DOCSLIB.ORG

CTI Corporate Presentation

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
CTI Corporate Presentation 20062006 InvestInvest NorthwestNorthwest conferenceconference JamesJames A.A. Bianco,Bianco, M.D.M.D. PresidentPresident andand CEOCEO C E L L T H E R A P E U T I C S, I N C. (N A S D A Q : C T I C) ForwardForward LookingLooking StatementStatement This presentation contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. These statements are based on management’s current expectations and beliefs and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The forward-looking statements contained in this presentation include statements about future financial and operating results, and risks and uncertainties that could affect CTI’s product and products under development. These statements are not guarantees of future performance, involve certain risks, uncertainties and assumptions that are difficult to predict, and are based upon assumptions as to future events that may not prove accurate. Therefore, actual outcomes and results may differ materially from what is expressed herein. In any forward-looking statement in which CTI expresses an expectation or belief as to future results, such expectation or belief is expressed in good faith and believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will result or be achieved or accomplished. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: risks associated with preclinical, clinical and sales and marketing developments in the biopharmaceutical industry in general and in particular including, without limitation, the potential failure of XYOTAX™ to prove safe and effective for treatment of non-small cell lung and ovarian cancers, the potential failure of pixantrone to prove safe and effective for treatment of non-Hodgkin’s lymphoma, determinations by regulatory, patent and administrative governmental authorities, competitive factors, technological developments, costs of developing, producing and selling CTI’s products under development; and other economic, business, competitive, and/or regulatory factors affecting CTI’s business generally, including those set forth in CTI’s filings with the SEC, including its Annual Report on Form 10-K for its most recent fiscal year and its most recent Quarterly Report on Form 10-Q, especially in the “Factors Affecting Our Operating Results” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections, and its Current Reports on Form 8-K. CTI is under no obligation to (and expressly disclaims any such obligation to) update or alter its forward-looking statements whether as a result of new information, future events, or otherwise. CTICTI CompanyCompany SnapshotSnapshot ••Singular focus: build a profitable cancer company ••Successful product acquisition track record - 1 product approved, 1 filing for FDA review, 1 in phase III, 1 in phase II ••Key value drivers in 2006 - Feedback from FDA/EMEA on pre-NDA/MAA meetings - Phase III interim results for pixantrone - NDA/MAA submissions for XYOTAX - CT-2106 phase II results ••Retained worldwide rights to all products CTICTI OncologyOncology StrategyStrategy Improve tolerability and/or efficacy of the most frequently used “cornerstone” chemotherapy drugs 2+ Cl + NH H N + NH Pt 3 R 2 Pt 3 H N Cl 3 NH2 H3N Taxanes Anthracyclines Camptothecins Platinum Agents XYOTAXXYOTAX™ PixantronePixantrone CTCT--21062106 BisBis--platinumplatinum XYOTAXXYOTAX™™ (paclitaxel(paclitaxel poliglumex)poliglumex) AA potentiallypotentially safer,safer, moremore effectiveeffective taxanetaxane XYOTAXXYOTAX PaclitaxelPaclitaxel poliglumexpoliglumex A subunit of the macromolecular complex Paclitaxel Macromolecular poly–Lcomplex–glutamate of XYOTAX backboneTM Singer et al. In: Adv Exp Med Biol. 2003; 519:81-99 XYOTAXXYOTAX AccumulatesAccumulates