Top Stories
Story: Curagen Initiates Study of CG53135 in Bone Marrow Transplant Patiets
Article
Story: Xcyte Therapies, Inc., Begins Construction of New Facility To Manufacture Xcellerated T Cells
Article
Science
Curagen Initiates Study of CG53135 in Bone Marrow Transplant Patiets CuraGen has initiated a Phase I study of CG53135 for oral mucositis (OM) in cancer patients undergoing bone marrow transplantation (BMT). CG53135 is a novel growth factor discovered by CuraGen’s integrated platform that promotes epithelial and mesenchymal cell proliferation in vitro and is active in animal models of OM. The study will evaluate the safety and potential treatment response of CG53135 in approximately 15 patients. This study in BMT patients complements the first Phase I study in colorectal cancer patients since CG53135 is being investigated for the prevention of OM in patients with solid tumors, such as colorectal cancer, as well as in patients with hematologic tumors, such as the ones that require BMT. In 2004, CuraGen expects to initiate Phase II trials with CG53135 in cancer patients at risk for developing OM such as patients undergoing BMT. Link
Xcyte Therapies, Inc., Initiates Phase II Clinical Trial of Xcellerated T Cells In Patients With Relapsed Multiple Myeloma Link
Cellular Therapy: From Graft Engineering to Immunotherapy Miltenyi Biotec & Kirin Brewery make abstract booklet from the ASH2003 corporate symposium available. Link
Cytotherapy releases latest Issue with focus on dendritic cells Cytotherapy online
TopAbstracts in Bone Marrow and PBSC Transplantation 04/22/2004 TopAbstracts™ in Bone Marrow and PBSC Transplantation are the abstracts most highly rated/most read by nearly 300,000 physicians who received a Doctor’s Guide™ newsletter or visited a website Powered by Doctor’s Guide™ in the past 14 days. Over 2000 peer-reviewed journals are covered by TopAbstracts. Stem cell transplantation for multiple myeloma – (Cancer Control J) An update on the role of high-dose therapy with autologous or allogeneic stem cell transplantation in mantle cell lymphoma – (Curr Opin Oncol) Association of melphalan and high-dose dexamethasone is effective and well tolerated in patients with AL (primary) amyloidosis who are ineligible for stem cell transplantation – (Blood) High-dose melphalan and autotransplantation followed by post transplant maintenance chemotherapy for acute lymphoblastic leukemia in first remission – (Bone Marrow Transplant) A pilot study of tacrolimus and mycophenolate mofetil graft-versus-host disease prophylaxis in childhood and adolescent allogeneic stem cell transplant recipients – (Biol Blood Marrow Transplant) Link
Effect of prior chemotherapy on hematopoietic stem cell mobilization – (Bone Marrow Transplant) Link
Harvard Stem Cell Institute Hosts Inaugural Symposia Story
Duke Targeting Future Of Stem Cell Therapy Story
Positive results from Cytogen and Kimmel Cancer Institute on study of tumor suppressor protein interactions Article
Stem cells could repair hearts US researchers have shown that stem cell therapy could help repair failing hearts Story
Stem cell therapy holds out hope to heart patients story
New Storage Method Amplifies Cells Available for Science Link
Medical Milestone Hoped To Save Children With Deadly Diseases Story
Stem cells for IVF research Story
Embryonic stem cells on the way Story
Bone Marrow Stem Cell Trial Approved for Heart Patients The U.S. Food and Drug Administration has approved the first clinical trial in the United States to test a bone marrow stem cell therapy for severe heart failure. The trial, due to begin within the next week or so, will be led by Emerson C. Perin and his colleagues at the Texas Heart Institute in Houston, Texas. Link
When ‘Switched On’ Muscle Stem Cells Morph To Resemble Nerve Cells Article
Fat stem cells heal broken skulls Article
New hope for diabetes patients in new research collaboration story
Circulation and Chemotaxis of Fetal Hematopoietic Stem Cells Link
Gene therapy repairs heart cells Scientists have succeeded in using gene therapy to repair damage to human heart cells in the laboratory. Story
Adult Stem Cells Could Produce Insulin, Researchers Find Scientists Craft Stem Cells From Adult Bone Marrow Story
Tissue-tailored Gel Can Help Regrow Body Parts Easy to modify for different cell types Article
New gene therapy to tackle alzheimers story
Policy
Massachussets legislator renews plea on stem cell research Article
Dolly’s creators want to do human stem-cell work Article
