a Phase 2 prostate cancer clinical trial is ongoing. Table 2: Squalamine vs Standard-of-care literature
|
|
- Marianna Ferguson
- 8 years ago
- Views:
Transcription
1 PRODUCT FACT SHEET Spring 2007 MISSION STATEMENT Genaera Corporation is a biopharmaceutical company with a focus on metabolic and respiratory diseases. The compounds in the Genaera pipeline address signal transduction pathways at the cellular level to treat a number of challenging diseases. These compounds hold promise as potential medical breakthroughs in asthma, obesity and diabetes. Genaera has made a strategic decision to out-license its non-core assets, including. CONTACT Genaera Corporation 5110 Campus Drive Plymouth Meeting, PA Ph: Fax: Investor Relations: Wed: info@genaera.com Henry Wolfe, Ph.D. Executive Vice President and Chief Scientific Officer (610) This Product Fact Sheet contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks and uncertainties, known and unknown. Forward-looking statements reflect management's current views and are based on certain expectations and assumptions. You may identify some of these forward-looking statements by the use of words in the statements such as anticipate, believe, continue, develop, expect, plan and potential or other words of similar meaning. Genaera s actual results and performance could differ materially from those currently anticipated and expressed in these and other forward-looking statements as a result of a number of risk factors, described more fully in Genaera s filings with the U.S. Securities and Exchange Commission, all of which are available from the Commission in its EDGAR database at or on the Company s website Lactate: lactate is an intravenously administered anti-angiogenic agent developed for the treatment of solid tumors. A Phase 2 clinical trial is ongoing in prostate cancer. Several Phase 2 trials have been conducted in advanced NSCLC and ovarian cancer patients. The active ingredient (squalamine) is a small molecule produced synthetically with an excellent cost of goods. CLINICAL STUDIES Multiple Phase 1 dose ranging studies have been conducted in advanced cancer patients at multiple sites. The drug was generally welltolerated, with reversible hepatic transaminases elevation at higher dose levels and frequency. Several small phase 2 clinical studies have been conducted in advanced (stage III or IV) ovarian cancer and nonsmall cell lung cancer (NSCLC) patients, a Phase 2 prostate cancer clinical trial is ongoing. Table 1: Oncology Study results SQUALAMINE vs. STANDARD-OF-CARE LITERATURE Clinical results obtained with squalamine in non-small cell lung cancer patients are promising (Table 1). The definitive study in this field is a study by Schiller, et al (1) which compared four different treatment regimens in a randomized study of 1155 stage IIIb and IV NSCLC patients. As seen in Table 2, the results for (Herbst, et al (2) ) showed slightly more promising response rates, but were comparable to those reported by Schiller (1). Table 2: vs Standard-of-care literature Response Ovarian 1 NSCLC 2 NSCLC 3 Complete 19% 0% 2% Partial 15% 28% 22% Stable 38% 19% 49% Progression 27% 53% 27% 1 Continuous 5-day squalamine (200 mg/m2/day) infusion with carboplatin (AUC = 6), every 3 weeks, x6 2 Continuous 5-day squalamine infusion (300 mg/m2/day) following carboplatin (AUC = 6) and paclitaxel (225 mg/m2/day), every 3 wks, x6 3 Weekly squalamine (100 or 200 mg/m2) infusion with carboplatin (AUC = 2) and paclitaxel (75 mg/m2), x12 Herbst Schiller Patients (similar eligibility 35 evaluable 290 evaluable criteria ) * Paclitaxel Day 1 = 225 mg/m 2 Day 1 = 225 mg/m 2 Carboplatin Day 2 = AUC = 6 Day 2 = AUC = 6 Day 2-6 at mg/ m 2 /day Rest between cycles 21 days 21 days Cycles Response Rates 34 % overall 17 % overall Complete Response 0 % < 1 % Partial response 28 % 16 % Stable 19 % 23 % Disease Progression 53 % 49 % Could not be determined 0 % 11 % Median Survival 8.5 months 8.1 months 1 year survival 33 % 34 % * For both studies, similar eligibility criteria were used for stage IIIB and IV NSCLC patients.
