A Phase 1, Placebo-Controlled, Randomized, Double-Blind Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Escalating, Single Oral Doses of Aes-103 in Subjects With Stable Sickle Cell Disease

The purpose of this study is to assess the safety, tolerability, pharmacokinetic, and pharmacodynamic effects of Aes-103 (active ingredient 5-hydroxymethyl-2-furfural [5-HMF]) compared with placebo in subjects with stable sickle cell disease (SCD). Safety will be measured by monitoring adverse events (AEs), electrocardiograms (ECGs), vital signs, and laboratory values. Pharmacokinetics of Aes-103 will be measured over time in plasma, red blood cell hemolysate and binding of Aes-103 to hemoglobin. Pharmacodynamic effects will be assessed by measuring partial pressure of oxygen at which 50% of hemoglobin is saturated with oxygen (p50) while breathing normal air, blood oxygen levels (SpO2), ex-vivo antisickling effects in a hypoxic environment, and by imaging related changes in tissue blood flow and oxygen levels.

开始日期2012-05-12

申办/合作机构

Baxalta, Inc.

[+7]

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2013-01-01·Methods in Molecular Biology

Teratology Studies in the Mouse

Article

作者: Mariline Leroy ; Edward Marsden

The rat is the routine species of choice as the rodent model for regulatory safety testing of xenobiotics such as medicinal products, food additives, and other chemicals. However, the rat is not always suitable for pharmacological, toxicological, immunogenic, pharmacokinetic, or even practical reasons. Under such circumstances, the mouse offers an alternative for finding a suitable rodent model acceptable to the regulatory authorities. Since all essential routes of administration are possible, the short reproductive cycle and large litter size of the mouse make it a species well adapted for use in teratology studies. Given that good quality animals, including virgin mated females, can be acquired relatively easily and inexpensively, the mouse has been used in reproductive toxicity studies for decades and study protocols are well established.

2013-01-01·Methods in Molecular Biology

Developmental Toxicity Testing of Vaccines

Article

作者: Paul C. Barrow ; Linda Allais

Preventative and therapeutic vaccines are increasingly used during pregnancy and present special considerations for developmental toxicity testing. The various components of the vaccine formulation (i.e., protein or polysaccharide antigen, adjuvants, and excipients) need to be assessed for direct effects on the developing conceptus. In addition, possible adverse influences of the induced antibodies on fetal and/or postnatal development need to be evaluated. A guidance document on the preclinical testing of preventative and therapeutic vaccines for developmental toxicity was issued by the FDA in 2006. Preclinical studies are designed to assess possible influences of vaccines on pre- and postnatal development. The choice of model animal for these experiments is influenced by species differences in the timing and extent of the transfer of the induced maternal antibodies to the fetus. The cross-placental transport of maternal immunoglobulins generally only occurs in late gestation and tends to be greater in humans and monkeys than in non-primate species. For many vaccines, the rabbit shows a greater rate of prenatal transfer of the induced antibodies than rodents. For biotechnology-derived vaccines that are not immunogenic in lower species, nonhuman primates may be the only appropriate models. It may be advisable to test new adjuvants using the ICH study designs for conventional pharmaceuticals in addition to the developmental toxicity study with the final vaccine formulation.

2013-01-01·Methods in Molecular Biology

Combined Fertility and Embryotoxicity Study

Article

作者: Lucie Reynaud ; Edward Marsden

Under normal circumstances, fertility and embryotoxicity studies are run separately according to the ICH S5(R2) guideline for the detection of toxicity to reproduction of medicinal products (1). However, the flexible approach of the S5(R2) guideline also allows the reproduction stages covered in the fertility and embryo-fetal development studies (stages A to D) to be combined into a single study design. The administration period covers the pre-mating and gestation phases through to closure of the hard palate. The principal advantages of the combined study include reductions in the number of animals required and cost. Although the rat is the routine species of choice, the mouse may also be used.

