-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, Etsh/M0uv36QaT94YxiXmZZDOjRlj6wHVh8XWp/ibBqmby+zB4Wx1K9r5q8BR2gw iaF91eN1TYmy/wyLyFYbEg== 0001157523-04-008891.txt : 20040930 0001157523-04-008891.hdr.sgml : 20040930 20040930090049 ACCESSION NUMBER: 0001157523-04-008891 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20040930 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20040930 DATE AS OF CHANGE: 20040930 FILER: COMPANY DATA: COMPANY CONFORMED NAME: ARIAD PHARMACEUTICALS INC CENTRAL INDEX KEY: 0000884731 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 223106987 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-21696 FILM NUMBER: 041054116 BUSINESS ADDRESS: STREET 1: 26 LANDSDOWNE ST CITY: CAMBRIDGE STATE: MA ZIP: 02139 BUSINESS PHONE: 6174940400 MAIL ADDRESS: STREET 1: 26 LANDSDOWNE CITY: CAMBRIDGE STATE: MA ZIP: 02139 8-K 1 a4730252.txt ARIAD PHARMACEUTICALS 8-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of The Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): September 30, 2004 ARIAD Pharmaceuticals, Inc. (Exact name of registrant as specified in its charter) Delaware 0-21696 22-3106987 (State or other jurisdiction (Commission (I.R.S. Employer of incorporation) File Number) Identification No.) 26 Landsdowne Street, Cambridge, Massachusetts 02139 (Address of principal executive offices) (Zip Code) Registrant's telephone number, including area code: (617) 494-0400 Not Applicable (Former name or former address, if changed since last report) Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below): |_| Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |_| Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |_| Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |_| Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) ITEM 8.01 Other Events. In a press release dated September 30, 2004, ARIAD Pharmaceuticals, Inc. announced, for the first time, updated results of two Phase 1 clinical trials of its novel mTOR inhibitor, AP23573 as a single agent, showing documented tumor regression in patients with advanced cancers - most of whom had progressive disease upon entering the trial and virtually all of whom had failed alternative treatments. These clinical results are being presented today at the 2004 EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics in Geneva, Switzerland. A copy of the press release is filed herewith as Exhibit 99.1 and the information contained therein is incorporated by reference into this Item 8.01 of this Current Report on Form 8-K. ITEM 9.01 Financial Statements and Exhibits. (c) The following exhibits are filed with this report Exhibit Number Description ------ ----------- 99.1 Press release dated September 30, 2004. 2 SIGNATURES Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized. ARIAD Pharmaceuticals, Inc. By: /s/ Edward M. Fitzgerald -------------------------------------- Edward M. Fitzgerald Senior Vice President and Chief Financial Officer Date: September 30, 2004 3 EXHIBIT INDEX ------------- Exhibit Number Description - ------ ----------- 99.1 Press release dated September 30, 2004. 4 EX-99.1 2 a4730252ex99.txt EXHIBIT 99.1 PRESS RELEASE EXHIBIT 99.1 ------------ ARIAD Reports Tumor Regression With AP23573 As a Single Agent in Patients with Relapsed and/or Refractory Cancer CAMBRIDGE, Mass.--(BUSINESS WIRE)--Sept. 30, 2004-- Updated Phase 1 Clinical Results on Novel mTOR Inhibitor Presented at International Cancer Symposium ARIAD Pharmaceuticals, Inc. (Nasdaq: ARIA) today announced, for the first time, updated results of two Phase 1 clinical trials of its novel mTOR inhibitor, AP23573 as a single agent, showing documented tumor regression in patients with advanced cancers - most of whom had progressive disease upon entering the trial and virtually all of whom had failed alternative treatments. These clinical results are being presented today at the 2004 EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics in Geneva, Switzerland. Combined Trial Results: Anti-tumor Responses Of 49 evaluable patients in the two trials, tumor regression was demonstrated in 9 patients (4 "partial responses" by RECIST with at least 30% reduction in tumor size and 5 "minor responses" with 15% to 29% reduction). In an additional 15 patients, disease stabilization was achieved. Overall, 49% (24 of 49) of the patients in the two trials had documented anti-tumor responses (including partial and minor responses and stable disease), with a median response of 5 months in those demonstrating anti-tumor responses, extending to greater than 18 months - the longest treatment to date. Anti-tumor responses were demonstrated in 9 different refractory and/or relapsed cancers, including all evaluable patients with sarcoma (5 of 5), kidney cancer (7 of 7) and lymphoma (1 of 1), as well as 2 of 3 patients with non-small cell lung (NSCL) cancer. "We are extremely encouraged by the number of patients with relapsed and/or refractory cancer who demonstrated tumor regression with AP23573 in Phase 1 clinical trials, as well as the breadth of tumors that are responding to our novel mTOR inhibitor," said Harvey J. Berger, M.D., chairman and chief executive officer of ARIAD. "As a clinician, I was particularly struck by the results in one patient with a Ewing's sarcoma who had received nine prior anticancer regimens. After four cycles of AP23573, CT scans showed a 62% reduction in the size of the mass; this patient continues on study. Phase 2 studies of AP23573 are ongoing in patients with hematologic cancers and solid tumors." Daily Dosing Trial Results In the 27 evaluable patients in the daily