2 PRECLINICAL ACTIVITY Anti-angiogenic activity has been demonstrated in several solid tumor xenograft models, which lead to the clinical development of squalamine in oncology. LUNG CANCER XENOGRAFT Effect of combination chemotherapy Nude mice bearing the MV-522 human lung tumor were treated for days 1 5 with vehicle (5% dextrose in water; t) or with paclitaxel (10 mg/kg/day, q.d. for 5 days) and carboplatin (20 mg/kg/day, q.d. for 5 days; r, X). Some treatment groups (, X) received squalamine (20 mg/kg/day) on days 1 5 and 8 9. Error bars, SE; hatched box, squalamine dosing period. (2) Vehicle Paclitaxel and Carboplatin Paclitaxel, carboplatin and squalamine Ovarian Cancer Xenograft CAOV3 ovarian cancer cells were inoculated subcutaneously in nude mice. After 7 days, animals with tumors of comparable size were randomized to treatment with control solution, squalamine (2 mg/kg on days 1 ± 10), cisplatin (4 mg/ kg on day 1), or cisplatin administered in combination with squalamine. Tumor volumes (mm3) are expressed as mean+s.e.m. for measurements to assess tumor growth delay due to the several treatments. (3) Tumor Volume (mm 3 ) /Cis-Plat 200 Cis-Platin Control Time, Months Page 2 of 5
3 MECHANISM OF ACTION: ANTI-ANGIOGENIC Unlike other treatments for anti-angiogenic therapies, squalamine does not interfere with the binding of VEGF to its receptor on proliferating endothelial cells. is a potent small molecule that works INSIDE these actively growing cells to specifically block the multiple intracellular pathways generated by the binding of VEGF and PDGFβ to their respective receptors. is rapidly eliminated from the systemic circulation (t 1/2 = 7.5 hours in humans), but retained in its intracellular site of action for more than 5 days. We believe this may be a key to the excellent safety observed with squalamine in clinical studies to date. Once inside the cell, exerts a number of effects which prevent activation of the p38 inflammatory pathway as well as VE-cadherin and α v β 3 and their downstream signaling pathways. This multi-faceted inhibition of intracellular pathways converts the actively proliferating endothelial cells into a dormant, normal vasculature, slowing tumor growth. lis a systemically administered anti-angiogenic drug being tested for the treatment of wet AMD. Unlike other treatments for wet AMD, squalamine does not interfere with the binding of VEGF to its receptor on proliferating endothelial cells. squalamine works INSIDE these actively growing cells to block the intracellular signals generated by the binding of VEGF and PDGFβ to their respective receptors. squalamine is rapidly eliminated from the systemic circulation (half-life = 7.5 hours in humans), but retained in its intracellular site of action for more than 5 days. Once inside the cell, squalamine exerts a number of effects which prevent activation of the p38 inflammatory pathway as well as VE-cadherin and ανβ3 and their downstream signaling pathways. This multi-faceted inhibition of intracellular pathways converts the actively proliferating endothelial cells into a more normal vasculature (Figure 1) Figure 1: EVIZON Mechanism of Action (blue dots) enters endothelial cells inhibits angiogenesis and inflammatory pathways (inhibits activities of MAPK, p38, a v β 3, and VE cadherin) No enos inhibition Page 3 of 5
4 SQUALAMINE AND HYPERTENSION The Competition: Anti-VEGF therapies, such as Avastin, block all intracellular downstream VEGF pathways, including enos, an enzyme which helps maintain normal blood pressure (Figure 2). As a result, administration of Avastin has been associated with clinically significant increases in blood pressure in patients. :, however does not block all intracellular VEGF pathways in proliferating endothelial cells, but rather only blocks specific pathways, such as the MAP kinase proliferative pathway, the p38 inflammatory pathway, as well as VEcadherin and α v β 3 and their downstream signaling pathways. A key difference in the mechanism of is that it does not block enos activity (Figure 2). Figure 2: does not inhibit enos activity % Maximum Response 100% 75% 50% 25% No inhibition by EVIZON Avastin inhibits enos (p<0.001) 0% Control VEGF EVIZON +VEGF Avastin +VEGF Page 4 of 5
5 We believe this mechanistic difference with will have a profound impact on patient safety. A Preliminary analysis of patients treated with squalamine in our Phase 2 wet AMD studies provides a first look at this effect. As seen in Figure 3, treatment of wet AMD patients with up to 40 mg of squalamine is not associated with clinically significant increases in systolic and diastolic blood pressure. Figure 3: Preliminary Analysis of Blood Pressure in wet AMD Patients treated with squalamine 10 5 Mean Change from Systolic Diastolic -15 N = 17 N = 26 N = 81 * 4 to 29 weeks of intravenous therapy REFERENCES Schiller JH, Harrington D, Belani CP, Langer C, Sandler A, Krook J, Zhu J, Johnson DH 2002 Comparison of four chemotherapy regimens for advanced non-small-cell lung cancer. N Engl J Med 346:92-98 Herbst RS, Hammond LA, Carbone DP, Tran HT, Holroyd KJ, Desai A, Williams JI, Bekele BN, Hait H, Allgood V, Solomon S, Schiller JH 2003 A phase I/IIA trial of continuous five-day infusion of squalamine lactate (MSI-1256F) plus carboplatin and paclitaxel in patients with advanced non-small cell lung cancer. Clin Cancer Res 9: Li D, Williams JI, Pietras RJ 2002 and cisplatin block angiogenesis and growth of human ovarian cancer cells with or without HER-2 gene overexpression. Oncogene 21: McLane, et al, Angiogenesis Foundation 4th Annual International Conference Antiangiogenesis, New Frontiers in Therapeutic Development. Boston, MA. October 2006 Page 5 of 5
Emerging Drug List GEFITINIB
Generic (Trade Name): Manufacturer: Gefitinib (Iressa ) formerly referred to as ZD1839 AstraZeneca NO. 52 JANUARY 2004 Indication: Current Regulatory Status: Description: Current Treatment: Cost: Evidence:
More informationNational Horizon Scanning Centre. Vandetanib (Zactima) for advanced or metastatic non-small cell lung cancer. December 2007
Vandetanib (Zactima) for advanced or metastatic non-small cell lung cancer December 2007 This technology summary is based on information available at the time of research and a limited literature search.
