Exelixis, Inc. (EXEL) | Stock Discussion Forums

SiliconInvestor

register

Biotech / Medical | Exelixis, Inc. (EXEL)

Previous 10 | Next 10

From: IRWIN JAMES FRANKEL	6/26/2011 7:47:19 PM
	of 892

The Best of ASCO® Miami Program agenda Friday, July 29, 2011 7:15 AM – 3:30 PM Exhibit Hall Open 7:15 – 8:00 AM Continental Breakfast Provided 8:00 AM Welcome & Chair Remarks Daniel F. Hayes, MD – Chair, 2011 Best of ASCO Program Committee 8:00 AM – 8:45 AM Breast Cancer – HER/ER Harold J. Burstein, MD, PhD - Dana-Farber Cancer Institute Abstract #505: TBCRC 006: A multicenter phase II study of neoadjuvant lapatinib and trastuzumab in patients with HER2-overexpressing breast cancer. (J. Chang) Abstract #509:LANDSCAPE: A FNCLCC phase II study with lapatinib (L) and capecitabine (C) in patients with brain metastases (BM) from HER2-positive (+) metastatic breast cancer (MBC) before whole brain radiotherapy (WBR). (T. Bachelot) Abstract #506: Correlation of molecular effects and pathologic complete response to preoperative lapatinib and trastuzumab, separately and combined prior to neoadjuvant breast cancer chemotherapy. (F. Holmes) Abstract #LBA504: NCIC CTG MAP.3: a phase III placebo-controlled Breast Cancer Prevention Trial of exemestane in postmenopausal women at risk for breast cancer. (P.E. Goss) 8:45 AM – 9:45 AM Breast Cancer – Triple-negative/Cytotoxics/Local Therapy Carey Anders, MD - University of North Carolina, Chapel Hill Abstract #1004: First analysis of SWOG S0221: A phase III trial comparing chemotherapy schedules in high risk early breast cancer. (G.T. Budd) Abstract #1007: A randomized phase III study of iniparib (BSI-201) in combination with gemcitabine/carboplatin (G/C) in metastatic triple-negative breast cancer (TNBC). (J. O’Shaughnessy) Abstract #LBA1003: NCIC-CTG MA.20: An intergroup trial of regional nodal irradiation in early breast cancer. (T. J. Whelan) Abstract #LBA1005: The effect on pCR of bevacizumab and/or antimetabolites added to standard neoadjuvant chemotherapy: NSABP protocol B-40. (H.D. Bear) Abstract #1000: Genetic associations with taxane-induced neuropathy by genome-wide association study (GWAS) in E5103. (B. P. Schneider) 9:45 AM – 10:00 AM Break 10:00 AM – 11:00 AM Head and Neck Cancer D. Neil Hayes, MD, MPH - University of North Carolina, Chapel Hill Abstract #5500: A randomized phase III trial (RTOG 0522) of concurrent accelerated radiation plus cisplatin with or without cetuximab for stage III-IV head and neck squamous cell carcinomas (HNC). (K. K. Ang) Abstract #5502: A randomized phase II/III trial of a tumor vascular disrupting agent fosbretabulin tromethamine (CA4P) with carboplatin (C) and paclitaxel (P) in anaplastic thyroid cancer (ATC): Final survival analysis for the FACT trial. (J. A. Sosa) Abstract #5501: Sequential chemoradiotherapy (SCRT) for larynx preservation (LP): Results of the randomized phase II TREMPLIN study. (J. Lefebvre) Abstract #5505: Prediction of clinical outcome in patients with primary laryngeal carcinoma using gene expression profiling. (E. Fountzilas) Abstract #LBA5524: Phase ??? trial of low-level laser therapy to prevent induced oral mucositis in head and neck cancer patients submitted to concurrent chemoradiation. (H. Antunes) 11:00 AM – 12:00 PM Genitourinary Cancer William K. Oh, MD - Mt. Sinai School of Medicine Abstract #4503: Axitinib vs sorafenib as second-line therapy for metastatic renal cell carcinoma (mRCC): Results of phase