DOCSLIB.ORG

Ovarian Cancer

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Ovarian Cancer 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. Except as may be required by Italian law, 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. AgendaAgenda •• General corporate overview •• Current portfolio status: development stage, time horizons to commercial launch •• New product acquisitions, portfolio synergies and status •• Commercial Opportunity: Pixantrone, XYOTAX® •• Capital Structure, financials, stock performance •• Milestones next 12 months: key messages GeneralGeneral OverviewOverview ••CTI- Incorporated 1991: University of Washington and Fred Hutchinson Cancer Research Center Seattle, WA (Nobel Prize recipient E.D.Thomas) - Founders: Former Chief of Oncology and Former Director Marrow Transplant Program ••Selected biotech companies originating from the UW/Fred Hutchinson Cancer Center - Immunex 1987, purchased by Amgen 2004 $16B - ICOS 1991, purchased by Eli Lilly 2005 $3.5B - Pathogenesis 1991, purchased by Chiron 2003 $650M ••Average time and expenditure for biotech companies to become profitable: 15 to 17 years >$1B • Most significant Value Appreciation in Biotech Stocks occurs between phase III results and NDA approval - CTIC: In 2000 was 2nd best performing stock on NASDAQ: (~1500% annual return) following Trisenox® NDA GeneralGeneral OverviewOverview ••Established operations March 1992, Seattle WA ••Singular focus: build profitable cancer company - Bring to market less toxic more effective cancer drugs ••Initial Public Offering : March 1997 ••Growth through acquisition strategy - Successful product acquisition track record • 1 product (Trisenox®) approved and marketed in US/EU/Japan • Sold to CEPH in 2005 for $70,000,000 and potential $80,000,000 earnouts • 1 product (XYOTAX) pending MAA filing • 2 products (Xyotax, pixantrone) completing phase III trials ••Merged with Novuspharma January 2004 TRISENOX® (arsenic trioxide) IntegratedIntegrated DevelopmentDevelopment CapabilitiesCapabilities Post-Novuspharma merger • Former oncology drug development unit of Boehringer Mannheim, and later part of Roche oncology - Expertise in pre-development, pharmacology, CMC, Phase I/II - Cost efficient, pharma drug development expertise ResearchResearch DevelopmentDevelopment Target Target Lead Lead Pharmacology Clinical Sales & Manufacture Regulatory Identification Validation Generation Optimization Preclinical Trials Marketing MergerMerger gavegave CTICTI fullyfully integratedintegrated capabilitiescapabilities fromfrom targettarget discoverydiscovery throughthrough commercializationcommercialization InternationalInternational ReachReach United States Europe - SEATTLE, WASHINGTON - BRESSO, ITALY ••~140 FTEs in, clinical, regulatory ••~80 employees in and commercial operations pharmacology, toxicology, preclinical studies, CMC, QA/QC PortfolioPortfolio StrategyStrategy •• Improve the safety and effectiveness of the most frequently prescribed anti-cancer drugs - Taxanes - Anthracyclines - Platinates •• Develop new agents with unique mechanisms of tumor cell killing without more side effects - Bis-platinates - Hif-1α inhibitors CommercialCommercial StrategyStrategy •• BloodBlood--relatedrelated CancerCancer MarketMarket (lymphoma, leukemia, myeloma, MDS) - Typical market size between 10,000 to 60,000 patients/year - Middle-tier companies have been successful with product entries - Strategy: Establish sales and marketing presence to promote CTI products •• SolidSolid TumorTumor MarketMarket (NSCLC, breast, ovarian, CRC, prostate) - Typical market size between 120,000 to 200,000 patients/year - Dominated by top 5 multi-national pharma-companies - Strategy: Establish commercial partnerships with co-promotion option CurrentCurrent ProductProduct PipelinePipeline StatusStatus 22 LateLate StageStage ProductsProducts NearingNearing ApprovalApproval Maturing phase III programs for pixantrone and XYOTAX Pixantrone results in DBCL and Follicular have high probability of success Phase III results 2007 Potential NDA late 2008 