dosing trial - the dosing regimen being used in current Phase 2 clinical trials - AP23573 produced tumor regression in 7 patients: -- Partial response - Sarcoma, lymphoma, and NSCL cancer (1 each) -- Minor response - Sarcoma, NSCL, kidney, and thyroid cancers (1 each). An additional 9 patients in this trial had stabilization of their disease (overall 59% with anti-tumor response). Weekly Dosing Trial Results In the 22 evaluable patients in the weekly dosing trial, AP23573 also produced tumor regression in 2 patients, both with particularly difficult-to-treat cancers, even when the drug was administered only once each week: -- Partial response - Bladder cancer (1) (unconfirmed, repeat scans pending) -- Minor response - Mesothelioma, a form of chest-cavity cancer (1). An additional 6 patients in this trial had stabilization of their disease (overall 36% with anti-tumor response). Additional Combined Trial Results The daily dosing trial is ongoing at the Institute for Drug Development, Cancer Therapy and Research Center, San Antonio (M. Mita, M.D. and A. Tolcher, M.D.), and the weekly dosing trial is ongoing at the University of Chicago Cancer Center (A. Desai, M.D. and M. Ratain, M.D.). AP23573 has been well tolerated by patients in both trials, with generally mild or moderate, readily reversible adverse events. The dose-limiting toxicity was severe oral mucositis, an inflammatory irritation of the mucous membranes of the mouth and a common finding in cancer patients on various types of treatments. Pharmacodynamic assays on patient samples demonstrated a good correlation of blood levels of AP23573 with inhibition of AP23573's molecular target, the protein mTOR. Greater than 90% inhibition was observed within 1 hour after dosing in all patients in both trials. With daily dosing of AP23573, there was sustained inhibition of mTOR activity for up to 10 days in the majority of patients studied. The pharmacokinetic (blood-clearance) profile of AP23573 was found to be highly predictable and reproducible, with a median half-life of 49 hours for all patients with complete data in the two trials. In contrast to other mTOR inhibitors in clinical trials, AP23573 was stable in vivo and is not a pro-drug. About AP23573 The small-molecule drug, AP23573, starves cancer cells and shrinks tumors by inhibiting the critical cell-signaling protein, mTOR, which regulates the response of tumor cells to nutrients and growth factors, and controls tumor blood supply and angiogenesis through effects on Vascular Endothelial Growth Factor (VEGF). About the Company ARIAD is engaged in the discovery and development of breakthrough medicines to treat cancer by regulating cell signaling with small molecules. The Company is developing a comprehensive approach to patients with cancer that addresses the greatest medical need - aggressive and advanced-stage cancers for which current treatments are inadequate. ARIAD also has an exclusive license to pioneering technology and patents related to certain NF-(kappa)B treatment methods, and the discovery and development of drugs to regulate NF-(kappa)B cell-signaling activity, which may be useful in treating certain diseases. Additional information about ARIAD can be found on the web at http://www.ariad.com. Some of the matters discussed herein are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements are identified by the use of words such as "anticipate," "estimate," "expect," "project," "intend," "plan," "believe," and other words and terms of similar meaning in connection with any discussion of future operating or financial performance. Such statements are based on management's current expectations and are subject to certain factors, risks and uncertainties that may cause actual results, outcome of events, timing and performance to differ materially from those expressed or implied by such forward-looking statements. These risks include, but are not limited to, risks and uncertainties regarding the Company's ability to accurately estimate the actual research and development expenses and other costs associated with the preclinical and clinical development of our product candidates, the adequacy of our capital resources and the availability of additional funding, risks and uncertainties regarding the Company's ability to successfully conduct preclinical and clinical studies of its product candidates, risks and uncertainties that clinical trial results, such as those noted in this press release, at any phase of development may be adverse or may not be predictive of future result or lead to regulatory approval of any of the Company's product candidates, and risks and uncertainties relating to regulatory oversight, intellectual property claims, the timing, scope, cost and outcome of legal proceedings, future capital needs, key employees, dependence on the Company's collaborators and manufacturers, markets, economic conditions, products, services, prices, reimbursement rates, competition and other risks detailed in the Company's public filings with the Securities and Exchange Commission, including ARIAD's Annual Report on Form 10-K for the fiscal year ended December 31, 2003. The information contained in this document is believed to be current as of the date of original issue. The Company does not intend to update any of the forward-looking statements after the date of this document to conform these statements to actual results or to changes in the Company's expectations, except as required by law. CONTACT: ARIAD Pharmaceuticals, Inc. Tom Pearson, 610-407-9260 or Kelly Lindenboom, 617-621-2345 -----END PRIVACY-ENHANCED MESSAGE-----