More informationAvastin in breast cancer: Summary of clinical data
Avastin in breast cancer: Summary of clinical data Worldwide, over one million people are diagnosed with breast cancer every year 1. It is the most frequently diagnosed cancer in women 1,2, and the leading
More informationNew Advances in Cancer Treatments. March 2015
New Advances in Cancer Treatments March 2015 Safe Harbour Statement This presentation document contains certain forward-looking statements and information (collectively, forward-looking statements ) within
More informationGT-020 Phase 1 Clinical Trial: Results of Second Cohort
GT-020 Phase 1 Clinical Trial: Results of Second Cohort July 29, 2014 NASDAQ: GALT www.galectintherapeutics.com 2014 Galectin Therapeutics inc. Forward-Looking Statement This presentation contains, in
More informationAdjuvant Therapy Non Small Cell Lung Cancer. Sunil Nagpal MD Director, Thoracic Oncology Jan 30, 2015
Adjuvant Therapy Non Small Cell Lung Cancer Sunil Nagpal MD Director, Thoracic Oncology Jan 30, 2015 No Disclosures Number of studies Studies Per Month 12 10 8 6 4 2 0 1 2 3 4 5 6 7 8 9 10 11 12 1 2 3
More informationBNC105 CANCER CLINICAL TRIALS REACH KEY MILESTONES CLINICAL PROGRAM TO BE EXPANDED
ASX ANNOUNCEMENT 3 August 2011 ABN 53 075 582 740 BNC105 CANCER CLINICAL TRIALS REACH KEY MILESTONES CLINICAL PROGRAM TO BE EXPANDED Data from renal cancer trial supports progression of the trial: o Combination
More informationHow To Treat Mesothelioma With A Tumor Stem Cell Inhibitor
FAK INHIBITOR DEFACTINIB (VS-6063) TARGETS MESOTHELIOMA CANCER STEM CELLS Rationale for maintenance therapy after conventional therapy Jonathan Pachter, Ph.D. Vice President of Research, Verastem, Inc.
More informationIMMUNOMEDICS, INC. February 2016. Advanced Antibody-Based Therapeutics. Oncology Autoimmune Diseases
IMMUNOMEDICS, INC. Advanced Antibody-Based Therapeutics Oncology Autoimmune Diseases February 2016 Forward-Looking Statements This presentation, in addition to historical information, contains certain
More informationCLINICAL POLICY Department: Medical Management Document Name: Opdivo Reference Number: CP.PHAR.121 Effective Date: 07/15
Page: 1 of 6 IMPORTANT REMINDER This Clinical Policy has been developed by appropriately experienced and licensed health care professionals based on a thorough review and consideration of generally accepted
More informationPrior Authorization Guideline
Prior Authorization Guideline Guideline: PS Inj - Alimta Therapeutic Class: Antineoplastic Agents Therapeutic Sub-Class: Antifolates Client: PS Inj Approval Date: 8/2/2004 Revision Date: 12/5/2006 I. BENEFIT
More informationREPORT ASCO 2002 ORLANDO : LUNG CANCER Johan F. Vansteenkiste, MD, PhD, Univ. Hospital and Leuven Lung Cancer Group
REPORT ASCO 2002 ORLANDO : LUNG CANCER Johan F. Vansteenkiste, MD, PhD, Univ. Hospital and Leuven Lung Cancer Group In the 2002 edition of the ASCO meeting, a total of 315 abstracts in the field of respiratory
More informationAvastin in breast cancer: Summary of clinical data
Avastin in breast cancer: Summary of clinical data Worldwide, over one million people are diagnosed with breast cancer every year 1. It is the most frequently diagnosed cancer in women 1,2, and the leading
More informationGemcitabine, Paclitaxel, and Trastuzumab in Metastatic Breast Cancer
Gemcitabine, Paclitaxel, and Trastuzumab in Metastatic Breast Cancer Review Article [1] December 01, 2003 By George W. Sledge, Jr, MD [2] Gemcitabine (Gemzar) and paclitaxel show good activity as single
More informationBackground. t 1/2 of 3.7 4.7 days allows once-daily dosing (1.5 mg) with consistent serum concentration 2,3 No interaction with CYP3A4 inhibitors 4
Abstract No. 4501 Tivozanib versus sorafenib as initial targeted therapy for patients with advanced renal cell carcinoma: Results from a Phase III randomized, open-label, multicenter trial R. Motzer, D.