III AXIS trial. (B. I. Rini) Abstract #4516: Cabozantinib (XL184) in metastatic castration resistant prostate cancer (mCRPC): Results from a phase II randomized discontinuation trial. (M. Hussain) Abstract #4512: Towards a rational strategy for prostate cancer screening based on long-term risk of prostate cancer metastases and death: Data from a large, unscreened, population-based cohort followed for up to 30 years. (H. Lilja) Abstract #4514: A phase III randomized trial of intermittent vs. continuous androgen suppression for PSA progression after radical therapy (NCIC CTG PR.7/SWOG JPR.7/CTSU JPR.7/ UK Intercontinental Trial CRUKE/01/013). (J. M. Crook) Abstract #LBA4517^: Evaluation of circulating tumor cell (CTC) enumeration as an efficacy response biomarker of overall survival (OS) in metastatic castration resistant prostate cancer (mCRPC): Planned final analysis (FA) of COU-AA-301, a randomized double blind placebo controlled phase 3 study of abiraterone acetate (AA) plus low dose prednisone (P) post docetaxel. (H. I. Scher) 12:00 PM– 12:45 PM Boxed Lunch Provided 12:45 PM – 1:15 PM Faculty Case Q & A Panel Open-attendance question-and-answer panel with faculty, where attendees can seek the panel’s expert advice on challenging patient cases and issues raised during the Meeting presentations Daniel F. Hayes, MD, University of Michigan Medical Center Harold J. Burstein, MD, PhD, Dana-Farber Cancer Institute Carey Anders, MD, University of North Carolina, Chapel Hill D. Neil Hayes, MD, MPH, University of North Carolina, Chapel Hill William K. Oh, MD, Mt. Sinai School of Medicine 1:15 – 1:45 PM Education Session Ann H. Partridge, MD - Dana-Farber Cancer Institute Survivorship Care: Whose Job is it? Assessing Patients’ Psychosocial Needs: How To Do This in Your Busy Practice Role of Nutrition, Supplements, and Integrative Medicine in Cancer Prevention, Treatment and Survivorship 1:45 PM – 2:30 PM Sarcoma Margaret von Mehren, MD - Fox Chase Cancer Center Abstract #10005: Results of the phase III, placebo-controlled trial (SUCCEED) evaluating the mTOR inhibitor ridaforolimus (R) as maintenance therapy in advanced sarcoma patients (pts) following clinical benefit from prior standard cytotoxic chemotherapy (CT). (S. P. Chawla) Abstract #LBA10002: PALETTE: A randomized double blind phase III trial of pazopanib versus placebo in patients with soft tissue sarcoma (STS) whose disease has progressed during or following prior chemotherapy. An EORTC STBSG global network study (EORTC 62072). (W. T. Van Der Graaf) Abstract #LBA1: Twelve versus 36 months of adjuvant imatinib (IM) as treatment of operable GIST with a high risk of recurrence: Final results of a randomized trial (SSGXVIII/AIO). (H. Joensuu) Abstract #2: Busulphan-melphalan is the superior myeloablative therapy (MAT) for high risk neuroblastoma: Results from the HR-NBL1/SIOPEN trial. (R. L. Ladenstein) 2:30 PM – 3:15 PM Lymphoma James Foran, MD, FRCPC - Mayo Clinic Florida Abstract #8000: R-CHOP14 vs r-CHOP21: Result of a randomised phase III trial for the treatment of patients with newly diagnosed diffuse large b-cell non-hodgkin's lymphoma. (D. Cunningham) Abstract #8001: Randomized phase III US/Canadian intergroup trial (SWOG S9704) comparing CHOP±R x 8 to CHOP±R x 6 followed by autotransplant for patients with high-intermediate (H-Int) or high IPI grade diffuse aggressive non-hodgkin's lymphoma (NHL). (P. J. Stiff) Abstract #8004: Maintenance with