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SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
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FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15 (d) of the
Securities Exchange Act of 1934
DATE OF REPORT - MARCH 31, 1997
(Date of earliest event reported)
ALKERMES CLINICAL PARTNERS, L.P.
(Exact name of Registrant as specified in its charter)
DELAWARE 0-26758 043-145043
(State of organization) (Commission file number) (IRS employer
identification
number)
64 SIDNEY STREET, CAMBRIDGE, MASSACHUSETTS 02139
(Address of principal executive offices, zip code)
AREA CODE (617) 494-0171
(Telephone number)
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ITEM 5. OTHER INFORMATION.
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As reported in the press release, published March 31, 1997, of Alkermes,
Inc. ("Alkermes"), which is developing RMP-7 for Alkermes Clinical Partners,
L.P., Alkermes announced preliminary results of its third Phase II clinical
trial of the drug delivery agent RMP-7 administered intravenously in conjunction
with the chemotherapeutic agent carboplatin in patients with recurrent,
malignant brain tumors. Study ALK01-017 was a multi-center, blinded, randomized,
placebo controlled Phase II clinical trial designed to compare the safety and
efficacy of treatment with intravenous RMP-7 and carboplatin to treatment with
intravenous placebo and carboplatin. The study did not meet its primary endpoint
of time to tumor progression as measured by changes in tumor volume on magnetic
resonance imaging (MRI). The study was designed to include multiple additional
endpoints, and data analysis is continuing. Observed trends toward increased
survival time, six month survival rate and slowed progression of functional
impairment for patients receiving the combination of RMP-7 and carboplatin
compared to patients receiving treatment with carboplatin alone are being
analyzed.
ITEM 7. FINANCIAL STATEMENTS AND EXHIBITS.
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(c) Exhibits
99 Press Release, dated March 31, 1997
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SIGNATURES
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Pursuant to requirements of Section 13 or 15(d) 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.
Dated: April 2, 1997 Alkermes Clinical Partners, L.P.
By its General Partner
Alkermes Development Corporation II
By: /s/ Michael J. Landine
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Michael J. Landine
Vice President and Chief
Financial Officer
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ALKERMES CLINICAL PARTNERS, L.P.
CURRENT REPORT ON FORM 8-K
EXHIBIT INDEX
Exhibit No. Exhibit
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99 Press Release, dated March 31, 1997
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Exhibit 99
NEWS RELEASE
ALKERMES
FOR IMMEDIATE RELEASE
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ALKERMES ANNOUNCES PRELIMINARY RESULTS OF U.S. PHASE II CLINICAL
TRIAL OF INTRAVENOUS RMP-7(TM) AND CARBOPLATIN
THIRD PHASE II STUDY OF DRUG DELIVERY AGENT IN PATIENTS WITH BRAIN TUMORS
CAMBRIDGE, MA, MARCH 31, 1997 - Alkermes, Inc. (NASDAQ:ALKS) announced today
preliminary results of its third Phase II clinical trial of the drug delivery
agent RMP-7 administered intravenously in conjunction with the chemotherapeutic
agent carboplatin in patients with recurrent, malignant brain tumors. Study
ALK01-017 was a multi-center, blinded, randomized, placebo controlled Phase II
clinical trial designed to compare the safety and efficacy of treatment with
intravenous RMP-7 and carboplatin to treatment with intravenous placebo and
carboplatin. The study did not meet its primary endpoint of time to tumor
progression as measured by changes in tumor volume on magnetic resonance imaging
(MRI). The study was designed to include multiple additional endpoints, and data
analysis is continuing. Observed trends toward increased survival time, six
month survival rate and slowed progression of functional impairment for patients
receiving the combination of RMP-7 and carboplatin compared to patients
receiving treatment with carboplatin alone are being analyzed.
This study is the third Phase II study of intravenous RMP-7 and carboplatin to
be completed. In December 1996, Alkermes announced the results of two, open
label, European Phase II clinical trials of RMP-7 and carboplatin in patients
with recurrent, malignant brain tumors. The results showed that the drug
combination was well tolerated and provided positive responses as measured by
patients' neurological impairment, performance status and tumor volume. The
European clinical trials employed a different carboplatin dosing regimen than
the U.S. trial and had different patient enrollment criteria.
"The analysis of the results of ALK01-017 is ongoing and will provide a
significant amount of additional data relating to the effect of RMP-7 and
carboplatin," said Richard Pops, Chief Executive Officer of Alkermes. "These
data, when completed and analyzed together with the data from our two previously
completed European Phase II studies, will provide us with information necessary
for designing a Phase III clinical trial of RMP-7 and carboplatin in
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patients with recurrent brain tumors."
The Phase II study enrolled 121 patients who had relapsed following previous
treatment with surgery, radiotherapy and, in most cases, chemotherapy. The study
was unblinded the evening of Friday, March 28, 1997 and data analysis is
currently underway.
RMP-7 is being developed by Alkermes for Alkermes Clinical Partners, L.P., a
limited partnership which raised $46 million in 1992 to develop RMPs. Alkermes
has the option to purchase the partnership's technology.
Alkermes is a leader in the development of products based on sophisticated drug
delivery technologies. Alkermes' focus is on two important drug delivery
opportunities: (i) controlled, sustained release of injectable drugs lasting
several days to several weeks, utilizing its ProLease(R) and Medisorb(R)
technologies; and (ii) the delivery of drugs into the brain past the blood-brain
barrier, utilizing its RMP-7 technology. In addition to its Cambridge,
Massachusetts headquarters, Alkermes operates a manufacturing facility in Ohio
and a medical affairs office in Cambridge, England.
This press release contains forward-looking statements within the meaning of the
Private Securities Litigation Reform Act of 1995. Actual results could vary
materially from those described in this press release as a result of a number of
factors, including but not limited to the following: There can be no assurance
that RMP-7 or any other product candidate of Alkermes will be successfully
developed or manufactured, or that Alkermes will be permitted to conduct
additional clinical trials of RMP-7 or any other product candidate, or that
final results of human clinical trials of RMP-7 or any other product candidate
will be supportive of regulatory approvals required to market products, or that
final regulatory approval of RMP-7 or any other product candidate will be
received in a timely manner, if at all. The Company undertakes no obligation to
revise or update these forward-looking statements to reflect events or
circumstances after the date of this press release.
Contact:
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Richard F. Pops Investor Relations:
Chief Executive Officer Lisa Burns
Alkermes, Inc. Burns McClellan
(617)494-0171 (212)505-1919
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