired deficiencies with the orphan designation and will continue to pursue medical device development using rhFIB through partnerships.
Recombinant human fibrinogen is being developed as a replacement therapy to treat bleeding in patients with fibrinogen deficiency. Fibrinogen is a critical protein involved in the clotting of blood. Consequently, deficiency of fibrinogen can result in uncontrolled bleeding. Bleeding resulting from low levels of fibrinogen develops in numerous clinical settings including trauma, surgery, liver disease, sepsis, and cancer.
In the United States, approximately 100,000 patients develop bleeding episodes each year due to a fibrinogen deficiency. Replacement of fibrinogen in these patients can result in normal hemostasis. Current standard of care for patients in the United States who are deficient in fibrinogen is the use of impure human blood products such as cryoprecipitate, which is composed mainly of fibrinogen. In select countries in Europe, plasma-derived fibrinogen is used to treat such bleeding.
Dr. Francis Pinto, Chief Executive Officer of Pharming commented, "Pharming's development strategy for rhFIB will utilize the successful model of recombinant blood clotting proteins to control bleeding for various genetic and acquired deficiencies. As Rhucin® nears its first market authorization, rhFIB represents another avenue of growth for Pharming and demonstrates our strength in developing therapeutic recombinant proteins for unmet medical needs.”
In addition to the protection provided by the Orphan Drug designation, Pharming has a portfolio of patents covering transgenic production, purification and use of various proteins, including recombinant human fibrinogen. The resulting intellectual property position provides Pharming broad protection on rhFIB for pharmaceutical and medical device applications.
Background on Orphan Drug Designation and Recombinant Human Fibrinogen
The FDA Orphan Drug designation is reserved for promising new therapies being developed to treat diseases that affect fewer than 200,000 people in the United States. The designation provides an accelerated review process, tax advantages and a seven-year period of market exclusivity in the US upon product approval.
Pharming is developing recombinant human fibrinogen as a pharmaceutical product for genetic and acquired deficiencies of fibrinogen. The existing market size for fibrinogen deficiencies is estimated to be over USD 500 million in the developed world. Current standard of care in the United States for patients deficient in fibrinogen is the use of cryoprecipitate, which is composed mainly of fibrinogen. In select countries in Europe, a plasma fibrinogen product is marketed. With pharmaceutical development ongoing for rhFib, Pharming will continue to pursue partnerships with medical device manufacturers to build further value for its fibrinogen franchise.
Over the last few years, Pharming has been building a program on biomaterials through collaborations with the BioMedical Materials consortium (BMM), Novathera Ltd and other institutions. Pharming has successfully produced high levels of recombinant human fibrinogen using its production technology. Human fibrinogen is a natural blood protein that can form insoluble fibrin poymers to stop bleeding. In laboratory tests and initial animal studies, rhFIB has been demonstrated to be virtually identical in structure and function to plasma fibrinogen. The Company has already provided rhFIB for evaluation to device manufacturers and research institutions to facilitate novel product development for various applications.
Use of human lysozyme transgenic goat milk in cheese making: effects on lactic acid bacteria performance.
Scharfen EC, Mills DA, Maga EA.
Department of Animal Science, University of California, Davis 95616, USA.
http://www.ncbi.nlm.nih.gov/sites/entrez?db=pubmed&uid=17699025&cmd=showdetailview&index...
Genetically engineered goats expressing elevated levels of the antimicrobial enzyme lysozyme in their milk were developed to improve udder health, product shelf life, and consumer well-being. The purpose of this study was to evaluate the effect of lysozyme on the development of lactic acid bacteria (LAB) throughout the cheese-making process. Raw and pasteurized milk from 7 lysozyme transgenic goats and 7 breed-, age-, and parity-matched nontransgenic controls was transformed into cheeses by using industry methods, and their microbiological load was evaluated. The numbers of colony-forming units of LAB were determined for raw and pasteurized goat milk, whey, and curd at d 2 and at d 6 or 7 of production. Selective plating media were used to enumerate lactococcal species separately from total LAB. Although differences in the mean number of colony-forming units between transgenic and control samples in raw milk, whey, and cheese curd were non-significant for both total LAB and lactococcal species from d 2 of production, a significant decrease was observed in both types of LAB among d 6 transgenic raw milk cheese samples. In pasteurized milk trials, a significant decrease in LAB was observed only in the raw milk of transgenic animals. These results indicate that lysozyme transgenic goat milk is not detrimental to LAB growth during the cheese-making process.
