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GTC BIOTHERAPEUTICS AND LFB BIOTECHNOLOGIES DEVELOPING CD20 ANTIBODY
http://biz.yahoo.com/bw/070802/20070802005253.html?.v=1
FRAMINGHAM, MA and PARIS, FRANCE – August 2, 2007 -- GTC Biotherapeutics, Inc. ("GTC", Nasdaq: GTCB) and LFB Biotechnologies, a wholly owned subsidiary of LFB S.A. (Laboratoire francais du Fractionnement et des Biotechnologies S.A.), announced today that they have initiated development of a transgenically produced CD20 monoclonal antibody under the existing agreement between GTC and LFB Biotechnologies. The resulting product is expected to have target specificity similar to Rituximab (Rituxan®, Mabthera®) and to have relatively higher antibody dependent cell-mediated cytotoxicity, or ADCC. The existing relevant CD20 antibody patents will expire by 2014. The transgenically produced CD20 antibody is anticipated to be commercially developed for oncology and auto-immune indications. Rituximab is used in the treatment of B-cell non-Hodgkin’s lymphoma, B-cell leukemia and rheumatoid arthritis. It is also under investigation for a range of auto-immune conditions such as systemic lupus erythematosus, immune thrombocytopenic purpura (ITP), and type-1 diabetes. Rituximab had worldwide sales of nearly $4 billion in 2006 and is projected to have a $5 billion market by 2010.
“Rituximab, an antibody targeting CD20, has proven its therapeutic value in Non Hodgkin’s Lymphoma and rheumatoid arthritis,” stated Yann Echelard, Ph.D., Vice President of Research and Development for GTC. “We believe our transgenic production technology enables us to develop an anti-CD20 monoclonal antibody which may have clinical benefits due to enhanced ADCC and provide an attractive price to the market to encourage broader use.”
“Transgenic production has the capability to drive economically beneficial large-scale production of the CD20 antibody,” stated Sami Chtourou, Ph.D., Director Biopharmaceutical Development and Transgenesis Program for LFB. “The enhanced ADCC characteristics have the potential to establish a product that may offer efficacy benefits or reduced dosing requirements for patients.”
This CD20 antibody may be considered for clinical development as a follow-on biologic in the US and a biosimilar in the EU as the appropriate legislation is enacted and regulatory guidance is established.
The transgenically produced CD20 antibody is being developed under the agreement between GTC and LFB established in October 2006. Costs and profits from the program are anticipated to be shared 50/50. GTC will have exclusive marketing rights in the US and Canada. LFB will have exclusive marketing rights in the EU. GTC and LFB have co-exclusive marketing rights to the rest of the world. LFB has initially demonstrated production of this CD20 antibody with enhanced ADCC in cell culture.
Production in the milk of transgenic goats is anticipated to be established in 2008 with an investigational new drug application to the US Food and Drug Administration planned for 2010.
Non-Hodgkin Lymphoma, or NHL, is a group of cancers originating in the lymphatic system that is characterized by the malignant transformation of lymphocytes. NHL has an incidence rate of about 20 cases per 100,000 population in the United States, and a worldwide incidence of 5 –15 per 100,000. It is more prevalent in males and occurs at an average age of 50. The incidence of NHL in the US rose 84% from 1975 to 2004, an average yearly increase of 2.8%. NHL is the fifth most common cancer in the United States, where an estimated 63,000 new cases of NHL will be diagnosed in 2007, and where the National Cancer Institute estimates that 18,660 deaths due to NHL will occur (approximately 5% of all US cancer deaths).
CD20 is an antigen located on the surface of mature B-lymphocytes and B-cell derived tumor cells. The CD20 monoclonal antibody recruits the body's natural defenses to target marked B-cells. Stem cells (B-cell progenitors) in bone marrow lack the CD20 antigen, allowing healthy B-cells to regenerate after treatment.
Maybe there is a Big One, who's collecting all the shares he can buy cheap.
And a day like today or last week is good news for him, very bad news, because he want them very cheap.
Just an idea.
Anybody, another or maybe better explanation?
1 Dollar/pps (is this a joke?)
I thought it looking good, this morning with:
Initial Benefit From Genetic Engineering Likely to Be Medicine.
By ANDREW POLLACK
Published: July 30, 2007
http://tinyurl.com/3cjetp
And what we get, minus ~6 %, and only one buck now.
Last week (07.24.07) just the same with:
Nerve gas antidote made by goats.
http://news.bbc.co.uk/2/hi/science/nature/6912807.stm
And what we got, minus ~4 %
Like i said, this is Madness.