Senate passes ‘historic’ bill on reproductive technology The Senate passed a controversial bill on reproductive technology yesterday, paving the way for a long-awaited law to allow stem-cell research on human embryos and ban human cloning in Canada after a decade of debate. Article
New Jersey Project To Promote Stem Cell Research A group led by New Jersey legislator Neil Cohen plans to roll out a project on Saturday aimed at bringing together scientists, banks, drug companies and universities to push forward stem cell research. Representatives from leading drug companies, such as Pfizer Inc. and Merck & Co. Inc., biotechs Amgen Inc. and Geron Corp., as well as bankers and researchers, will meet at the Marriott hotel at Newark airport to discuss and formally launch the project. The move follows a similar initiative in California, which is considering a $3 billion state bond to fund stem cell research, including work on embryonic stem cells, and coincides with an announcement by Harvard University that seven of the school’s affiliated teaching hospitals and about 100 researchers are joining to explore new areas of stem cell research article
Stem Cells: Policies and Players Link
Singapore Hunts for Diabetes Cure with Stem Cells Article
After 2 children via IVF, pair faced stem cell issue Story
U.S. Congressmen Ask President Bush to Relax Stem Cell Restrictions In response to President Bush’s embryonic stem cell policy that effectively restricts U.S. federal funding to 19 embryonic stem cell lines, a bipartisan congressional group has presented the president with an open letter asking him to relax those restrictions. Link
Business
Market Reports
Malachite Management has joined forces with an established and reputable author to bring you a report outlining the very latest in the Cell Therapy industry. Cell Therapy – Technologies, Markets, and Companies is over 400 pages of the basic technologies, clinical applications, market analysis, and company profiles related to the cell therapy industry worldwide. For more information and order information see: Report Summary Sample Chapter Table of Contents Order Form Malachite Management Inc. has teamed up with an established publisher to bring you the latest reports in immunotherapeutic approaches to cancer. A Shift in Cancer Immunotherapy Stategies? Executive Summary Table of Contents Future Perspectives in Cancer Immunotherapy Executive Summary Table of Contents Immunotherapy Reports Order Form
Drug and Market Development Publications (D&MD) predicts that the cell therapy market will near $30 billion by 2010. D&MD has recently published a Market Analysis Report called Cell Therapy: Technology, Markets & Opportunities. This Report describes the strategies and technologies corporations are employing to capture their share of this growing market. In addition, the Report answers many important questions, including what diseases will significantly benefit from current and future research, how regulatory and ethical hurdles will come into play, and which corporations are poised to win. For more information, including a FREE copy of the complete Table of Contents and Executive Summary, and sample Report excerpts, send an email to [email protected] or for more information online go to http://www.drugandmarket.com/9086.
Business News
Xcyte Therapies Begins Construction of Bothell Facility Seattle biotech company Xcyte Therapies Inc. said it has broken ground on a new, $4 million manufacturing facility in Bothell, where it will manufacture its most advanced product, Xcellerated T Cells. The facility could make enough T Cells to use in clinical trials beginning in 2005, Xcyte said. story press release
Stem Cells Efficient in Treating Heart Disease Gamida-Cell Study Data Shows that Expanded Populations of Stem Cells Are Efficient in Treating Heart Disease link
FDA Approves ENBREL to Treat Psoriasis; New Convenient Treatment Provides Rapid and Significant Relief of Symptoms Link
NeoStem opens first commercial adult stem cell bank Link
AnorMED licenses cancer compound to NeoRx Link
BioE, University of Southern California Collaborate to Develop Non-Embryonic Stem Cell Therapies for Neurodegenerative Diseases Link
NIH
NIH Guide for Grants and Contracts Week Of April 30, 2004 Link
PRE-APPLICATION MEETING FOR THE RFA ON SENATOR PAUL D. WELLSTONE MUSCULAR DYSTROPHY COOPERATIVE RESEARCH CENTERS (RFA-AR-04-008) (NOT-AR-04-002) National Institute of Arthritis and Musculoskeletal and Skin Diseases National Institute of Child Health and Human Development National Institute Link