rituximab after autologous stem cell transplantation in relapsed patients with CD20 diffuse large b-cell lymphoma (DLBCL): CORAL final analysis. (C. Gisselbrecht) 3:15 – 3:30 PM Break 3:30 PM – 4:30 PM Gynecologic Cancer Daniela Matei, MD - Indiana University Simon Cancer Center Abstract #5003: Phase II randomized placebo-controlled study of olaparib (AZD2281) in patients with platinum-sensitive relapsed serous ovarian cancer (PSR SOC). (J. A. Ledermann) Abstract #5001: Effect of screening on ovarian cancer mortality in the prostate, lung, colorectal and ovarian (PLCO) cancer randomized screening trial. (S. S. Buys) Abstract #5000: Establishing a molecular taxonomy for epithelial ovarian cancer (EOC) from 363 formalin fixed paraffin embedded (FFPE) specimens. (C. Gourley) Abstract #LBA5007: OCEANS: A randomized, double-blinded, placebo-controlled, phase III trial of chemotherapy with or without bevacizumab (BEV) in patients with platinum-sensitive recurrent epithelial ovarian (EOC), primary peritoneal (PPC), or Fallopian tube cancer (FTC). (C. Aghajanian) Saturday, July 30, 2011 7:15 AM – 8:00 AM Continental Breakfast Provided 8:00 AM – 9:00 AM Gastrointestinal (Colorectal) Cancer Howard Hochster, MD - Yale Cancer Center Abstract #3503: The impact of capecitabine and oxaliplatin in the preoperative multimodality treatment in patients with carcinoma of the rectum: NSABP R-04. (M.S. Roh) Abstract #3504: Capecitabine (Cape) versus 5-fluorouracil (5-FU)–based (neo-)adjuvant chemo-radiotherapy (CRT) for locally advanced rectal cancer (LARC): Long-term results of a randomized, phase III trial. (R. Hofheinz) Abstract #3535: Primary colorectal tumors and their metastasis are genetically not the same: Implications for choice of targeted treatment? (J. S. P. Vermaat) Abstract #3510^: Final results from PRIME: Randomized phase III study of panitumumab (pmab) with FOLFOX4 for first-line metastatic colorectal cancer (mCRC). (J. Douillard) Abstract #3507: The efficacy of oxaliplatin (Ox) when added to 5-fluorouracil/leucovorin (FU/L) in stage II colon cancer. (G. A. Yothers) Abstract #3511: Influence of KRAS G13D mutations on outcome in patients with metastatic colorectal cancer (mCRC) treated with first-line chemotherapy with or without cetuximab. (S. Tejpar) Abstract #10500: Comparative genomic analysis of primary versus metastasis in colorectal carcinomas. (E. Vakiani) 9:00 AM – 10:00 AM Gastrointestinal (Noncolorectal) Cancer Mahesh A. Shah, MD - Memorial Sloan-Kettering Cancer Center Abstract #4003: Postoperative adjuvant chemoradiation for gastric or gastroesophageal junction (GEJ) adenocarcinoma using epirubicin, cisplatin, and infusional (CI) 5-FU (ECF) before and after CI 5-FU and radiotherapy (CRT) compared to bolus 5-FU/LV before and after CRT: Intergroup trial CALGB 80101. (C. S. Fuchs) Abstract #4004: A multicenter, randomized phase III trial comparing second-line chemotherapy (SLC) plus best supportive care (BSC) with BSC alone for pretreated advanced gastric cancer (AGC). (S. H.Park) Abstract #LBA4002: Adjuvant capecitabine and oxaliplatin for gastric cancer: Results of the ?Phase III CLASSIC trial. (Y.