01-xJun-06 1.00 1.01 0.96 0.98 120,200 0.98
31-May-06 0.99 1.02 0.99 1.00 177,200 1.00
30-May-06 1.00 1.02 1.00 1.01 116,900 1.01
1 Dollar it is?.
Sorry guys, i can't understand this anymore.
This is more than 100 % lower than before the approval
This is Madness
Initial Benefit From Genetic Engineering Likely to Be Medicine
By ANDREW POLLACK
Published: July 30, 2007
http://tinyurl.com/3cjetp
Because of the high prices that drugs can command, medicine — not food — might provide the earliest payoff from genetically engineered livestock.
A herd of goats engineered to produce a therapeutic human protein called antithrombin in their milk live on a farm in central Massachusetts. The animals are owned by a company called GTC Biotherapeutics, which extracts the protein for use in treating a human hereditary condition in which people lack antithrombin, which helps keep blood from clotting.
GTC’s drug has already been approved in Europe, and the company is now conducting clinical trials in hopes of filing for United States approval early next year.
Other companies, too, are at work on medicines that would be extracted from a transgenic animal’s milk or blood, saying the approach might be less expensive than other ways of making protein drugs.
Pharming Group, a Dutch company, has applied for European approval of a drug made in the milk of transgenic rabbits. Pharmathene, based in Annapolis, Md., is developing transgenic goats whose milk produces an antidote to nerve gas.
Hematech, a South Dakota company owned by the pharmaceutical division of Krin, the Japanese beer company, has developed cows with human immune systems to produce human antibodies to treat diseases. Other companies and academic scientists are developing chickens that produce drugs in their eggs and pigs with organs that would not be acutely rejected if transplanted into people.
But the path has not been easy, and many companies have had financial or technological setbacks.
Medical therapies produced in genetically engineered animals would generally be regulated like other drugs. But the new federal regulatory guidelines being developed for transgenic animals might also cover at least the creation and testing of the drug-bearing creatures. And those rules would apply if the companies tried to sell their animals for food after their drug-producing days were over.
One ambiguity involves the offspring of genetically engineered animals, some of which do not inherit their parents’ foreign gene and as a result are genetically normal. There is also the question of what to do about non-engineered animals that are used simply as surrogate mothers to carry embryos that have been given foreign genes. The surrogate mothers’ own genetic makeup remains normal.
GTC, at least, says it has no intention of putting any of its animals, even the non-transgenic ones, into the food supply, to avoid additional regulatory headaches and the chances of a mix-up. The company incinerates its genetically altered goats after they die, and it has the non-altered ones buried by a licensed contractor, according to Thomas Newberry, a GTC spokesman.
“We think it’s better to deal with all the animals at the same quality level, at the same access control,” Mr. Newberry said, “and not try to make a nickel here and there trying to sell goat cheese.”
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
<< All over (good) news here, but
'The fact is' that shareprice only 1.03 Dollar is.
What's about that?>>
Before the approval, we take a lot more risks,
we paid a lot more, pps.
We put plenty of money in this share,
and what we get, yes, so far nothing.
You can hear a mouse running, so quiet is the
GTC-Management.
Unfortunately.
All over (good) news here, but
'The fact is' that shareprice only 1.03 Dollar is.
What's about that?
Thx Dew
I don't known, maybe it's a possibility?
The management is always so quiet.
Merrimack Pharmaceuticals Reduces Drug Discovery Time with SimBiology:
Pharmaceutical Research Company Uses MathWorks Tools to Efficiently Profile Complex Biological Systems
http://www.prweb.com/ebooknews/9936Engineering_2007-07-09_digest.pdf
The MathWorks(tm) today announced that Merrimack Pharmaceuticals is using SimBiology(R) to streamline the research and development of therapeutics to treat autoimmune disease and cancer.
NATICK, Mass. (BusinessWire EON) July 9, 2007 -- SimBiology plays an integral role in Merrimack's discovery platform, Network Biology, which is multidisciplinary, integrating computational tools from engineering and high throughput biology to rationally guide drug design and development.
By using SimBiology, Merrimack has further improved collaboration across the various components of the drug development process, enabled better analysis and simulation of drug candidates, and may significantly reduce the time required for drug discovery and development.
Network Biology seeks to understand the system dynamics that govern protein networks - the functional set of proteins that regulate cellular decisions. SimBiology, the industry's first graphical systems biology tool, is an essential piece of the modeling technology in Network Biology. It is used by Merrimack researchers to simulate, model, and analyze the biochemical pathways in cancer and other diseases, enabling researchers to make more informed decisions throughout the entire drug discovery, development, and commercialization process.
