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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): May 5, 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 May 5, 2005, Sangamo BioSciences Inc. issued a press release announcing
that it had initiated a Phase I clinical trial 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.
99.1 Press Release Issued May 5, 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: May 5, 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 INITIATES CLINICAL TRIAL FOR NOVEL THERAPY FOR DIABETIC
NEUROPATHY
FIRST PATIENT TREATED IN PHASE I TRIAL
RICHMOND, Calif., May 5 /PRNewswire-FirstCall/ -- Sangamo BioSciences, Inc.
(Nasdaq: SGMO) today announced that the company has initiated a Phase I clinical
trial of SB-509, a novel therapeutic designed to protect and stimulate the
regeneration of peripheral nerve function in diabetics suffering from peripheral
neuropathy. The multi-center study is designed to evaluate clinical safety of
SB-509 in diabetics with mild to moderate diabetic peripheral sensory motor
neuropathy in the legs.
"We are successfully translating our zinc finger DNA-binding protein (ZFP)
technology into products that are now being tested in human clinical trials to
address significant unmet medical needs," said Edward Lanphier, Sangamo's
president and CEO. "This is an important step on our path to realizing our goal
of building the first new therapeutic product development platform for the 21st
century."
The U.S. Food and Drug Administration cleared an Investigational New Drug
(IND) filing for the single blind, placebo-controlled, dose-escalation trial in
February 2005. The trial began with the screening and treatment of the first
patient at the Diabetes and Glandular Disease Clinic in San Antonio, Texas.
Other trial sites are expected to begin recruitment shortly and Sangamo expects
to have up to a total of 4 sites participating in the study.
"We are very excited to be involved in testing this unique approach to what
has so far been an inevitable problem for the majority of long-term diabetics,"
stated Mark S. Kipnes, M.D., a clinical investigator for Sangamo and
Endocrinologist at the Diabetes and Glandular Disease Clinic. "Currently, apart
from very strict glucose control which is unattainable for most patients; there
is nothing available to treat or protect the damaged nerves directly, only
products, such as analgesics, that treat the symptoms."
SB-509 is an injectable formulation of plasmid DNA that encodes a zinc
finger DNA-binding protein transcription factor (ZFP TFTM), designed to
upregulate the vascular endothelial growth factor A (VEGF-A) gene. VEGF-A has
been demonstrated to have 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 disease-induced
nerve damage. These data will be presented at the 65th Annual Scientific
Sessions of the American Diabetes Association held June 10-14, 2005 in San
Diego, California.
"In previous studies, VEGF-A has been shown to be efficacious for
maintenance of nerve function in this condition and we believe that our approach
of activating the patient's own VEGF-A gene directly may have important
advantages over introducing a cloned gene or recombinant protein," said Dale
Ando, M.D., Sangamo's vice-president of therapeutic development and chief
medical officer. "Although this is primarily a safety study, all of the patients
participating will be given treatment in one leg and placebo in the other. The
trial is designed as a 'single blinded' study therefore neither the treating
doctor nor the patient knows which leg received the treatment. Patient safety
will be monitored throughout the study, and visits at one, two, three and six
months will include neurological examination and electrophysiological testing.
The ability to compare parameters in the treated and untreated leg and in
addition compare to baseline measurements may allow us to gain some preliminary
data on the therapy's effectiveness in improving patients' neurological
functions and electrophysiological parameters."
It is expected that approximately 12 patients will be treated in the trial.
Subjects will receive injections in a distribution that targets the major
peripheral nerves in the legs and feet. The first dose level will be injected in
a distribution to treat nerves in the foot, the second will be distributed to
include nerves in the outside of the lower leg and foot, the third for the whole
lower leg and foot and the fourth for the major nerves in the whole leg from the
thigh down. The trial is expected to take approximately 12 months to screen and
enroll patients and 6 months for patient follow-up. Patients interested in
participating in this trial may visit the Sangamo website at
http://www.sangamo.com/human/human_phase1_trial.html for a list of study sites
and their contact information.
About Diabetic Neuropathy
Diabetic peripheral sensory motor neuropathy is one of the most frequent
complications of diabetes and affects an estimated 50% of diabetics who have
lived with their diabetes for ten years or more. The American Diabetes
Association estimates that there are currently approximately 18.3 million people
with diabetes in the United States. 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. 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.
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 TFTM) 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 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- 05/05/2005
/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