-J. Bang) Abstract #4005: Long-term update of U.S. GI intergroup RTOG 98-11 phase III trial for anal carcinoma: Disease-free and overall survival with RT+5FU-mitomycin versus RT+5FU-cisplatin. (L. L. Gunderson) Abstract #4001: Global Investigation of Therapeutic Decisions in Hepatocellular Carcinoma and of tts Treatment with Sorafenib (GIDEON) second interim analysis in more than 1,500 patients: Clinical findings in patients with liver dysfunction. (J.A. Marrero) 10:00 AM – 10:15 AM Break 10:15 AM –11:00 AM Myeloma Asher Alban Akmal Chanan-Khan, MD - Roswell Park Cancer Institute Abstract #8007: Incidence of second primary malignancy (SPM) in melphalan-prednisone-lenalidomide combination followed by lenalidomide maintenance (MPR-R) in newly diagnosed multiple myeloma patients (pts) age 65 or older. (A. P. Palumbo) Abstract #8031: Phase I study of lorvotuzumab mertansine (LM, IMGN901) in combination with lenalidomide (Len) and dexamethasone (Dex) in patients with CD56-positive relapsed or relapsed/refractory multiple myeloma (MM). (J. G. Berdeja) Abstract #8020: Melphalan/prednisone/lenalidomide (MPR) versus high-dose melphalan and autologous transplantation (MEL200) in newly diagnosed multiple myeloma (MM) patients : A phase III trial. (M. Boccadoro) Abstract #8025: Interim results from PX-171-006, a phase (Ph) II multicenter dose-expansion study of carfilzomib (CFZ), lenalidomide (LEN), and low-dose dexamethasone (loDex) in relapsed and/or refractory multiple myeloma (R/R MM). (M. Wang) 11:00 – 12:00 PM Leukemia Jane Liesveld, MD - University of Rochester Abstract #6500: Results of COMFORT- I, a randomized double-blind phase III trial of JAK1/2 inhibitor INCB18424 (424) vs placebo (PB) for patients with myelofibrosis (MF). (Srdan Verstovsek, MD, PhD) Abstract #6503^: Clofarabine plus cytarabine compared to cytarabine alone in older patients with relapsed or refractory (R/R) acute myelogenous leukemia (AML): Results from the phase III CLASSIC 1 trial. (S.Faderl) Abstract #LBA6501: Results of a randomized study of the JAK inhibitor INC424 compared to best available therapy (BAT) in primary myelofibrosis (PMF), post-polycythemia vera-myelofibrosis (PPV-MF) or post-essential thrombocythemia myelofibrosis (PET-MF). (C. N. Harrison) Abstract #3: High dose methotrexate (HD-MTX) as compared to capizzi methotrexate plus asparaginase (C-MTX/ASNase) improves event-free survival (EFS) in children and young adults with high-risk acute lymphoblastic leukemia (HR-ALL): a report from the Children’s oncology group study AALL0232. (E. C. Larsen) 12:00 PM – 12:45 PM Boxed Lunch Provided 12:45 PM – 1:15 PM Faculty Case Q &A Panel Open-attendance question-and-answer panel with faculty, where attendees can seek the panel’s expert advice on challenging patient cases and issues raised during the Meeting presentations Daniel F. Hayes, MD - University of Michigan Medical Center Howard Hochster, MD - Yale Cancer Center Manesh A. Shah, MD - Memorial Sloan-Kettering Cancer Center Asher Alban Akmal Chanan-Khan, MD - Roswell Park Cancer Institute Jane Liesveld, MD - University of Rochester 1:15 PM – 1:45 PM Education Session Gary Lyman, MD - Duke University Medical Center Implementing an Electronic Health Record in Different Practice Settings: Strategies for Success Managing Electronic Education Direct to Consumer Genetic Testing: What Physicians Need to Know 1:45 PM – 2:30 PM Patient and Survivor Care Marie Wood, MD - University of Vermont Abstract #9009: Yoga improves QOL, cortisol rhythym and HRV for women with BREAST CANCER undergoing radiotherapy. (L. Cohen) Abstract #LBA9014: The ultra-low-molecular-weight heparin (ULMWH) semuloparin for prevention of venous thromboembolism (VTE) in cancer patients receiving chemotherapy: SAVE ONCO