"In order to compete in an industry dominated by large pharmaceutical companies with larger research efforts, we've adopted a unique approach to drug discovery that incorporates the principles of Model-Based Design," said Birgit Schoeberl, director of Network Biology at Merrimack Pharmaceuticals. "SimBiology and other MathWorks tools have been instrumental in giving us the competitive edge we need, delivering a combination of powerful mathematics and an easy-to-use graphical interface that makes it easy to create and share models of pathways with other teams throughout each stage of research and development."
"The MathWorks tools have dramatically increased the speed with which we can identify drug candidates," continued Schoeberl. "For example, a group of six researchers were able to create seven candidates in less than three years with SimBiology. That would've taken a lot more time without using modeling or by using multiple tools from other companies, and it would have required that we learn three or four different software packages."
Researchers can also use SimBiology to simulate the pathway and the systems reaction to inhibitors. Once the best inhibitor is identified, Merrimack's computational biologists and researchers work in combination to produce drug candidates for preclinical testing. In addition to SimBiology, Merrimack used the Bioinformatics Toolbox to identify critical signal transmission pathways.
"The MathWorks is committed to providing powerful and easy-to-use tools to help innovative companies like Merrimack improve the speed and quality of their research efforts," said Kristen Zannella, marketing manager for biotech, pharmaceutical, and medical at The MathWorks. "In particular, the rapidly growing field of systems biology, in which Merrimack is an innovator, is fraught with complexity that must be mitigated with technology such as SimBiology, which combines a drag-and-drop interface with the proven mathematical capabilities of
MATLAB(R). We look forward to working with Merrimack as they continue to broaden their use of SimBiology and other MathWorks tools, which will help them introduce even greater time and cost savings into their drug.
If you have any questions regarding information in these press releases please contact the company listed in the press release. Our complete disclaimer appears here. - PRWeb eBooks - Another online visibility tool from PRWeb development process."
Currently, MathWorks tools are being used solely by the computational modelers. However, over the next year, use of MathWorks tools such as MATLAB and SimBiology will be expanded to Merrimack's experimentalists.
About Merrimack
Merrimack Pharmaceuticals, Inc. is a biotechnology company focused on the discovery and development of novel treatments for diseases in the areas of autoimmune disease and cancer. Its lead compound, MM-093, is currently in clinical development to treat patients with rheumatoid arthritis or with psoriasis.
MM-093 is an investigational drug and has not been approved by the U.S. Food and Drug Administration or any international
regulatory agency. The company's proprietary Network Biology discovery platform, developed with the help of leading scientists from MIT and Harvard, enables the high throughput profiling of protein networks as a basis for improved validation, lead identification, and speed in the development of innovative, effective, and safe therapeutics. Merrimack is a privately held company based in Cambridge, Massachusetts. For additional information, please visit http://www.merrimackpharma.com
About The MathWorks
The MathWorks is the world's leading developer of technical computing and Model-Based Design software for
engineers and scientists in industry, government, and education. With an extensive product set based on
MATLAB and Simulink(R), The MathWorks provides software and services to solve challenging problems and accelerate innovation in automotive, aerospace, communications, financial services, biotechnology, electronics, instrumentation, process, and other industries.
The MathWorks was founded in 1984 and employs more than 1,600 people worldwide, with headquarters in Natick, Massachusetts. For additional information, visit www.mathworks.com.
MATLAB, Simulink, Stateflow, Handle Graphics, Real-Time Workshop, SimBiology, SimEvents, SimHydraulics, and xPC TargetBox are registered trademarks and The MathWorks, the L-shaped membrane logo, and Embedded MATLAB are trademarks of The MathWorks, Inc. Other product or brand names are trademarks
or registered trademarks of their respective holders.
If you have any questions regarding information in these press releases please contact the company listed in the press release. Our complete disclaimer appears here. - PRWeb eBooks - Another online visibility tool from PRWeb
Contact Information
Dave Smith
The MathWorks, Inc.
http://www.mathworks.com
508-647-7427
Online Web 2.0 Version
You can read the online version of this press release here.
News Image
If you have any questions regarding information in these press releases please contact the company listed in the press release. Our complete disclaimer
appears here. - PRWeb eBooks - Another online visibility tool from PRWeb
And what about this?