More informationExelixis Showcases R&D Pipeline at JPMorgan Healthcare Conference
Exelixis Showcases R&D Pipeline at JPMorgan Healthcare Conference Two New Clinical Programs and Significant Expansion of Cancer Pipeline Planned for 2004 SOUTH SAN FRANCISCO, Calif., Jan. 13 /PRNewswire-FirstCall/
More informationSur les nouveaux médicaments et les perspectives qu ils offrent (traitement à la carte et survie longue)
Sur les nouveaux médicaments et les perspectives qu ils offrent (traitement à la carte et survie longue) Professeur Jean Trédaniel Unité de cancérologie thoracique Hôpital Saint-Louis Comparison of Four
More informationPARP Inhibitors in Lung Cancer. Primo N. Lara, Jr., MD Professor of Medicine UC Davis Comprehensive Cancer Center
PARP Inhibitors in Lung Cancer Primo N. Lara, Jr., MD Professor of Medicine UC Davis Comprehensive Cancer Center Poly (ADP-ribose) Polymerase (PARP): Mechanism of Action PARPs: family of enzymes that repair
More informationNCCN Non-Small Cell Lung Cancer V.1.2011 Update Meeting 07/09/10
Guideline Page and Request NSCL-3 Stage IA, margins positive delete the recommendation for chemoradiation. Stage IB, IIA, margins positive delete the recommendation for chemoradiation + Stage IIA, Stage
More informationMaintenance therapy in in Metastatic NSCLC. Dr Amit Joshi Associate Professor Dept. Of Medical Oncology Tata Memorial Centre Mumbai
Maintenance therapy in in Metastatic NSCLC Dr Amit Joshi Associate Professor Dept. Of Medical Oncology Tata Memorial Centre Mumbai Definition of Maintenance therapy The U.S. National Cancer Institute s
More informationProtein kinase C alpha expression and resistance to neo-adjuvant gemcitabine-containing chemotherapy in non-small cell lung cancer
Protein kinase C alpha expression and resistance to neo-adjuvant gemcitabine-containing chemotherapy in non-small cell lung cancer Dan Vogl Lay Abstract Early stage non-small cell lung cancer can be cured
More informationEvaluating the Efficiency of Targeted Designs for Randomized Clinical Trials
Vol. 0, 6759 6763, October 5, 004 Clinical Cancer Research 6759 Perspective Evaluating the Efficiency of Targeted Designs for Randomized Clinical Trials Richard Simon and Aboubakar Maitournam Biometric
More information18.5 Percent Overall Response Rate Observed in Pembrolizumab-Treated Patients with this Aggressive Form of Breast Cancer
News Release Media Contacts: Annick Robinson Investor Contacts: Joseph Romanelli (514) 837-2550 (908) 740-1986 Stephanie Lyttle NATIONAL Public Relations (514) 843-2365 Justin Holko (908) 740-1879 Merck
More informationTargeting Specific Cell Signaling Pathways for the Treatment of Malignant Peritoneal Mesothelioma
The Use of Kinase Inhibitors: Translational Lab Results Targeting Specific Cell Signaling Pathways for the Treatment of Malignant Peritoneal Mesothelioma Sheelu Varghese, Ph.D. H. Richard Alexander, M.D.
More information( targeted therapy ) ( oncogenesis ) ( epidermal. growth factor receptor tyrosine kinase inhibitor EGFR-TKI ) ( epidermal growth
2008 19 8-13 growth factor receptor tyrosine kinase inhibitor EGFR-TKI ) ( targeted therapy ) ( oncogenesis ) ( epidermal factor receptor monoclonal antibody EGFR-moAb ) growth factor monoclonal antibody
More informationActivity of pemetrexed in thoracic malignancies
Activity of pemetrexed in thoracic malignancies Results of phase III clinical studies of pemetrexed in malignant pleural mesothelioma and non-small cell lung cancer show benefit P emetrexed (Alimta) is
More informationRecruiting now. Could you help by joining this study?
Non-Small Cell Lung Cancer Recruiting now AstraZeneca is looking for men and women with locally advanced or metastatic non-small cell lung cancer (NSCLC) to join ATLANTIC, a clinical study to help investigate
More informationAdaptimmune Reports Full Fiscal Year 2015 Financial Results. - Conference call to be held today at 8:00 AM ET (1:00 PM BST) -
Adaptimmune Reports Full Fiscal Year 2015 Financial Results - Conference call to be held today at 8:00 AM ET (1:00 PM BST) - PHILADELPHIA, Pa. and OXFORD, United Kingdom., October 13, 2015 Adaptimmune
More informationMATHEMATICAL MODELS OF TUMOR GROWTH INHIBITION IN XENOGRAFT MICE AFTER ADMINISTRATION OF ANTICANCER AGENTS GIVEN IN COMBINATION
MATHEMATICAL MODELS OF TUMOR GROWTH INHIBITION IN XENOGRAFT MICE AFTER ADMINISTRATION OF ANTICANCER AGENTS GIVEN IN COMBINATION Nadia Terranova UNIVERSITÀ DI PAVIA New model development: course of action
More informationLOOKING FORWARD PUMA BIOTECHNOLOGY, INC. 2014 ANNUAL REPORT
LOOKING FORWARD PUMA BIOTECHNOLOGY, INC. 2014 ANNUAL REPORT Puma Biotechnology, Inc. is a development stage biopharmaceutical company that acquires and develops innovative products for the treatment of
More informationAffitech A/S reports financial result for the first six months of 2012
Release no. 23/2012 Affitech A/S reports financial result for the first six months of 2012 Clinical trials sites initiated in Russia in late June 2012 by Affitech s collaboration partner IBC Generium for
More informationSummary of treatment benefits
Risk Management Plan PEMETREXED Powder for concentrate for Solution for infusion Pemetrexed is also indicated as monotherapy for the maintenance treatment of locally advanced or metastatic non small cell