study. (G. Agnelli) Abstract #9005: Results of a multicenter randomized trial to evaluate a survivorship care plan for breast cancer survivors. (E. Grunfeld) 2:30 PM – 3:15 PM Melanoma/Skin Cancers Steven O'Day, MD - The Angeles Clinic and Research Institute Abstract #8509: BRIM-2: An open-label, multicenter phase II study of RG7204 (PLX4032) in previously treated patients with BRAF V600E mutation-positive metastatic melanoma. (A. Ribas) Abstract #8505: Randomized phase III trial of high dose interferon alfa-2b (HDI) for four weeks induction only in patients with intermediate and high-risk melanoma (Intergroup trial E 1697) . (S. S. Agarwala) Abstract #LBA5: A phase 3 randomized study of ipilimumab plus dacarbazine versus dacarbazine alone as first line treatment in patients with unresectable stage III or IV melanoma. (J.D. Wolchok) Abstract #LBA4: Phase III randomized, open-label, multicenter trial (BRIM3) comparing BRAF inhibitor RG7204 with dacarbazine in patients with V600E BRAF mutated melanomas. (P. B. Chapman) Abstract #2006: RTOG 0525: a randomized phase III trial comparing standard adjuvant temozolomide (TMZ) with a dose-dense (dd) schedule in newly diagnosed glioblastoma (GBM). (M. R. Gilbert) 3:15 – 3:45 PM Lung Cancer – Local-Regional and Adjuvant Therapy/Small Cell Rogerio Lilenbaum, MD - Cleveland Clinic Florida Abstract #7004: Evaluation of disease-free survival as surrogate endpoint for overall survival using two individual patient data meta-analyses of adjuvant chemotherapy in operable non-small cell lung cancer. (S. Michiels) Abstract #7002: Randomized phase II trial on refinement of early stage NSCLC adjuvant chemotherapy with cisplatin and pemetrexed (CPx) versus cisplatin and vinorelbine (CVb) - TREAT. (M. Kreuter) Abstract #7003: Proteomic analysis for detection of NSCLC: Results of ACOSOG Z4031. (D. Harpole, Jr) 3:45 PM – 4:30 PM Lung Cancer – Metastatic/Non-small Cell Suresh Ramalingam, MD - Winship Cancer Institute at Emory University Abstract #CRA7510: PARAMOUNT: Phase III study of maintenance pemetrexed (pem) plus best supportive care (BSC) versus placebo plus BSC immediately following induction treatment with pem plus cisplatin for advanced nonsquamous non-small cell lung cancer (NSCLC). (L. G. Paz-Ares, MD) Abstract #7503: Erlotinib vs chemotherapy (CT) in advanced non-small-cell lung cancer (NSCLC) patients (p) with epidermal growth factor receptor (EGFR) mutations: Interim results of the european Tarceva vs chemotherapy (EURTAC) phase III randomized trial. (R. Rosell) Abstract #CRA7506: Identification of driver mutations in tumor specimens from 1000 patients with lung adenocarcinoma: The NCI’s lung cancer mutation consortium (LCMC). (M. G. Kris.) Abstract #7505: Final efficacy results from OAM4558g, a randomized phase II study evaluating MetMAb or placebo in combination with erlotinib in advanced NSCLC. (D. R. Spigel) Abstract #LBA7511: Efficacy, tolerability and biomarker analyses from a phase III, randomized, placebo controlled, parallel group study of gefitinib as maintenance therapy in patients with locally advanced or metastatic non-small-cell lung cancer (NSCLC) in China (INFORM) (C-TONG 0804). (L. Zhang) Abstract #LBA7512: Prospective biomarker analysis from MONET1, a randomized, placebo-controlled, double-blind phase 3 study of motesanib plus carboplatin/paclitaxel (C/P) in advanced nonsquamous non–small-cell lung cancer (NSCLC). (M. B. Bass) 4:30 PM Meeting Adjourns

