Volume 5.01 | May 3

Cell Therapy News 5.1, May 3, 2004
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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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 Therapyhttp://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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