Volume 9.31 | Aug 11

Cell Therapy News 9.31, August 11, 2008
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Scientists Replicate Diseases in the Lab with New Stem Cell Lines: A set of new stem cell lines will make it possible for researchers to explore ten different genetic disorders-including muscular dystrophy, juvenile diabetes, and Parkinson’s disease-in a variety of cell and tissue types as they develop in laboratory cultures.
Article

Researchers Halt Spread of HIV with RNAi: Using a novel method to deliver small molecules called siRNAs into T cells, researchers dramatically suppressed HIV in the first-ever animal model that mirrors progression of the disease in humans.
Article

Science

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October 6, 2008  |  New York, New York
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The TriMark Stem Cell Conference 2008
October 20, 2008  |  San Fransisco, California
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Recipe for Cell Reprogramming Adds Protein
A drug-like molecule called Wnt can be substituted for the cancer gene c-Myc, one of four genes added to adult cells to reprogram them to an embryonic-stem-cell-like state, according to Whitehead researchers.
Article

Putting MicroRNAs on the Stem Cell Map
Whitehead reasearchers have discovered how microRNAs fit into the map of embryonic stem cell circuitry. With this map, the scientists have moved one step closer to understanding how adult cells can be reprogrammed to an embryonic state and then to other types of cells, and to understanding the role of microRNAs in cancer and other diseases.
Article

SickKids Scientists Uncover the Key to Controlling How Stem Cells Develop
One of the biggest hurdles to overcome before the clinical use of embryonic stem cells is our current inability to effectively control the process of stem cell differentiation. This study provides a clear picture of how we might control the early steps of endoderm tissue differentiation.
Article

Non-Healing Bones Repaired in Clinical Trial Using Adult Stem Cells
The Royal Melbourne Hospital and Mesoblast Limited, jointly announced successful results from the long bone fracture repair clinical trial using Mesoblast’s proprietary adult stem cell technology.
Article

Argos Therapeutics’ Arcelis(TM) Personalized Immunotherapy Platform in HIV Achieves Primary Endpoint in Phase 1 Trial
Argos Therapeutics recently announced the presentation of positive immune response data from a Phase 1 clinical trial of AGS-004 in HIV-infected adults in combination with antiretroviral therapy.
Article

Aegera Therapeutics Initiates a Fifth Phase 1 and 2 Clinical Trial for AEG35156
Aegera Therapeutics Inc. is pleased to announce the dosing of the first patient in a fifth phase 1 and 2 clinical oncology study of AEG35156, a second generation antisense therapeutic targeting XIAP, a key member of the Inhibitor of Apoptosis protein family.
Article

ABSTRACTS, REVIEWS AND SPECIAL REPORTS

Directed Differentiation of Hippocampal Stem/Progenitor Cells in the Adult Brain
The researchers found that retrovirus-mediated overexpression of a single gene, the bHLH transcription factor Ascl1, redirected the fate of the proliferating adult hippocampal stem/progenitor progeny and lead to the exclusive generation of cells of the oligodendrocytic lineage at the expense of newborn neurons, demonstrating that AHPs in the adult mouse brain are not irrevocably specified in vivo.
Article

Potential of Stem Cell-Based Therapies for Liver Regeneration
The researchers constructed implantable bioartificial liver assist system with the stem cell derived hepatocytes as the seed cells by means of biofabrication, and explored effects of biochemical and mechanic characters on hepatic modality, structure and function.
Article

Human Embryonic Stem Cell-Derived Dopaminergic Neurons Reverse Functional Deficit in Parkinsonian Rats
In this paper, the researchers show that hESC-derived dopaminergic neurons survived a long-term transplantation to the neurotoxin 6-hydroxydopamine (6-OHDA) lesioned rat striatum, and in combination with those cells newly differentiated from their progenitors, contributed to locomotive function recovery at 5 months.
Article

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Policy

California Institute for Regenerative Medicine President Looks to Push Stem Cell Research Forward
California Institute for Regenerative Medicine President Alan Trounson hopes to attract a wave of additional leading stem cell researchers to California and will set up disease teams to create a variety of stem cell therapies that can be ready for clinical trials in five years.
Article

Business

Veridex Completes Acquisition of Immunicon Corporation Assets
Veridex, LLC announced recently it has completed its previously announced acquisition of substantially all of the assets of Immunicon Corporation and its wholly-owned subsidiaries.
Article

