Idera Pharmaceuticals Reports Financial Results for the Three Months Ended March 31, 2007.-Company Outlines Expanded Oncology Clinical Development Strategy for IMO-2055- CAMBRIDGE, Mass. -- Idera Pharmaceuticals (AMEX AMEX See: American Stock Exchange : IDP) today announced financial results for the quarter ended March 31, 2007 and provided an outline of its expanded oncology clinical trials program for its lead candidate, IMO-2055. "Idera completed the first quarter in a stronger financial position to expand its Toll-like receptor Toll-like receptors (TLRs) are a class of single membrane-spanning non-catalytic receptors that recognize structurally conserved molecules derived from microbes once they have breached physical barriers such as the skin or intestinal tract mucosa, and activate immune cell (TLR TLR Trailer TLR Toll Like Receptor (immunological research) TLR Temple (University) Law Review TLR Twin Lens Reflex TLR Texas Law Review TLR The Last Resort (gaming clan) ) targeted drug discovery and development programs," stated Sudhir Agrawal, D.Phil., Chief Executive and Chief Scientific Officer of Idera. "As part of our oncology clinical development strategy, we plan to initiate additional studies with IMO-2055 in combination with approved, targeted anti-cancer agents. We have developed this strategy in consultation with members of our Oncology Clinical Advisory Board. In addition, we recently submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) for our second lead product candidate, IMO-2125, and plan to commence a Phase 1 trial of IMO-2125 in patients with hepatitis C Hepatitis C Definition Hepatitis C is a form of liver inflammation that causes primarily a long-lasting (chronic) disease. Acute (newly developed) hepatitis C is rarely observed as the early disease is generally quite mild. in the second half of 2007." Robert W. Karr, M.D., President of Idera, commented, "Combinations of drugs with different mechanisms of action have often shown promise in the treatment of cancer. Our preclinical studies preclinical studies, n.pl a term used to describe research done before a clinical study. May be laboratory or epidemiologic research. demonstrate increased anti-tumor activity when IMO-2055 is combined with approved targeted agents such as Avastin([R]), Erbitux([R]) and Tarceva([R])compared to the activity of any of these agents alone. We intend to expand our oncology clinical development program based on these encouraging data and consistent with our strategy for a combination therapy approach. The recent addition of Dr. Alice Bexon as Vice President of Clinical Development increases our internal human resources The fancy word for "people." The human resources department within an organization, years ago known as the "personnel department," manages the administrative aspects of the employees. to execute our clinical development strategies." Update on Clinical Programs
Oncology program: IMO-2055
-- Idera intends to initiate clinical trials to investigate
IMO-2055 in combination with Tarceva(R), and in triple
combination with Tarceva(R) and Avastin(R), in patients with
non-small cell lung cancer as second-line therapy. The Company
expects to initiate a Phase 1b trial to assess the safety of
the combinations in the third quarter of this year and, subject
to an analysis of the results of the Phase 1b trial, to conduct
a four-arm, randomized, placebo-controlled Phase 2 trial of the
combinations. The Company is currently discussing the protocols
for both trials with the FDA.
-- Idera also plans to initiate clinical trials to investigate
IMO-2055 in combination with Erbitux(R) and Camptosar(R) in
patients with colorectal cancer as second-line therapy. The
Company expects to initiate a Phase 1b trial to assess the
safety of this combination in the fourth quarter of this year
and, subject to an analysis of the results of the Phase 1b
trial, to conduct a randomized, placebo-controlled Phase 2
trial of the combination.
-- Idera is currently conducting a Phase 1/2 clinical trial of
IMO-2055 in combination with the chemotherapy agents Gemzar(R)
and carboplatin in patients with refractory solid tumors. The
Company expects to complete Phase 1 enrollment of this trial in
the second quarter and report the initial results at an
appropriate scientific meeting by the end of 2007.
-- In Idera's on-going Phase 2, Stage A, clinical evaluation of
IMO-2055 monotherapy in patients with renal cell carcinoma
(RCC), the Company has completed enrollment of the planned 46
treatment-naive patients and has enrolled 44 of the intended 46
second-line patients. Idera plans to close enrollment of this
trial on June 29, 2007 if the remaining 2 patients are not
recruited by that time. When final data are available, the
Company will report the results at an appropriate scientific
meeting and decide on the next steps for evaluation of IMO-2055
in RCC.
Hepatitis C program: IMO-2125
-- Idera recently submitted an IND to the FDA for IMO-2125, a
second TLR9 agonist. The Company expects to initiate a Phase 1
trial of IMO-2125 in patients with hepatitis C during the
second half of 2007.