PMID: 17699025 [PubMed - indexed for MEDLINE]
Who sells now on this <very, very> low share price?
226 K in one hour, i can't get it?
Goats For Your Health?
http://www.thebostonchannel.com/video/9697030/index.html
<<Maybe someone can contact Thomas N >>
Maybe you also can ask him, why the share value is so low?
And guess what's he gonna say, it's a nice
Buy 0pportunity.
One.03 Dollar
Thx Cox & Co
Three years ago, 24-sept-2004,
the value pps was 1.85 Dollar.
And that was pps, without approval ATryn EU, without almost now approval ATryn US, without LFB, without PharmAthene, without Trial Phase II ATryn DIC in Sepsis, without better Trials RA, Psoriasis and Uveitis.
Without ... Today, pps 1.06 Dollar?
Can you hear the Management? Silence?
Where are all those IP-agreements?
EuroBiO 2007
26 to 28 September 2007
Lille
France
Thursday September 27 th, 2007
BIOTECH ECONOMY AND BUSINESS DEVELOPMENT
16:30 - 18:30
Biotech to Biotech Strategic and Economic Alliances in 2007 : lessons & perspectives
With the emergence of "big biotech" and the sometimes fluctuating windows of opportunity for IPOs, the last couple of years have testified to the realization that biotech-to-pharma deals are not the only opportunities for external growth and partnering. A professionally managed biotech-to-biotech alliance with a solid strategic and economic basis can deliver early revenue streams and long-term shareholder value. Senior managers from European and North American biotech firms share their experience.
Chairman
John Hodgson | United Kingdom | Critical I
Speakers
Rick Finnegan | United States | GTC Biotherapeutics
Jean François Mouney | France | Genfit
Evelyne Nguyen | France | LFB BIOTECHNOLOGIES
Marc Pennacino | France | LFB BIOTECHNOLOGIES
Thursday September 27 th, 2007
WHITE AND GREEN BIOTECH
14:00 - 16:00
Food, Agriculture and Animal: Innovative products from genomic research - Plant- & Animal-based recombinant products.
Despite the persistence of regulatory & ethical issues, plant- and animal-based recombinant products are capable of adding value to the agricultural, medical and feed & food sectors. High-throughput studies of pest resistance biomarkers herald higher but more sustainable yields for economically important crops, whilst genotyping techniques can profile population dynamics in plant and animal species and help conserve biodiversity. In the medical field, transgenesis technology enables production of high-added-value proteins in the milk of farm animals. Experts from around the world will provide insight and commentary on the latest innovations and products.
Chairman
Marc Zabeau | Belgium | Flanders Institute for Biotechnology / European Plant Science Organisation
Speakers
Sami Chtourou | France | LFB BIOTECHNOLOGIES
Bill Gavin | United States | GTC Biotherapeutics
Barry Saville | Canada | Trent University / Genopod
Arjen van Tunen | Netherlands | Keygene
http://www.eurobio-event.com/conferences.php
Rick Finnegan | United States
GTC Biotherapeutics
>> Biography <<
Frederick J. Finnegan joined GTC Biotherapeutics in 2007 and is responsible for the development and execution of the Company’s overall commercialization strategy.Mr. Finnegan has over 20 years experience in marketing and sales with various biotechnology and pharmaceutical companies including Merck, Genzyme, and Critical Therapeutics.
Mr. Finnegan received a Master’s degree in Management from the MIT/Sloan School of Management and a Bachelor’s degree in Business Administration from the University of New Hampshire.
Bill Gavin | United States
GTC Biotherapeutics
>> Biography <<
Dr. William Gavin is the General Manager, Charlton/Spencer Manufacturing Operations and Attending Veterinarain at GTC Biotherapeutics Corporation, U.S.A. He received a Bachelor of Science, with honors, from the University of Massachusetts and a Doctorate in Veterinary Medicine, with honors, from Tufts University, School of Veterinary Medicine. Dr. Gavin has numerous peer reviewed scientific publications, authored book chapters, has multiple international awarded patents, presented internationally at scientific conferences and symposia, and has over 15 years of experience in the field of embryology, transgenics and nuclear transfer/cloning.
http://www.eurobio-event.com/conferences-speaker.php
VIII th International Conference on Lactoferrin.