More informationUpdate in Hematology Oncology Targeted Therapies. Mark Holguin
Update in Hematology Oncology Targeted Therapies Mark Holguin 25 years ago Why I chose oncology People How to help people with possibly the most difficult thing they may have to deal with Science Turning
More informationCellular, Molecular, and Biochemical Targets in Breast Cancer
Cellular, Molecular, and Biochemical Targets in Breast Cancer Kristy Kummerow Ingrid Meszoely December 12, 2012 VUMC Resident Bonus Conference One size fits all surgical treatment of breast cancer Wilhelm
More informationDec. 9, 2013, 11:00 a.m. EST
Dec. 9, 2013, 11:00 a.m. EST Portola Pharmaceuticals Announces New Phase 2 Results Confirming Immediate, Dose-Dependent and Well-Tolerated Reversal of Anticoagulation Activity of XARELTO(R) (rivaroxaban)
More informationScottish Medicines Consortium
Scottish Medicines Consortium pemetrexed 500mg infusion (Alimta ) No. (192/05) Eli Lilly 8 July 2005 The Scottish Medicines Consortium has completed its assessment of the above product and advises NHS
More informationIs the third-line chemotherapy feasible for non-small cell lung cancer? A retrospective study
Turkish Journal of Cancer Volume 34, No.1, 2004 19 Is the third-line chemotherapy feasible for non-small cell lung cancer? A retrospective study MUSTAFA ÖZDO AN, MUSTAFA SAMUR, HAKAN BOZCUK, ERKAN ÇOBAN,
More informationTHE CANCER STEM CELL INHIBITORS VS-6063 AND VS-5584 EXHIBIT SYNERGISTIC ANTICANCER ACTIVITY IN PRECLINICAL MODELS OF MESOTHELIOMA
THE CANCER STEM CELL INHIBITORS VS-6063 AND VS-5584 EXHIBIT SYNERGISTIC ANTICANCER ACTIVITY IN PRECLINICAL MODELS OF MESOTHELIOMA Mitchell Keegan, Ph.D. Vice President of Development, Verastem, Inc. 1
More informationAnti-PD1 Agents: Immunotherapy agents in the treatment of metastatic melanoma. Claire Vines, 2016 Pharm.D. Candidate
+ Anti-PD1 Agents: Immunotherapy agents in the treatment of metastatic melanoma Claire Vines, 2016 Pharm.D. Candidate + Disclosure I have no conflicts of interest to disclose. + Objectives Summarize NCCN
More informationCancer Treatments Subcommittee of PTAC Meeting held 18 September 2015. (minutes for web publishing)
Cancer Treatments Subcommittee of PTAC Meeting held 18 September 2015 (minutes for web publishing) Cancer Treatments Subcommittee minutes are published in accordance with the Terms of Reference for the
More informationChapter 7: Lung Cancer
Chapter 7: Lung Cancer Contents Chapter 7: Lung Cancer... 1 Small Cell... 2 Good PS + Limited stage... 2 Cisplatin/etoposide... 2 Concurrent chemotherapy + XRT... 2 Good / Intermediate PS... 2 Carboplatin
More informationThe EGFR mutation and precision therapy for lung cancer
for lung cancer Outcomes in advanced lung cancer have seen meaningful improvement in the past decade thanks to new precision drug therapies. Because tumors usually develop resistance to the drugs, scientists
More informationFuture Directions in Clinical Research. Karen Kelly, MD Associate Director for Clinical Research UC Davis Cancer Center
Future Directions in Clinical Research Karen Kelly, MD Associate Director for Clinical Research UC Davis Cancer Center Outline 1. Status of Cancer Treatment 2. Overview of Clinical Research at UCDCC 3.
More informationJSPS. Modeling & Simulation: A Tool to Enable Efficient Clinical Drug Development. March 29, 2005
Dr. Kunihiro Sasahara, Ph.D. Dr. Russell Wada, Ph.D. Dr. Yuying Gao, M.D., Ph.D. Modeling & Simulation: A Tool to Enable Efficient Clinical Drug Development JSPS March 29, 2005 Agenda Overview of Clinical
More informationBNC105 PHASE II RENAL CANCER TRIAL RESULTS
ABN 53 075 582 740 ASX ANNOUNCEMENT 19 March 2014 BNC105 PHASE II RENAL CANCER TRIAL RESULTS Results show BNC105 utility in patients with advanced disease Identified biomarkers which correlate with patient
More informationSORRENTO THERAPEUTICS, INC. (Exact name of registrant as specified in its charter)
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 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
More informationImmunovaccine Inc. (TSX-V: IMV) July 2011
Immunovaccine Inc. (TSX-V: IMV) July 2011 2 Forward Looking Statements This document contains forward-looking information pursuant to applicable securities law. All information that addresses activities
More informationMonoclonal Antibodies in Cancer. Ralph Schwall, PhD Associate Director, Translational Oncology Genentech, Inc.
Monoclonal Antibodies in Cancer Ralph Schwall, PhD Associate Director, Translational Oncology Genentech, Inc. Disclaimer I had nothing to do with Herceptin Using lessons learned in new antibody projects
More informationSAKK Lung Cancer Group. Current activities and future projects
SAKK Lung Cancer Group Current activities and future projects SAKK Lung Cancer Group Open group of physicians interested in lung cancer Mostly Medical Oncologists, but also Thoracic Surgeons Radiation
More informationCancer patients waiting for potentially live-saving treatments in UK
Cancer patients waiting for potentially live-saving treatments in UK 29 May 2005 UK patients are waiting too long for new treatments, according to a 'Dossier of Delay' compiled by information charity CancerBACUP.