Cytori Enters Binding Letter of Intent for StemSource(R) Cell Bank Sales for Singapore
Cytori Therapeutics entered into a Binding Letter of Intent to complete a StemSource(R) Cell Bank sales agreement with Astrea International to purchase one StemSource Cell Bank for Singapore following receipt of regulatory clearance in Singapore on a pending application on the use of the Celution(R) System for tissue banking.
Article

Invitrogen, Lentigen to Provide Lentivirus Products and Services for Gene Over-Expression
Invitrogen Corporation and Lentigen Corporation, announced recently a partnership to develop and supply gene over-expression products and services. Invitrogen will exclusively commercialize the products and services from the partnership.
Article

University of Florida researchers receive Juvenile Diabetes Research Foundation’s ‘Excellence in Clinical Research Award’
The three researchers are involved in several innovative JDRF-funded studies to accelerate the development of a cure for type I diabetes, including using umbilical cord blood stem cells as a potential therapy and investigating drug treatments used in tandem to provide immune suppression while boosting the regeneration of insulin-producing cells.
Article

New $8.9 Million Project Aims to Unlock Stem Cell Secrets
With the help of an $8.9 million grant from the National Institute of General Medical Sciences, a team of researchers from the University of Wisconsin-Madison will embark on a quest over the next five years to tease out the secrets of stem cells’ ability to morph into all of the cell types that make up the body.
Article

Two Faculty Will Benefit From Keck Awards to do Research
Stanford University has received two, million-dollar grants from the W.M. Keck Foundation for projects aimed at using light to control a variety of cells and exploring how specific enzymes help embryonic stem cells turn into adult cells.
Article

MDRNA, Inc. Announces Additional Corporate Restructuring
MDRNA Inc. of Bothell said Monday that it would lay off 23 employees, including its president and chief business officer, as the biotech company continues to restructure around its RNA interference programs, while trying to unload its nasal spray business.
Article

iZumi Bio, Inc. Recruits Leading iPS Scientist, John Dimos, to Translate Stem Cell Breakthrough Into Patient Benefits
iZumi Bio, Inc., announced recently that John T. Dimos, Ph.D., first author of the landmark Science paper “Induced Pluripotent Stem Cells Generated from Patients with ALS Can Be Differentiated into Motor Neurons,” will join its team of scientists translating induced pluripotent stem cell research into patient benefits.
Article

Alnylam Consolidates Intellectual Property for RNA Activation, a New Biological Discovery for Activation of Gene Expression
Alnylam Pharmaceuticals, Inc. recently announced that it has consolidated the key intellectual property for RNA activation, creating a dominant IP position in this new area of biology.
Article

Introgen Receives Nasdaq Notice Regarding Minimum Market Value of Listed Securities
Introgen Therapeutics, Inc. recently announced that on July 30, 2008, it received a letter from The Nasdaq Stock Market indicating that it does not comply with the minimum $50,000,000 market value of listed securities nor the alternative requirement of a minimum $50,000,000 in total assets and total revenue required for continued listing on The Nasdaq Global Market.
Article

NIH

Announcing the Availability of the Application Guide for the Pilot Transition from PureEdge to Adobe-based SF424 (R&R) Grant Application Forms (RFA-AI-08-020, RFA-DE-09-001 and RFA-DE-09-002)
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AMMENDMENT: PAR-07-446 – Exploratory/Developmental Investigations on Primary Immunodeficiency Diseases (R21)
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AMMENDMENT: PAR-07-447 – Exploratory/Developmental Investigations on Primary Immunodeficiency Diseases (R03)
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CBER

Guidance for Industry: Advisory Committee Meetings-Preparation and Public Availability of Information Given to Advisory Committee Members
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Guidance for the Public, FDA Advisory Committee Members, and FDA Staff: Procedures for Determining Conflict of Interest and Eligibility for Participation in FDA Advisory Committees
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Guidance for the Public, FDA Advisory Committee Members, and FDA Staff: Public Availability of Advisory Committee Members’ Financial Interest Information and Waivers
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Public Workshop Announcement: Blood Establishment Computer Software
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Regulatory

FOOD AND DRUG ADMINISTRATION (United States)

FDA Announces Improved Policies Regarding Transparency, Public Disclosure for Advisory Committees
The Food and Drug Administration recently announced several improved policies and procedures strengthening its management of FDA advisory committees.
Article

MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY (United Kingdom)

Updated Notification of the Use of a Non-GLP Complaint Facility Form
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DEPARTMENT OF HEALTH AND AGEING THERAPEUTIC GOODS ADMINISTRATION (Australia)

Guideline for the Preparation of Technical Master Files for Blood, Blood Components and Haematopoietic Progenitor Cells
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