Share	Recommend \| Keep \| Reply \| Mark as Last Read

From: IRWIN JAMES FRANKEL	6/27/2011 1:40:00 PM
	of 892

YM - earnie to hbomb better link for multiple myelome MET rationale 40 minutes ago You raised a number of interesting points about which I would like to comment. First, what little info we have on Cabo and normal sclerotic remineralization following apparent resolution of lesions was summed up by Dr. Smith during the companies post ASCO presentation. Anyone interested should start listening at the 1:00:00 point. He begins by talking about circulating tumor cells and then mentions bone healing. He shows one CT scan showing a vertebrae with a hot spot that he says is representative of a healing effect observed multiple times. exelixis.com Regarding MM, Zometa is approved and FDA declined the opportunity to approve Denosumab in this indication. MM is characterised by purely lytic lesions with no abnormal osteoblastic activity. One of Cabo's strengths vis a vis Zometa and Dmab is that it curbs both osteoblastic and osteoclastic activity whereas Z and Dmab only directly impact osteoclastic activity. Since MM bone mets are purely osteoclastic in nature, targeting this indication would not play into Cabo's strength. <<I was wondering if anyone knew of common endpoints for mm drugs?>> It depends. There are a number of approved treatments for MM. If EXEL is presenting Cabo as a bone met treatment, then the appropriate control would be Zometa with an endpoint that incorporates SRE's and perhaps pain. If it is as a systemic treatment, then the control depends on disease stage and the endpoint would be survival or some sort of progression endpoint for more refractory patients. I think it likely that Cabo will be investigated as a potential MM treatment, but not until other more promising opportunities (CRPC, HCC, Ovarian, Melanoma, BrCa bone mets) are looked at first. <<P.S. bone scan criteria wouldn't fly in this disease type.>> The jury is still out on the appropriateness of a bone scan endpoint for any indication. Keep your fingers crossed that the FDA decides to be forward thinking and innovative enough to allow it for a yet to be defined CRPC indication.

Share	Recommend \| Keep \| Reply \| Mark as Last Read

From: IRWIN JAMES FRANKEL	7/2/2011 5:10:19 PM
	of 892

YM by earnie: Dr. SchernVideo on CTC's 1-Jul-11 02:08 pm youtube.com We have discussed endpoint validation here in the past. Here Dr. Scher discusses circulating tumor cell counts as a possible surrogate for survival. YM responsive comments by Joeflow: We actually worked on this briefly ~ 15 years ago (in prostate cancer, coincidently) when I was at Sloan-Kettering. The primary goal at the time was to develop a diagnostic assay using peripheral blood that corresponded with clinical stage of disease. CTCs in prostate cancer patients are readily detectable by PCR based on elevated levels of cells expressing transcript for cytokeratins. There are numerous problems associated with standardizing/quantifying PCR data. We attempted to enumerate CTCs by flow cytometry. Very little time was spent on the project as physicians have very little patience for technology/assay development and they quickly lost interest. A brief look at the literature shows a flow cytometry/imaging-based approach has been approved by the FDA and may be what Howard Sher is referring to - see links below. Joe veridex.com questdiagnostics.com

