Sangamo 936386: Financial Times heute:Durchbruch

Seite 1 von 1
neuester Beitrag: 04.12.06 13:20
eröffnet am: 04.04.05 15:01 von: Biomedi Anzahl Beiträge: 8
neuester Beitrag: 04.12.06 13:20 von: derFahrer Leser gesamt: 9199
davon Heute: 2
bewertet mit 2 Sternen

4861 Postings, 7791 Tage BiomediSangamo 936386: Financial Times heute:Durchbruch

 
  
    
2
04.04.05 15:01
in der Gentherapie auf S. 29 zu lesen. Habe gerade gekauft; lege evtl. nacher nach  

7965 Postings, 7368 Tage gvz1Chart sieht gut aus.

 
  
    
05.04.05 15:19
Werkstatt für unser Erbgut
von Sascha Karberg
Nach herben Rückschlägen schöpfen Gentherapeuten wieder Hoffnung. Neue Methoden sollen helfen, defekte Gene zu reparieren.

Prinzip der DNA-AnalyseNimmt man ihre Berufsbezeichnung wörtlich, müssten Gentherapeuten eigentlich Gene behandeln. Doch obwohl seit fast 15 Jahren Tausende von Gentherapien getestet wurden, war es bisher unmöglich, auch nur ein defektes Gen in einer menschlichen Zelle gezielt zu reparieren. Bestenfalls eine intakte Version des mutierten Gens ließ sich ins Erbgut einschleusen. Erst heute berichten Forscher der kalifornischen Biotech-Firma Sangamo im Fachmagazin " Nature" von der ersten erfolgreichen Reparatur eines menschlichen Gens mit Hilfe eines neu entwickelten molekularen Werkzeugs. Und weisen der Gentherapie damit einen Ausweg aus der Krise, in der sie nach diversen Fehlschlägen und sogar tragischen Todesfällen steckt.

Es ist sicherlich kein Zufall, dass das Team um Michael Holmes für den Test des neuen Werkzeugs ausgerechnet die Erbkrankheit wählte, mit der die Euphorie um die Gentherapie begann: Am 14. September 1990 präsentierten US-Forscher die damals vierjährige Ashanti da Silva, deren Immunsystem durch ein mutiertes Gen lahm gelegt war.

SCID (Severe Combined Immunodeficiency) heißt die Krankheit, die sonst harmlose Keime zur tödlichen Bedrohung für Patienten macht. Die Forscher entnahmen dem Mädchen blutbildende Zellen und schleusten intakte Kopien des Gens ein. Und tatsächlich wuchsen genügend Immunzellen heran. Ashanti, vorher hermetisch von der Außenwelt abgeschirmt, konnte fortan ohne Angst vor Infektionen auf den Spielplatz.


Noch kein glücklicher Patient

Einen glücklichen Patienten kann Michael Holmes, Leiter der Studie und Forschungsdirektor bei Sangamo, leider noch nicht präsentieren. Er hat die neue Methode bisher nur an menschlichen Zellen in der Petrischale getestet. Die Wissenschaftler sind vorsichtiger geworden, seit die erste Euphorie verflogen ist und die ersten technischen Probleme aufgetreten sind. Unvergessen ist der Fall des 18-jährigen Jesse Gelsinger, der bei einem Gentherapie-Versuch starb. Unvergessen sind auch die drei SCID-kranken Kinder, die in Paris zunächst erfolgreich mit einer Gentherapie behandelt wurden, später aber an Blutkrebs erkrankten - ein Kind starb inzwischen.

Denn das ist die größte Gefahr beim Einschleusen von künstlicher DNA: Nachgebaute Gene können offenbar Krebsgene aktivieren, weil sie zufällig ins Erbgut eingebaut werden und dabei wichtige Erbinformationen zerstören.

Diese Gefahr lässt sich mit dem neuen Werkzeug vermeiden, da es aus zwei Komponenten besteht. Der so genannte Zinkfinger ist ein Protein, das eine bestimmte Abfolge der DNA-Bausteine erkennt. So lässt sich jede gewünschte Stelle im Erbgut ansteuern. Dann wird die zweite Komponente aktiv, eine Art molekulare Schere, die DNA schneidet. Durch den Schnitt wird ein natürlicher Reparaturmechanismus ausgelöst, bei dem die losen DNA-Enden nicht nur zusammengeführt, sondern auch die DNA-Bausteine vor und hinter dem Schnitt ersetzt werden. Damit die richtige und nicht wieder die mutierte Abfolge von DNA-Bausteinen ergänzt wird, stellen die Wissenschaftler außer ihrem Werkzeug auch noch ein Stück DNA mit der korrekten Gensequenz als Korrekturvorlage zur Verfügung.


Der " Quantensprung" der Sangamo-Forscher

Einen " Quantensprung" nennt Albert Jeltsch von der International University Bremen die Arbeit der Sangamo-Forscher neidlos. Der Molekularbiologe bastelt ähnliche Werkzeuge, indem er an den DNA-bindenden Zinkfinger eine Komponente hängt, die die DNA nicht schneidet, sondern nur verändert. Jeltsch hofft, Gene des Herpes-Virus, das beim Menschen Herpesbläschen verursacht, stillzulegen.