XYOTAX has good likelihood of approval in EU with existing STELLAR data MAA filing early ’08 with potential approval 1H-‘09 XYOTAX gender based Lung and Ovarian trials have high probability of success NDA potential filing for NSCLC 1-H ’09, Ovarian 2H- ’09 Commercial Launch in 12-18 months Clinical Pipeline Gap Only pre-clinical candidates after pixantrone and Xyotax 2 new “first in class” cancer drugs OncologyOncology PipelinePipeline CurrentCurrent ApprovalApproval && LaunchLaunch DateDate TargetsTargets 2007 2008 2009 2010 2011 Pixantrone Phase III Phase III Launch Q1-3rd Launch Launch results results line DBCL Year +1 Year +2 DBCL Follicular Launch Q4-2nd File NDA line Follicular Xyotax File MAA EU launch Q2 Launch – Launch File NDA (NI)-Lung Ovarian Year +2 US launch-Q4 Year +1 Lung-women Bis- Select File IND Start phase II Start Pivotal lead, Start trial(s) pivotal trial(s) platinate Start phase IND I trial trial(s) continue studies HIF-1α Lead Lead Start IND File IND Start phase II Optimize selection studies Start phase trial(s) preclinical I trial studies = commercial 20072007 ProductProduct PipelinePipeline StrategyStrategy “Jump start” commercial effort in blood related cancer market Acquire marketed product that has synergies with pixantrone Re-establish commercial infrastructure in advance of pixantrone launch Generates awareness of pixantrone trials and indications Synergies in selling to same target audience Sales training, MSL support, clinical trial support Add additional phase II/III product to pipeline that could permit a focused selling effort in targeted solid tumor applications Initial indications <20,000 patients annually Allows utilization of the 35FTE’s under NVS agreement Allows CTI to back integrate into the larger solid tumor market once resources and infrastructure permit OncologyOncology PipelinePipeline Proposed Additions and Target Dates 2007 2008 2009 2010 2011 2012 2013 Marketed Phase III Phase Expand Expand PRODUCT A st Relapsed 1 line III’s Label- Label DBCL st st Follicular results 1 line 1 line st NHL 1 line DBCL Follicular Follicular Pixantrone Launch Launch Launch DBCL Year +1 Year +2 Follicular XYOTAX Launch Launch Launch Lung Ovarian Year +2 PRODUCT B Phase II- Pivotal File Launch Launch III Lipo- Year +1 Lipo- NDA Lipo- sarcoma sarcoma sarcoma Bis-platinates Select File IND Start Start Phase III NDA Launch lead Start Phase phase continues filing Phase 1 II III Hif-1α Lead Select Start File IND Start Start Phase Optimize Lead IND Start phase II Phas III Start studies phase I e III (cont) preclin = commercial ByBy yearyear endend --20072007 CTI will have marketed product with annual sales ~$15M Market expansion phase III studies in progress CTI will have reported on pixantrone Phase II/III trial results Meet with FDA to discuss
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]
  • 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]
  • 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
    [Show full text]
  • Section B Changed Classes/Guidelines Final
    EPHMRA ANATOMICAL CLASSIFICATION GUIDELINES 2019 Section B Changed Classes/Guidelines Final Version Date of issue: 24th December 2018 1 A3 FUNCTIONAL GASTRO-INTESTINAL DISORDER DRUGS R2003 A3A PLAIN ANTISPASMODICS AND ANTICHOLINERGICS R1993 Includes all plain synthetic and natural antispasmodics and anticholinergics. A3B Out of use; can be reused. A3C ANTISPASMODIC/ATARACTIC COMBINATIONS This group includes combinations with tranquillisers, meprobamate and/or barbiturates except when they are indicated for disorders of the autonomic nervous system and neurasthenia, in which case they are classified in N5B4. A3D ANTISPASMODIC/ANALGESIC COMBINATIONS R1997 This group includes combinations with analgesics. Products also containing either tranquillisers or barbiturates and analgesics to be also classified in this group. Antispasmodics indicated exclusively for dysmenorrhoea are classified in G2X1. A3E ANTISPASMODICS COMBINED WITH OTHER PRODUCTS r2011 Includes all other combinations not specified in A3C, A3D and A3F. Combinations of antispasmodics and antacids are classified in A2A3; antispasmodics with antiulcerants are classified in A2B9. Combinations of antispasmodics with antiflatulents are classified here. A3F GASTROPROKINETICS r2013 This group includes products used for dyspepsia and gastro-oesophageal reflux. Compounds included are: alizapride, bromopride, cisapride, clebopride, cinitapride, domperidone, levosulpiride, metoclopramide, trimebutine. Prucalopride is classified in A6A9. Combinations of gastroprokinetics with other substances
