Idera Pharmaceuticals Amends HYB2055 Phase 2 Renal Cell Carcinoma Protocol
October 20 2005 - 9:05AM
PR Newswire (US)
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: DATASOURCE: Idera Pharmaceuticals, Inc. CONTACT:
Tim Sullivan of Idera Pharmaceuticals, Inc., +1-617-679-5500, ext
5526, ; or Douglas MacDougall of MacDougall Biomedical
Communications, +1-508-647-0209 ext. 12 Web site:
http://www.iderapharma.com/
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