Sangamo will die Zinkfinger-Technologie vor allem zur Therapie von Erbkrankheiten einsetzen, die Blutzellen betreffen, wie zum Beispiel Sichelzellenanämie. Außerdem entwickelt das Unternehmen nach eigenen Angaben eine Therapie gegen HIV-Infektion. Dabei soll das Werkzeug in den Blutzellen ein Gen zerstören, das die Aids-Viren für die Infektion der T-Zellen benötigen.

Aaron Klug, Nobelpreisträger und Entdecker der Zinkfinger-Proteine aus dem britischen Cambridge, ist schon jetzt von den neuen Perspektiven begeistert: " Die Arbeit ist ein Meilenstein auf dem Weg zu genverändernden Therapien."


--------------------------------------------------

Variantenreiche Wissenschaft
Herkömmlich Die intakte Version eines mutierten Gens wird ins Erbgut eingeschleust. Noch gibt es eine Reihe ungelöster technischer Probleme.

Neu Die Forscher lösen im Erbgut einen natürlichen Reparaturmechanismus aus. Dazu haben sie ein Werkzeug entwickelt, das sich aus einem speziellen Protein, dem so genannten Zinkfinger, und einer Art molekularen Schere zusammensetzt, mit der sich DNA schneiden lässt.

ftd.de, 03. 04. 2005
© 2005 Financial Times Deutschland, © Illustration: FTD/am; Quelle: Mark Benecke






Hier der Chart

http://chart.finance.yahoo.com/c/5y/s/sgmo.gif

 

4861 Postings, 7791 Tage BiomediSchoen dass es noch einen Interessenten gibt! o. T.

 
  
    
05.04.05 18:49

29 Postings, 6286 Tage derFahrerPositive HIV/CCR5-ZFN Data

 
  
    
28.09.06 11:17
Sangamo BioSciences Announces Positive HIV/CCR5-ZFN Data in Presentation at 46th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy

RICHMOND, Calif., Sept. 27 /PRNewswire-FirstCall/ -- Sangamo BioSciences, Inc. (Nasdaq: SGMO) announced today data demonstrating that human immune system cells can be made permanently resistant to HIV infection by treatment with zinc finger DNA-binding protein nucleases (ZFN(TM)). Sangamo's ZFNs are designed to permanently modify the DNA sequence encoding CCR5, a co-receptor that enables HIV to enter and infect cells of the immune system. The presentation, entitled, "Towards Gene Knock Out Therapy for AIDS/HIV: Targeted Disruption of CCR5 Using Engineered Zinc Finger Protein Nucleases" is taking place today at the 46th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy in San Francisco.

The presentation is co-authored by Sangamo's collaborators in the laboratory of Dr. Carl June, Director of Translational Research at the Abramson Family Cancer Research Institute at the University of Pennsylvania School of Medicine.

The reported results demonstrate that in T-cell lines and in primary human CD4+ T-cells, administration of Sangamo's CCR5-ZFNs enabled the generation of a population of CCR5-modified, HIV resistant cells. ZFN-modified T-cell lines survived continuous exposure to HIV and expanded to the point that they represented the vast majority of cells in the population at the end of the experiment (70 days). Significant enrichment was also reported for ZFN- modified primary human CD4+ T-cells exposed to HIV. In addition, plasmid DNA plus electroporation and adenoviral vectors were evaluated as modes of delivery of CCR5-specific ZFNs. While both methods support ZFN-mediated CCR5 disruption of T-cells, adenoviral delivery resulted in a ten-fold increase in CCR5-modified cells compared with non-viral methods. Researchers at Sangamo and the University of Pennsylvania are evaluating the long-term consequences and advantages of both delivery methods. Sangamo's clinical goal is to treat T-cells of HIV-infected individuals to generate a reservoir of T-cells that is permanently resistant to HIV infection.

Dale Ando, M.D., Sangamo's vice president of therapeutic development and chief medical officer, commented, "These are very important data, demonstrating that we are able to generate a population of HIV-resistant immune cells similar to the situation in individuals carrying the natural CCR5-delta32 mutation which confers resistance to HIV infection. We believe such a reservoir of healthy and uninfectable T-cells in a patient would be available to fight both opportunistic infections and HIV itself. In addition, we have made significant advances in the production process for this therapeutic approach and determined that delivery of our ZFNs by adenovirus may give us advantages in delivery efficiency and T-cell survival over other delivery methods that we are evaluating."

Dr. Carl June stated, "The positive results being presented at ICAAC continue to strengthen our belief that CCR5-ZFNs are a novel and potentially promising class of anti-HIV compounds. I am greatly encouraged by these findings and look forward to collaborating with Sangamo further to bring this program into the clinic as quickly as possible."

CCR5 is a highly validated therapeutic target for development of drugs to treat HIV. Individuals carrying a naturally occurring mutation of their CCR5 gene, a variant known as CCR5-delta32, have been shown to be resistant to HIV infection. Several major pharmaceutical companies have initiated programs developing small molecule or antibody approaches to block the binding of HIV to CCR5. However, a small molecule or antibody approach to this problem requires the constant presence of a sufficiently high concentration of drug to block therapeutically relevant numbers of the CCR5 protein, which is present in thousands of copies on the surface of each T-cell. The development of several programs to test small molecule antagonists of CCR5 has been halted due to concerns about toxicity of the compounds. In contrast, Sangamo believes that its ZFN technology represents a means of circumventing these limitations. Only brief exposure of immune cells to ZFNs is required for permanent modification of cells' CCR5 protein making them resistant to HIV infection.