inin thethe TumorTumor EnhancedEnhanced permeabilitypermeability andand retentionretention effecteffect • Enhanced uptake in tumor tissue due to EPR effect • Decreases systemic toxicity; reduced normal tissue exposure to free drug • Increases half-life in tumor tissue XYOTAXXYOTAX EntersEnters CancerCancer CellsCells ThroughThrough DifferentDifferent MechanismMechanism thanthan TaxolTaxol® XYOTAXXYOTAX IntracellularIntracellular Uptake,Uptake, MetabolismMetabolism andand ReleaseRelease ofof ChemotherapyChemotherapy MayMay bebe enhancedenhanced inin presencepresence ofof estrogenestrogen IntracellularIntracellular UptakeUptake ofof XYOTAXXYOTAX inin LungLung TissueTissue AA LessLess Toxic,Toxic, MoreMore EffectiveEffective11,, EasierEasier toto UseUse TaxaneTaxane XYOTAX Paclitaxel 15-20 minute infusion 3 to 24 hour infusion 1STELLAR 3 and 4 data in women with PS2 NSCLC XYOTAXXYOTAX forfor lunglung cancercancer XYOTAXXYOTAX PhasePhase IIIIII studiesstudies forfor NSCLCNSCLC Comparator XYOTAX Primary # of TRIAL Design dose (mg/m2) dose (mg/m2) Endpoint pts STELLAR 2 Superiority 210 Docetaxel 75 2nd Line Open-label Q3 wks Survival 850 2 Line Q3 weeks NSC Lung Randomized (PS2 pts = 175) STELLAR 3 Superiority Paclitaxel 225 + 210 + 1st Line Open-label carbo AUC 6 carbo AUC 6 Survival 400 NSC Lung PS2 Randomized Q3 weeks Q3 wks STELLAR 4 Gemcitabine Superiority st 1000 d1, 8, 15 or 175 1 Line Open-label Survival 476 Navelbine 20 Q3 wks NSC Lung PS 2 Randomized d1, 8, 15 SurvivalSurvival EstimatesEstimates byby GenderGender STELLARSTELLAR 33 andand 44 XYOTAX Comparator XYOTAX Comparator Women Women Men Men N=97 N=101 N=293 N=290 Median Survival 285 days 233 days 220 days 207 days 1 year survival 40% 25% 30% 33% p=0.013 EstrogenEstrogen andand XYOTAXXYOTAX MetabolismMetabolism DoesDoes GenderGender Matter?Matter? XYOTAXXYOTAX PotentialPotential forfor gender/estrogengender/estrogen enhancedenhanced effectivenesseffectiveness ••Role of estrogen in lung cancer - Normal lung cells and NSCLC cells express estrogen receptors (ERβ) - Pre-menopausal status associated with worse survival ••Role of estrogen in XYOTAX metabolism - Significant Increase in how much XYOTAX goes to lung tissue compared to standard paclitaxel - Increased metabolism of XYOTAX and release of free paclitaxel ••Potentially broadly applicable to ERβ + cancers - Lung, Colorectal, Prostate, Breast, Uterus, Ovary XYOTAXXYOTAX StrongStrong evidenceevidence forfor estrogenestrogen enhancedenhanced effectivenesseffectiveness ••STELLAR 3+4 composite analysis (n=198 women) - Significant improvement in overall survival (log rank p=0.03) • 40% survival vs. 25% at 1 year (p=0.01) ••Highly significant correlation with age and estrogen status - Age <55 or normal estrogen levels (n=113 women) - Median survival 309 days XYOTAX vs. 181 days Controls (HR 0.56, log rank p=0.008) - 43% survival XYOTAX vs. 19% Control at 1 year (p=0.003) ••Benefit prospectively confirmed in phase II trial - 35 women (no control comparator arm) - Median survival normal estrogen: 216 days vs. low estrogen: 126 days - Survival (last contact) women with normal estrogen: 75% alive vs. 41% of women with low estrogen XYOTAXXYOTAX EvidenceEvidence forfor gender/estrogengender/estrogen enhancedenhanced effectivenesseffectiveness ••Reduction in severe side effects in men and women - Anemia (p=0.008) - Neutropenia (p=0.009) - Infection (p=0.003)1 - Pneumonia (p=0.017)1 ••Minimal to no hair loss ••Short 15-20 minute infusion without need for pre-meds ••Significant cost savings (less EPO, G-CSF, antibiotics) XYOTAXXYOTAX RegulatoryRegulatory approvalapproval strategystrategy forfor lunglung cancercancer PIONEERPIONEER (PGT305)(PGT305) GenderGender specificspecific trialtrial ofof XYOTAXXYOTAX vs.vs. paclitaxelpaclitaxel ••PGT305 multi-national, randomized