项与 Concord Biosciences LLC 相关的新闻（医药）

2022-12-19

·PRNewswire

DUBLIN, Dec. 19, 2022 /PRNewswire/ -- The "Global Biosimilars Partnering Terms and Agreements 2010 to 2022" report has been added to ResearchAndMarkets.com's offering. The Global Biosimilars Partnering Terms and Agreements 2010 to 2022 report provides an understanding and access to 190 biosimilars partnering deals and agreements entered into by the worlds leading healthcare companies. The report provides a detailed understanding and analysis of how and why companies enter biosimilars partnering deals. The majority of deals are early development stage whereby the licensee obtains a right or an option right to license the licensors biosimilars technology or product candidates. These deals tend to be multicomponent, starting with collaborative R&D, and commercialization of outcomes. Understanding the flexibility of a prospective partner's negotiated deals terms provides critical insight into the negotiation process in terms of what you can expect to achieve during the negotiation of terms. Whilst many smaller companies will be seeking details of the payments clauses, the devil is in the detail in terms of how payments are triggered - contract documents provide this insight where press releases and databases do not. This report contains links to online copies of actual biosimilars deals and contract documents as submitted to the Securities Exchange Commission by companies and their partners. Contract documents provide the answers to numerous questions about a prospective partner's flexibility on a wide range of important issues, many of which will have a significant impact on each party's ability to derive value from the deal. Contract documents provide the answers to numerous questions about a prospective partner's flexibility on a wide range of important issues, many of which will have a significant impact on each party's ability to derive value from the deal. The initial chapters of this report provide an orientation of biosimilars dealmaking and business activities. Chapter 1 provides an introduction to the report, whilst chapter 2 provides an overview of the trends in biosimilars dealmaking since 2010, including details of average headline, upfront, milestone and royalty terms. Chapter 3 provides a review of the leading biosimilars deals since 2010. Deals are listed by headline value, signed by big pharma, most active biosimilars dealmaking companies. Where the deal has an agreement contract published at the SEC a link provides online access to the contract. Chapter 4 provides a comprehensive listing of the top 25 most active companies in biosimilars dealmaking with a brief summary followed by a comprehensive listing of biosimilars deals, as well as contract documents available in the public domain. Where available, each deal title links via Weblink to an online version of the actual contract document, providing easy access to each contract document on demand. Chapter 5 provides a comprehensive and detailed review of biosimilars partnering deals signed and announced since Jan 2010, where a contract document is available in the public domain. The chapter is organized by company A-Z, deal type (collaborative R&D, co-promotion, licensing etc), and specific therapy focus. Each deal title links via Weblink to an online version of the deal record and where available, the contract document, providing easy access to each contract document on demand. Chapter 6 provides a comprehensive and detailed review of biosimilars partnering deals signed and announced since Jan 2010. The chapter is organized by specific biosimilars technology type in focus. Each deal title links via Weblink to an online version of the deal record and where available, the contract document, providing easy access to each contract document on demand. In addition, a comprehensive appendix is provided organized by biosimilars partnering company A-Z, deal type definitions and biosimilars partnering agreements example. Each deal title links via Weblink to an online version of the deal record and where available, the contract document, providing easy access to each contract document on demand. Analyzing actual company deals and agreements allows assessment of the following: What is actually granted by the agreement to the partner company? What exclusivity is granted? What are the precise rights granted or optioned? What is the payment structure for the deal? How are sales and payments audited? What is the deal term? How are the key terms of the agreement defined? How are IPRs handled and owned? Who is responsible for commercialization? Who is responsible for development, supply, and manufacture? How is confidentiality and publication managed? How are disputes to be resolved? Under what conditions can the deal be terminated? What happens when there is a change of ownership? What sublicensing and subcontracting provisions have been agreed? Which boilerplate clauses does the company insist upon? Which boilerplate clauses