About HIV/AIDS and CCR5

HIV stands for Human Immunodeficiency Virus. HIV infection kills or impairs cells of the immune system, progressively destroying the body's ability to fight infections and certain cancers resulting in AIDS (Acquired Immune Deficiency Syndrome). Individuals diagnosed with AIDS are susceptible to life-threatening diseases called opportunistic infections, which are caused by microbes that usually do not cause illness in healthy people. According to Worldaidsday.org, over 3 million people were infected with HIV in 2005. There are now over 40 million people living with HIV and AIDS worldwide.

CCR5 is the chemokine receptor that HIV uses as a coreceptor to gain entry into immune cells. CCR5 is perhaps the most important of the known coreceptors for HIV, since the most commonly transmitted strains of HIV are strains that bind to CCR5 -- so-called "R5" strains. A small fraction of the population carries a mutation in their CCR5 gene, called the delta32 mutation. This mutated version of the gene produces malformed CCR5 proteins, which cannot be used by HIV as a coreceptor. Individuals that have mutant delta 32 versions of both of their CCR5 genes are resistant to infection by R5 HIV strains.

About Sangamo

Sangamo BioSciences, Inc. is focused on the research and development of novel DNA-binding proteins for therapeutic gene regulation and modification. The most advanced ZFP Therapeutic(TM) development programs are currently in Phase 1 clinical trials for evaluation of safety in patients with diabetic neuropathy and peripheral artery disease. Other therapeutic development programs are focused on ischemic heart disease, neuropathic pain, cancer and infectious and monogenic diseases. Sangamo's core competencies enable the engineering of a class of DNA-binding proteins known as zinc finger DNA- binding proteins (ZFPs). By engineering ZFPs that recognize a specific DNA sequence Sangamo has created ZFP transcription factors (ZFP TF(TM)) that can control gene expression and, consequently, cell function. Sangamo is also developing sequence-specific ZFP Nucleases (ZFN(TM)) for therapeutic gene modification as a treatment for a variety of monogenic diseases, such as X- linked SCID and hemophilia, and for infectious diseases, such as HIV. Sangamo has established several Enabling Technology Agreements with companies to apply its ZFP Technology to enhance the production of protein pharmaceuticals. Research at Sangamo is partially funded by an Advanced Technology Program (ATP) grant awarded by the National Institute of Standards and Technology (NIST). For more information about Sangamo, visit the company's web site at www.sangamo.com.

This press release may contain forward-looking statements based on Sangamo's current expectations. These forward-looking statements include, without limitation, references to the research and development of novel ZFP TFs and ZFNs as ZFP Therapeutics, applications of Sangamo's ZFP TF technology platform and clinical trials of ZFP Therapeutics. Actual results may differ materially from these forward-looking statements due to a number of factors, including technological challenges, uncertainties relating to the initiation and completion of stages of ZFP Therapeutic clinical trials, Sangamo's ability to develop commercially viable products and technological developments by our competitors. See the company's SEC filings, and in particular, the risk factors described in the company's Annual Report on Form 10-K and its most recent 10-Q. Sangamo BioSciences, Inc. assumes no obligation to update the forward-looking information contained in this press release.

SOURCE  Sangamo BioSciences, Inc.
   -0-                             09/27/2006
   /CONTACT:  Elizabeth Wolffe, Ph.D. of Sangamo BioSciences, Inc.,
+1-510-970-6000, ext. 271, or ewolffe@sangamo.com; or media, Justin Jackson of
Burns McClellan, Inc., +1-212-213-0006, or jjackson@burnsmc.com, for Sangamo
BioSciences, Inc./
   /Web site:  http://www.sangamo.com /
   (SGMO)

CO:  Sangamo BioSciences, Inc.
ST:  California
IN:  HEA BIO MTC
SU:  TRI TDS

HD
-- SFW100 --
9238 09/27/2006 16:30 EDT http://www.prnewswire.com
 

29 Postings, 6286 Tage derFahrerErgebnis des dritten Quartals - Verlust verringert

 
  
    
31.10.06 14:26
Sangamo BioSciences Corrects Third Quarter 2006 Financial Results

              Net Loss Per Share Improves From $0.09 to $0.08

RICHMOND, Calif., Oct. 30 /PRNewswire-FirstCall/ -- Sangamo BioSciences, Inc. (Nasdaq: SGMO) today reported the shares used in computing the basic and diluted net loss per common share for the third quarter ended September 30, 2006 were incorrect. As a result, the basic and diluted net loss per common share was incorrectly stated as $0.09 per share and should have been stated as $0.08 per share. Set forth below is a complete corrected Selected Financial Data schedule for the three and nine month periods ended September 30, 2006.