trial - 80 sites North America/80 sites ex-NA ••Entry criteria: (identical to STELLAR 4) - chemotherapy naïve - Stage IIIb/IV - PS=2 - women ••Treatment arms: - XYOTAX 175mg/m2; 15-20” no routine pre-meds - paclitaxel 175mg/m2; 3 hrs, routine pre-meds ••Sample size: N = 600 patients PIONEERPIONEER (PGT305)(PGT305) GenderGender specificspecific trialtrial ofof XYOTAXXYOTAX vs.vs. paclitaxelpaclitaxel ••Stratification: - Geographic region US/Australia vs. ROW - Age <55 yrs vs. ≥55 yrs - Stage IIIB vs. IV ••Primary endpoint: - Overall survival and overall survival by estrogen level ••Statistical Plan - Planned interim analysis 1H07 estradiol directed: 63 in events in 300 patients for HR 0.48 (p=0.005) or HR 0.68 (p=0.05) - Final analysis 80% power to detect a constant HR 0.75 at p=0.048 level two sided log-rank test after 379 events XYOTAXXYOTAX EstimatedEstimated regulatoryregulatory timelinestimelines 2006 2007 1st H 2nd H 1st H 2nd H U STELLAR 3, 4 N I ♦♦ ♦♦ ♦♦ T NDA ODAC Approval E D PIONEER ♦♦ S Interim T Results A T E GOG maintenance ovarian cancer trial S ♦♦ Interim Results EU STELLAR 2, 3, 4 ♦♦ MAA PixantronePixantrone AnthracyclinesAnthracyclines ••Established “cornerstone” potentially curative therapy - Breast cancer / acute leukemia / lymphoma ••However all cause cumulative, irreversible damage to heart muscle ••Patients limited to life time maximum dose 550mg/m2 Prevents use in combination with Prevents use as repeat therapy* Prevents use in combination with targeted therapies# Dose m/mg2 Herceptin 7% 400 5% Herceptin + 500 16% paclitaxel 11% Herceptin + 550 anthracycline 26% 28% 0% 5% 10% 15% 20% 25% 30% 0% 5% 10% 15% 20% 25% 30% * Incidence of Congestive
Load more

Recommended publications
  • Re-Visiting Hypersensitivity Reactions to Taxanes: a Comprehensive Review
    Clinic Rev Allerg Immunol DOI 10.1007/s12016-014-8416-0 Re-visiting Hypersensitivity Reactions to Taxanes: A Comprehensive Review Matthieu Picard & Mariana C. Castells # Springer Science+Business Media New York 2014 Abstract Taxanes (a class of chemotherapeutic agents) Keywords Taxane . Paclitaxel . Taxol . Docetaxel . are an important cause of hypersensitivity reactions Taxotere . Nab-paclitaxel . Abraxane . Cabazitaxel . (HSRs) in cancer patients. During the last decade, the Chemotherapy . Hypersensitivity . Allergy . Skin test . development of rapid drug desensitization has been key Desensitization . Challenge . Diagnosis . Review . IgE . to allow patients with HSRs to taxanes to be safely re- Complement . Mechanism treated although the mechanisms of these HSRs are not fully understood. Earlier studies suggested that solvents, such as Cremophor EL used to solubilize paclitaxel, Introduction were responsible for HSRs through complement activa- tion, but recent findings have raised the possibility that Hypersensitivity reactions (HSRs) to chemotherapy are in- some of these HSRs are IgE-mediated. Taxane skin creasingly common and represent an important impediment testing, which identifies patients with an IgE-mediated to the care of cancer patients as they may entail serious sensitivity, appears as a promising diagnostic and risk consequences and prevent patients from being treated with stratification tool in the management of patients with the most efficacious agent against their cancer [1]. During the HSRs to taxanes. The management of patients following last decade, different groups have developed rapid drug de- a HSR involves risk stratification and re-exposure could sensitization (RDD) protocols that allow the safe re- be performed either through rapid drug desensitization introduction of a chemotherapeutic agent to which a patient or graded challenge based on the severity of the initial is allergic, and their use have recently been endorsed by the HSR and the skin test result.