October 21 - 25th
2007
Nice
France
http://www.lactoferrin-conference.com/
GTC reports the successful launch of ATryn by its partner, LEO Pharma, in July 2007 at the International Society on Thrombosis and Haemostasis meeting in Geneva. LEO continues to establish prices in several European countries, a 12-18 month process; ATryn will be commercialized first in the UK.
<<a 12-18 month process>>
Why so long, that means no revenue in 2007 and a part of 2008?
Correct me, if i'm wrong.
High Growth Reported in the Worldwide Protein Therapeutics Market Thanks to the Field of Biogenerics
LYON, France, Sep 21, 2007 (BUSINESS WIRE) --
http://www.individual.com/story.php?story=70690297
A - Research and Development
AWARDS - September 23, 2007
http://www.fbodaily.com/archive/2007/09-September/23-Sep-2007/a-awd.htm
Protein Production
Thursday, 2008 January 10
Production of Proteins in the Milk of Transgenic Goats
Harry Meade, Ph.D., Senior Vice President, R&D, GTC Biotherapeutics Inc.
This talk will first look at the process of producing proteins in the milk of transgenic goats. Then I will discuss ATryn, the first recombinant antithrombin approved for human use.
http://www.chi-peptalk.com/08_PPD_day1.asp
http://www.chi-peptalk.com/index.asp
Please, can you repeat it Geoffrey Cox?
<<We share your frustration that the value we have created and continue to create is not yet being recognized in our share price. However, we believe that we have a clear and coherent strategy for success and this will be recognized as we execute on this strategy.>>
<<Our opportunity for news flow over the coming months is strong and I greatly look forward to updating you on our progress in future calls. It is also important for me to say, that we greatly value our investors' interest and support, many of whom have been investors for a long time. Your opinions, thoughts and continuing engagement with the Company's progress is important to me personally, the management, and the employees of GTC. I look forward to updating you on our progress.>>
Thank you.
09.04.2007
Good news, GTC Obtains FDA Fast Track Designation for ATryn and Permission to Submit a Rolling BLA, yes it was,
but we went down, nearly every day?
Recombinant Therapeutic Proteins: Delivering a $53 Billion Mature Market by 2010.
...The monoclonal antibody therapy market is lucrative. There are still many opportunities for companies to penetrate this market by focusing on relevant technologies and niche markets, and thus capitalize on the lack of biogeneric competition...
The mAbs market is expected to almost triple in value over the next six years from $10.3 billion in 2004 to $30.3 billion. Oncology products will continue to dominate the market. However, sales of arthritis, immune and inflammatory disorders (AIID) products are forecast to grow strongly and account for 40.1% of the market by 2010.
Investigation of the recombinant therapeutic proteins sector in terms of innovation and business development.
http://www.leaddiscovery.co.uk/reports/dmhc2069_rsm.pdf
Joint symposium of Europäische Akademie GmbH and Berlin-Brandenburgische Akademie der Wissenschaften.
Last year, the first "zoopharming" product reached market approval: it is a recombinant human protein for medical use that is produced in the milk of transgenic goats. This is only one example of upcoming applications of livestock genetic engineering. Other applications include enhancement of productivity (e.g. higher milk or meat yields), alterations of product quality (e.g. leaner meat), disease resistance (e.g. against udder inflammations), and alterations of environmental variables (e.g. reduced levels of phosphate in the faeces). Also, transgenic livestock may be used for xenotransplantation where genetic engineering is hoped to improve the animals' suitability as organ donors for humans. Currently, livestock genetic engineering is becoming increasingly feasible: the techniques to remove, modify, replace or add genes are being refined, and an increasing amount of genomic information about farm animals can be utilised. However, while genetic engineering in livestock opens a huge range of possibilities, it also raises safety and justification concerns: does genetic engineering affect animal welfare? Is it safe and morally acceptable to apply genetic engineering to farm animals for the various purposes that are envisaged?