   SELECTED FINANCIAL DATA
   (in thousands, except per share data)
   (unaudited)

                                        Three Months Ended  Nine Months Ended
                                           September 30,      September 30,
                                           2006     2005     2006      2005
   Consolidated Statement of Operations
    Data:
   Revenues                               $1,779     $412   $5,692    $1,087
   Operating expenses:
   Research and development                3,853    2,988   11,470     8,210
   General and administrative              1,569    1,216    5,145     3,705
   Total operating expenses                5,422    4,204   16,615    11,915
   Loss from operations                   (3,643)  (3,792) (10,923)  (10,828)
   Interest income, net                      798      125    2,007       228
   Net loss                              $(2,845) $(3,667) $(8,916) $(10,600)

   Basic and diluted net loss per common
    share                                 $(0.08)  $(0.14)  $(0.28)   $(0.42)

   Shares used in computing basic and
    diluted net loss per common share     33,939   25,430   31,960    25,386


   CONDENSED BALANCE SHEET DATA
                                           September 30, 2006   Dec. 31, 2005
   Cash, cash equivalents, and
    investments                                  56,990             $47,174
   Total assets                                  58,299              48,983
   Total stockholders' equity                    50,935              37,814


   About Sangamo BioSciences, Inc.

Sangamo BioSciences, Inc. is focused on the research and development of novel DNA-binding proteins for therapeutic gene regulation and modification. The most advanced ZFP Therapeutic(TM) development programs are currently in Phase 1 clinical trials for evaluation of safety in patients with diabetic neuropathy and peripheral artery disease. Other therapeutic development programs are focused on ischemic heart disease, neuropathic pain, cancer and infectious and monogenic diseases. Sangamo's core competencies enable the engineering of a class of DNA-binding proteins known as zinc finger DNA-binding proteins (ZFPs). By engineering ZFPs that recognize a specific DNA sequence Sangamo has created ZFP transcription factors (ZFP TF(TM)) that can control gene expression and, consequently, cell function. Sangamo is also developing sequence-specific ZFP Nucleases (ZFN(TM)) for therapeutic gene modification as a treatment for a variety of monogenic diseases, such as X-linked SCID and hemophilia, and for infectious diseases, such as HIV. Sangamo has established several Enabling Technology Agreements with companies to apply its ZFP Technology to enhance the production of protein pharmaceuticals. Research at Sangamo is partially funded by an Advanced Technology Program (ATP) grant awarded by the National Institute of Standards and Technology (NIST). For more information about Sangamo, visit the company's web site at www.sangamo.com.

This press release may contain forward-looking statements based on Sangamo's current expectations. These forward-looking statements include, without limitation, references to the research and development of novel ZFP TFs and ZFNs, clinical trials and therapeutic applications of Sangamo's ZFP technology platform. Actual results may differ materially from these forward-looking statements due to a number of factors, including technological challenges, Sangamo's ability to develop commercially viable products and technological developments by our competitors. See the company's SEC filings, and in particular, the risk factors described in the company's Annual Report on Form 10-K and its most recent 10-Q. Sangamo assumes no obligation to update the forward-looking information contained in this press release.

SOURCE  Sangamo BioSciences, Inc.
   -0-                             10/30/2006
   /CONTACT:  Elizabeth Wolffe, Ph.D. of Sangamo BioSciences, Inc.,
+1-510-970-6000, ext. 271, or ewolffe@sangamo.com/
   /Web site:  http://www.sangamo.com /
   (SGMO)

CO:  Sangamo BioSciences, Inc.
ST:  California
IN:  HEA BIO MTC
SU:  ERN

TH-TX
-- SFM134 --
1970 10/30/2006 23:00 EST http://www.prnewswire.com


Gruß,
dF  

29 Postings, 6286 Tage derFahrerMeilensteine erreicht

 
  
    
16.11.06 20:33
Dow AgroSciences and Sangamo BioSciences Announce the Achievement of Multiple Milestones in Their Plant Agriculture Collaboration

Dow AgroSciences and Sangamo BioSciences Announce the Achievement of Multiple Milestones in Their Plant Agriculture Collaboration
Successful Application of Sangamo's ZFN Technology in Plants

INDIANAPOLIS and RICHMOND, Calif., Nov 16, 2006 /PRNewswire-FirstCall via COMTEX News Network/ -- Dow AgroSciences LLC and Sangamo BioSciences, Inc. (Nasdaq: SGMO) today announced the successful completion of multiple research milestones as part of their Research and Commercial License Agreement initiated October 2005.

"We are delighted with the overall progress of the collaboration. The successful completion of these milestones demonstrates that Sangamo's ZFP Nuclease (ZFN(TM)) platform is proving to be as robust and powerful as expected, and we look forward to the successful achievement of additional milestones," said Dan Kittle, Ph.D., Vice President of Research and Development for Dow AgroSciences. "Our recent work at Dow AgroSciences employing ZFNs in plant systems confirms our conviction that the ZFP platform has the potential to truly transform the field of plant genetics."

The three-year agreement provides Dow AgroSciences with access to Sangamo's proprietary zinc finger DNA-binding protein (ZFP) technology for the development of products in plants and plant cell cultures.

"Our ZFP technology can be used to both regulate and modify genes. Because ZFPs function at the DNA level, a molecule common to essentially every organism, our ZFP platform offers great versatility enabling us to address virtually any gene target in any species," said Philip Gregory, D. Phil., Sangamo's vice president of research. "Investments globally in plant genomics continue to uncover an increasing number of genes with the potential to substantially improve crop quality, expand crop uses and improve agronomic performance. All of these genes are potential targets for our ZFP technology, and it is therefore particularly exciting for all of us to have already achieved significant milestones validating the applications of our nuclease technology in plant agriculture. ZFNs provide the ability to make specific modifications to genes, to rapidly and reliably knock out specific genes and to insert genes reproducibly into specific target sites. Combined with the ZFP TF(TM) technology for the up or down-regulation of specific genes in plants, these capabilities hold the potential to revolutionize both the rate of development and the quality of plant products in applications in many different areas of plant agriculture."