We have entered into a contract with Cambrex Bio Science MA, Inc. for the large scale purification of our lead product candidate, ATryn_. We have a five year, renewable supply agreement with Cambrex, which will expire in 2007 if not renewed. Although we have identified possible alternative suppliers with respect to the purification of this product, interruptions in these services and the process of changing to an alternative manufacturer could have a material adverse effect on our timely ability to manufacture bulk delivery of ATryn_ for delivery to our collaborators.
http://www.transgenics.com/investorinfo/prospectussupplement.pdf
Study seeks ways to cut feed antibiotics
http://www.upi.com/NewsTrack/Science/2007/06/18/study_seeks_ways_to_cut_feed_antibiotics/5897/
TAIPEI, Taiwan, June 18 (UPI)
Taiwanese scientists are developing protein-enriched milk that they hope might reduce the need for antibiotics in animal feed.
Winston Cheng at National Taiwan University and colleagues at National Chung Hsing University said their search for ways to promote growth of farm animals without adding antibiotics to feed has led them to an advance toward genetically engineering animals that produce higher levels of a natural growth-promoting protein in their milk.
Cheng's team notes the protein lactoferrin, or LF, has anti-bacterial and anti-inflammatory qualities and might serve as an alternative to antibiotics in agriculture. The researchers genetically engineered laboratory mice to produce milk enriched in pig LF and then studied the growth of 10 generations of mice pups fed on the milk. Mice fed LF-enriched milk grew 10 percent to 15 percent faster than those fed on ordinary milk.
The scientists said transgenic animals expressing the LF protein in their mammary glands and secreting high levels of LF in their milk might be generated to produce a whole new herd of diarrhea- and anemia-resistant piglets with better growth performance and commercial value.
The research is reported in the Journal of Agricultural and Food Chemistry.
Copyright 2007 by United Press International.
All Rights Reserved
1) Merrimack one of these days good news about,
MM-093 RA and psoriasis Phase II.
And maybe "Merrimack Pharmaceuticals Initiates Enrollment in a Phase III" We still wait, but ...
2) Only three weeks to go
"ATryn launch for HD in EU"
XXIst Congress of the International Society on Thrombosis and Haemostasis"
7 - 12 July 2007
Geneva, Switzerland
3) And maybe next, ATryn DIC in Sepsis program in EU start of Phase II.
But have we here a fair value, 1.18$, i don't think so!
Yes, it's very undervalued.
The question is, when we can go up, is it the 1, 2 or 3, or all together, or have we to wait for the FDA, for a fair price?
Is no news, good news?
EULAR 2007
http://www.eurekalert.org/pubnews.php?start=0
Antithrombin Deficiency
Article Last Updated: Jun 4, 2007
http://www.emedicine.com/med/topic150.htm
http://www.wfs.org/2007f3.htm
SPECIAL EVENT
Future Applications of Biotechnology
<< 3) transgenic animals—goats’ milk can be the source of spider web material which is stronger, lighter, and more flexible than steel >>
http://www.wfs.org/2007tech.htm
Research and commercialization of new biological technologies is once again moving quickly ahead after a lull following the completion of the Human Genome Project. A graduate course in futures studies at the University of Houston has been investigating some of the more startling applications of these technologies. This session reviews the overall state of biotechnology research and commercialization and showcases some fascinating breakthroughs in five different domains: 1) human health—researchers are now growing neurons that attach to and directly communicate with computer chips; 2) biofuels—microbes might produce hydrogen for fuel from biomass more cheaply than from other energy sources; 3) transgenic animals—goats’ milk can be the source of spider web material which is stronger, lighter, and more flexible than steel; 4) bioweapons—some claim that it is too easy to construct and distribute a highly contagious disease vector; and 5) environmental remediation—microbes could close the recycling loop from waste products back to useful resources.
Who should attend: Anyone interested in long-term technological developments.
What you’ll learn: Attendees will gain an overview of the science and technology that allows us to manipulate living organisms, the applications of that technology for agriculture, industry, and medicine, and some potential social consequences of using that technology, particularly on human beings.
How this knowledge can be applied: The effects of biotechnology will go well beyond the strict use of micro-organisms in agriculture, industry, and health. It could even change how we think about the world. Until now, machines were the most complicated systems that we understood in our world so that mechanistic and hierarchical models of systems are common today, if not required. As we understand more about how living organisms work, however, we may be able to design and build systems and organizations that are more organic, responsive, evolutionary, and robust than the mechanistic systems we have today.