More informationGenomic Medicine The Future of Cancer Care. Shayma Master Kazmi, M.D. Medical Oncology/Hematology Cancer Treatment Centers of America
Genomic Medicine The Future of Cancer Care Shayma Master Kazmi, M.D. Medical Oncology/Hematology Cancer Treatment Centers of America Personalized Medicine Personalized health care is a broad term for interventions
More informationTreatment of Metastatic Non-Small Cell Lung Cancer: A Systematic Review of Comparative Effectiveness and Cost Effectiveness
Treatment of Metastatic Non-Small Cell Lung Cancer: A Systematic Review of Comparative Effectiveness and Cost Effectiveness Investigators: Paul G. Shekelle, MD, PhD, Director Alicia R. Maher, MD Clinical
More informationTargeted Therapies in Lung Cancer
Targeted Therapies in Lung Cancer I Edited by: Simona Carnio Thoracic Oncology Division - St Luigi Hospital Orbassano (TO) - Italy Silvia Novello Department of Oncology - University of Torino - Italy Why
More informationNon Small Cell Lung Cancer: Scientific Discoveries and the Pursuit of Progress
Non Small Cell Lung Cancer: Scientific Discoveries and the Pursuit of Progress Lung Cancer Accounts for 14% of All New Cancer Diagnoses in the United States 1 Lung cancer is the second most common malignancy
More informationManagement of stage III A-B of NSCLC. Hamed ALHusaini Medical Oncologist
Management of stage III A-B of NSCLC Hamed ALHusaini Medical Oncologist Global incidence, CA cancer J Clin 2011;61:69-90 Stage III NSCLC Includes heterogeneous group of patients with differences in the
More informationGUIDELINES FOR THE MANAGEMENT OF LUNG CANCER
GUIDELINES FOR THE MANAGEMENT OF LUNG CANCER BY Ali Shamseddine, MD (Coordinator); as04@aub.edu.lb Fady Geara, MD Bassem Shabb, MD Ghassan Jamaleddine, MD CLINICAL PRACTICE GUIDELINES FOR THE TREATMENT
More informationDaiichi Sankyo to Acquire Ambit Biosciences
For Immediate Release Company name: DAIICHI SANKYO COMPANY, LIMITED Representative: Joji Nakayama, Representative Director, President and CEO (Code no.: 4568, First Section, Tokyo Stock Exchange) Please
More informationNovel Targeted Immunotherapy Approach for Metastatic Melanoma Under Phase 3 Investigation
Novel Targeted Immunotherapy Approach for Metastatic Melanoma Under Phase 3 Investigation Hans S. Keirstead President, NeoStem Oncology NeoStem Presented by GTC, a conference production company 626-256-6405
More informationBREAST CANCER - METASTATIC & LOCALLY ADVANCED CHEMOTHERAPY REGIMENS Capecitabine. Capecitabine + Docetaxel. Capecitabine + Vinorelbine
Capecitabine Capecitabine 1000-1250mg/m 2 oral TWICE daily for 14 days Until disease progression Capecitabine + Docetaxel Capecitabine 750-1000mg/m 2 oral TWICE daily for 14 days Up to 6 cycles Capecitabine
More informationNEW CLINICAL RESEARCH OPTIONS IN PANCREATIC CANCER IMMUNOTHERAPY. Alan Melcher Professor of Clinical Oncology and Biotherapy Leeds
NEW CLINICAL RESEARCH OPTIONS IN PANCREATIC CANCER IMMUNOTHERAPY Alan Melcher Professor of Clinical Oncology and Biotherapy Leeds CANCER IMMUNOTHERAPY - Breakthrough of the Year in Science magazine 2013.
More informationCorporate Presentation June 2, 2015
Corporate Presentation June 2, 2015 SAFE HARBOR STATEMENT This presentation contains forward-looking statements. Although the Company believes its expectations are based on reasonable assumptions, these
More informationCheckMate -057, a Pivotal III Opdivo (nivolumab) Lung Cancer Trial, Stopped Early
April 21, 2015 CheckMate -057, a Pivotal III Opdivo (nivolumab) Lung Cancer Trial, Stopped Early Opdivo Demonstrates Superior Overall Survival Compared to Docetaxel in Patients with Previously-Treated
More informationCorporate Medical Policy
Corporate Medical Policy Ado-Trastuzumab Emtansine (Trastuzumab-DM1) for Treatment of File Name: Origination: Last CAP Review: Next CAP Review: Last Review: ado_trastuzumab_emtansine_(trastuzumab-dm1)_for_treatment_of_her-2_positivemalignancies
More informationTargeted Chemotherapy Delivery Platform. Igor Sherman, PhD President & CEO Richard Potts, Chairman
Targeted Chemotherapy Delivery Platform Igor Sherman, PhD President & CEO Richard Potts, Chairman 2014 Change in Age Adjusted US Death Rates by Cause Almost unchanged over 50 years Source: U.S. National
More informationUpdate on Small Cell Lung Cancer
Welcome to Master Class for Oncologists Session 3: 2:45 PM - 3:30 PM Washington, DC March 28, 2009 Small Cell Lung Cancer: Best Practices & Recent Advances Speaker: Bruce E. Johnson, MD Professor of Medicine,
More informationCD22 Antigen Is Broadly Expressed on Lung Cancer Cells and Is a Target for Antibody-Based Therapy
CD22 Antigen Is Broadly Expressed on Lung Cancer Cells and Is a Target for Antibody-Based Therapy Joseph M. Tuscano, Jason Kato, David Pearson, Chengyi Xiong, Laura Newell, Yunpeng Ma, David R. Gandara,
More informationPeptide and Sustained Release Technology to Treat Ocular Diseases and Cancer
Peptide and Sustained Release Technology to Treat Ocular Diseases and Cancer Jordan Green, PhD, Co-Founder and CEO Wendy Perrow, MBA, Senior Business Advisor February 11, 2015 www.asclepix.com Advantages
More informationHow To Understand The Effects Of A Drug On Your Health
Farmacologia degli inibitori TK e mtor Romano Danesi Professore ordinario di Farmacologia UOC Farmacologia Universitaria Azienda Ospedaliero-Universitaria Pisana Dipartimento di Medicina Interna Università
More informationAeterna Zentaris. 11 th Annual Needham Healthcare Conference April 3, 2012. Committed to cure
11 th Annual Needham Healthcare Conference April 3, 2012 Forward-Looking Statements This presentation contains forward-looking statements made pursuant to the safe harbor provisions of the U.S. Securities
More informationTargeted Therapy What the Surgeon Needs to Know
Targeted Therapy What the Surgeon Needs to Know AATS Focus in Thoracic Surgery 2014 David R. Jones, M.D. Professor & Chief, Thoracic Surgery Memorial Sloan Kettering Cancer Center I have no disclosures
More informationFACT SHEET TESTETROL, A NOVEL ORALLY BIOACTIVE ANDROGEN
FACT SHEET TESTETROL, A NOVEL ORALLY BIOACTIVE ANDROGEN General Pantarhei Bioscience B.V. is an emerging specialty pharmaceutical company with a creative approach towards drug development. The Company
More informationNon-small cell lung cancer, advanced or metastatic, switch-therapy after gemcitabine/carboplatin
COMPENDIA TRANSPARENCY TRACKING FORM DRUG: Docetaxel INDICATION: Non-small cell lung cancer, advanced or metastatic, switch-therapy after gemcitabine/carboplatin COMPENDIA TRANSPARENCY REQUIREMENTS 1 Provide
More informationRole of taxanes in the treatment of advanced NHL patients: A randomized study of 87 cases
Role of taxanes in the treatment of advanced NHL patients: A randomized study of 87 cases R. Shraddha, P.N. Pandit Radium Institute, Patna Medical College and Hospital, Patna, India Abstract NHL is a highly
More informationClinical Trials for Patients with
Clinical Trials for Patients with Malignant Pleural Mesothelioma Lee M. Krug, M.D. Memorial Sloan-Kettering Cancer Center New York, New York Challenges in MPM Clinical Trials Mesothelioma is a rare disease,
More informationClinical Trial Designs for Incorporating Multiple Biomarkers in Combination Studies with Targeted Agents
Clinical Trial Designs for Incorporating Multiple Biomarkers in Combination Studies with Targeted Agents J. Jack Lee, Ph.D. Department of Biostatistics 3 Primary Goals for Clinical Trials Test safety and
More informationMiquel Àngel Seguí Palmer
Miquel Àngel Seguí Palmer HER2+ Breast Cancer is characterized by overexpression of HER2 receptors HER2+ Breast Cancer is characterized by overexpression of HER2 receptors HER2+ status is associated with
More informationThe Clinical Trials Process an educated patient s guide
The Clinical Trials Process an educated patient s guide Gwen L. Nichols, MD Site Head, Oncology Roche TCRC, Translational and Clinical Research Center New York DISCLAIMER I am an employee of Hoffmann-
More informationOvarian Cancer and Modern Immunotherapy: Regulatory Strategies for Drug Development
Ovarian Cancer and Modern Immunotherapy: Regulatory Strategies for Drug Development Sanjeeve Bala, MD, MPH Ovarian Cancer Endpoints Workshop FDA White Oak September 3, 2015 Overview Immune agents from
More informationAttached from the following page is the press release made by BMS for your information.
July 22, 2015 CheckMate -025 (global clinical trial), a Pivotal Phase III Opdivo (nivolumab) Renal Cancer Trial Stopped Early (PRINCETON, NJ, July 20, 2015) Bristol-Myers Squibb Company (NYSE:BMY) announced
More informationWhat s New With HER2?
What s New With HER2? Trastuzumab emtansine and pertuzumab for metastatic breast cancer Lindsay Livingston Pharmacist CancerCare Manitoba October 3, 2014 Presenter Disclosure Faculty: Lindsay Livingston
More informationUpdate on Clinical Trials and Foundation Funded Grants
Update on Clinical Trials and Foundation Funded Grants Mary Hesdorffer, MS, APRN-BC Medical Liaison Meso Foundation www.curemeso.org Delivering the Diagnosis Delivering the Diagnosis Day 1 Taking control
More informationWntResearch. Foxy-5 A unique Phase 1 opportunity to combat the spreading of cancer
WntResearch Foxy-5 A unique Phase 1 opportunity to combat the spreading of cancer Why WntResearch is developing novel anti-cancer drugs Approximately 55 000 Swedish citizens are diagnosed with cancer every
More informationPost-operative intrapleural chemotherapy for mesothelioma
Post-operative intrapleural chemotherapy for mesothelioma Robert Kratzke, MD John Skoglund Chair for Lung Cancer Research Section of Heme-Onc-Transplant University of Minnesota Medical School Efficacy
More informationOut-Patient Chemotherapy for Lung Cancer
Lung Cancer Out-Patient Chemotherapy for Lung Cancer Principles and practice JMAJ 46(12): 542 546, 2003 Shuichi YONEDA Director, Department of Pulmonary Medicine, Saitama Cancer Center Abstract: Recent
More informationAnti-angiogenesis Treatment
Anti-angiogenesis Treatment The search for better cancer drugs Today we are better able to treat cancer than ever. More than half of all people with cancer now live at least 5 years after being diagnosed.