"Dow AgroSciences has a strong tradition of innovation and early adoption of new technologies and is recognized as a world leader in innovative plant biotechnology," said Edward Lanphier, Sangamo's president and chief executive officer. "Coupled with Sangamo's expertise in the design and engineering of ZFPs, our combined forces have helped achieve an early competitive advantage for Dow AgroSciences that has the potential to maximize the commercial applications of this technology across the plant and agriculture fields. Because we are developing therapeutics, the application of ZFP TFs and ZFNs in plant agriculture tends to be overlooked. But this is a strategic collaboration for us and one that may realize significant financial return, and I am pleased that the Dow AgroSciences and Sangamo are working so well together as evidenced by the achievement of these early milestones."

ZFPs are the dominant class of naturally occurring transcription factors in organisms from yeast to humans. Transcription factors, which are found in the nucleus of every cell, bind to DNA to regulate gene expression. The ability to selectively control specific genes is emerging as a critical tool in modern biotechnology. Though there are many kinds of transcription factors, only ZFPs are amenable to engineering and precise targeting to a particular gene or genes of interest. By engineering ZFPs that recognize a specific DNA sequence Sangamo scientists have created ZFP TFs(TM) that can control gene expression and consequently, cell function. For example, Sangamo has demonstrated that plant oils can be improved using ZFP TFs.

Sangamo has also developed sequence-specific ZFNs(TM) for precision gene modification and targeted gene insertion. These technologies have the potential to play a major role in bringing new discoveries in genomics forward to the marketplace. The use of Sangamo's ZFP technology to enable the efficient and reproducible generation of combinations or stacks of multiple traits and the insertion of new traits could address increasing demand.

About Dow AgroSciences LLC

Dow AgroSciences LLC, based in Indianapolis, Indiana, USA, is a top tier agricultural company providing innovative crop protection, seeds, and biotechnology solutions to serve the world's growing population. A wholly owned subsidiary of The Dow Chemical Company, global sales for Dow AgroSciences are $3.4 billion. Visit dowagro.com for more information.

About Sangamo BioSciences, Inc.

Sangamo BioSciences, Inc. is focused on the research and development of novel DNA-binding proteins for therapeutic gene regulation and modification. The most advanced ZFP Therapeutic(TM) development programs are currently in Phase 1 clinical trials for evaluation of safety in patients with diabetic neuropathy and peripheral artery disease. Other therapeutic development programs are focused on ischemic heart disease, neuropathic pain, cancer and infectious and monogenic diseases. Sangamo's core competencies enable the engineering of a class of DNA-binding proteins known as zinc finger DNA- binding proteins (ZFPs). By engineering ZFPs that recognize a specific DNA sequence Sangamo has created ZFP transcription factors (ZFP TF(TM)) that can control gene expression and, consequently, cell function. Sangamo is also developing sequence-specific ZFP Nucleases (ZFN(TM)) for therapeutic gene modification as a treatment for a variety of monogenic diseases, such as X- linked SCID and hemophilia, and for infectious diseases, such as HIV. Sangamo has established several Enabling Technology Agreements with companies to apply its ZFP Technology to enhance the production of protein pharmaceuticals. A portion of Sangamo's research in plant agriculture is supported by an Advanced Technology Program (ATP) grant awarded by the National Institute of Standards and Technology. For more information about Sangamo, visit the company's web site at www.sangamo.com.

This press release may contain forward-looking statements based on Dow AgroSciences LLC and Sangamo BioScience, Inc's current expectations. These forward-looking statements include, without limitation, references to the achievement of additional milestones under the Research and Commercial License Agreement and the application of Sangamo's ZFP TFs and ZFNs in plant agriculture. Actual results may differ materially from these forward-looking statements due to a number of factors, including technological challenges, Dow AgroSciences ability to develop commercially viable products and technological developments by our competitors. See the company's SEC filings, and in particular, the risk factors described in the company's Annual Report on Form 10-K and its most recent 10-Q. Dow AgroSciences and Sangamo BioSciences, Inc. assume no obligation to update the forward-looking information contained in this press release.

SOURCE Sangamo BioSciences, Inc.

Robyn Heine of Dow AgroSciences LLC, +1-317-337-4807; or Elizabeth Wolffe, Ph.D. of
Sangamo BioSciences, Inc., +1-510-970-6000, ext. 271, or ewolffe@sangamo.com; or
media, Justin Jackson of Burns McClellan, Inc., +1-212-213-0006, or
jjackson@burnsmc.com

http://www.sangamo.com


Gruß,
dF  

29 Postings, 6286 Tage derFahrerKlinische Phase 2 gestartet

 
  
    
30.11.06 02:39
Sangamo BioSciences Initiates Phase 2 Clinical Trial of Novel Therapy for Diabetic Neuropathy

   Triggers Milestone Payment From Juvenile Diabetes Research Foundation

RICHMOND, Calif., Nov. 29 /PRNewswire-FirstCall/ -- Sangamo BioSciences, Inc. (Nasdaq: SGMO) today announced that the company has initiated a multi-center Phase 2 clinical trial of SB-509 for diabetic neuropathy (DN). The clinical trial is a double-blind, placebo-controlled, repeat-dosing study designed to evaluate the clinical safety and clinical effects of repeat administration of SB-509 in diabetics with mild to moderate diabetic peripheral sensory motor neuropathy in the legs. SB-509 is an injectable formulation of plasmid DNA that encodes a zinc finger DNA-binding protein transcription factor (ZFP TF(TM)), designed to upregulate the vascular endothelial growth factor A (VEGF-A) gene.