The symposium on 21st and 22nd September addresses livestock genetic engineering with an interdisciplinary panel of speakers. They will give talks on the state of the art of the technology and its applications, animal welfare considerations, and ethical aspects. A forthcoming publication will be published in spring 2008.
The organisers gratefully acknowledge funding obtained from the programme of the German Federal Ministry of Education and Research "Innovations- und Technikanalyse", and from the Hermann und Elise.
http://idw-online.de/pages/en/news223690
Saturday, 22nd September 2007
11.00 – 13.00
First market approval of a
zoopharming biopharmaceutical
Harry M. Meade, Ph.D.
GTC Biotherapeutics Framingham, MA, USA
http://www.europaeische-akademie-aw.de/susanis/global/download.php/news/pdf/id/46/Herbsttagung_onlin....
ATryn was launched at ISTH in July.
Last there was, Estimated launch: Summer 2007.
Now there is, Estimated launch: Autumn 2007.
http://tinyurl.com/mhkfy
Sorry, but i don't understand it?
Approval June 02' 2006,
now 16 months later!
Launch ATryn® isn't yet started?
Autumn 2007
http://tinyurl.com/q6rc2
Is this the reason of this low share price?
And again slowly to a price around one buck.
Who is guilty?
Shame on you.
Get up, yes, but when?
Can we expect something of these events?
http://www.transgenics.com/pressreleases/events.html
Thx
The LFB Group and MAbgene Sign a Major Agreement.
http://www.medadnews.com/News/Index.cfm?articleid=471717
LES ULIS (France), September 4th 2007--The agreement covers the incorporation of a new company (controlled by LFB BIOTECHNOLOGIES, a subsidiary of LFB S.A.) which will host the industrial and commercial activities currently performed at MAbgène's manufacturing site at Alès (southern France), all MAbgène staff and, lastly, the MAbgène brand name.
For LFB and MAbgène, the stated objective is to scale up their activities in the biomanufacturing sector by expanding the Alès site (which features a pilot development unit and an existing GMP clinical batch production facility) in order to achieve a truly industrial dimension and manufacture commercial batches of biomolecules.
The agreement stipulates that LFB BIOTECHNOLOGIES will acquire 41% of the stock capital and 51% of the voting rights in the new company and will provide MAbgène with the funds needed to develop its activities, build new operating facilities and recruit additional personnel.
This integration is part of LFB's biotech development strategy and follows on from 2006's creation of a dedicated subsidiary - LFB Biotechnologies. LFB's long-term objective is to acquire all the shares in the newly formed company.
According to Christian Béchon (Chairman of the LFB group), integration of MAbgène and the investments made in the ‘Languedoc Roussillon’ region on the Alès site "correspond to an true industrial logic and are fully in line with our commitment to growing the group in the biomanufacturing sector. This operation will also enable us to become more autonomous in developing our own monoclonal antibodies."
According to Patrick Henno (Founder & Chairman of MAbgène and CEO of the new company), "partnering with a pharmaceutical group like LFB had become a decisive milestone for MAbgène, in view of our need to achieve a critical mass and respond to our customer's requirements in a setting which reconciles economic considerations with compliance with good manufacturing practice."
"We decided to commit the resources needed to develop MAbgène's business activities and meet the requirements of the company's customers" added Evelyne Nguyen (LFB's Director of Financial Affairs), who will assume the chairmanship of the new company.
Hopely, it don't stop again at 1.20 dollar.
Page 3
The Company also intends to submit a Biologics License Application to treat Hereditary Deficiencies in the U.S. Management estimates that the market for plasma-sources Antithrombin is currently $250 million and that U.S. sales are only $10 million because the sole supplier cannot meet demand.
http://www.researchworksllc.com/Research/GTCB/gtcb.pdf
Latest transgenic rabbit-milk drug results positive.
22/08/2007 - Positive interim Phase III trial results for an experimental new transgenic rabbit-milk anti-inflammatory drug has prompted its developers to halt the placebo arm and treat all patients with this promising new therapy.
The drug, Rhucin (recombinant human C1 esterase inhibitor), is a human protein being to treat acute attacks of hereditary angioedema (HAE), a rare disease characterised by painful swelling of soft tissue.