Peter Bishop, associate professor of Strategic Foresight; coordinator, graduate program in Future Studies, University of Houston; president, Strategic Foresight and Development, Houston, Texas
Jim Lee, student, Future Studies graduate program, University of Houston, Houston, Texas
Mark Niles, student, Future Studies graduate program, University of Houston, Houston, Texas
Kerry Ramirez, student, Future Studies graduate program, University of Houston, Houston, Texas
Jason Siko, student, Future Studies graduate program, University of Houston, Houston, Texas
key words: biotechnology, research, science, living organisms
issue areas: Technology and Science; Health and Wellness Futures
Can we get it, tomorrow or maybe this week?
http://finance.yahoo.com/q/ta?s=GTCB&t=2y&l=on&z=m&q=l&p=m50,m200&a=&c=
Fair value,
thx Dew :
> GTCB – Dew, back when we where waiting for atryn to be approved you would often give what you believed was fair value per share? Care to give us an update.<
The two best valuation comparators, in my opinion, are Pharming (#msg-17760532) and GlycoFi (#msg-11037571). These suggest a fair enterprise value for GTC in the $300-400M range.
GTC has approximately 108M fully-diluted shares outstanding for valuation purposes (#msg-15309465). However, if all of these shares come into play from warrant exercises, GTC’s cash balance will be boosted. Adding these warrant proceeds to the net cash on hand now comes to about $60M; hence, a $300-400M enterprise value translates into a $360-460M fully-diluted market cap.
Dividing this by 108M shares gives a share price of $3.33 - 4.26.
GTCB
Nears Completion of Studies for Filing of BLA w/FDA for ATryn®.
Ridgeland, MS, MAY 25, 2007
By Fain Hughes,
fhughes@knobias.com
http://finance.comcast.net/indices/news_body.html?ID_NOTATION=324985&ID_NEWS=47646746
GTC Biotherapeutics, Inc. (GTCB) announced that it is also nearing completion of the clinical studies necessary to support the filing of a Biologics License Application for ATryn® planned for the first quarter of 2008.
ATryn® is GTC's recombinant form of human antithrombin. Antithrombin, produced in the liver and circulated in blood plasma, has both anticoagulant and anti-inflammatory properties. The recombinant form is able to be produced using GTC's transgenic production platform, enabling large volume supply. ATryn® has been approved for use in Europe for the prophylactic treatment of deep vein thrombosis in hereditary antithrombin deficient patients undergoing surgical procedures.
KNOBIAS DISCLAIMER: All statements made in this article were made by the Company and do not in any way reflect the opinions of Knobias. Knobias is not a registered broker-dealer, nor investment advisor, and does not endorse or recommend any securities mentioned. This story is provided for informational purposes only and is not intended for trading purposes. Knobias shall not be liable for any actions taken in reliance of any information provided herein. Republication or redistribution of Knobias content is expressly prohibited without prior written consent of Knobias.com, LLC.
ABOUT KNOBIAS: Knobias is a premier financial information provider of trading and investing data covering all U.S. equities for investors and security professionals. Knobias is best described by its three major components: Real-time desktop applications providing quotes, charts, level 2, analysis etc.; Knobias RAiDAR providing thousands of real-time news stories, alerts and documents daily; Knobias fundamentals providing a comprehensive database of fundamental research information.
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Knobias.com, LLC
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MM-093 IS SAFE AND WELL TOLERATED IN AN EXPLORATORY PHASE 2 STUDY AND PATIENTS WITH THE HIGHEST SERUM LEVELS OF MM-093 ACHIEVED ROBUST CLINICAL RESPONSES
http://tinyurl.com/2zkgnj
J. Murray1, A. Sawitzke2
1Clinical, Merrimack Pharmaceuticals, Inc, Cambridge, 2Rheumatology, University of Utah, Salt Lake City, United States
Background: MM-093 is a non-glycosylated, recombinant version of human alpha-fetoprotein that is produced by recombinant DNA technology in a transgenic goat expression system. The purpose of this exploratory dose-ranging study was to evaluate the safety and efficacy of MM-093 in patients with moderate-severe RA despite current MTX therapy.
Methods: Adults with active RA [ ≥6 swollen joints; ≥6 tender joints]; ≥6 months’ duration of RA; and on stable MTX therapy were randomized to receive MM-093 (2.5mg, 7.5mg, 20mg) or placebo. Study drug was administered by the patient as a subcutaneous injection in their abdomen once a week for 6 months. A total of 259 patients were randomized at 39 centers in the United States. The primary endpoints were safety and efficacy as measured by ACR20 response. Secondary efficacy endpoints included DAS28-CRP and EULAR.
Results: MM-093 was safe and well tolerated across all dosing groups. The number of patients experiencing an adverse event (AE); the relationship of AE’s to study drug; and the severity of AE’s was similar between groups. There were no dose relationships in any of the lab analytes or in any of the clinically significant lab abnormalities. Additionally, there were no drug related SAE’s in the active groups and none of the patients had detectable limits of anti-MM-093 antibodies.