    [Show full text]
  • BC Cancer Benefit Drug List September 2021
    Page 1 of 65 BC Cancer Benefit Drug List September 2021 DEFINITIONS Class I Reimbursed for active cancer or approved treatment or approved indication only. Reimbursed for approved indications only. Completion of the BC Cancer Compassionate Access Program Application (formerly Undesignated Indication Form) is necessary to Restricted Funding (R) provide the appropriate clinical information for each patient. NOTES 1. BC Cancer will reimburse, to the Communities Oncology Network hospital pharmacy, the actual acquisition cost of a Benefit Drug, up to the maximum price as determined by BC Cancer, based on the current brand and contract price. Please contact the OSCAR Hotline at 1-888-355-0355 if more information is required. 2. Not Otherwise Specified (NOS) code only applicable to Class I drugs where indicated. 3. Intrahepatic use of chemotherapy drugs is not reimbursable unless specified. 4. For queries regarding other indications not specified, please contact the BC Cancer Compassionate Access Program Office at 604.877.6000 x 6277 or [email protected] DOSAGE TUMOUR PROTOCOL DRUG APPROVED INDICATIONS CLASS NOTES FORM SITE CODES Therapy for Metastatic Castration-Sensitive Prostate Cancer using abiraterone tablet Genitourinary UGUMCSPABI* R Abiraterone and Prednisone Palliative Therapy for Metastatic Castration Resistant Prostate Cancer abiraterone tablet Genitourinary UGUPABI R Using Abiraterone and prednisone acitretin capsule Lymphoma reversal of early dysplastic and neoplastic stem changes LYNOS I first-line treatment of epidermal
    [Show full text]
  • Monotherapy with Pixantrone in Histologically Confirmed Relapsed Or
    research paper Monotherapy with pixantrone in histologically confirmed relapsed or refractory aggressive B-cell non-Hodgkin lymphoma: post-hoc analyses from a phase III trial Ruth Pettengell,1 Catherine Sebban,2 This post hoc analysis of a phase 3 trial explored the effect of pixantrone in Pier Luigi Zinzani,3 Hans Gunter patients (50 pixantrone, 47 comparator) with relapsed or refractory aggres- 4 5 Derigs, Sergey Kravchenko, Jack W. sive B-cell non-Hodgkin lymphoma (NHL) confirmed by centralized histo- 6 7 Singer, Panteli Theocharous, Lixia logical review. Patients received 28-d cycles of 85 mg/m2 pixantrone 7 8 Wang, Mariya Pavlyuk, Kahina M. dimaleate (equivalent to 50 mg/m2 in the approved formulation) on days Makhloufi8 and Bertrand Coiffier9,10 1, 8 and 15, or comparator. The population was subdivided according to 1St George’s University of London, London, UK, 2 previous rituximab use and whether they received the study treatment as Leon Berard Cancer Centre, Lyon, France, – 3Institute of Haematology “Le A Seragnoli”, 3rd or 4th line. Median number of cycles was 4 (range, 2 6) with pix- – University of Bologna, Bologna, Italy, 4St€adt Kli- antrone and 3 (2 6) with comparator. In 3rd or 4th line, pixantrone was Á Á nikum, Frankfurt-Hoeschest, Klinik fur€ Innere associated with higher complete response (CR) (23 1% vs. 5 1% compara- Medizin III, Frankfurt am Main, Germany, tor, P = 0Á047) and overall response rate (ORR, 43Á6% vs. 12Á8%, 5Chemotherapy and Intensive Treatment of Hae- P = 0Á005). In 3rd or 4th line with previous rituximab (20 pixantrone, 18 matology Diseases, Haematology Scientific Centre comparator), pixantrone produced better ORR (45Á0% vs.
