Amendment to Accommodate Increased Enrollment of Treatment-Naive Patients
CAMBRIDGE, Mass., Oct. 20 /PRNewswire-FirstCall/ -- Idera Pharmaceuticals,
Inc. (Amex: IDP) announced today that it has submitted to the U.S. Food & Drug
Administration a protocol amendment for its ongoing Phase 2 trial of HYB2055
in patients with metastatic or recurrent clear cell renal carcinoma. The
Company submitted the amendment in response to a higher than expected
enrollment rate of treatment-naive patients in the Phase 2 trial. The
amendment provides for enrollment of up to 23 treatment-naive patients at each
of the two dose levels being used in the trial, in addition to the 23 second-
line patients per dose level described in the original study design. HYB2055
(also known as IMO-2055 or IMOxine(R)) is Idera's lead Toll-like Receptor 9
(TLR9) agonist for the treatment of cancer and is based on Idera's proprietary
Immune Modulatory Oligonucleotide (IMO(TM)) technology.
"Our original goal for stage A of the trial was to enroll approximately 50
patients to meet the requirement for 23 second-line patients in each of the
two dose groups," said Tim Sullivan, Vice President of Development Programs at
Idera. "We have 22 active U.S. sites and 52 patients have been enrolled
through October 14, 2005. Over 40% of these patients are treatment naive,
which is markedly higher than we anticipated. As a result, we have submitted
the protocol amendment and plan to continue Phase 2 stage A patient
recruitment into the first half of 2006 as we seek to accrue sufficient
numbers of both treatment-naive and second-line patients to meet the
statistical design. We plan to use the Phase 2 stage A data in the design of
appropriate follow-up trials."
About HYB2055
HYB2055 (also known as IMO-2055 or IMOxine(R)) is Idera's lead Toll-like
Receptor 9 (TLR9) agonist for the treatment of cancer and is based on Idera's
proprietary Immune Modulatory Oligonucleotide (IMO(TM)) technology. The
Company conducted a Phase 1 clinical trial of HYB2055 at Georgetown University
Medical Center, Washington, D.C., which was reported at ASCO 2005 (Abstract
2503). As described in this press release, patient enrollment is ongoing for
a Phase 2 multi-center, open-label study of HYB2055 for injection in patients
with metastatic or locally recurrent clear cell renal carcinoma. The primary
objective is to determine tumor response by RECIST (Response Evaluation
Criteria in Solid Tumors). Secondary objectives are safety, duration of
response, time to progression, survival one year after the last HYB2055 dose,
and effect on quality of life. The Company is planning additional trials for
HYB2055 in non-small cell lung cancer (NSCLC) patients.
About Toll-like Receptors (TLRs)
Toll-like Receptors are immune system receptors that recognize elements of
pathogens such as bacteria and trigger a defensive immune response. Idera's
IMO compounds mimic bacterial DNA and are specifically identified by TLR9.
When TLR9 is activated, it stimulates a response that involves multiple immune
system components acting to fight disease through both innate and adaptive
immunity. Idera's IMO drug candidates have potential applications in a wide
variety of diseases, including cancer, infectious diseases and
asthma/allergies, and can be used in combination with vaccines.
About Idera Pharmaceuticals, Inc.
Idera Pharmaceuticals, Inc. is a biotechnology company focused on the
discovery, development, and commercialization of targeted immune therapies
based on modulation of Toll-like receptors. Idera has identified novel
chemical entities that modulate immune responses through interactions with
TLR9. The Company continues to identify new drug candidates specific to
various diseases, including cancer, infectious diseases and asthma/allergies,
based on the differentiated biological activities of its proprietary
compounds. The Company's website is located at http://www.iderapharma.com.
Idera Pharmaceuticals (Amex: IDP) is based in Cambridge, Massachusetts.
Idera's lead candidate is HYB2055, also known as IMO-2055, a TLR9 agonist
currently in Phase 2 clinical testing for cancer. Idera is also collaborating
with Novartis for the discovery, development, and commercialization of IMO
drug candidates targeting asthma and allergies.
Forward Looking Statements
This press release contains forward-looking statements concerning Idera
Pharmaceuticals, Inc. that involve a number of risks and uncertainties. For
this purpose, any statements contained herein that are not statements of
historical fact may be deemed to be forward-looking statements. Without
limiting the foregoing, the words "believes," "anticipates," "plans,"
"expects," "estimates," "intends," "should," "could," "will," "may," and
similar expressions are intended to identify forward-looking statements. There
are a number of important factors that could cause Idera's actual results to
differ materially from those indicated by such forward-looking statements,
including whether products based on Idera's technology such as HYB2055 will
advance through the clinical trial process on a timely basis or at all and
receive approval from the United States Food and Drug Administration or
equivalent foreign regulatory agencies; whether the Company will complete
enrollment of the trial in the time expected; whether the FDA will comment on
the revised protocol for HYB2055; whether, if the Company's products such as
HYB2055 receive approval, they will be successfully distributed and marketed;
whether Idera's cash resources will be sufficient to fund product development
and clinical trials; and such other important factors as are set forth under
the caption "Risk Factors" in Idera's Quarterly Report on Form 10-Q filed on
August 9, 2005, which important factors are incorporated herein by reference.
Idera disclaims any intention or obligation to update any forward-looking
statements.
Contacts:
Idera Pharmaceuticals, Inc. MacDougall Biomedical Communications
617-679-5500, x5526 508-647-0209 x12
Tim Sullivan Douglas MacDougall
E-mail: tsullivan@iderapharma.com
SOURCE Idera Pharmaceuticals, Inc.
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Related links:
http://www.iderapharma.com
CONTACT:
Tim Sullivan of Idera Pharmaceuticals, Inc.,
+1-617-679-5500, ext 5526, tsullivan@iderapharma.com; or Douglas
MacDougall of MacDougall Biomedical Communications,
+1-508-647-0209 ext. 12
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