Share	Recommend \| Keep \| Reply \| Mark as Last Read

From: IRWIN JAMES FRANKEL	7/6/2011 4:08:00 PM
	of 892

Exelixis Provides Update on Cabozantinib Development Activities Timeline for reporting top-line data from EXAM extended by approximately three months Protocol for XL184-306 pivotal trial in CRPC submitted to FDA for review Management to hold conference call at 6:00 p.m. EDT/3:00 p.m. PDT today EXEL 9.16 +0.05 Press Release Source: Exelixis, Inc. On Wednesday July 6, 2011, 4:00 pm SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Exelixis, Inc. (NASDAQ:EXEL - News) today announced an update to the timing for reporting top-line data from the ongoing phase 3 pivotal trial of cabozantinib in patients with medullary thyroid cancer (MTC), known as the EXAM trial. The company has extended the timing to report top-line data from this trial by approximately three months. The timeline is being extended from the middle of this year to provide additional time for the trial to reach the pre-specified number of progression-free survival (PFS) events required for un-blinding of the data. “We continue to be optimistic about a positive outcome for the EXAM trial. We believe the activity that cabozantinib has demonstrated in MTC as part of the ongoing phase 1 clinical trial of cabozantinib in this indication as well as the selection of MTC patients with rapidly progressing disease increase the possibility of a positive outcome for the EXAM study,” said Michael M. Morrissey, Ph.D., president and chief executive officer of Exelixis. “We also continue to advance the development program in castration-resistant prostate cancer (CRPC). The protocol for the XL184-306 pivotal trial using a combined endpoint of pain reduction and bone scan response was submitted to the U.S. Food and Drug Administration (FDA) in June for consideration of a special protocol assessment (SPA) and our goal is to initiate this trial by the end of 2011. Additionally, we are planning the XL184-307 and XL184-308 pivotal trials in the CRPC for overall survival and bone metastasis-free survival respectively and expect to initiate both of these trials in 2012.“ EXAM Trial Design EXAM is an international, randomized, placebo-controlled, double-blinded study of cabozantinib in patients with unresectable, locally advanced, or metastatic MTC. Patients are randomized in a 2:1 ratio to receive cabozantinib or placebo administered at a daily dose of 175 mg. The study does not allow for cross-over from the placebo arm to cabozantinib. With an enrollment target of 315 patients and a planned event-driven analysis, the trial provides 90% power to detect a 75% increase in progression-free survival, the primary endpoint of the study. Additionally the study is designed to assess overall survival at a later time point once those events have been achieved, and is powered to detect a 50% improvement in survival compared with placebo. Exelixis is conducting this trial under a SPA from the FDA, which allows for full approval on the basis of PFS if the data are supportive. EXAM completed enrollment in the first quarter of 2011. EXAM Patient Population To best assess cabozantinib’s ability to impact progressive disease, enrollment in the EXAM trial was restricted to patients with rapidly progressing MTC, which was defined as evidence of progressive disease per RECIST comparing the baseline scan with an assessment obtained within the previous 14 months. Medullary thyroid cancer typically follows a slow path of progression, and patients may live for a period of years without their condition worsening. Patients after surgery who have stage I disease have median survival in excess of 10 years. Median survival in patients with stage IV disease (metastatic MTC) is two years. It is expected that median survival in EXAM’s patient population would be less than two years given that their disease is unresectable, locally advanced, or metastatic MTC that is actively progressing. Phase 1 Experience in MTC Data from the ongoing phase 1 clinical trial have been presented at several oncology and thyroid meetings over the past few years and the phase 1 clinical data was recently published in the Journal of Clinical Oncology in late May of this year. Investigators are still following a number of patients who are on continued study treatment. The phase 1 trial enrolled a total of 37 patients with 35 patients being response evaluable. It showed a 29% rate of confirmed partial responses. These responses were generally durable with a response duration of up to 48+ months per the most recent update. Four patients are in continued response at the current time. Additionally, 15 patients (41%) had stable disease lasting longer than 6 months with some patients continuing on study 3+ years after study initiation. Activity was independent of both RET mutation status and prior treatment with tyrosine kinase inhibitors, including vandetanib. NDA Filing Plans for MTC As previously reported, the FDA has granted cabozantinib orphan drug designation and fast track status for MTC, and the latter confers several important benefits, including the potential ability to file a rolling New Drug Application (NDA). Given the extension of the timing for the un-blinding of the EXAM trial, Exelixis now plans to initiate a