-- Idera has established a Hepatitis C Clinical Advisory Board
which has been advising the Company on the development of
IMO-2125 for hepatitis C. Members of the board are experienced
hepatitis C clinical investigators and include:
-- John McHutchison, M.D., Chairman
Dr. McHutchison is Professor of Medicine at Duke University
Medical Center and Associate Director of GI/Hepatology
Research at Duke Clinical Research Institute, Duke
University School of Medicine in Durham, NC.
-- Michael P. Manns, M.D.
Dr. Mann is Professor and Chairman at the Department of
Gastroenterology, Hepatology and Endocrinology at Hannover
Medical School in Hannover, Germany.
-- Stefan Zeuzem, M.D.
Dr. Zeuzem is Professor of Medicine and Chief of the
Department of Medicine at J. W. Goethe University Hospital
in Frankfurt, Germany.
-- Nezam Afdhal, M.D.
Dr. Afdhal is Associate Professor of Medicine at Harvard
Medical School and Chief of Hepatology and Director of the
Liver Center at Beth Israel Deaconess Medical Center in
Boston, MA.
First Quarter Results The Company reported a net loss of $2.5 million, or $0.12 per share for the three months ended March 31, 2007, compared to a net loss of $3.7 million, or $0.26 per share for the same period in 2006. Total revenues for the three months ended March 31, 2007 were $1.8 million, compared to $0.6 million for the same period in 2006. The increase in revenue is primarily due to license fees recognized under the Company's collaboration agreement with Merck & Co., Inc. (Merck) signed in December 2006. Research and Development expenses for the three months ended March 31, 2007 totaled $2.8 million, compared to $3.0 million for the same period in 2006. The decrease in R&D expense is primarily due to decreased clinical costs in the 2006 period associated with the Phase 2 trial of IMO-2055 in RCC RCC - An extensible language. . General and Administrative expenses for the three months ended March 31, 2007 were $2.0 million, compared to $1.3 million for the same period in 2006. The increase in G&A is primarily attributable to increased professional fees associated with market analysis of therapeutic areas and legal services legal services n. the work performed by a lawyer for a client. . The increase also reflects higher payroll expenses associated with the addition of employees and higher compensation expense related to employee and consultant stock options. Cash, cash equivalents and short-term investments on March 31, 2007 totaled approximately $33.5 million, compared to $38.2 million at December 31, 2006. Recent Accomplishments * In April 2007, two preclinical presentations were made at the Annual Meeting of the American Association for Cancer Research Wikipedia is not the place for advertisement or self-advertising. The American Association for Cancer Research (AACR) is an organization based in Philadelphia, Pennsylvania, that focuses on all aspects of cancer research including basic, clinical and translational . The first presentation was made by a third party contractor of the Company reporting on a preclinical study it conducted in which Idera's IMO-2055 in combination with Nexavar([R]), a drug approved for RCC, showed enhanced antitumor an·ti·tu·mor also an·ti·tu·mor·al adj. Counteracting or preventing the formation of malignant tumors; anticancer. Adj. 1. activity compared to either agent alone in a mouse xenograft xenograft /xeno·graft/ (zen´o-graft) a graft of tissue transplanted between animals of different species; it may be concordant, model. The second presentation was made by Idera reporting on a preclinical study it conducted in which an analog of IMO-2055 optimized for mice was administered by the intranasal route The intranasal route is the route of administration of a drug through the nose, including nose drops or other medications. Some drugs have a higher rate of absorption, and are thus more effective in smaller doses, through this route. and showed potent antitumor activity in mouse models of lung metastases lung metastases Oncology Cancer that has spread from the original–primary tumor to the lung; primary lung cancer spreads to the brain, bone, BM, liver. See Metastasis. of colon carcinoma and melanoma. * In March 2007, Novartis extended the research program under the Company's existing collaboration agreement with Novartis for an additional year until May 2008. In connection with this extension, Novartis made a $1 million milestone payment to Idera in May 2007. The collaboration between Idera and Novartis involves the discovery, development, and commercialization of TLR9 agonists for the treatment of asthma and allergy indications. * In February 2007, the Company presented preclinical data on novel DNA-based TLR antagonists at a Keystone Symposium. In murine murine /mu·rine/ (mur´en) pertaining to, derived from, or characteristic of mice or rats. mu·rine adj. models of lupus lupus (l `pəs), noninfectious chronic disease in which antibodies in an individual's immune system attack the body's own substances. , TLR antagonist-treated mice showed improvement in several disease
parameters.