REQUEST FOR INFORMATION ON THE TRANSLATION OF CELL-BASED THERAPIES FOR CARDIOVASCULAR DISEASES (NOT-HL-04-108) National Heart, Lung, and Blood Institute Link
SUPPORT FOR HUMAN SPECIMEN BANKING IN NCI-SUPPORTED CANCER CLINICAL TRIALS (RFA-CA-05-017) National Cancer Institute Link
NOTICE OF LIMITED COMPETITION REQUEST FOR COMPETING APPLICATIONS: NHLBI PROGRAMS OF EXCELLENCE IN GENE THERAPY FOR HEART, LUNG AND BLOOD DISEASES (NOT-HL-04-110) National Heart, Lung, and Blood Institute Link
CONFERENCE ON CONFLICTS OF INTEREST, PRIVACY/CONFIDENTIALITY AND TISSUE REPOSITORIES, MAY 3 – 5, 2004 (NOT-CA-04-012) National Cancer Institute Link
CLINICAL TRIALS NETWORK CLINICAL LABORATORY SERVICES (NOT-DA-04-024) National Institute on Drug Abuse Link
EXPLORATORY CENTER GRANTS FOR HUMAN EMBRYONIC STEM CELL RESEARCH (RFA-GM-05-004) National Institute of General Medical Sciences APPLICATION RECEIPT DATE: October 19, 2004 Link
NIH Roadmap: Accelerating Medical Discovery to Improve Health Link
NIH and FDA Launch New Human Gene Transfer Research Data System GeMCRIS will facilitate faster reporting of adverse events in human gene transfer trials Link
CBER
All new CBER information can be reached from the Whats New page
Q and A’s Concerning Establishment Registration and Listing for Human Cells, Tissues, and Cellular and Tissue-Based Products(HCT/Ps) – Update Link
CBER 101 – Introduction to the Center for Biologics Evaluation and Research (Slide Presentations) Link
Updated CBER Organizational Information Link
Updated Licensed Products and Establishments List Link
Updated 2004 Biological Product Approvals Link
Updated Cleared 510(k) Device Applications Link
Updated Blood Establishment Registration and Product Listing – Electronic Form Instructions Link
Bar Code Label Requirement for Human Drug Products and Biological Products; Final Rule; Correction Link
CBER Issues Annual Report for Fiscal Year 2003 And Outlines New Directions for 2004 FDA’s Center for Biologics Evaluation and Research (CBER) issued its annual report that provides highlights from CBER’s activities during Fiscal Year (FY) 2003 and introduces key initiatives for 2004.Link
CBER’s annual report is available here
Draft Guidance for Industry: Acceptable Full-Length Donor History Questionnaire and Accompanying Materials for Use in Screening Human Donors of Blood and Blood Components Link
Tissue Reference Group Annual Report – FY2003 Update Link
Electronic Records; Electronic Signatures; Public Meeting Date: 6/11/2004 Link
Workshop on Long-Term Follow Up of Participants in Human Gene Transfer Research Link
Summary – Substantially Equivalent 510(k) Device – BacT/ALERT BPN Culture Bottles (BioMerieux, Inc) one two
Biological Response Modifiers Advisory Committee Roster Update Link
Biological Response Modifiers Advisory Committee Posted the Final Agenda for the 03/18-19/04 meeting Posted the Slides for the 03/18/04 meeting Posted the Slides for the 03/19/04 meeting Posted the Transcript for the 03/18/04 meeting Posted the Transcript for the 03/19/04 meeting http://www.fda.gov/ohrms/dockets/ac/cber04.html#BiologicalResponseModifiers
Regulatory
ICH Draft Guidance: Q5E Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process Link
NIH and FDA Launch New Human Gene Transfer Research Data System Link
Tenth Annual Surviving the Challenges of FDA and Other Regulatory Authorities’ GMPs (Slide Presentation) Link
Cellular Therapy Primer: Potential Treatment for Heart Disease Link
Transcript – Identifying Optimal Methods For Clinical Quantitative Flow Cytometry Link
Summary – Substantially Equivalent 510(k) Device – Dynal Reli SSO HLA-A Typing Kit (Dynal Biotech Ltd) Link
Summary – Substantially Equivalent 510(k) Device – Dynal Reli SSO HLA-B Typing Kit (Dynal Biotech Ltd) Link
Summary – Substantially Equivalent 510(k) Device – Dynal Reli SSO HLA-Cw Typing Kit (Dynal Biotech Ltd) Link
Summary – Substantially Equivalent 510(k) Device – Dynal Reli SSO HLA-DQB1 Typing Kit (Dynal Biotech Ltd) Link
Summary – Substantially Equivalent 510(k) Device – Dynal Reli SSO HLA-DRB Typing System (Dynal Biotech Ltd) Link
Meetings
2003-4 Cell Therapy Audioconference Series – Link
Conferences 2004
May 7-10 Cell Therapy 2004: ISCTs 10th Annual Mtg – Dublin, Ireland. Link
May 14-19 Amer. Society of Transplantation (AST) Congress. Boston, MA. Link
June 2-6 Amer. Society for Gene Therapy Annual Meeting – Minneapolis, MN. Link
June 3-6 Cdn Blood & Marrow Transplant Group (CBMTG) Biennial Mtg. London, ON, Canada. Link
June 5-8 Amer. Society for Clinical Oncology (ASCO) 40th Annual Meeting. New Orleans, LA. Link