The Juvenile Diabetes Research Foundation (JDRF) is providing up to $3 million of financial support for the study. Regulatory acceptance of the trial triggered the first milestone payment from the Foundation.

"Based on the extremely encouraging data that we have observed in our Phase 1 studies, we are very pleased and excited to initiate this Phase 2 trial," said Dale Ando, M.D., Sangamo's vice-president of therapeutic development and chief medical officer. "Our primary objective in the Phase 2 study will be to determine the effect of treatment with SB-509 on the clinical profile of neurologic damage in association with DN. In our Phase 1 studies we observed anecdotal clinical improvements after a single treatment in quantitative sensory testing (QST) which measures perception of vibration, and improvements in average total neuropathy score (TNS), a composite of several measurements including neurologic exam, QST, nerve conduction velocity (NCV) studies and neurologic symptoms."

Activation of VEGF-A has been demonstrated to have potent and direct neurotrophic and neuroprotective properties. In preclinical animal efficacy studies in a diabetic rat model, SB-509 has proven effective in protecting motor and sensory nerve function from diabetes-induced nerve damage. Data from Sangamo's Phase 1 trials demonstrate that a single treatment of SB-509 was well-tolerated and that no drug-related severe adverse events were observed. Injection site reactions were the most common adverse events reported in both treated and placebo groups and were mild and reversible. Importantly, subjects in the Phase 1b study and in the top dose cohorts of the Phase 1a trial were treated within the pharmacologically effective dose range that had been demonstrated to be efficacious in preclinical animal studies, and anecdotal improvements in clinical symptoms were observed.

"This is Sangamo's first Phase 2 trial, an important milestone that demonstrates that we are making significant progress in translating our zinc finger DNA-binding protein (ZFP) technology into a novel class of drugs capable of addressing unmet medical needs," said Edward Lanphier, Sangamo's president and CEO. "We commence this study on a strong scientific, clinical and economic foundation, having reported positive safety findings and preliminary, anecdotal evidence of clinical improvement from our Phase 1 studies of this drug. Currently, patients with DN are treated with analgesics and antidepressants to control pain symptoms. In contrast, SB-509 is designed to address the underlying problem of nerve damage and therefore could have a profound impact on the lives of patients suffering with diabetic neuropathy. It is also gratifying to have the commitment and support of an organization of the stature of JDRF as we advance the clinical development of this drug."

About the Phase 2 study of SB-509

The clinical trial is a double-blind, placebo-controlled, repeat-dosing study designed to evaluate the clinical safety and clinical effects of repeat administration of SB-509 in diabetics with mild to moderate diabetic peripheral sensory motor neuropathy in the legs. The trial will be conducted at multiple sites. SB-509 is an injectable formulation of plasmid DNA that encodes a ZFP TF, designed to upregulate the VEGF-A gene.

Approximately 100 subjects will be enrolled into the trial. Subjects will be randomized to one of two groups in a 2:1 ratio. The larger group (approximately 66 subjects) will be treated by intramuscular injection of 60 mg of SB-509 (30 mg of SB-509 per leg) into the lower limb every 2 months. The remaining group (approximately 33 subjects) will receive an equal volume of placebo on the same schedule. Each subject will receive a total of three treatments (Day 0, 60 and 120). Subjects will receive injections in a distribution pattern that targets the major peripheral nerves in the legs and feet.

The symptoms of diabetic peripheral neuropathy and any changes that occur during the trial will be evaluated based on neurological examination data, electrophysiological testing data, subject neurological questionnaire, and subject pain assessment. Specifically, investigators will use the following tests: the visual analog scale for pain intensity (VASPI), total neuropathy score (TNS) to assess signs and symptoms of the condition. A composite scoring system is widely regarded by neurologists as the most comprehensive approach to evaluating changes in nerve health. In addition to qualitative assessment of symptoms, the TNS includes electrophysiological testing using nerve conduction velocity (NCV) to assess the rate at which a nerve can conduct an electrical signal, and quantitative sensory testing (QST) with the Vibratron II instrument, to assess the threshold of detection of vibration. In addition, skin biopsies will be taken to evaluate the direct therapeutic effect of SB-509 on nerve regrowth. This test is a very sensitive marker of DN severity and may provide an important mechanistic marker for efficacy.

The trial is expected to take approximately 12 months to screen and enroll subjects, four months for subject treatment and a further 8 months for subject follow-up. Individuals interested in participating in this trial should visit http://www.clinicaltrials.com/ or the Sangamo website at http://www.sangamo.com/ .

