Idera Pharmaceuticals Initiates Phase 1/2 Oncology Trial of HYB2055 in Combination with Chemotherapy Agents Gemcitabine and Carb
October 26 2005 - 9:05AM
PR Newswire (US)
Study to be Conducted at Georgetown University Medical Center
Includes Phase 2 Component in First-Line Non-Small Cell Lung Cancer
CAMBRIDGE, Mass., Oct. 26 /PRNewswire-FirstCall/ -- Idera
Pharmaceuticals, Inc. (AMEX:IDP) announced today that it has
initiated a new Phase 1/2 clinical trial of HYB2055 in combination
with the chemotherapy agents gemcitabine (Gemzar(R), Eli Lilly and
Company) and carboplatin. The trial is now open to patient
enrollment at the Lombardi Comprehensive Cancer Center at
Georgetown University Medical Center. 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 preclinical studies in animal tumor models demonstrated a
significant added benefit from IMO treatment combined with several
standard chemotherapies," said Tim Sullivan, Vice President of
Development Programs at Idera. "As a result, we have initiated the
trial and are seeking to enroll 12 to 18 refractory solid tumor
patients in the Phase 1 portion of the trial. We plan to use the
Phase 1 data for dose selection for the subsequent Phase 2 portion
of the trial in the treatment of naive non-small cell lung cancer
patients." "We have direct experience with HYB2055, because the
initial Phase 1 oncology trial of HYB2055 was conducted by us at
Georgetown," said Shakun Malik, M.D., Chief of the Center for
Thoracic Medical Oncology, and Principal Investigator for the
trial. "Gemcitabine plus carboplatin is a well established doublet
regimen for first-line non-small cell lung cancer, and we look
forward to the evaluation of safety for the three-way combination
with HYB2055 immunotherapy." About the Trial The Phase 1/2 trial is
a two-phase, open-label, dose escalation study of the safety and
efficacy of HYB2055 combined with a standard
gemcitabine/carboplatin treatment regimen. The primary endpoint of
the Phase 1 portion of the trial is to establish an appropriate
HYB2055 dose in combination with a fixed dose of
gemcitabine/carboplatin in patients with solid tumors. In the Phase
2 portion of the study, the primary endpoint is overall response
rate and toxicity of the triplet combination in previously
untreated, advanced non-small cell lung cancer patients. HYB2055
will be administered by subcutaneous injection once per week.
Intended Phase 1 dose levels are 4, 12, and 36 mg/week. Gemcitabine
(Gemzar(R), Eli Lilly and Company) has first-line indications in
the U.S. for breast, pancreatic, and non-small cell lung cancers.
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 recently
announced an amendment of its ongoing Phase 2 trial of HYB2055
monotherapy in patients with renal cell carcinoma, with expansion
of the enrollment targets to 46 treatment-naive and 46 second-line
patients. The Company has previously conducted a Phase 1
monotherapy trial of HYB2055 in solid tumor oncology patients at
Georgetown University Medical Center, data from which was reported
at ASCO 2005 (Abstract 2503). In addition to the chemotherapy
combination trial described in this press release, the Company is
planning additional trials for HYB2055 in other oncology
indications. About Toll-like Receptors (TLRs) Toll-like Receptors
are a family of receptors that control modulation of immune
responses. 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 (TLRs). 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. In addition to the HYB2055 oncology program, Idera
is 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 clinical trials in the time expected; whether the FDA will
comment on the clinical protocols 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 617-679-5500,
x5526 Communications Tim Sullivan 508-647-0209 x12 E-mail: Douglas
MacDougall Georgetown University Medical Center Laura Cavender
202-687-5100 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; or Laura Cavender of Georgetown University
Medical Center, +1-202-687-5100 Web site:
http://www.iderapharma.com/
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