June 6-9 BIO Annual Meeting San Francisco, CA. Link
June 10-13 International Society for Stem Cell Research 2nd Annual Meeting. Boston. Link
June 16 The First International Conference on Cell Therapy for Cardiovascular Diseases:A One Day Symposium. Mount Sinai Medical Center. New York, NY. Link
June 17-19 Strategies in Tissue Engineering. Würzburg, Germany. Link
July 17-20 ISEH 33rd Annual Scientific Meeting. New Orleans. LA. Link
July 18-23 Federation of Clinical Immunology Societies (FOCIS) Annual Meeting & 12th International Congress of Immunology (ICI 2004). Montreal, Canada. Link
September 5-9 13th International Conference of the International Society of Differentiation. Honolulu. Link
September 21-22 Safeguarding Adult and Pediatric Stem Cell Donors: Basic Science, Clinical, and Ethical Issues. Bethesda, MD. Link
October 1-3 4th Annual Somatic Cell Therapy Symposium. Houston,TX. Link
October 3-7 Cell & Tissue BioProcessing Conference. Houston, Texas. Link
October 13 – 16 13th International Conference of the European Association of Tissue Banks. Prague/Czech Republic. Link
Oct. 14-16 4th Annual Mesencnymal & Nonhematopoietic Stem Cells Conference. New Orleans, LA. Link
October 23-26 Amer. Assoc. of Blood Banks – Baltimore, Maryland. Link
November 4-7 European Society for Gene Therapy. Tampere, Finland. Link
December 3-7 Amer. Society for Hematology: 46h Annual Mtg – San Diego, California – San Diego, CA Link
Courses cGMP in the Transfusion Service. An online training course. Link
Fall/Winter 2004 7 or 21-day short-term Course in Human Embryonic Stem Cell Culture – Technion-Israel Institute of Technology Technion City, Haifa, and in the United States Link
Regular Courses Weekly – UCSFs Human Embryonic Stem Cell Training Program (3-day training course)- Link
Conferences 2005 Feb. 10-14 Tandem BMT Meetings (Combined ASBMT and IBMTR/ABMTR annual meetings). Keystone, Colo. Sept 21-25 International Society of Pedriatic Oncology Conference. Vancouver, Canada.
Careers
MD Anderson Cancer Center Link
StemCell Technologies Link
ISCT
International Society for Cellular Therapy – http://www.celltherapy.org Upcoming meetings include:
~10th Annual Conference for International Society for Cellular Therapy, May 7-10, 2004, Dublin, Ireland (Republic)
~ 4th Annual Somatic Cell Therapy Symposium (to be held in conjunction with the WilBio Cell & Tissue BioProcessing Conference). October 1-3, 2004. Houston, Texas.
2003-4 Cell Therapy Audioconference Series – link
Webcast from 4th International Symposium on Miminal Residual Cancer. Oslo, Norway. 13-16 November 2003 – Link
Nonhematopoietic & Mesenchymal Stem Cells Conference 2003 abstracts online – Link
Profiled Journal
Enjoy Cytotherapy in 2004. Join ISCT ($130) and receive the journal as a benefit of membership – Link
Cytotherapy publishes original research, reviews, meeting reports, special focus issues and letters in the general field of cell therapy. The scope of the journal includes includes basic and applied research with hematopoietic and non-hematopoietic stem cells , immune cells, and antigen-presenting cells. Therapeutic topics within the scope of Cytotherapy include ex-vivo and in-vivo aspects of gene therapy, immunotherapy, stem cell transplantation and tissue regeneration. Cytotherapy particularly welcomes contributions from researchers, clinicians, technicians and individuals involved in regulatory aspects of cell therapy.
cytotherapy.com
Cytotherapy volume 6, number 2 now online. Click here. Introduction p. 87 Dnj Hart DCs as targets for vaccine design p. 88 Gt Belz, Cm Smith, M Bharadwaj, Am Rice, Dc Jackson DC preparations for therapy p. 99 Am Rice, Kl Jones, Dnj Hart Current issues in delivering DCs for immunotherapy p. 105 Sm Barratt-boyes, Cg Figdor Loading DCs with Ag p. 111 F Vari, Dnj Hart DC-based cancer vaccines: lessons from clinical trials p. 122 Jd Brody, Eg Engleman DC in multiple myeloma immunotherapy p. 128 Cj Turtle, Rd Brown, De Joshua, Dnj Hart DCs in lymphoma — biology and therapeutic aspects p. 138 Jl Schultze, F Fiore, M von Bergwelt-baildon DC therapy for metastatic melanoma p. 148 S B Ingram, M G O’Rourke The immune response to breast cancer, and the case for DC immunotherapy p. 154 Cp Allan, Cj Turtle, Pn Mainwaring, C Pyke, Dnj Hart DC therapy for prostate cancer p. 164 Pw Swindle, S Tepes, J Clements Campath-1 Abs ‘in the bag’ for hematological malignancies: the Cape Town experience p. 172 N Novitzky, V Thomas, G Hale, H Waldmann
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