In the intent to treat population, there was a non-statistically significant improvement in ACR20 in the 20mg group versus placebo. The percentage of patients achieving a EULAR “good” + “moderate” response was statistically significant in the 20mg group versus placebo (p = 0.038) and there was a -1.6 improvement in the DAS28-CRP score from baseline in the 20mg group, compared to a -1.3 improvement in the placebo group.
In general, clinical responses increased as serum levels of MM-093 increased. In patients with the highest serum levels of MM-093 (i.e. >1600ng/ml), 7/9 achieved an ACR20, 8/9 achieved a moderate/good EULAR response and 6/9 had low disease activity or were in remission as measured by DAS28-CRP (See Table below).
Conclusion: In an exploratory dose-ranging study, MM-093 was safe and well tolerated. Patients with serum levels above 1600ng/ml showed a robust clinical response, suggesting that higher doses need to be tested in future trials with MM-093.
19th FAOBMB Seoul Conference
Model Organisms and Diseases
Yoichiro Iwarkura, University of Tokyo, JAPAN
Title of Talk:
Rheumatoid arthritis models generated by using transgenic techniques.
http://www.biochem.or.kr/faobmb2007/sub/catalog.php?CatNo=14&Sort=&OutLine=menu1outline
TRANSGENIC ANIMAL RESEARCH CONFERENCE VI
August 12-16, 2007
Hosted by UC Davis
(Animal Science Department and Biotechnology Program)
http://www.cevs.ucdavis.edu/Cofred/Public/Aca/WebSec.cfm?confid=282&webid=1413
The Transgenic Animal Research Conference will be held from Sunday afternoon, August 12, 2007, through Thursday morning, August 16, 2007. The sessions will be held at the Conference Center at Granlibakken on the north shore of Lake Tahoe, California. Granlibakken is located two hours from Davis, and 55 minutes from the Reno Airport. Transportation from Davis and from the Reno airport at fixed times will be included in the cost of registration. Transportation from Reno outside the set times will be provided by Granlibakken at a cost of $60.00 for one person and $35.00 per person (2 or more in the vehicle) one way. This must be booked in advance. You will be informed of the set times for organized transportation when we receive attendees itineraries. Please mark the appropriate box in the registration form informing us if you will need transportation from Davis or Reno (including airline name, flight number, arrival time, and departure time). Lodging at the Conference Center consists of one, two or three bedroom townhouses, and suites comprised of a studio and bedroom. All rooms have private bath, cable tv, and direct-dial telephones. Common area kitchens, fireplaces, dining areas, lofts, and decks or patios are also typical.
Description:
This is the sixth international meeting hosted by UC Davis to bring together representatives from the leading laboratories worldwide doing cutting edge work on transgenic research in non-murine animals, including livestock, fish and poultry species. The previous meetings were each attended by over 150 participants from 16 different countries throughout the globe. Each conference, in addition to reviews and papers on transgenic animals, included presentations covering technical developments in areas such as nuclear transfer-based cloning, cell transformation, sperm mediated gene transfer and construct design that affect the production of transgenic animals. Oral presentations are by invitation, with participants encouraged to contribute poster presentations.
The upcoming conference will again focus on state-of-the-art science in the field of transgenic research. Presentations will address cutting-edge methodology, technical improvements, and current progress towards producing transgenic animals for biomedical and agricultural applications. The intent of these meetings is to bring together scientists to discuss progress, problems, and potential application of transgenic technology for animal applications.
The meeting will consist of invited presentations and submitted posters. Two afternoons from noon to 4 p.m. and one evening will be free to allow for small group interactions and to take advantage of the great natural beauty and recreational activities in the Lake Tahoe area.
Harry Meade, GTC Biotherapuetics
ATryn® the first transgenic drug
http://www.cevs.ucdavis.edu/Cofred/Public/Aca/WebSec.cfm?confid=282&webid=1417
Rodman & Renshaw
4th Annual Global Healthcare Conference
May 14-15, 2007
Le Meridien Beach Plaza Hotel, Monte Carlo, Monaco.
by Geoffrey Cox
http://tinyurl.com/25s22l
The content of the Special Symposia was approved by the Scientific Programme Committee.
Special Symposia are thus an integral part of the Scientific
Programme of ISTH 2007.
Special Symposia
http://www.isth2007.com/Special_Satellite_symposia.pdf
WEDNESDAY, 11 JULY 2007
Room Salève 13:00 - 13:45
GTC Biotherapeutics/LEO Pharma
ATryn®, the First Recombinant Antithrombin;
Innovation or Alternative?