appear to differ from partner to partner or deal type to deal type? Which jurisdiction does the company insist upon for agreement law? Global Biosimilars Partnering Terms and Agreements 2010 to 2022 includes: Trends in biosimilars dealmaking in the biopharma industry since 2010 Access to headline, upfront, milestone and royalty data Access to over 190 biosimilars deal records and contract documents where available The leading biosimilar deals by value since 2010 Most active biosimilars dealmakers since 2010 The leading biosimilars partnering resources In Global Biosimilars Partnering Terms and Agreements 2010 to 2022, the available contracts are listed by: Company A-Z Headline value Stage of development at signing Deal component type Specific therapy and technology target Key Topics Covered: Executive Summary Chapter 1 - Introduction Chapter 2 - Trends in biosimilars dealmaking 2.1. Introduction 2.2. Biosimilars partnering over the years 2.3. Most active biosimilars dealmakers 2.4. Biosimilars partnering by deal type 2.5. Biosimilars partnering by therapy area 2.6. Deal terms for biosimilars partnering 2.6.1 Biosimilars partnering headline values 2.6.2 Biosimilars deal upfront payments 2.6.3 Biosimilars deal milestone payments 2.6.4 Biosimilars royalty rates Chapter 3 - Leading biosimilars deals 3.1. Introduction 3.2. Top biosimilars deals by value Chapter 4 - Most active biosimilars dealmakers 4.1. Introduction 4.2. Most active biosimilars dealmakers 4.3. Most active biosimilars partnering company profiles Chapter 5 - Biosimilars contracts dealmaking directory 5.1. Introduction 5.2. Biosimilars contracts dealmaking directory Chapter 6 - Biosimilars dealmaking by technology type Appendices Appendix 1 - Biosimilars deals by company A-Z Appendix 2 - Biosimilars deals by stage of development Appendix 3 - Biosimilars deals by deal type Appendix 4 - Biosimilars deals by therapy area Appendix 5 - Appendix 6 - Recent report titles from Companies Mentioned 3SBio 180 Life Sciences Abbvie Abreos Biosciences Abzena Accord Healthcare Aceno Biotherapeutics AdAlta AET Biotech Aetos Biologics AffaMed Therapeutics Agila Specialties AIT Bioscience Algorithme Pharma Holdings Alteogen Altiora Alvogen Alvotech Amedica Amgen Amneal Pharmaceuticals Arecor Avid Bioservices Axantia Back-A-Line Bacterin International Baxalta Baxter International BeiGene Bio-Manguinhos/Fiocruz Bio-Thera Solutions Biocnd Biocon Bioeq IP Bio Farma Biogen Biooutsource BiosanaPharma BioSavita BioSciencesCorp Bioton BioXpress Boehringer Ingelheim Bolt Biotherapeutics Boston Oncology Bruker C-Bridge Capital Catalent CEA-Leti Celares Celerion Cellectis Celltrion Changchun High & New Technology Industries Chemo Sa Lugano Chungnam National University Cipla CJ Corp Clinigen Cobra Biologics Coherus Biosciences Compass Biotechnologies Concord Biosciences Cook Pharmica CR Pharma Daiichi Sankyo Diabeloop DM Corporation Dong-A ST Dr. Reddy's Laboratories Dyadic International EirGenix EMD Millipore Enzene Biosciences Epirus Biopharmaceuticals Epivax European Commission Evercyte Evotec Ewopharma Formosa Pharmaceuticals Formycon Fujifilm Fujifilm Kyowa Kirin Biologics Fuji Pharma GC Pharma Gedeon Richter GE Healthcare Genentech Genhelix Biopharmaceutical Genor Biopharma GenScript ProBio Gerresheimer Hadasit Medical Research Services and Development Hanwha Chemical Helvetic Biopharma Henlius Biotech Hikma Pharmaceuticals Hoffmann La Roche Horizon 2020 Hospira Innovent Biologics Intas Pharmaceuticals inVentiv Health Ipca Laboratories Ipsen Jacobson Pharma JAMP Pharma Group JHL Biotech Kamada Karolinska Institute Kemwell BioPharma Kymos Pharma Services Kyowa Hakko Kirin Laboratorios Liomont LABORATORIOS SAVAL Ligacept Livzon Mabpharm Lupin M+W Group Mab-Venture Biopharma Mabion mAbXience Medicago Medicure Medipolis Meiji Seika Merck and Co Merck BioVentures Merck KGaA Merck Serono MGC Diagnostics Ministry of Health (Brazil) Mithra Pharmaceuticals Mitsubishi Chemical Mochida Pharmaceutical Momenta Pharmaceuticals Mundipharma Mylan Laboratories Mylan Pharmaceuticals Nan Fung Group NanoLock Natco Pharmaceuticals National Cancer Institute National Comprehensive Cancer Network (NCCN) NCPC GeneTech Neoletix Biotechnology NeuClone Nora Pharma Novo Nordisk Ocumension Therapeutics Oncobiologics ORF Genetics Orox Pharmaceuticals Orygen Biotecnologia Pall Corporation Pangen Biotech Parexel PBS Biotech Perfinity Biosciences Pfenex Pfizer Pharmapark PharmaPraxis PlantForm PlantPraxis Biotecnologia Polpharma Portal Instruments PPD PRA Health Sciences Premier Inc Premier Research Prestige BioPharma ProBioGen PT Etana Biotechnologies Qilu Pharmaceutical Quanta BioDesign QuiaPEG Pharmaceuticals For more information about this report visit Media Contact: Research and Markets Laura Wood, Senior Manager [email protected] For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 U.S. Fax: 646-607-1907 Fax (outside U.S.): +353-1-481-1716 Logo: SOURCE Research and Markets

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