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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 13, 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 13, 2005, Sangamo BioSciences Inc. issued a press release
announcing that preclinical data from its program to develop a ZFP
Therapeutic(TM) for diabetic neuropathy were presented at the American Diabetes
Association 65th Scientific Sessions held in San Diego, June 10-14th, 2005.
A copy of the press release issued by Sangamo BioSciences, Inc. relating to this
event 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 13, 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 13, 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
SANGAMO BIOSCIENCES ANNOUNCES PRESENTATION OF DATA AT AMERICAN DIABETES
ASSOCIATION MEETING
DATA SUPPORTS ONGOING PHASE I CLINICAL TRIAL
RICHMOND, Calif., June 13 /PRNewswire-FirstCall/ -- Sangamo BioSciences,
Inc. (Nasdaq: SGMO) today announced that preclinical data from its program to
develop a ZFP Therapeutic(TM) for diabetic neuropathy were presented at the
American Diabetes Association 65th Scientific Sessions held in San Diego, June
10-14th, 2005. Professor David Tomlinson, Faculty of Life Sciences, University
of Manchester, U.K. presented the work which demonstrates animal efficacy for a
zinc finger DNA-binding protein transcription factor (ZFP TF(TM)) that is
currently being tested in a Phase I human clinical trial.
"These data clearly show that local, intramuscular injection of the ZFP TF
plasmid significantly increases both motor and sensory nerve conduction
velocities in rats with experimental diabetic neuropathy," said Professor
Tomlinson. "This effect was durable after just a single treatment. Clearly, this
approach has massive potential for the management of diabetic neuropathy."
Professor Tomlinson tested a plasmid DNA that encodes ZFP TF(TM), designed
to "turn on" the vascular endothelial growth factor A (VEGF-A) gene. VEGF-A has
been demonstrated to have direct neurotrophic and neuroprotective properties. In
this study, the DNA was injected into two sites in the hind limb of diabetic
rats and, after one month, nerve conduction velocities in both the treated and
untreated limb were compared. Diabetes results in a gradual decline in nerve
conduction velocities in both motor and sensory nerves. In contrast, Professor
Tomlinson observed that there was a significant, dose-related increase in both
motor and sensory nerve conduction velocities in the limbs treated with the
three highest doses of the ZFP TF compared with the untreated limbs. The same
therapeutic, SB-509, is now being tested in a multicenter, single blind,
placebo-controlled, dose-escalation Phase I trial in humans.
"We were greatly encouraged by Dr. Tomlinson's data and thus moved this
program into the clinic," explained Dr. Dale Ando, Sangamo's vice president of
therapeutic development and chief medical officer. "While our Phase I human
clinical trial is primarily designed to assess safety, we are also evaluating
this ZFP TF in patients with diabetic neuropathy and will be comparing the
effects of a single treatment in one leg compared with a placebo treatment in
the other leg. The ZFP TF will be administered by injection in a distribution
that targets the major peripheral nerves in the legs and feet. We will measure
nerve conduction velocities, the primary end-point in most clinical trials of
therapeutic agents targeted at neuropathy at one, two, three and six months. In
this way we hope to extract as much information from this study as possible."
"Currently, there are no effective therapies available to treat this
debilitating and frequent complication of diabetes and patients are generally
prescribed painkillers to alleviate symptoms," noted Mark Kipnes, M.D., a
clinical investigator for Sangamo and endocrinologist at the Diabetes and
Glandular Disease Clinic, San Antonio, Texas, one of the centers participating
in the Phase I clinical trial of SB-509. "We are excited to be involved in
testing this novel approach that may potentially have a dramatic therapeutic
effect in patients already suffering from neuropathy and those that are at risk
for developing it."
"We believe that our VEGF ZFP Therapeutic(TM) may address this growing unmet
medical need and provide an approach that may protect and treat the affected
nerves directly," said Edward Lanphier, Sangamo's president and CEO. "We are
also exploring the use of this ZFP Therapeutic in other animal models of nerve
trauma in an effort to learn more about the effects that we have observed in our
preclinical studies."
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 I
clinical trials for evaluation of safety in patients with peripheral artery
disease and diabetic neuropathy. Other therapeutic development programs are
focused on ischemic heart disease, congestive heart failure, cancer, neuropathic
pain, 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 and possible cure for a variety of monogenic
diseases, such as sickle cell anemia, and for infectious diseases such as HIV.
For more information about Sangamo, visit the company's web site at
www.sangamo.com or www.expressinglife.com
This press release contains forward-looking statements regarding Sangamo's
current expectations. These statements are not guarantees of future performance
and are subject to certain risks, uncertainties and assumptions that are
difficult to predict. Factors that could cause actual results to differ include
the early stage of ZFP Therapeutic development, uncertainties related to the
timing of initiation and completion of clinical trials, and whether clinical
trial results will validate and support the safety and efficacy of ZFP
Therapeutics. Further, there can be no assurance that the necessary regulatory
approvals will be obtained or that Sangamo will be able to develop commercially
viable gene based therapeutics. Actual results may differ from those projected
in forward-looking statements due to risks and uncertainties that exist in the
company's operations and business environments. These risks and uncertainties
are described more fully in the company's Annual Reports on Form 10-K and
Quarterly Reports on Form 10-Q as filed with the Securities and Exchange
Commission. Forward-looking statements contained in this announcement are made
as of this date and will not be updated.
SOURCE Sangamo BioSciences, Inc.
-0- 06/13/2005
/CONTACT: Elizabeth Wolffe, Ph.D. of Sangamo BioSciences, Inc.,
+1-510-970-6000, ext. 271, or ewolffe@sangamo.com; or investors,
John Cummings, +1-415-352-6262, or media, Justin Jackson, +1-212-213-0006, or
jjackson@burnsmc.com, both of Burns McClellan, Inc./
/Web site: http://www.sangamo.com /