    [Show full text]
  • Current Advances of Nitric Oxide in Cancer and Anticancer Therapeutics
    Review Current Advances of Nitric Oxide in Cancer and Anticancer Therapeutics Joel Mintz 1,†, Anastasia Vedenko 2,†, Omar Rosete 3 , Khushi Shah 4, Gabriella Goldstein 5 , Joshua M. Hare 2,6,7 , Ranjith Ramasamy 3,6,* and Himanshu Arora 2,3,6,* 1 Dr. Kiran C. Patel College of Allopathic Medicine, Nova Southeastern University, Davie, FL 33328, USA; [email protected] 2 John P Hussman Institute for Human Genomics, Miller School of Medicine, University of Miami, Miami, FL 33136, USA; [email protected] (A.V.); [email protected] (J.M.H.) 3 Department of Urology, Miller School of Medicine, University of Miami, Miami, FL 33136, USA; [email protected] 4 College of Arts and Sciences, University of Miami, Miami, FL 33146, USA; [email protected] 5 College of Health Professions and Sciences, University of Central Florida, Orlando, FL 32816, USA; [email protected] 6 The Interdisciplinary Stem Cell Institute, Miller School of Medicine, University of Miami, Miami, FL 33136, USA 7 Department of Medicine, Cardiology Division, Miller School of Medicine, University of Miami, Miami, FL 33136, USA * Correspondence: [email protected] (R.R.); [email protected] (H.A.) † These authors contributed equally to this work. Abstract: Nitric oxide (NO) is a short-lived, ubiquitous signaling molecule that affects numerous critical functions in the body. There are markedly conflicting findings in the literature regarding the bimodal effects of NO in carcinogenesis and tumor progression, which has important consequences for treatment. Several preclinical and clinical studies have suggested that both pro- and antitumori- Citation: Mintz, J.; Vedenko, A.; genic effects of NO depend on multiple aspects, including, but not limited to, tissue of generation, the Rosete, O.; Shah, K.; Goldstein, G.; level of production, the oxidative/reductive (redox) environment in which this radical is generated, Hare, J.M; Ramasamy, R.; Arora, H.
    [Show full text]
  • Filed by Cell Therapeutics, Inc. Pursuant to Rule 425 Under The
    Filed by Cell Therapeutics, Inc. Pursuant to Rule 425 under the Securities Act of 1933 And deemed filed pursuant Rule 14a-12 Of the Securities Exchange Act of 1934 Subject Company: Cell Therapeutics, Inc. Commission File No.: 001-12465 The following is a transcript of a presentation given by Cell Therapeutics, Inc. at its annual meeting of shareholders, held on June 20, 2003. Moderator: Jim Bianco Operator: Good day everyone and welcome to the Cell Therapeutics annual shareholder meeting. As a reminder, this call is being recorded. We’ll soon be going live to Seattle where the call will begin shortly. Please stand by. Jim Bianco: Welcome. My name is Jim Bianco. I’m the President and CEO of Cell Therapeutics. Welcome to our 2003 shareholders meeting. Our business meeting agenda today is to approve the minutes, elect the directors, and approve the equity incentive plan as well as the amendment to the employees stock purchase plan, and ratify the selection of E&Y as independent auditors. Mike Kennedy, the Secretary of the company, will act as secretary of this meeting, and George Pabst has been appointed inspector of elections to examine and count proxies and ballots. At the conclusion of the business portion of today’s meeting, members of management will present highlights from the past year and outline some of our future milestones and objectives for the next 12 to 18 months. At this time, I’d like to call the meeting to order. Let me begin by introducing our directors who are present today and let me start by saying that Dr.
    [Show full text]
  • Pharmacogenomic Biomarkers in Docetaxel Treatment of Prostate Cancer: from Discovery to Implementation
    G C A T T A C G G C A T genes Review Pharmacogenomic Biomarkers in Docetaxel Treatment of Prostate Cancer: From Discovery to Implementation Reka Varnai 1,2, Leena M. Koskinen 3, Laura E. Mäntylä 3, Istvan Szabo 4,5, Liesel M. FitzGerald 6 and Csilla Sipeky 3,* 1 Department of Primary Health Care, University of Pécs, Rákóczi u 2, H-7623 Pécs, Hungary 2 Faculty of Health Sciences, Doctoral School of Health Sciences, University of Pécs, Vörösmarty u 4, H-7621 Pécs, Hungary 3 Institute of Biomedicine, University of Turku, Kiinamyllynkatu 10, FI-20520 Turku, Finland 4 Institute of Sport Sciences and Physical Education, University of Pécs, Ifjúság útja 6, H-7624 Pécs, Hungary 5 Faculty of Sciences, Doctoral School of Biology and Sportbiology, University of Pécs, Ifjúság útja 6, H-7624 Pécs, Hungary 6 Menzies Institute for Medical Research, University of Tasmania, Hobart, Tasmania 7000, Australia * Correspondence: csilla.sipeky@utu.fi Received: 17 June 2019; Accepted: 5 August 2019; Published: 8 August 2019 Abstract: Prostate cancer is the fifth leading cause of male cancer death worldwide. Although docetaxel chemotherapy has been used for more than fifteen years to treat metastatic castration resistant prostate cancer, the high inter-individual variability of treatment efficacy and toxicity is still not well understood. Since prostate cancer has a high heritability, inherited biomarkers of the genomic signature may be appropriate tools to guide treatment. In this review, we provide an extensive overview and discuss the current state of the art of pharmacogenomic biomarkers modulating docetaxel treatment of prostate cancer. This includes (1) research studies with a focus on germline genomic biomarkers, (2) clinical trials including a range of genetic signatures, and (3) their implementation in treatment guidelines.
