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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): January 10, 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 January 10, 2005, Sangamo BioSciences Inc. issued a press release
announcing that it had submitted an investigational new drug application (IND)
to the U.S. Food and Drug Administration (FDA) for SB-509, a novel therapeutic
designed to protect and stimulate the regeneration of peripheral nerve function
in diabetics suffering from peripheral neuropathy.
The press release is filed as Exhibit 99.1 to this Form 8-K and is incorporated
herein by reference.
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 January 10, 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: January 10, 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 FILES INVESTIGATIONAL NEW DRUG APPLICATION FOR ZFP
THERAPEUTIC TO TREAT DIABETIC NEUROPATHY
RICHMOND, Calif., Jan. 10 /PRNewswire-FirstCall/ -- Sangamo BioSciences,
Inc. (Nasdaq: SGMO) announced today that it has submitted an investigational new
drug application (IND) to the U.S. Food and Drug Administration (FDA) for
SB-509, a novel therapeutic designed to protect and stimulate the regeneration
of peripheral nerve function in diabetics suffering from peripheral neuropathy.
"Our first IND filing is a major milestone for Sangamo and brings us closer
to addressing a serious unmet medical need for the diabetic population," said
Edward Lanphier, Sangamo's president and chief executive officer. "Currently,
the only approved drugs being used treat the symptoms of diabetic neuropathy,
there is nothing approved for therapy of peripheral nerve function. We believe
that our ZPF Therapeutic, SB-509, may provide a new approach to treating this
debilitating condition."
SB-509 is an injectable formulation of plasmid DNA that encodes a zinc
finger DNA-binding protein transcription factor (ZFP TF), designed to upregulate
the vascular endothelial growth factor A (VEGF-A) gene. VEGF A has been
demonstrated to have direct neuroproliferative, neuroregenerative and
neuroprotective properties. In preclinical animal efficacy studies, SB-509 has
proven effective in protecting motor and sensory nerve function in a diabetic
model and in stimulating nerve regeneration.
Pending FDA review of the IND, a multicenter Phase I/II human clinical trial
is scheduled to begin in the first half of 2005. The single-blind,
dose-escalation study is designed to evaluate clinical safety of SB-509 in
diabetics with mild to moderate diabetic peripheral sensory motor neuropathy in
the legs.
"The Phase I/II trial is powered primarily to assess the safety and maximum
tolerated dose of SB-509. However, the subjects enrolled in the study will be
diabetics suffering from diabetic neuropathy," said Dale Ando, M.D., Sangamo's
vice president, therapeutic development and chief medical officer. "In a single
visit, SB-509 will be administered to subjects via injection into one leg and
placebo administered into the contra-lateral limb. This will allow us to
evaluate effects of SB-509 on neurologic symptoms and electrophysiologic nerve
function in the treated versus the untreated limb compared to baseline. The
study is a multi-center trial involving sites experienced in treating diabetic
neuropathy and there is great interest by these centers in participating in the
initial trial of this novel approach and compound."
Diabetic Neuropathy
Diabetic peripheral sensory motor neuropathy is one of the most frequent
complications of diabetes. Symptoms include numbness, tingling sensations and
pain particularly in the toes or feet. This is gradually replaced by 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 goes unnoticed.
Despite adequate treatment, these areas of trauma frequently become infected
and this infection may spread to the bone, necessitating amputation of the leg
or foot. More than 60% 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. The American Diabetes
Association estimates that there are approximately 18.3 million people with
diabetes in the United States and that of those about 60% to 70% have mild to
severe forms of neuropathy. According to the CDC, diabetes is becoming more
common in the United States. From 1980 through 2002, the number of Americans
with diabetes more than doubled.
About Sangamo
Sangamo BioSciences, Inc is focused on the research and development of novel
DNA-binding proteins for therapeutic gene regulation and modification. The
company's most advanced therapeutic development program, currently in a Phase I
clinical trial, involves the use of transcription factors for the treatment of
peripheral artery disease. 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 TFs) that can control gene
expression and, consequently, cell function. Sangamo is also developing
sequence-specific ZFP-Nucleases (ZFNs) 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 SB-509's 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 SB-509. 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- 01/10/2005
/CONTACT: Elizabeth Wolffe, Ph.D. of Sangamo BioSciences, Inc.,
+1-510-970-6000, ext. 271, or ewolffe@sangamo.com; or media, Kathy Nugent,
+1-212-213-0006, or investors, John Cummings, +1-415-352-6262, both of Burns
McClellan, Inc., for Sangamo BioSciences, Inc./
/Web site: http://www.sangamo.com /
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