Rhucin is fairly unique in that it is developed from a therapeutic protein produced in the milk of rabbits which have been engineered to carry and express the gene of interest in the mammary glands. The protein is collected using the proprietary technology of its developers, Dutch biotech company Pharming.
Only one such transgenic animal-derived drug is currently available on the market, GTC Biotherapeutics' goat-derived ATryn - which was approved last year as an anticoagulant to treat a rare congenital disease - and these latest trial results will bolster Pharming's bid to make its drug the second on the market.
Pharming announced this week that early results in a European placebo-controlled study designed to evaluate the efficacy and safety of Rhucin, showed that none of the patients taking the drug suffered a relapse of their HAE attack, nor any treatment-related adverse events.
These results reflect those from earlier studies, said the firm, who will be presenting the data in detail on August 30th at an analyst meeting in London.
"Based on the results and after consulting with the independent data monitoring committee, the Company has decided to discontinue further randomised treatments within the clinical study for methodological and ethical reasons…All investigators have been informed", Pharming said in a statement.
The company is pushing to have Rhucin approved and launched in Europe by the end of this year and said it has now included this latest analysis in its dossier submitted to the European Medicines Agency (EMEA) to further support its request for marketing authorisation.
While Pharming awaits a decision from the European regulator, it is also preparing to apply for US Food and Drug Administration approval (FDA) for Rhucin. An additional trial is required for the US application, which is currently ongoing but expected to be finished within the next few months, with the application to be submitted later this year. Pharmaing said it has now also submitted data from this latest analysis to the FDA to help its case.
Meanwhile, in July Pharming was advised that its five facilities used in the manufacture of Rhucin complied with the standards of good manufacturing practices (GMP), following inspections by the EMEA. The GMP approval was the first in the world for a transgenic rabbit facility.
Pharming chief commercial officer Rein Strijker told in-PharmaTechnologist.com at the time that the GMP success indicated a change in thinking and showed there was a move towards greater acceptance of transgenic animal-derived drugs.
"Many people in the past have questioned whether we can use animals to make drugs and often said we could not get to the stage where authorities would approve to GMP standards. This is proof that the authorities are satisfied with our production using animals. This is quite an achievement."
A new area in the drug world, transgenic drug-producing animals have been wrought with controversy and ethical debate, but according to Strijker the technology is more cost effective than conventional protein-producing mechanisms and has a lot of potential in the biopharmaceutical industry.
"Milk is very rich in proteins and mammary glands are good at producing high amounts in a high quality."
The transgenic rabbits are able to produce between 10 and 12 grams of protein per litre of milk, he said. This is compared to highly optimised cell cultures that can typically generate 0.2 to 1 grams of protein per litre of culture medium.
The high protein levels were achieved by including an extra bovine milk-specific promoter sequence (alpha-S1 casein) functionally linked to the gene encoding human C1 inhibitor. Rabbits can produce up to 10 litres of milk a year. Scaling up was an easy process, said Strijker.
Meanwhile, other companies active in the transgenic arena include US firm Hematech, owned by Japan's Kirin Brewery, which is focusing on human antibody-producing cows that will be used for the development of large quantities of polyclonal antibodies, while US-based Avigenics is pursuing avian transgenesis for treatments in oncology, infectious disease and autoimmune disease.
The use of animals in the production of biopharmaceuticals is clearly an exciting and emerging new field being explored by many cutting-edge firms - could breakthrough drugs using such technologies be the milky way forward?
http://www.biopharma-reporter.com/news/ng.asp?n=79169&m=1BPR822&c=ukpsipxgnfzvqja
AMSTERDAM (FD.nl/Betten)
PHARMING REPORTS POSITIVE RESULTS IN EUROPEAN PLACEBO-CONTROLLED TRIAL OF RHUCIN(R) IN HEREDITARY ANGIOEDEMA
Independent data monitoring committee advises Pharming to stop placebo arm on ethical grounds.