    [Show full text]
  • (12) Patent Application Publication (10) Pub. No.: US 2007/0209082 A1 Lih Et Al
    US 20070209082A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2007/0209082 A1 Lih et al. (43) Pub. Date: Sep. 6, 2007 (54) TXR1 AND ENHANCED TAXANE Publication Classification SENSTIVITY BASED ON THE MODULATION OF A PATHWAY MEDIATED (51) Int. Cl. THEREBY AOIK 67/027 (2006.01) CI2O I/68 (2006.01) (76) Inventors: Chih Jian Lih, Palo Alto, CA (US); A6IR 48/00 (2006.01) Stanley N. Cohen, Stanford, CA (US) A6II 3L/337 (2006.01) CI2P 2/06 (2006.01) C07K I4/705 (2006.01) Correspondence Address: C07K 6/30 (2006.01) BOZICEVIC, FIELD & FRANCIS LLP (52) U.S. Cl. .............................. 800/14: 514/449; 514/44; 1900 UNIVERSITY AVENUE 435/6: 435/69. 1; 435/325; 435/320.1; SUTE 200 530/350; 530/388.8; 536/23.5 EAST PALO ALTO, CA 94.303 (US) (57) ABSTRACT (21) Appl. No.: 11/357,728 Methods and compositions for enhancing taxane sensitivity are provided. Aspects of the Subject methods include admin (22) Filed: Feb. 16, 2006 istering to a subject a tXrl pathway modulatory agent in Related U.S. Application Data conjunction with a taxane. Also provided are tXrl polypep tides and nucleic acids encoding the same. The Subject (60) Provisional application No. 60/654,343, filed on Feb. methods and compositions find use in a variety of different 17, 2005. applications. Patent Application Publication Sep. 6, 2007 Sheet 1 of 7 US 2007/0209082 A1 Fig 1. A. 5 dTR is s dTR 3 dTR 3 tr downstream u gene crp Tc RP B. 120 e-M2182tTA 60 40 M2182TA M2182TATc Cone 18 Cone 18+Tc CHO M2182tTA Clone 18 -Tc +c -Tc +Tc B-tubulin (25X, 154bp) Extes (25X, 22Obp) Osas sessie etPisaray be it (25x,B -actin 12Obp) Patent Application Publication Sep.
    [Show full text]
  • Homoharringtonine: a Pharmacognosy Success Story by Dr
    THE AMERICAN SOCIETY OF PHARMACOGNOSY The ASP Newsletter Volume 48, Issue 4 Homoharringtonine: A Pharmacognosy Success Story By Dr. Richard Powell n October 26, 2012, the United States Food and Drug Administration (FDA) approved Syn- ribo® (omacetaxine mepesuccinate) to treat adults with chronic myelogenous leukemia O(CML), a blood and bone marrow disease. Approxi- mately 5,430 people will be diagnosed with CML in 2012, according to the NIH. Synribo is intended to be used in patients whose cancer progressed af- ter treatment with at least two drugs from a class called tyrosine kinase inhibitors (TKIs), also used to treat CML. My work on this drug began almost five decades ago, and I originally gave Synribo the common name homoharringtonine in 1970. The road to approval of Synribo for treatment of leukemia in the United States has been a long and torturous one, but in the beginning it ran closely parallel to that of the discovery of the well-known antitumor drug Taxol®. Cepha- lotaxus harringtonia (Cephalotaxaceae) and other Cephalotaxus species (commonly called plum yews) are mostly small trees native to Japan and mainland China. Cephalotaxus harringtonia had been intro- duced as an ornamental but gained little popularity in the United States prior to 1960. I began working at The Northern Regional Re- search Center, United States Department of Ag- riculture (USDA), Agricultural Research Service (ARS), Peoria, Illinois, in the summer of 1963. The position involved chemical analysis of seeds of pre- viously uninvestigated plants, determining struc- Above left: Homoharringtonine from China, 1mg/ml. continued on page 3 Dr. Richard Powell working out the structure of homoharringtonine, 1980.
    [Show full text]