* In February 2007, the Company announced the appointment of Dr. Alice Bexon as Vice President of Clinical Development. * In February 2007, the Company converted its 4% Convertible Subordinated notes due 2008 in the aggregate principal amount of $5,032,750 into shares of the Company's common stock. * In February 2007, the United States Patent and Trademark Office The United States Patent and Trademark Office (PTO or USPTO) is an agency in the United States Department of Commerce that provides patent protection to inventors and businesses for their inventions, and trademark registration for product and intellectual property issued the Company US patent 7,176,296 claiming compounds comprising a synthetic immunostimulatory motif and an immunomodulatory moiety moiety: see clan. . About Idera Pharmaceuticals, Inc. Idera Pharmaceuticals is a drug discovery and development company that is developing drug candidates to treat cancer and infectious, respiratory, and autoimmune diseases Autoimmune diseases A group of diseases, like rheumatoid arthritis and systemic lupus erythematosus, in which immune cells turn on the body, attacking various tissues and organs. Mentioned in: Complement Deficiencies, Premature Menopause , and for use as vaccine adjuvants. Idera's proprietary drug candidates are designed to modulate TLRs, the body's first line of immune defense. Idera's pioneering DNA DNA: see nucleic acid. DNA or deoxyribonucleic acid One of two types of nucleic acid (the other is RNA); a complex organic compound found in all living cells and many viruses. It is the chemical substance of genes. chemistry expertise enables it to identify drug candidates for internal development and creates opportunities for multiple collaborative alliances. Idera's most advanced clinical candidate, IMO-2055, is an agonist agonist /ag·o·nist/ (ag´ah-nist) 1. one involved in a struggle or competition. 2. agonistic muscle. 3. of TLR9 and is currently in a Phase 2 trial in oncology and in a Phase 1/2 chemotherapy combination trial in oncology. Idera has selected a second TLR9 agonist, IMO-2125, as a lead candidate for treating infectious diseases infectious diseases: see communicable diseases. . Idera is collaborating with Novartis International Pharmaceutical, Ltd. for the discovery, development, and commercialization of TLR9 agonists for the treatment of asthma and allergy indications. Idera is also collaborating with Merck & Co., Inc. for the use of Idera's TLR7, 8 and 9 agonists in combination with Merck's therapeutic and prophylactic prophylactic /pro·phy·lac·tic/ (pro?-fi-lak´tik) 1. tending to ward off disease; pertaining to prophylaxis. 2. an agent that tends to ward off disease. pro·phy·lac·tic n. vaccines in the areas of oncology, infectious diseases, and Alzheimer's disease Alzheimer's disease (ăls`hī'mərz, ôls–), degenerative disease of nerve cells in the cerebral cortex that leads to atrophy of the brain and senile dementia. . For more information, visit www.iderapharma.com. 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 will advance into or through the clinical trial process on a timely basis or at all and receive approval from the United States Food and Drug Administration United States Food and Drug Administration (FDA), n.pr a unit of the Public Health Service created to protect the health of the nation against impure and unsafe foods, drugs, and cosmetics. or equivalent foreign regulatory agencies; whether the Company will complete enrollment of clinical trials or announce trial results in the time expected; whether, if the Company's products receive approval, they will be successfully distributed and marketed; whether the results of preclinical studies will be indicative of results that may be obtained in clinical trials; whether the Company's collaborations with Novartis and Merck will be successful; whether the patents and patent applications owned or licensed by Idera will protect the Company's technology and prevent others from infringing it; 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 Form 10-Q See 10-Q. filed on May 14, 2007, which important factors are incorporated herein by reference. Idera disclaims any intention or obligation to update any forward-looking statements. Avastin([R]) is a registered trademark of Genentech, Inc. Erbitux([R]) is a registered trademark of ImClone Systems ImClone Systems Incorporated (NASDAQ: IMCL) is a biopharmaceutical company dedicated to developing biologic medicines in the area of oncology. It was founded in 1984 and is headquartered in New York City. It is traded on the NASDAQ stock exchange under the symbol IMCL. Incorporated. Tarceva([R]) is a registered trademark of OSI Pharmaceuticals OSI Pharmaceuticals, Inc. is an American pharmaceutical company based in Long Island, New York with facilities in Colorado, New Jersey and the United Kingdom. They specialize in the discovery and development of molecular targeted therapies, and are listed in the NASDAQ , Inc. Camptosar([R]) is a registered trademark of Pfizer. Gemzar([R]) is a registered trademark of Eli Lilly and Company Eli Lilly and Company (NYSE: LLY) is a global pharmaceutical company and one of the world's largest corporations. Eli Lilly's global headquarters is located in Indianapolis, Indiana, in the United States. . Nexavar([R]) is a registered trademark of Bayer Pharmaceuticals Corporation. [TABLE OMITTED] [TABLE OMITTED] |
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