About Diabetic Neuropathy

Diabetic peripheral neuropathy is one of the most frequent complications of diabetes. Symptoms include numbness, tingling sensations and pain particularly in the toes or feet. This may gradually evolve to loss of sensation and motor function as nerve damage progresses. Ulcers and sores may appear on numb areas of the foot because pressure or injury may go unnoticed. Despite treatment, these areas of trauma may become infected and this infection may spread to the bone, necessitating amputation of the lower leg. More than 60 percent of non-traumatic, lower-limb amputations in the United States occur among people with diabetes. In the period from 2000 to 2001, this translated to approximately 82,000 amputations. According to the Centers for Disease Control, the incidence of diabetes in the United States is growing rapidly. From 1980 through 2002, the number of Americans with diabetes more than doubled.

About Sangamo BioSciences, Inc.

Sangamo BioSciences, Inc. is focused on the research and development of novel DNA-binding proteins for therapeutic gene regulation and modification. The most advanced ZFP Therapeutic(TM) development program is currently in a Phase 2 clinical trial for evaluation of safety in patients with diabetic neuropathy. Phase 1 clinical trials are ongoing to evaluate a ZFP Therapeutic for peripheral artery disease. Other therapeutic development programs are focused on ischemic heart disease, neuropathic pain, cancer and infectious and monogenic diseases. Sangamo's core competencies enable the engineering of a class of DNA-binding proteins known as zinc finger DNA-binding proteins (ZFPs). By engineering ZFPs that recognize a specific DNA sequence Sangamo has created ZFP transcription factors (ZFP TF(TM)) that can control gene expression and, consequently, cell function. Sangamo is also developing sequence-specific ZFP Nucleases (ZFN(TM)) for therapeutic gene modification as a treatment for a variety of monogenic diseases, such as X-linked SCID and hemophilia, and for infectious diseases, such as HIV. Sangamo has established several Enabling Technology Agreements with companies to apply its ZFP Technology to enhance the production of protein pharmaceuticals. For more information about Sangamo, visit the company's web site at www.sangamo.com .

This press release may contain forward-looking statements based on Sangamo's current expectations. These forward-looking statements include, without limitation, references to the clinical trials of SB-509, the research and development of novel ZFP TFs and ZFNs, clinical trials and therapeutic applications of Sangamo's ZFP technology platform. Actual results may differ materially from these forward-looking statements due to a number of factors, including uncertainties relating to the timing of completion of the Phase 2 clinical trial of SB-509, whether the results of the Phase 2 clinical trial will validate the safety and efficacy of SB-509, technological challenges, Sangamo's ability to develop commercially viable products and technological developments by our competitors. See the company's SEC filings, and in particular, the risk factors described in the company's Annual Report on Form 10-K and its most recent 10-Q. Sangamo assumes no obligation to update the forward-looking information contained in this press release.

SOURCE  Sangamo BioSciences, Inc.
   -0-                             11/29/2006
   /CONTACT:  Elizabeth Wolffe, Ph.D. of Sangamo BioSciences, Inc.,
+1-510-970-6000, ext. 271, or ewolffe@sangamo.com; or Justin Jackson of Burns
McClellan, Inc., +1-212-213-0006/
   /Web site:  http://www.sangamo.com/
   (SGMO)

CO:  Sangamo BioSciences, Inc.; Juvenile Diabetes Research Foundation
ST:  California
IN:  HEA BIO MTC
SU:  TRI

GM-SF
-- SFW060 --
7946 11/29/2006 07:00 EST http://www.prnewswire.com
 

29 Postings, 6286 Tage derFahrerProgram to be Acquired

 
  
    
04.12.06 13:20
Edwards' Angiogenesis Program to Be Acquired by Sangamo

Agreement Transfers Edwards' ZFP Therapeutics Program to Sangamo and Enables
            Coordinated Implementation of Future Clinical Trials

IRVINE, Calif. and RICHMOND, Calif., Dec. 4 /PRNewswire-FirstCall/ -- Edwards Lifesciences Corporation (NYSE: EW) and Sangamo BioSciences, Inc. (Nasdaq: SGMO) jointly announced today that the two companies have entered into a definitive asset purchase agreement under which Sangamo will acquire Edwards' angiogenesis program. The Edwards program was originally initiated in 2000 in collaboration with and under license from Sangamo using their proprietary zinc finger protein (ZFP) platform. Under the agreement announced today, Edwards will transfer the assets of its program to Sangamo in exchange for 1 million shares of Sangamo common stock. Edwards will also receive royalties on certain products commercialized in the future based upon ZFP activation of the vascular endothelial growth factor (VEGF) gene. The transaction is expected to be completed by December 31, 2006.

"This transaction with Sangamo provides for focused, combined development of our respective ZFP therapeutics programs and resolves the ongoing issue between the two parties regarding the scope of our respective rights," said Michael Mussallem, Edwards' chairman and CEO. "We're proud that our program has developed products with the potential to help patients dealing with ischemic vascular and cardiovascular disease. Additionally, the transfer of these assets allows these important programs to continue under Sangamo's stewardship and frees up additional Edwards' resources to drive R&D priorities more central to our strategy."

"We are excited about the opportunity to add an additional clinical stage ZFP therapeutic program to our portfolio," said Edward Lanphier, founder, president and CEO of Sangamo BioSciences. "We initiated this program in 2000 and are pleased with the significant investment and progress that Edwards has made in the past six years. In addition to acquiring two clinical stage programs in peripheral vascular disease (PAD) and a late stage pre-clinical program in ischemic heart disease (IHD), this agreement will have a significant impact on Sangamo's future corporate partnering opportunities involving VEGF-ZFP therapeutic programs."