Chairman: M. von Depka
Introduction & Welcome
M. von Depka 13:00 - 13:05
The Transgenic Production System;
An Emphasis on Safety & Purity
H. Meade 13:05 - 13:20
ATryn®, An Alternative to Plasma Derived Antithrombin
M. von Depka 13:20 - 13:35
Discussion
Chairman and Faculty 13:35- 13:45
Study identifies new Huntington's disease proteins.
11th May 2007
By Clare Watson
http://www.pharmaceutical-business-review.com/article_news.asp?guid=77E5307F-1F12-4F70-BE06-58A3565F....
Researchers from four organizations, including the Buck Institute, have identified more than 200 new proteins that bind to normal and mutant forms of the protein that causes Huntington's disease. It is hoped that the proteins could help to develop a cure for the degenerative disease, which currently has no effective treatment.
The Huntington's disease (HD) study involved high-tech screening of the human genome and proteome, and was unprecedented both in terms of its scale and in the way the protein interactions were validated in a genetic model of the disease, the researchers said.
In addition, by conducting additional experiments in fruit flies genetically altered to express features of human HD, scientists showed that changing the expression of these interacting proteins affected the degree of damage seen in the fly neurons. The Buck Institute said that this indicates that a significant number of the proteins might be potential drug targets for HD.
The research was led by Buck Institute faculty member Robert Hughes. He said that now researchers have discovered the interacting proteins using human libraries and human protein extracts and tested them in the fly, the next step is to bring the research back into the mammalian world.
The new genes and proteins discovered in the study are now being screened and analyzed in cultured mammalian cells and those that show activity in ongoing experiments will be tested in mouse models of HD.
The research, which will be published in the May 11, 2007 edition of PLoS Genetics, has been supported by HD advocacy organizations. It is hoped that making the results public will enable scientists from around the world to take advantage of the findings immediately, possibly facilitating the discovery of an effective treatment for HD.
"Here at the Buck Institute, we're going to be focusing on a few dozen proteins," said Hughes. "Effective follow-up on any target protein depends, in large part, on how much expertise a scientist has with that target. We are hoping that researchers will look at this study and that those with specific expertise in a particular protein will move forward with their own inquiries."
Careers: Opportunities
-----------
Director, Regulatory Affairs
This position will manage all CMC regulatory activities for products, including all phases of development through commercial production of drug product to support all US and international regulatory filings. The person selected for this position will interact extensively with Manufacturing, Development, Facilities, and Quality departments in the planning of all phases of production to support product registration and post-approval activities.
Merrimack has the following ongoing or anticipated programs:
MM-093
*Three active IND’s requiring ongoing attention:
*** Phase II Rheumatoid Arthritis trial
*** Phase II Uveitis trial
*** Open Label Extension (RA)
http://www.merrimackpharma.com/careers/clin_reg.html
Thx DEW
Nice work.
Animal Based Therapeutics in New Zealand
New Zealand has an unrivalled position with an impeccable animal health status, food safety and traceability programs. It has some of the safest ingredients available for large scale drug development processes, and is recognized internationally as a viable source of animal-derived ingredients for human therapeutics.
New Zealand is fuelled by an educated, flexible and collaborative workforce, supported by a depth of experience in animal-based products from equine to bovine, and extensive expertise in sheep-orientated research. New Zealand has some of the world's strictest quarantine and customs controls, ensuring the country remains disease-free. Many of the country's universities and research institutes have a strong focus on agricultural research technology, building on New Zealand's world-leading agri-bio industry.
http://tinyurl.com/2crjhf
Thx
Anybody here, what we can expect from
the CC tomorrow?
Merrimack, launch ATryn® ...
Biotech in the Barnyard
Implications of genetically engineered animals
http://pewagbiotech.org/events/0924/proceedings1.pdf
And again, a little bit lower.
http://tinyurl.com/2rkgzh
Bristol-Myers Squibb and Pfizer Enter into Anticoagulant and Metabolic Disorder Collaborations
http://patentdocs.typepad.com/patent_docs/2007/04/bristolmyers_sq.html
Bristol-Myers Squibb Co. and Pfizer Inc. announced today that the companies will be entering into two separate collaborations
In the first, the two companies will be working together to develop and commercialize Bristol-Myers Squibb's anticoagulant, apixaban. In the second, the collaboration will focus on the research, development, and commercialization of pre-clinical compounds identified in Pfizer's metabolic disorder discovery program.
With respect to the apixaban collaboration, Pfizer will be making an upfront payment of $250 million to Bristol-Myers Squibb and will be funding 60% of all future developmental costs. Under the terms of the agreement, Bristol-Myers Squibb could receive additional payments of up to $750 million from Pfizer depending on the attainment of development and regulatory milestones. With regard to the commercialization of apixaban, the companies will share expenses and profits/losses equally.
Apixaban is an inhibitor of factor Xa, which plays a role in the coagulation cascade. According to the Bristol-Myers Squibb release, apixaban has entered Phase III clinical trials to investigate the use of the compound to prevent venous thromboembolism (the process by which blood clots travel through the veins) and stroke in patients with atrial fibrillation (abnormal heart rhythm), and has entered Phase II clinical trials to investigate the use of the compound to treat acute symptomatic deep vein thrombosis and to prevent cardiovascular events in patients with acute coronary syndrome.
With respect to the metabolic disorder collaboration, Pfizer will be responsible for early-stage research and development, and the companies will jointly conduct Phase III development and commercialization activities. Under the terms of the agreement, Bristol-Myers Squibb will be making an upfront payment of $50 million to Pfizer and will be responsible for 40% of the expenses for Phase III development and commercialization. The companies will split profits/losses on a 60-40 basis, with Pfizer taking or assuming the larger share.
Additional information regarding the collaboration can be found in Bristol-Myers Squibb's press release and in Pfizer's press release.
A Phase 2 Study to Evaluate the Efficacy and Safety of 60mg of MM-093 in Patients With Active Rheumatoid Arthritis.
This study is currently recruiting patients.
Verified by Merrimack Pharmaceuticals April 2007
http://clinicaltrials.gov/ct/show/NCT00458146?order=3
Thomas.Newberry@gtc-bio.com
GTC Biotherapeutics Obtains License to Nuclear Transfer Patents
Tuesday April 10, 9:00 am ET
FRAMINGHAM, Mass.--(BUSINESS WIRE)--GTC Biotherapeutics, Inc. ("GTC", Nasdaq: GTCB) announced today that it has been granted a non-exclusive worldwide license from Start Licensing, Inc., a joint venture between Geron Corporation (Nasdaq: GERN - News) and Exeter Life Sciences, Inc., for the patents and patent applications developed by the Roslin Institute to apply nuclear transfer to the production of therapeutic proteins in the milk of transgenic animals. Nuclear transfer may be utilized, as an alternative to micro-injection, to provide schedule predictability in developing the first animal that incorporates into its genome the transgene for a therapeutic protein to be expressed in milk. Nuclear transfer may also be used to speed the development of large scale transgenic production capacity. Financial terms include an upfront payment of $200,000 to Start and a total of 278,370 shares of GTCB common stock, based on the 10-day average closing price ending April 5, divided equally between Start and Exeter. There will also be a royalty payable to Start for those products developed with the patented nuclear transfer technology. The license agreement remains in place through the last patent to expire, which is expected in 2016 for the currently issued patents.
"We are pleased to enter into this licensing agreement to ensure we have the freedom to operate for those programs where the application of nuclear transfer is appropriate for product development," stated Geoffrey F. Cox, Ph.D., GTC's Chairman of the Board and Chief Executive Officer. "Our intellectual property portfolio provides patent protection for both the practice of our technology and the commercialization of our products. Last year, we received a patent in the United States for the production of therapeutic proteins in the milk of any transgenic mammal through 2021. This broad and long-lived intellectual property, all of which is independent of traditional bioreactor-based intellectual property, supports our strategic focus on the development and commercialization of recombinant plasma proteins and monoclonal antibodies."
About Start Licensing
Start is a joint venture of the Geron Corporation (Nasdaq: GERN - News) and Exeter Life Sciences, Inc. Start manages and licenses a broad portfolio of intellectual property rights related to animal reproductive technologies, including foundational nuclear transfer cloning technology that was developed at the Roslin Institute for the cloning of Dolly the sheep. Start's licensees are on the cutting edge of research and product development in food production, medical applications and many other fields.
<< MM-093 RA >>
<< MM-093 Psoriasis >>
<< MM-093 Uveitis >>
http://www.merrimackpharma.com/pipeline/index.html
Is Multiple Sclerosis not anymore a hot item?
Thanks for the updates, Dew.
Best regards.
And we have also this:
ANNAPOLIS, Md., April 3 /PRNewswire
PharmAthene, Inc.'s Recombinant Butyrylcholinesterase (rBChE) Program the Subject of Promising New Alzheimer's Research.
http://www.biospace.com/news_story.aspx?StoryID=51147&full=1
Important for GTCB?
I can't found anything about it,
have you some more info?
Thank you
Maybe goes to vra-forum