    [Show full text]
  • Exosomes and Breast Cancer Drug Resistance Xingli Dong1,2, Xupeng Bai 2,3,Jieni2,3,Haozhang 4,Weiduan5, Peter Graham2,3 Andyongli 2,3,6
    Dong et al. Cell Death and Disease (2020) 11:987 https://doi.org/10.1038/s41419-020-03189-z Cell Death & Disease REVIEW ARTICLE Open Access Exosomes and breast cancer drug resistance Xingli Dong1,2, Xupeng Bai 2,3,JieNi2,3,HaoZhang 4,WeiDuan5, Peter Graham2,3 andYongLi 2,3,6 Abstract Drug resistance is a daunting challenge in the treatment of breast cancer (BC). Exosomes, as intercellular communicative vectors in the tumor microenvironment, play an important role in BC progression. With the in-depth understanding of tumor heterogeneity, an emerging role of exosomes in drug resistance has attracted extensive attention. The functional proteins or non-coding RNAs contained in exosomes secreted from tumor and stromal cells mediate drug resistance by regulating drug efflux and metabolism, pro-survival signaling, epithelial–mesenchymal transition, stem-like property, and tumor microenvironmental remodeling. In this review, we summarize the underlying associations between exosomes and drug resistance of BC and discuss the unique biogenesis of exosomes, the change of exosome cargo, and the pattern of release by BC cells in response to drug treatment. Moreover, we propose exosome as a candidate biomarker in predicting and monitoring the therapeutic drug response of BC and as a potential target or carrier to reverse the drug resistance of BC. ● Facts Tumor-derived exosomes mediate enhanced EMT and stem-like property of drug-resistant BC. ● ● Tumor-derived exosomes mediate the chemoresistance TME-derived exosomes mediate the tumor of BC by reducing the intracellular accumulation of microenvironmental remodeling that favors the drug resistance of BC. 1234567890():,; 1234567890():,; 1234567890():,; 1234567890():,; chemotherapeutic drugs and delivering functional ● cargos that activate pro-survival signaling and The exosome is proposed as a candidate biomarker in unchecked cell cycle progression.
    [Show full text]
  • W O 2 11/ 28571Al
    (12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property Organization International Bureau (10) International Publication Number (43) International Publication Date / 10 March 2011 (10.03.2011) W O 2 1 1/ 28 57 1 A l (51) International Patent Classification: (74) Agents: UDAL, Robert, P., Ph. D. et al; Morgan, Lewis A 43/02 (2006.01) & Bockius LLP, 1701 Market Street, Philadelphia, PA 19103 (US). (21) International Application Number: PCT/US20 10/046627 (81) Designated States (unless otherwise indicated, for every kind of national protection available): AE, AG, AL, AM, (22) International Filing Date: AO, AT, AU, AZ, BA, BB, BG, BH, BR, BW, BY, BZ, 25 August 2010 (25.08.2010) CA, CH, CL, CN, CO, CR, CU, CZ, DE, DK, DM, DO, (25) Filing Language: English DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, HN, HR, HU, ID, IL, IN, IS, JP, KE, KG, KM, KN, KP, (26) Publication Language: English KR, KZ, LA, LC, LK, LR, LS, LT, LU, LY, MA, MD, (30) Priority Data: ME, MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, 61/238,787 1 September 2009 (01 .09.2009) US NO, NZ, OM, PE, PG, PH, PL, PT, RO, RS, RU, SC, SD, SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, TN, TR, (71) Applicant (for all designated States except US): TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW. TAPESTRY PHARMACEUTICALS, INC. [US/US]; 6304 Spine Road, Unit A, Boulder, CO 80301 (US). (84) Designated States (unless otherwise indicated, for every kind of regional protection available): ARIPO (BW, GH, (72) Inventors; and GM, KE, LR, LS, MW, MZ, NA, SD, SL, SZ, TZ, UG, (75) Inventors/ Applicants (for US only): MCCHESNEY, ZM, ZW), Eurasian (AM, AZ, BY, KG, KZ, MD, RU, TJ, James, D.
