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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM 8-K
CURRENT REPORT PURSUANT
TO SECTION 13 OR 15(D) OF THE
SECURITIES EXCHANGE ACT OF 1934
Date of report (Date of earliest event reported): June 23, 2005
SANGAMO BIOSCIENCES, INC.
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(Exact Name of Registrant as Specified in Its Charter)
Delaware
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(State or Other Jurisdiction of Incorporation)
000-30171 68-0359556
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(Commission File Number) (IRS Employer Identification No.)
501 Canal Blvd, Suite A100 Richmond, California 94804
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(Address of Principal Executive Offices) (Zip Code)
(510) 970-6000
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(Registrant's Telephone Number, Including Area Code)
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(Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to
simultaneously satisfy the filing obligation of the registrant under any of the
following provisions (see General Instruction A.2. below):
[ ] Written communications pursuant to Rule 425 under the Securities
Act (17 CFR 230.425)
[ ] Soliciting material pursuant to Rule 14a-12 under the Exchange
Act (17 CFR 240.14a-12)
[ ] Pre-commencement communications pursuant to Rule 14d-2(b) under the
Exchange Act (17 CFR 240.14d-2(b))
[ ] Pre-commencement communications pursuant to Rule 13e-4(c) under the
Exchange Act (17 CFR 240.13e-4(c))
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ITEM 8.01 OTHER EVENTS
On June 23, 2005, Edwards Lifesciences Corporation issued a press release
announcing that it had initiated a second clinical trial of EW-A-401 at Duke
University Medical Center for the treatment of critical limb ischemia, a symptom
of peripheral artery disease. EW-A-401 is a therapeutic compound developed by
Sangamo Biosciences, Inc designed to stimulate the growth of normal blood
vessels.
A copy of the press release issued by Edwards Lifesciences Corporation relating
to the clinical trial is filed as an exhibit to this Current Report on Form 8-K.
ITEM 9.01 FINANCIAL STATEMENTS AND EXHIBITS
(c) Exhibits. The following material is filed as an exhibit to this Current
Report on Form 8-K:
Exhibit No.
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99.1 Press Release Issued June 23, 2005.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the
Registrant has duly caused this report to be signed on its behalf by the
undersigned hereunto duly authorized.
DATE: June 23, 2005
SANGAMO BIOSCIENCES, INC.
By: /s/ EDWARD O. LANPHIER II
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Edward O. Lanphier II
President, Chief Executive Officer
Exhibit 99.1
EDWARDS LIFESCIENCES ANNOUNCES CLINICAL TRIAL INITIATED
FOR THERAPY TO TREAT CRITICAL LIMB ISCHEMIA
RALEIGH, N.C., June 23 /PRNewswire-FirstCall/ -- Edwards Lifesciences
Corporation (NYSE: EW), a world leader in medical technologies to treat advanced
cardiovascular disease, announced today that Duke University Medical Center has
initiated a Phase I clinical trial to evaluate EW-A-401's safety in the
treatment of critical limb ischemia, a severe form of peripheral artery disease
(PAD) that can result in amputation and limb loss. EW-A-401 is a novel
therapeutic gene transfer compound based on technology licensed from Sangamo
BioSciences, Inc. (Nasdaq: SGMO) that is designed to stimulate the natural
healing and repair of oxygen-starved tissue.
"We've initiated a trial that we think will provide critical information
that will help us understand how the body can improve perfusion in patients with
critical limb ischemia," said Brian Annex, M.D., professor of medicine and
director of vascular medicine at Duke University Medical Center in Durham, North
Carolina. "The patients treated to date have been referred by Dr. Bill Marston
from the vascular surgery division at the University of North Carolina at Chapel
Hill. Through his efforts and those of my colleges in vascular surgery and cell
therapy at Duke, we are optimistic about the study and the progress that is
being made."
EW-A-401 encodes a zinc finger DNA-binding protein transcription factor
which activates a set of the patient's genes, including all isoforms of the
Vascular Endothelial Growth Factor A (VEGF-A), to repair oxygen-starved (or
ischemic) tissue. In preclinical models, the compound was shown to be effective
in stimulating the growth of functionally normal vessels, increasing blood flow
in ischemic limbs, and protecting ischemic tissue. EW-A-401 is also currently
being tested at the National Institutes for Health for the treatment of
intermittent claudication, an early symptom of PAD that results in leg muscle
pain during exercise.
"By combining Edwards Lifesciences' cardiovascular knowledge with Sangamo's
gene regulation technology, we have developed a compound that has the promise to
help patients suffering from some of the most pervasive forms of cardiovascular
disease," said Donald E. Bobo, Jr., Edwards' vice president and general manager
responsible for this initiative. "With this therapy in the early stages of
development, we are cautiously optimistic about the potential benefits EW-A-401
could offer to ischemic vascular disease patients worldwide."
Designed as a multi-dose, dose-escalation study involving up to 16 patients
with 12 months of follow-up, the trial primarily seeks to measure EW-A-401's
safety in treating patients with critical limb ischemia. Among other
measurements, changes in progenitor cell populations will be evaluated to
determine the extent to which tissue repair can be accomplished. In addition,
investigators hope to obtain preliminary data on the therapy's effectiveness in
improving patients' clinical status.
Peripheral Artery Disease Affects between 8 Million and 10 Million Americans
According to the American Heart Association, PAD is estimated to affect
between 8 million and 10 million people in the United States, although the
condition is often under-diagnosed and undertreated. PAD is caused by blockages
to the arteries that supply the legs with blood. The initial sign of PAD is leg
muscle pain during exercise, a symptom known as intermittent claudication. As
the disease progresses, patients can experience leg pain even when resting.
Eventually, some PAD patients have such poor blood flow that they develop
critical limb ischemia and may develop leg ulcers that do not heal, resulting in
limb amputation if unsuccessfully treated.
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 opportunities 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, Fogarty, LifeStent, PERIMOUNT and
Swan-Ganz. Additional company information can be found at
http://www.edwards.com.
For more information about Sangamo BioSciences, Inc., visit the company's
web site at http://www.sangamo.com.
This news release includes forward-looking statements that involve risks and
uncertainties including those related to the successful enrollment of clinical
trials; the ability of EW-A-401 to successfully restore function of ischemic
muscle tissue and help millions of patients with PAD; and other risks detailed
in the company's filings with the Securities and Exchange Commission. These
forward-looking statements are based on estimates and assumptions made by
management of the company and are believed to be reasonable, though they are
inherently uncertain and difficult to predict. Actual results or experience
could differ materially from that expressed or implied by forward-looking
statements.
Edwards is a trademark of Edwards Lifesciences Corporation. Edwards
Lifesciences, Carpentier-Edwards, Cosgrove-Edwards, Fogarty, PERIMOUNT and
Swan-Ganz are trademarks of Edwards Lifesciences Corporation and are registered
in the U.S. Patent and Trademark Office. LifeStent is a trademark of Edwards
Lifesciences AG and is registered in the United States Patent and Trademark
Office.
SOURCE Edwards Lifesciences Corporation
-0- 06/23/2005
/CONTACT: Media, Barry R. Liden, +1-949-250-5070, or Investors,
David K. Erickson, +1-949-250-6826, both of Edwards Lifesciences Corporation/
/First Call Analyst: /
/FCMN Contact: /
/Web site: http://www.edwards.com /
(EW SGMO)
CO: Edwards Lifesciences Corporation; Sangamo BioSciences, Inc.
ST: North Carolina, California
IN: HEA MTC BIO
SU: