UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C.
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
April 1, 2002
-------------
(Date of Report)
ENTROPIN, INC.
--------------
(Exact name of registrant as specified in its charter)
Colorado 33-23693 84-1090424
- ---------------------------- ------------ -------------------
(State or other jurisdiction (Commission (IRS Employer
of incorporation) File Number) Identification No.)
45926 Oasis Street, Indio, California 92201
-------------------------------------------
(Address of principal executive offices, including zip code)
(760) 775-8333
--------------
(Registrant's telephone number, including area code)
N/A
----
(Former name or former address, if changed since last report)
ITEM 5. OTHER EVENTS.
- ---------------------
Entropin, Inc. ("Entropin") issued the following Press Release on
March 27, 2002:
ENTROPIN UPDATES ESTEROM(R) PHASE II/III CLINICAL TRIAL
ENROLLMENT PROGRESS
INDIO, Calif. (March 27, 2002) - Entropin, Inc. (Nasdaq: ETOP, ETOPW), a
specialty pharmaceutical company developing new topical therapeutics for
painful soft tissue injuries and diseases, today updated enrollment
progress for its Phase II/III Clinical Trial of Esterom(R).
Entropin's President and Chief Executive Officer, Thomas G. Tachovsky,
Ph.D., commented, "Our Phase II/III study with Esterom(R) in treating
impaired range of motion associated with acute painful shoulder is well
underway. A total of 57 patients are currently enrolled in our 150
patient Phase II/III Study. Additional patients are being screened and
we continue to receive inquiries daily from individuals interested in
participating."
"We are pleased with the current pace of patient enrollment and continue
to be enthusiastic about the potential positive outcome of this study.
We expect to complete patient enrollment and report the results of this
study in the third quarter of 2002. While we continue to anticipate the
need for at least one additional clinical study, we remain on track to
file a New Drug Application (NDA) for Esterom(R) in 2004," added Dr.
Tachovsky.
This study is examining patients between the ages of 18 and 65 years who
have a soft tissue affliction resulting in impaired function of the
shoulder. The prior Phase II study, demonstrated that Esterom(R) provided
statistically significant improvement for soft tissue afflictions for
both the shoulders and the lower back.
It is management's opinion that Esterom(R) has the potential to replace
other current therapeutics for treating impaired physical function
resulting from soft tissue injuries and diseases - such as tendonitis,
impingement syndrome, bursitis and lower back sprain, and possibly, forms
of arthritis. Esterom(R) is Entropin's investigational drug for patients
suffering from these painful and limiting range of motion medical
conditions.
About Entropin
- --------------
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 PRE-CLINICAL AND
2
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
----------
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: April 1, 2002 ENTROPIN, INC.
By /s/ THOMAS G. TACHOVSKY
--------------------------------
Thomas G. Tachovsky
President and Chief Executive Officer
3