    [Show full text]
  • Treatment of Taxane Acute Pain Syndrome (TAPS) in Cancer Patients Receiving Taxane-Based Chemotherapy—A Systematic Review
    Support Care Cancer (2016) 24:1583–1594 DOI 10.1007/s00520-015-2941-0 ORIGINAL ARTICLE Treatment of taxane acute pain syndrome (TAPS) in cancer patients receiving taxane-based chemotherapy—a systematic review Ricardo Fernandes1 & Sasha Mazzarello2 & Habeeb Majeed3 & Stephanie Smith 2 & Risa Shorr4 & Brian Hutton5 & Mohammed FK Ibrahim1 & Carmel Jacobs1 & Michael Ong1 & Mark Clemons1,2,6 Received: 21 May 2015 /Accepted: 3 September 2015 /Published online: 19 September 2015 # Springer-Verlag Berlin Heidelberg 2015 Abstract randomized open-label trials 76 patients), and one was a ret- Background Taxane acute pain syndrome (TAPS) is charac- rospective study (10 patients). The agents investigated includ- terized by myalgias and arthralgias starting 1–3 days and last- ed gabapentin, amifostine, glutathione, and glutamine. Study ing 5–7 days after taxane-based chemotherapy. Despite nega- sizes ranged from 10 to 185 patients. Given the heterogeneity tively impacting patient’s quality of life, little is known about of study designs, a narrative synthesis of results was per- the optimal TAPS management. A systematic review of treat- formed. Neither glutathione (QoL, p = 0.30, no 95 % CI re- ment strategies for TAPS across all tumor sites was performed. ported) nor glutamine (mean improvement in average pain Methods Embase, Ovid MEDLINE(R), and the Cochrane was 0.8 in both treatment arms, p = 0.84, no 95 % CI reported) Central Register of Controlled Trials were searched from were superior to placebo. Response to amifostine (pain re- 1946 to October 2014 for trials reporting the effectiveness of sponse) and gabapentin (reduction in taxane-induced arthral- different treatments of TAPS in cancer patients receiving gias and myalgias) was 36 % (95 % CI, 16–61 %) and 90 % taxane-based chemotherapy.
    [Show full text]
  • Distinct Cargos of Small Extracellular Vesicles Derived from Hypoxic Cells and Their Effect on Cancer Cells
    International Journal of Molecular Sciences Review Distinct Cargos of Small Extracellular Vesicles Derived from Hypoxic Cells and Their Effect on Cancer Cells Geoffroy Walbrecq, Christiane Margue, Iris Behrmann and Stephanie Kreis * Department of Life Sciences and Medicine (DLSM), University of Luxembourg, 6, avenue du Swing, L-4367 Belvaux, Luxembourg; Geoff[email protected] (G.W.); [email protected] (C.M.); [email protected] (I.B.) * Correspondence: [email protected] Received: 17 June 2020; Accepted: 17 July 2020; Published: 17 July 2020 Abstract: Hypoxia is a common hallmark of solid tumors and is associated with aggressiveness, metastasis and poor outcome. Cancer cells under hypoxia undergo changes in metabolism and there is an intense crosstalk between cancer cells and cells from the tumor microenvironment. This crosstalk is facilitated by small extracellular vesicles (sEVs; diameter between 30 and 200 nm), including exosomes and microvesicles, which carry a cargo of proteins, mRNA, ncRNA and other biological molecules. Hypoxia is known to increase secretion of sEVs and has an impact on the composition of the cargo. This sEV-mediated crosstalk ultimately leads to various biological effects in the proximal tumor microenvironment but also at distant, future metastatic sites. In this review, we discuss the changes induced by hypoxia on sEV secretion and their cargo as well as their effects on the behavior and metabolism of cancer cells, the tumor microenvironment and metastatic events. Keywords: exosomes; extracellular vesicles; cancer; hypoxia; TME; immunity; biomarker 1. Introduction Extracellular vesicles are defined as particles, which are delimited by a lipid bilayer and which cannot replicate [1].
    [Show full text]
  • CLINICAL CANCER LETTER Cancer Research News for Clinicians
    Vol. 27 No. 1 THE January 2004 CLINICAL CANCER LETTER Cancer research news for clinicians © Copyright 2004 American Society of Hematology: The Cancer Letter Inc. New Treatment Approaches For A Variety All rights reserved. Of Leukemias Described At ASH Meeting By Lawrence M. Prescott SAN DIEGO—A number of new treatment approaches appear to ASH Annual Meeting: be of real value in patients with a variety of leukemias including acute Trisenox In Children promyelocytic leukemia, chronic lymphocytic leukemia, acute myeloid With APML leukemia, and chronic myeloid leukemia, according to investigators . Page 2 presenting their findings at the 45th annual meeting of the American Society of Hematology last month. (Continued to page 2) Campath In CLL . Page 2 ASH Highlights: Improved Treatments For NHL, Genasense In AML Poor Prognostic Factors For B-Cell In Children . Page 3 By Lawrence M. Prescott SAN DIEGO—New therapeutic modalities for the treatment of Gleevec For CML adults with relapsed and aggressive non-Hodgkin’s lymphoma, as well as . Page 4 the identification of poor prognostic factors in children with advanced B- cell NHL and ways to combat this problem are proving to be of particular Zevalin In Mantle Cell benefit in developing effective therapeutic modalities for patients with . Page 4 forms of difficult-to-treat NHL, said investigators at the 45th annual meeting of the American Society of Hematology. Rituxan In NHL . Page 6 Pixantrone in Relapsed Aggressive NHL A variant of the CHOP (cyclophosphamide, vincristine, prednisone, Sphingosomal Vincristine and doxorubicin) regimen, which substitutes the new anthracycline-derived drug pixantrone for doxorubicin in elderly patients with aggressive NHL Tested in Relapsed NHL who had failed prior doxorubicin-containing CHOP, proved to be a feasible .
    [Show full text]
  • PIXUVRI, INN-Pixantrone
    28 March 2019 EMA/250839/2019 Committee for Medicinal Products for Human Use (CHMP) Assessment report Pixuvri International non-proprietary name: pixantrone Procedure No. EMEA/H/C/002055/R/0046 Note Assessment report as adopted by the CHMP with all information of a commercially confidential nature deleted. Official address Domenico Scarlattilaan 6 ● 1083 HS Amsterdam ● The Netherlands Address for visits and deliveries Refer to www.ema.europa.eu/how-to-find-us Send us a question Go to www.ema.europa.eu/contact Telephone +31 (0)88 781 6000 An agency of the European Union © European Medicines Agency, 2019. Reproduction is authorised provided the source is acknowledged. Status of this report and steps taken for the assessment Current Description Planned Actual Date Need for step¹ date discussion² Start of procedure: 03 Dec 2018 03 Dec 2018 CHMP and PRAC Rapporteurs Joint Assessment 03 Jan 2019 07 Jan 2019 Report CHMP and PRAC members comments 07 Jan 2019 11 Jan 2019 Updated CHMP and PRAC Rapporteurs Joint 10 Jan 2019 17 Jan 2019 Assessment Report PRAC endorsed relevant sections of the 17 Jan 2019 17 Jan 2019 assessment report³ Request for supplementary information 31 Jan 2019 MAH responses to (RfSI) received on 05 Mar 2019 06 Mar 2019 CHMP and PRAC Rapporteurs' joint assessment 13 Mar 2019 15 Mar 2019 report PRAC endorsed relevant sections of the 14 Mar 2019 15 Mar 2019 assessment report CHMP and PRAC members comments 18 Mar 2019 21 Mar 2019 Updated CHMP and PRAC Rapporteurs joint 21 Mar 2019 22 Mar 2019 assessment report Opinion 28 Mar 2019 5 Apr 2019 ¹ Tick the box corresponding to the applicable step – do not delete any of the steps.
    [Show full text]