Leiden, The Netherlands, August 20, 2007. Biotech company Pharming Group N.V. ("Pharming" or "the Company")
( Euronext : PHARM) announced today that it has completed an interim analysis of its European randomized placebo-controlled double-blind clinical study designed to evaluate efficacy and safety of Rhucin(R) in the treatment of acute attacks of Hereditary Angieoedema ("HAE"). The analysis complements the earlier publication of results of an open label study which showed strong positive effects of Rhucin(R). None of the patients receiving Rhucin(R) showed a relapse of their attack, nor any treatment-related adverse events during this study, confirming the safety profile of the product as was determined in earlier studies. Details of the clinical results will be presented on August 30th at a meeting in London to analysts and press (see details below).
Based on the results and after consulting with the Independent Data Monitoring Committee the Company has decided to discontinue further randomized treatments within the clinical study for methodological and ethical reasons. All investigators have been informed. All involved Ethics Committees and Regulatory Authorities have received or will shortly be receiving appropriate filings.
Pharming has included the analysis in its dossier submitted to the European Medicines Evaluation Agency ("EMEA") to further support its request for Marketing Authorization in Europe. Data from the analysis were also submitted to the FDA in the USA where an independent placebo-controlled randomized clinical study assessing the safety and efficacy of Rhucin(R) is expected to be completed in the next few months.
Dr. Bruno Giannetti, Chief Operations Officer of Pharming, commented: "We are extremely pleased with the outcome of this analysis. The data confirm the results obtained earlier in open label studies and show that Rhucin(R) is a very fast acting product that could be of great therapeutic benefit for patients with HAE. The product has an excellent safety profile based on the results of various studies in which, in total , well over 100 infusions were given to subjects. Importantly, no relapses of any of the attacks occurred. The Company has filed an amendment to stop further randomized treatments, whereas open label treatment of acute attacks with Rhucin(R) remains possible to allow patients in Europe and elsewhere to get access to and continue to benefit from this treatment.
A meeting for analysts and press will be held at the offices of Financial Dynamics in London on August 30th to discuss clinical results. Please contact Mo Noonan or Claire Rowell at FD on +44 20 7269 7116 for full details.
(c) Het Financieele Dagblad in samenwerking met Betten Beursmedia News (contact: webred@fd.nl/ 020-5928456)
The Use of Transgenic Animals in the European Union
The Report and Recommendations of
ECVAM Workshop 28-1,2
http://altweb.jhsph.edu/publications/ecvam/ecvam28.htm
The 47th Society of Toxicology Annual Meeting and ToxExpo will be held at the Washington State Convention and Trade Center in Seattle, Washington on
March 16-20, 2008.
The Use of Transgenic Animal Technology
in Toxicological Research.
http://www.toxicology.org/AI/MEET/AM2008/ce.asp
BASIC
Chairperson(s): Daniel K. Ness, Elan Pharmaceuticals, Inc., South San Francisco, CA and Roy Forster, CIT, Evreux, France
Endorsed by:
Comparative and Veterinary Specialty Section*
Drug Discovery Toxicology Specialty Section
Mechanisms Specialty Section
The ability to direct genetic changes at the molecular level in vivo has resulted in a revolution in biology. Nowhere has this been more apparent than in the production of transgenic animals. A host of techniques has been used to effect change in gene expression and develop new toxicological testing paradigms. Genetically modified animals are commonly produced and often yield important information relevant to safety/toxicological assessment. This session will help guide the toxicologist in the use and interpretation of data derived from transgenic models. The first speaker will introduce this topic and set the stage for subsequent speakers. The second speaker will review the history of genetic engineering technologies leading to the development of loss-of-function, gain-of-function modeling technologies across mammalian platforms. Transgenic animals have provided us with powerful tools to explore cellular and physiological processes in vivo. Current technologies allow us to modify cell-, tissue-or organ-specific gene expression in controlled temporal and spatial fashion. Accordingly, experimental considerations including strain-specific variability impacting experimental outcomes will be explored. The third speaker will cover current practice and previous experience gained in the regulatory use of transgenic animals in testing new products. In the area of safety evaluation, transgenic models have been used in the testing of biotechnology products (homologous models), in carcinogenicity testing, and in early toxicology screening. The presentation will cover the use of transgenics from the point of view of theory, the concrete practical aspects of putting such studies in place and new developments in this area. From gene-targeting, gene-trapping, and conditional expression modeling, gene knockout technology in mice is employed as an integrated platform to study physiological and behavioral functions and pharmaceutical utility of targeted genes. The fourth speaker will present recent data comparing pharmacological inhibition of selected targets, with a focus on differentiating between mechanism and nonmechanism-based toxicity and in determining on-target versus off-target toxicity for drug candidates. The final speaker will discuss how the lack of practical methods for the study of mutagenesis using endogenous genes stimulated the development of alternative mutation assays. These mutation analytical systems, developed first in rodents, and subsequently in fish share a similar general approach. Transgenic mutation models provide opportunities for comparative studies of complex processes of mutagenesis simply not possible otherwise. The introduction of a mutation model based on a transgenic fish, here the transgenic medaka, builds upon the knowledge and experience gained from the rodent models, and expands opportunities for increasing the understanding of fundamental mechanisms of mutagenesis.