rolling submission in the fourth quarter 2011 by submitting key parts of the NDA, including the preclinical and chemistry, manufacturing and controls (CMC) information later this year, and expects to complete the file in the first quarter of 2012. Assuming a positive outcome in the EXAM trial, the Company currently anticipates a commercial launch of cabozantinib in MTC in the second half of 2012. Conference Call and Webcast Information Exelixis’ management will discuss the updated timeline for reporting top-line data from EXAM and provide an update on the comprehensive cabozantinib development program in MTC and CRPC during a conference call beginning at 6:00 p.m. EDT / 3:00 p.m. PDT today, Wednesday, July 6, 2011. To listen to a live webcast of the discussion, visit the Event Calendar page under Investors at www.exelixis.com. An archived replay of the webcast will be available on the Event Calendar page under Investors at www.exelixis.com and via phone until 11:59 p.m. EDT on August 6, 2011. Access numbers for the phone replay are: 888-286-8010 (domestic) and 617-801-6888 (international); the passcode is 50152278. About Cabozantinib Cabozantinib is a potent, dual inhibitor of MET and VEGFR2. Cabozantinib is an investigational agent that provides coordinated inhibition of metastasis and angiogenesis to kill tumor cells while blocking their escape pathways. The therapeutic role of cabozantinib is currently being investigated across several tumor types. MET is upregulated in many tumor types, thus facilitating tumor cell escape by promoting the formation of more aggressive phenotypes, resulting in metastasis. MET-driven metastasis may be further stimulated by hypoxic conditions in the tumor environment, which are often exacerbated by selective VEGF-pathway inhibitors. In preclinical studies, cabozantinib has shown powerful tumoricidal, antimetastatic and antiangiogenic effects, including: Extensive apoptosis of malignant cells Decreased tumor invasiveness and metastasis Decreased tumor and endothelial cell proliferation Blockade of metastatic bone lesion progression Disruption of tumor vasculature About Exelixis Exelixis, Inc. is a biotechnology company committed to developing small molecule therapeutics for the treatment of cancer. Exelixis is focusing its resources and development efforts exclusively on cabozantinib, its most advanced solely-owned product candidate, in order to maximize the therapeutic and commercial potential of this compound. Exelixis believes cabozantinib has the potential to be a high-quality, differentiated pharmaceutical product that can make a meaningful difference in the lives of patients. Exelixis has also established a portfolio of other novel compounds that it believes have the potential to address serious unmet medical needs. For more information, please visit the company's web site at www.exelixis.com. Forward-Looking Statements This press release contains forward-looking statements, including, without limitation, statements related to: the continued development and clinical, therapeutic and commercial potential of cabozantinib; the timeline for the ongoing phase 3 pivotal trial of cabozantinib in MTC, including the timing for reporting top-line data, the timing for submitting an NDA and the anticipated timing for the commercial launch of cabozantinib in MTC; the possibility of a positive outcome in the phase 3 pivotal trial of cabozantinib in MTC; Exelixis' goal to initiate the first pivotal trial of cabozantinib in CRPC (XL184-306) by the end of 2011; and the planning for two additional pivotal trials in CRPC (XL184-307 and XL184-308) and Exelixis’ expectation to initiate these trials in 2012. Words such as “extended,” “optimistic,” “possibility,” “goal,” “planning,” “plans,” “expect,” “would,” “potential,” “anticipates,” “believes,” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Exelixis' current plans, assumptions, beliefs and expectations. Forward-looking statements involve risks and uncertainties. Exelixis' actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation: risks related to the potential failure of cabozantinib to demonstrate safety and efficacy in clinical testing; Exelixis' ability to conduct clinical trials of cabozantinib sufficient to achieve a positive completion; the availability of data at the referenced times; the sufficiency of Exelixis' capital and other resources; the uncertain timing and level of expenses associated with the development of cabozantinib; the uncertainty of the FDA approval process; market competition; and changes in economic and business conditions. These and other risk factors are discussed under "Risk Factors" and elsewhere in Exelixis' quarterly report on Form 10-Q for the quarter ended April 1, 2011 and Exelixis' other filings with the Securities and Exchange Commission. Exelixis expressly disclaims any duty, obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Exelixis' expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based. Contact: Exelixis, Inc. Charles Butler, 650-837-7277 Vice President, Investor Relations and Corporate Communications cbutler@exelixis.com

Share	Recommend \| Keep \| Reply \| Mark as Last Read

Previous 10 | Next 10

Copyright/IP Policy

Copyright © 1995-2013 Knight Sac Media. All rights reserved.