UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
September 28, 2001
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(Date of Report)
ENTROPIN, INC.
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(Exact name of registrant as specified in its charter)
Colorado 33-23693 84-1090424
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(State or other jurisdiction (Commission (IRS Employer
of incorporation) File Number) Identification No.)
45926 Oasis Street, Indio, California 92201
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(Address of principal executive offices, including zip code)
(760) 775-8333
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(Registrant's telephone number, including area code)
N/A
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(Former name or former address, if changed since last report)
ITEM 5. OTHER EVENTS.
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Entropin, Inc. ("Entropin") issued the following press release on
September 25, 2001:
NEWS RELEASE
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ENTROPIN TREATS FIRST PATIENT IN PHASE II/III
CLINICAL TRIAL OF ESTEROM(R)
Planned enrollment of 150 patients over next six months
INDIO, CALIF. (SEPTEMBER 25, 2001) - Entropin, Inc. (NASDAQ: ETOP; ETOPW)
today reported that its Phase II/III clinical trial has begun. The first
patient in this study was treated with Esterom(R), a revolutionary new
topical drug. Esterom(R) has the potential to replace other current
therapeutics for treating impaired physical function resulting from painful
soft tissue injuries and diseases - such as tendonitis, bursitis and lower
back sprain.
The Phase II/III protocol was designed with the assistance of a Blue Ribbon
Panel of medical experts and Entropin's distinguished Scientific and
Medical Advisory Board. The study is being conducted at four clinical
sites selected by Entropin. These are: The Cleveland Clinic in Ohio,
ProHEALTH Associates in New York, Tampa Medical Research Group in Florida,
and The Center for Rheumatology and Bone Disease Research in Maryland.
These sites are recognized centers of excellence where the study will be
led by principal investigators who are medical experts in orthopedics and
rheumatology.
It is estimated that each year 50 million Americans suffer from shoulder
and lower back pain. In a 1998 study, Front Line Strategic Management
Consulting found no products that specifically treat impaired range of
motion associated with back or shoulder sprain. Americans spend nearly
$4.2 billion annually for pain relief on both prescription and over-
the-counter drugs. While these treatments may help manage pain and
discomfort, they do not treat diminished range of motion. In previous
clinical studies, Esterom(R) was shown to be fast acting and
demonstrated no significant side effects.
Entropin's President and Chief Executive Officer, Thomas G. Tachovsky,
Ph.D., commented, "We are delighted to be starting Phase II/III clinical
testing of Esterom(R) following a rigorous protocol design procedure. We
are enthusiastic about the outcome of this study and look forward to
achieving the efficacy levels required by the FDA". Dr. Tachovsky added,
"We have established a positive working relationship with the FDA. As a
result of our discussions, we anticipate the need for at least one
additional clinical study beyond the Phase II/III trial."
The Phase II/III Study is a double blind, placebo-controlled study designed
to treat 150 patients for shoulder pain and disability. Each patient will
receive treatments of 10% Esterom(R) solution on three consecutive days
with a seven day follow-up period. The study has clearly defined endpoints
and will employ validated measurement tools to determine the effect of
Esterom(R) treatments. These tools include the Shoulder Pain and Disability
Index (SPADI), a questionnaire
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designed to assess improvement in pain and mobility associated with
shoulder impairment, as well as pain and range of motion measurements.
The Company expects enrollment of the 150 patients to take approximately
six months. Entropin has contracted with Medidata Solutions for state-
of-the-art on-line centralized data capture to provide real-time monitoring
and to shorten the time required to analyze the data when the study is
complete. Based on the time required to recruit patients that meet the
study's diagnostic entry criteria, the Company anticipates releasing the
results of this study in the first half of 2002.
Entropin, Inc. is a specialty pharmaceutical research and development
company focused on the development of Esterom(R), a revolutionary new
topical product with the potential to replace other current therapeutics
for treating impaired physical function resulting from painful soft tissue
injuries and diseases -- such as tendonitis, bursitis and lower back
sprain.
THIS NEWS RELEASE INCLUDES FORWARD-LOOKING STATEMENTS THAT REFLECT
ENTROPIN'S CURRENT VIEWS WITH RESPECT TO FUTURE EVENTS AND FINANCIAL
PERFORMANCE. THE WORDS "BELIEVE," "EXPECT," "ANTICIPATE," AND SIMILAR
EXPRESSIONS IDENTIFY FORWARD-LOOKING STATEMENTS. FORWARD-LOOKING STATEMENTS
ARE SUBJECT TO A VARIETY OF RISKS, UNCERTAINTIES, AND OTHER FACTORS THAT
COULD CAUSE ACTUAL RESULTS TO DIFFER MATERIALLY FROM THOSE EXPRESSED IN ANY
SUCH FORWARD-LOOKING STATEMENTS. THESE FACTORS INCLUDE, BUT ARE NOT LIMITED
TO: (1) THE ABILITY TO SUCCESSFULLY COMPLETE DEVELOPMENT AND
COMMERCIALIZATION OF PRODUCTS, INCLUDING THE COST, SCOPE AND RESULTS OF
PRECLINICAL AND CLINICAL TESTING; (2) THE ABILITY TO SUCCESSFULLY COMPLETE
PRODUCT RESEARCH AND FURTHER DEVELOPMENT, INCLUDING PRE-CLINICAL AND
CLINICAL STUDIES; (3) THE TIME, COST AND UNCERTAINTY OF OBTAINING
REGULATORY APPROVALS; (4) THE ABILITY TO OBTAIN SUBSTANTIAL ADDITIONAL
FUNDING; (5) THE ABILITY TO DEVELOP AND COMMERCIALIZE PRODUCTS BEFORE
COMPETITORS; AND (6) OTHER FACTORS DETAILED FROM TIME TO TIME IN FILINGS
WITH THE SECURITIES AND EXCHANGE COMMISSION.
SIGNATURES
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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, thereunto duly authorized.
Date: September 28, 2001 ENTROPIN, INC.
By /s/ THOMAS G. TACHOVSKY
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Thomas G. Tachovsky
President and Chief Executive Officer
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