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

To: tuck who wrote (1499)	5/4/2005 9:56:35 AM
From: PuddleGlum	Respond to of 4474

Ariad reports Q1 results: biz.yahoo.com ARIAD Reports First Quarter 2005 Results Wednesday May 4, 7:30 am ET Sarcoma Market Highlights CAMBRIDGE, Mass.--(BUSINESS WIRE)--May 4, 2005--ARIAD Pharmaceuticals, Inc. (Nasdaq: ARIA - News) today announced financial results for the quarter ended March 31, 2005 and provided an update on progress towards achievement of 2005 goals. "We recently chose the treatment of soft-tissue and bone sarcomas as the initial registration path for our novel mTOR inhibitor, AP23573, which was designated a fast-track product by the U.S. Food and Drug Administration (FDA) for this indication. We also initiated several additional clinical trials of AP23573: Phase 2 studies in patients with hormone-refractory prostate cancer and Phase 1b studies combining AP23573 with two chemotherapeutic agents in patients with various solid tumors. Finally, the Investigational New Drug (IND) application for the oral dosage form of AP23573 became effective, and we expect to begin enrollment in this clinical trial shortly," said Harvey J. Berger, M.D., chairman and chief executive officer of ARIAD. "We are clearly on track to achieve all of our key product-development milestones for 2005 on or ahead of schedule." Financial Highlights For the quarter ended March 31, 2005, the Company reported a net loss of $12.3 million, or $0.23 per share, as compared to $6.2 million, or $0.13 per share, for the quarter ended March 31, 2004. The increase in net loss for the quarter is due primarily to higher R&D expenses resulting from execution of the global development plan for its lead cancer product candidate, AP23573. Cash used in operations for the quarter was $10.1 million, consistent with the Company's guidance for 2005 of $39 million to $42 million. The Company ended the first quarter 2005 with $63.4 million in cash, cash equivalents, and marketable securities, compared with $75.5 million at the end of 2004. Sarcoma Market Highlights Urgent Unmet Medical Need. Fast-track designation by the FDA is granted only when there is an urgent need for a new treatment. Patients with soft-tissue and bone sarcomas have a serious and life-threatening condition for which treatment options are limited or non-existent. There are no effective therapies currently available for advanced soft-tissue sarcomas or metastatic refractory sarcomas in general. The Numbers. In the U.S. alone, public health authorities estimate current sarcoma prevalence and incidence of new cases and deaths as follows(1,2). Sarcoma Type Prevalence New Cases Sarcoma Deaths Soft Tissue 71,343 9,420 3,490 Bone and Joint 27,684 2,570 1,210 To put these numbers in perspective: * They are exclusive of Europe, Japan, China and the rest of the world. * The prevalence of all sarcomas is more than five times higher than the prevalence of chronic myelogenous leukemia (CML) - the initial indication for imatinib (Gleevec®). Types of Sarcoma. Sarcomas are malignant tumors associated with one of the various connective tissues that hold the body together, such as muscles, nerves, bones, fat, tendons, cartilage, blood vessel or deep skin tissues. Sarcomas can develop in any part of the body. Half of them develop in the arms or legs; the rest arise in the trunk, head and neck area, internal organs, or the back of the abdominal cavity. Sarcomas are generally divided into two broad classes: soft-tissue sarcomas and bone sarcomas. Soft-tissue Sarcomas. Soft-tissue sarcomas are the most frequent form of the disease. Since many patients with soft-tissue sarcoma are not diagnosed until the disease is far advanced, the 5-year survival rate of those patients with distant metastases is only 10% to 15%. Primary Bone Sarcomas. The three most common kinds of primary bone sarcomas are: osteosarcoma (35%), chondrosarcoma (30%) and the Ewing's family of tumors (16%). Osteosarcoma primarily affects adolescents and young adults and is almost always a highly aggressive tumor with either detectable or subclinical metastases. References. (1) Jemal A, et al. Cancer Statistics, 2005. CA: A Cancer Journal for Clinicians 55(1): 10-30(2005). (2) Statistical Research and Applications Branch National Cancer Institue. Website: seer.cancer.gov. Accessed April 19, 2005. <snip>

