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Biotech / Medical : ARIAD Pharmaceuticals -- Ignore unavailable to you. Want to Upgrade?

To: keokalani'nui who wrote (1501)	5/10/2005 4:30:21 PM
From: keokalani'nui	Respond to of 4474

Orbimed goes over 5% and files a 13d.

To: keokalani'nui who wrote (1501)	5/16/2005 9:16:25 AM
From: PuddleGlum	Read Replies (1) \| Respond to of 4474

This report sounds good to me. But there's essentially no pre-market activity in response. Let's see... we can get tumors to respond to a drug, but how can we get investors/speculators to respond to news? Maybe I'm viewing this through colored glasses, but I don't understand why this is still a sub-$7 stock. biz.yahoo.com ARIAD Reports Positive Early Phase 2 Results on AP23573, Novel mTOR Inhibitor, in Patients with Advanced Sarcomas at ASCO Monday May 16, 8:00 am ET Data Show Clinical Benefit and Symptomatic Improvement ORLANDO, Fla. and CAMBRIDGE, Mass.--(BUSINESS WIRE)--May 16, 2005--ARIAD Pharmaceuticals, Inc. (Nasdaq: ARIA - News) today announced, for the first time, that its novel mTOR inhibitor, AP23573, administered as a single agent, provides striking clinical benefit and symptomatic improvement in advanced sarcoma patients across multiple sarcoma subtypes in an ongoing Phase 2 multicenter clinical trial. Almost all the patients had failed alternative anti-cancer treatments and had progressive disease upon entering the trial. Generally, these patients have a median life expectancy of about one year. ADVERTISEMENT Patient Enrollment The trial began patient enrollment seven months ago in October 2004. Eighty-two patients have been enrolled, followed by a pause in enrollment specified in the protocol based on the trial design. As of the date of analysis, 52 of these patients were evaluable through at least four months on AP23573 treatment - the minimum duration for assessing protocol-defined clinical-benefit response. Full enrollment of 176 patients is expected within two to three months. Clinical-benefit Response and Symptomatic Improvement Thirty-seven percent (37%) of evaluable patients (19/52) in the trial have clinical-benefit responses - sustained anti-tumor activity as defined by strict RECIST guidelines - including three patients with partial responses (confirmed tumor regression >30%) and sixteen patients with stable disease for at least four months. Responding patients continue on trial receiving drug. Five of these patients have demonstrated stable disease for at least six months. Six-month progression-free survival or sustained disease stabilization is becoming a well-recognized surrogate endpoint for long-term survival benefit in patients with advanced sarcomas. Estimates of progression-free survival rates reported by the EORTC Soft Tissue and Bone Sarcoma Group (van Glabbeke et al, 2002) derived from their clinical-trials database provide a benchmark for evaluating the initial AP23573 Phase 2 clinical data. The EORTC six-month progression-free survival rate for patients who received inactive chemotherapies was estimated to be only 8%, which can serve as a comparative control for assessing new treatments for sarcoma such as AP23573. In addition, in an analysis from one major center, 72% (23/32) of patients that entered the AP23573 Phase 2 trial with tumor-related clinical symptoms (e.g., pain, shortness of breath and cough) demonstrated clinically beneficial improvement in these symptoms during AP23573 treatment. "Given the absence of any effective treatments for advanced soft-tissue sarcomas or refractory bone sarcomas that have spread, the initial Phase 2 results being reported today are particularly meaningful for patients with this devastating disease and will form the basis for designing our initial registration trial of AP23573, which we expect to begin by early 2006," said Camille L. Bedrosian, M.D., chief medical officer of ARIAD. Functional Imaging as In Vivo Biomarker Fifty-three patients also underwent glucose-radiotracer positron emission tomographic (PET) imaging as an in vivo biomarker to determine whether functional imaging early in the course of treatment could predict the clinical response to AP23573. The relationship between the mTOR cell-signaling and glucose metabolic pathways provides a strong mechanistic rationale for the use of PET imaging in conjunction with this glucose radiotracer as a non-invasive indicator of in vivo mTOR activity. The decrease in glucose metabolism visualized with PET imaging in the first week of AP23573 treatment was substantially greater in patients with AP23573 anti-tumor responses than in those patients that progressed. This trial provides the first promising indication of the utility of functional imaging to prospectively identify those patients likely to benefit clinically from mTOR inhibition with AP23573 treatment. Trial Objective and Design The primary objective of this multicenter clinical trial is to assess the efficacy of AP23573 in four groups of sarcomas: (1) bone sarcoma, (2) leiomyosarcoma, (3) liposarcoma, and (4) other soft tissue sarcomas. Patients receive a fixed dose of 12.5 mg of AP23573 intravenously, using a daily dosing regimen of drug (five days on, nine days off, drug). The trial uses Simon's two-stage design within each of these sarcoma groups. Four of the initial 19 patients within each group must exhibit a predefined four-month clinical-benefit response based on strict RECIST guidelines before the group can be expanded and enrollment to 44 patients continued. While the full set of patients enrolled in stage 1 of the trial are being followed, further enrollment in the group is paused. Since the strict criteria for continued enrollment have already been met in three of the four cohorts (all except liposarcoma), enrollment into stage 2 of the two-stage design is currently proceeding. Expansion of the liposarcoma group is expected shortly pending review of additional initial response data. These clinical results are being presented at the 2005 American Society of Clinical Oncology (ASCO) annual meeting in Orlando, Florida by clinical investigators, Sant P. Chawla, M.D. (abstract 9068) and Kamalesh K. Sankhala, M.D. (abstract 9028). <snip>