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
JUNE 27, 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
June 27, 2001:
NEWS RELEASE
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ENTROPIN ADDS FOURTH CLINICAL SITE FOR
ESTEROM(R) PHASE II/III STUDY
INVESTIGATOR TRAINING AT THREE EXISTING SITES COMPLETED
INDIO, Calif. (June 27, 2001) - Entropin, Inc. (Nasdaq: ETOP, ETOPW), a
specialty pharmaceutical company developing new therapeutics for painful
soft tissue injuries and diseases, today announced the addition of a fourth
clinical study site for its upcoming Phase II/III study with Esterom(R).
Entropin also completed an Investigator Training Meeting in preparation for
the study at the Company's first three clinical study sites. Investigators
from these three sites, study site coordinators and representatives from
key support vendors all attended a single comprehensive Investigator
Training Meeting.
The fourth clinical trial site, The Center for Rheumatology and Bone
Disease Research of Wheaton, Maryland, is a division of Arthritis &
Rheumatism Associates, a specialty medical group with more than 30,000
patient visits annually. The Company expects to complete the Investigator
Training Meeting for this site within two weeks.
"The addition of another premier clinical site and thoroughly educating the
personnel at all four sites are integral to the success of our upcoming
trial," said Thomas G. Tachovsky, Ph.D., Entropin's president and chief
executive officer. "It is vital for all of the investigators to perform
well-defined diagnostic tests uniformly prior to patient enrollment, to
apply Esterom(R) solution properly to the shoulder area of enrolled
patients, and to measure and record patient performance consistently
throughout the study."
Dr. Tachovsky continued, "At the conclusion of our comprehensive training
session, the investigators enthusiastically demonstrated their commitment
to the Phase II/III clinical trial of Esterom(R), and we are all looking
forward to the initial patient enrollment."
The Investigator Training Meetings featured a thorough review of the study
protocol, the investigator manual and instructions on the proper
application of Esterom(R). Attendees also participated in a hands-on
workshop to familiarize themselves with the electronic case report form and
the data collection system developed specifically for Entropin by Medidata
Solutions, whereby patient data from each of the sites will be collected
daily at a central website. This electronic data capture is designed to
assist with patient enrollment and screening, to facilitate data monitoring
throughout the study, to enhance data integrity and to shorten the time
required for an analysis of the study results.
The Company anticipates enrolling the first patient in the study during the
third quarter of this year. Each of the four clinical study centers - The
Cleveland Clinic Foundation, ProHealth Care
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Associates, Tampa Medical Research Group and The Center for Rheumatology
and Bone Disease Research - is a recognized center of excellence in
orthopedics and in rheumatology. Enrollment of the 150 patients planned
for the Phase II/III trial is expected to take six months.
Entropin, Inc. is a pharmaceutical research and development company,
initially focused on the development of Esterom(R), a novel topical
therapeutic for the treatment of painful soft tissue injuries, such as
tendonitis or back sprain, that result in impaired function.
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.
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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: June 27, 2001 ENTROPIN, INC.
By /s/ Thomas G. Tachovsky
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Thomas G. Tachovsky
President and Chief Executive Officer
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