In January of 2000 Edwards, then a division of Baxter International, entered into an exclusive license and research funding agreement with Sangamo to develop and commercialize VEGF-ZFP therapeutics for the treatment and prevention of ischemic cardiovascular and peripheral vascular diseases. Edwards completed pre-clinical efficacy and toxicology studies and initiated a Phase 1 clinical trial in June of 2004 for EW-A-401, a drug based on the VEGF-ZFP transcription factor and designed to treat critical limb ischemia (CLI) as well as intermittent claudication, both painful and limiting conditions of vascular disease. Edwards has stated that early results from the CLI trial have been encouraging and has submitted for approval with the U.S. Food and Drug Administration to begin a randomized, placebo controlled, repeat dosing Phase 2 clinical trial in patients with CLI.

Independently, Sangamo has initiated clinical trials in diabetic neuropathy with a VEGF-ZFP therapeutic known as SB-509. SB-509 and EW-A-401 are nearly identical in design and function. Sangamo recently announced that it has initiated a multi-center, double-blind, placebo controlled, repeat-dosing Phase 2 clinical trial in patients with diabetic neuropathy.

Sangamo and Edwards will host a conference call at 9:00 a.m. EST, Monday, December 4, 2006. The conference call dial-in numbers are 866-543-6411 for domestic callers and 617-213-8900 for international callers. The passcode for the call is 10338848. Participants may access the live webcast via a link on the Sangamo BioSciences website http://phx.corporate-ir.net/phoenix.zhtml?c=120938&p=irol-IRHome in the Investor Relations section under "Company Overview." For those unable to listen in at the designated time, a conference call replay will be available for one week following the conference call, from approximately 11:00 a.m. on December 4, 2006 to December 11, 2006. The conference call replay numbers for domestic and international callers are 888-286-8010 and 617-801-6888 respectively. The conference ID number for the replay is 16084942. The webcast will be available on the Sangamo website for two weeks after the call.

About Sangamo BioSciences

Sangamo BioSciences, Inc. is focused on the research and development of novel DNA-binding proteins for therapeutic gene regulation and modification. The most advanced ZFP Therapeutic(TM) development program is currently in a Phase 2 clinical trial for evaluation of safety in patients with diabetic neuropathy. Phase 1 clinical trials are ongoing to evaluate a ZFP Therapeutic for peripheral artery disease. Other therapeutic development programs are focused on ischemic heart disease, neuropathic pain, cancer and infectious and monogenic diseases. Sangamo's core competencies enable the engineering of a class of DNA-binding proteins known as zinc finger DNA-binding proteins (ZFPs). By engineering ZFPs that recognize a specific DNA sequence Sangamo has created ZFP transcription factors (ZFP TF(TM)) that can control gene expression and, consequently, cell function. Sangamo is also developing sequence-specific ZFP Nucleases (ZFN(TM)) for therapeutic gene modification as a treatment for a variety of monogenic diseases, such as X-linked SCID and hemophilia, and for infectious diseases, such as HIV. Sangamo has established several Enabling Technology Agreements with companies to apply its ZFP Technology to enhance the production of protein pharmaceuticals. For more information about Sangamo, visit the company's web site at www.sangamo.com.

About Edwards Lifesciences

Edwards Lifesciences, a leader in advanced cardiovascular disease treatments, is the number-one heart valve company in the world and the global leader in acute hemodynamic monitoring. Headquartered in Irvine, Calif., Edwards focuses on specific cardiovascular disease states including heart valve disease, peripheral vascular disease and critical care technologies. The company's global brands, which are sold in approximately 100 countries, include Carpentier-Edwards, Cosgrove-Edwards, FloTrac, Fogarty, LifeStent, PERIMOUNT Magna and Swan-Ganz. Additional company information can be found at http://www.edwards.com.

Statements in this announcement other than historical data and information constitute forward-looking statements that involve risks and uncertainties. A number of factors could cause actual results, performance, achievements or industry results to be very different from the results, performance or achievements expressed or implied by such forward-looking statements. Some of these factors include, but are not limited to, the risk factors set forth in each company's filings with the Securities and Exchange Commission including its Annual Report on Form 10-K for the year ended December 31, 2005, and such other filings that Edwards and Sangamo make with the SEC from time to time. Due to such uncertainties and risks, readers are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date hereof.

SOURCE  Edwards Lifesciences Corporation; Sangamo BioSciences, Inc.
   -0-                             12/04/2006
   /CONTACT:  Media, Jared B. Adams, +1-949-250-5070, or Investor, David K.
Erickson, +1-949-250-6826, both of Edwards Lifesciences; or Media, Justin
Jackson of Burns McClellan, Inc., +1-212-213-0006, for Sangamo BioSciences; or
Investor, Elizabeth Wolffe, Ph.D. of Sangamo BioSciences, +1-510-970-6000,
ext. 271/
   /Web site:  http://www.sangamo.com /
   /Web site:  http://www.edwards.com /
   (EW SGMO)

CO:  Edwards Lifesciences Corporation; Sangamo BioSciences, Inc.
ST:  California
IN:  HEA MTC
SU:  TNM CCA MAV

JS-LP
-- LAM020 --
8682 12/04/2006 07:00 EST http://www.prnewswire.com
 

   Antwort einfügen - nach oben