To: tuck who wrote (1499)	5/4/2005 1:59:19 PM
From: keokalani'nui	Read Replies (2) \| Respond to of 4474

First aria cc I've ever listened to. Sorry to be negative, as my thoughts have nothing to do with the mTOR cpd, but there was certainly more than a little posing and air blowing going on. Too many words too little said. And the personal, heartfelt, self-congratulating comments by company management over the report of the first patient to have ever received drug (with a partial though durable response), which was the subject of a local television program, was creepy. Why not just run an infomercial. Then, to have talked specifically about this patient and not have directly answered the question whether she was PTEN postive was embarrassing ('there will be data on biomarker issues at asco'). Is this aria group capable of getting it done? (Maybe I shouldn't have listened to INCY's CEO just before.)

To: tuck who wrote (1499)	11/4/2005 2:04:46 PM
From: tuck	Read Replies (1) \| Respond to of 4474

[mTOR a molecular target in HNSCC] >>Cancer Research 65, 9953-9961, November 1, 2005 Mammalian Target of Rapamycin, a Molecular Target in Squamous Cell Carcinomas of the Head and Neck Panomwat Amornphimoltham1,2, Vyomesh Patel1, Akrit Sodhi1, Nikolaos G. Nikitakis2,3, John J. Sauk2,3, Edward A. Sausville3, Alfredo A. Molinolo1 and J. Silvio Gutkind1 1 Oral and Pharyngeal Cancer Branch, National Institute of Dental and Craniofacial Research, NIH, Bethesda; 2 Department of Diagnostic Science and Pathology, Dental School; and 3 Greenebaum Cancer Center, University of Maryland, Baltimore, Maryland Requests for reprints: J. Silvio Gutkind, Oral and Pharyngeal Cancer Branch, National Institute of Dental and Craniofacial Research, NIH, Building 30, Room 212, Convent Drive, Bethesda, MD 20892-4330. Phone: 301-496-6259; Fax: 301-402-0823; E-mail: sg39v@nih.gov. Emerging knowledge on how the dysregulated function of signaling networks contributes to the malignant growth of squamous cell carcinoma of the head and neck (HNSCC) can now be exploited to identify novel mechanism-based anticancer treatments. In this regard, we have observed that persistent activation of the serine/threonine kinase Akt is a frequent event in HNSCC, and that blockade of its upstream kinase, 3'-phosphoinositide-dependent kinase 1, potently inhibits tumor cell growth. Akt promotes cell proliferation by its ability to coordinate mitogenic signaling with energy- and nutrient-sensing pathways that control protein synthesis through the atypical serine/threonine kinase, mammalian target of rapamycin (mTOR). This kinase, in turn, phosphorylates key eukaryotic translation regulators, including p70-S6 kinase and the eukaryotic translation initiation factor, 4E binding protein 1. Indeed, we show here that aberrant accumulation of the phosphorylated active form of S6, the most downstream target of the Akt-mTOR-p70-S6 kinase pathway, is a frequent event in clinical specimens from patients with HNSCC and their derived cell lines. Of interest, this enhanced level of the phosphorylated active form of S6 was rapidly reduced in HNSCC cell lines and HNSCC xenograft models at clinically relevant doses of rapamycin, which specifically inhibits mTOR. Furthermore, we observed that rapamycin displays a potent antitumor effect in vivo, as it inhibits DNA synthesis and induces the apoptotic death of HNSCC cells, ultimately resulting in tumor regression. These findings identify the Akt-mTOR pathway as a potential therapeutic target for HNSCC, and may provide the rationale for the early clinical evaluation of rapamycin and its analogues in patients with HNSCC. << Cheers, Tuck