More informationEndpoint Selection in Phase II Oncology trials
Endpoint Selection in Phase II Oncology trials Anastasia Ivanova Department of Biostatistics UNC at Chapel Hill aivanova@bios.unc.edu Primary endpoints in Phase II trials Recently looked at journal articles
More informationMOLOGEN AG German Equity Forum 2015
German Equity Forum 2015 Dr. Mariola Söhngen Chief Executive Officer Frankfurt am Main 24 November 2015 We are Pioneers in the Field of Immunotherapies Biotechnology company with focus on immunotherapies
More informationZeroing in on Non-Small Cell Lung Cancer: Integrating Targeted Therapies into Practice
Lung Cancer: Integrating Targeted Therapies into Practice Table of Contents Program Information... 2 Faculty Biographies... 3 Genomic Profiling of NSCLC for EGFR Inhibitors... 4 Fred R. Hirsch, MD, PhD
More informationEpizyme Announces First Quarter 2014 Financial Results and Provides Corporate Update
Epizyme Announces First Quarter 2014 Financial Results and Provides Corporate Update Initiated pediatric MLL-r Phase 1b dose escalation study of DOT1L inhibitor EPZ-5676 in May 2014; three proof-of-concept
More informationAvastin (Renal Cell Carcinoma) - Analysis and Forecasts to 2022
Brochure More information from http://www.researchandmarkets.com/reports/2228475/ Avastin (Renal Cell Carcinoma) - Analysis and Forecasts to 2022 Description: Avastin (Renal Cell Carcinoma) Analysis and
More informationLung Cancer Research: From Prevention to Cure!
Lung Cancer Research: From Prevention to Cure! Ravi Salgia, M.D, Ph.D Associate Professor of Medicine Director, Thoracic Oncology Research Program Department of Medicine Section of Hematology/Oncology
More informationBiomarker Trends in Breast Cancer Research
WHITE PAPER Biomarker Trends in Breast Cancer Research Jason Hill, PhD, Associate Director, External Science Affairs, Quintiles Quintiles examines the novel drug combinations and mechanisms of action that
More informationEU Media Inquiries: Satu Kaarina Glawe Phone: +49 (0) 2638 947 9218 Mobile: +49 (172) 294 6264 Email: sglawe@its.jnj.com
EU Media Inquiries: Satu Kaarina Glawe Phone: +49 (0) 2638 947 9218 Mobile: +49 (172) 294 6264 Email: sglawe@its.jnj.com Investor Relations: Stan Panasewicz Phone: +1 732-524-2524 Louise Mehrotra Phone:
More informationNew Directions in Treatment of Ovarian Cancer. Amit M. Oza Princess Margaret Hospital University of Toronto
New Directions in Treatment of Ovarian Cancer Amit M. Oza Princess Margaret Hospital University of Toronto Newly diagnosed: scenario Ist line Surgery chemotherapy Cure If can t cure can we turn into chronic
More informationOPG-Fc inhibits ovariectomy-induced growth of disseminated breast cancer cells in bone.
Title of the poster Authors Sheffield Cancer Research Centre University of Sheffield OPG-Fc inhibits ovariectomy-induced growth of disseminated breast cancer cells in bone. Dr Penelope Ottewell Background
More informationCOMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS (CPMP) NOTE FOR GUIDANCE ON THE PRE-CLINICAL EVALUATION OF ANTICANCER MEDICINAL PRODUCTS
The European Agency for the Evaluation of Medicinal Products Human Medicines Evaluation Unit London, 23 July 1998 COMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS (CPMP) NOTE FOR GUIDANCE ON THE PRE-CLINICAL
More informationBrigham and Women s Hospital, Boston, MA, USA; 2 Verastem, Inc., Boston, MA, USA
Determination of Biomarker Response in a Phase II Window of Opportunity Study of Defactinib (VS 6063), a Focal Adhesion Kinase (FAK) Inhibitor, in Patients with Resectable Malignant Pleural Mesothelioma
More informationAvastin in Metastatic Breast Cancer
Non-interventional study Avastin in Metastatic Breast Cancer ML 21165 / 2007 Clinical Study Report Synopsis ROCHE ML21165 / WiSP Project RH09 / V. 1.0 / 24.06.2013 ROCHE ML21165-2 - Name of Sponsor Roche
More informationSummary & Conclusion
The prognostic value of angiogenesis markers in patients with non-hodgkin lymphoma. Summary & Conclusion The current study aims to asses the prognostic value of some angiogenesis markers in patients with
More informationDevelopments in Biomarker Identification and Validation for Lung Cancer
Developments in Biomarker Identification and Validation for Lung Cancer Alexandre Passioukov, MD, PhD Alexandre.Passioukov@eortc.be Contents Introduction Lung cancer pathogenesis NSCLC treatment options
More information