Introduction
Daniel K. Ness, Elan Pharmaceuticals, Inc., South San Francisco, CA
Overview of Transgenic Animal Technology
Carl A. Pinkert, Auburn University
Current Use of Transgenics in Screening and Regulatory Toxicology
Roy Forster, CIT, Evreux, France
Using Mouse Knockouts to Predict Mechanism-Based Toxicity
Brian P. Zambrowicz, Lexicon Pharmaceuticals, The Woodlands, TX
From Transgenic Rodent to Fish Modeling: Enhancing Insights into Shared Mechanisms of Mutagenesis
Richard N. Winn, University of Georgia, Athens, GA
European BioPharm Scale-Up Congress 2007
Why can't i find GTCB here?
http://www.lifescienceworld.com/2007/biopharm/confprog.stm
ISB News Report AUGUST 2007
Minichromosomes: The Next Generation Technology for Plant Genetic Engineering
http://www.isb.vt.edu/news/2007/artspdf/aug0703.pdf
Thx Dew!
Are these the times when the boys are separated from the men?
This is not the reason here, as such good company, only 0.98 dollar pps?
I can't get it?
Recombinant Human Antithrombin (rhAT) in Patients With Hereditary Antithrombin Deficiency Undergoing Surgery or Delivery
Verified by GTC Biotherapeutics August 2007
Last Updated: August 7, 2007
http://clinicaltrials.gov/ct/show/NCT00110513?order=1
Medical advances and aniMal research
http://www.rds-online.org.uk/upload/docs/Medical%20Advances%20final.pdf
Medical News Article on Thrombosis Risk Factors
Researchers' work from Leiden University focuses on thrombosis risk factors
2007 AUG 13 -- Fresh data on thrombosis are presented in the report "Past and future of genetic research in thrombosis." According to recent research from Leiden, Netherlands, "Genetic studies in thrombosis started with coining of the term thrombophilia by Jordan and Nandorff in 1956. Next, antithrombin deficiency was identified in 1965 as a simple genetic entity that increased thrombotic risk, albeit in a small subset of patients."
"This subset was enlarged when, in the 1980s, family studies showed that deficiency of protein C (PC) or its co-factor protein S (PS) increased thrombotic risk. Ten years later activated PC resistance and the underlying genetic...
http://www.newsrx.com/article.php?articleID=671200
Whats happen?
Where they want to go with this stock,
next week, next month?
0.98 dollar, and still no manipulation?
Sentiment of the stock market? No way.
A very disipointed shareholder,
like all of them, i think.
Under one buck, this is not the way to be satisfied.
<< Dew refuses to accept any of these possibilities and he thinks this is normal trading but he is very wrong on that count. He is however very knowledgeable and very right on almost every other aspect of GTCB...>>
A company with a lot of expectancies, and that for only one buck? This is not normal trading,
'since 06.02.06', i can't believe it.
Posted by: DB9
In reply to: None Date:7/28/2007 2:00:47 PM
Post #of 4468
Recombinant Human Antithrombin (ATryn®) in the Treatment of Patients With DIC Associated With Severe Sepsis
This study is currently recruiting patients.
Verified by LEO Pharma July 2007
Phase II
Last Updated: July 23, 2007
http://clinicaltrials.gov/ct/show/NCT00506519?order=3
Yes, it was already discussed here.
Thx