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
|
|
|
