Angioblast is committed to a program of clinical development of universal MPC products which target cardiovascular & vascular conditions including heart failure, heart attacks, peripheral artery diseases, wound ulcers and diabetic retinopathy/macular degeneration.

Overview

The process incorporates:

• completion of pre-clinical regulatory development and scale-up of its MPC products to good manufacturing practice (GMP) standards to meet US FDA requirements;
  
• completion of proof-of-principle clinical trials in one or more cardiovascular indications;
  
• completion of all pre-clinical and clinical requirements for submission of an investigational new drug ( IND ) application for the use of MPCs in a cardiovascular field; and
  
• The pre-clinical dossiers that will be presented by Angioblast to the US FDA as part of the IND applications will consist of a GMP manufacturing and scale-up component, and the results of trials demonstrating safety and efficacy of MPC administration to animals with cardiovascular conditions

Angioblast anticipates that the results of the proof-of-principle clinical trials using an individual's own MPC will be available at the same time as those of the pre-clinical studies. The inclusion of these data in the dossiers submitted to the FDA is expected to enhance significantly the likelihood of approval of IND applications to initiate multi-centre clinical trials using donated MPC in cardiovascular indications.

Due to the shared nature of the platform technology, the cost of the pre-clinical development program up to the stage of submitting the IND application will be shared between Angioblast and its affiliated company, Mesoblast, according to commercially agreed terms. After completion of the pre-IND phase, each company will be responsible for completing its own multi-centre studies.

Please select an option from the menu below:

Product Development

MPC GMP Process Development
MPC Proof of Principle Model
MPC Clinical Trials - Autologous
MPC Clinical Trials - Allogeneic

MPC GMP Process Development

For large-scale manufacture of one or more monoclonal antibodies under FDA-compliant conditions to isolate MPC, Angioblast will contract a leading manufacturer of GMP monoclonal antibodies with extensive experience in the stem cell field and in dealing with the FDA approval process. The FDA-compliant monoclonal antibodies will preferentially bind to and be used to isolate an enriched population of MPC from a mixed starting cell population. The MPC are then grown in the laboratory under Angioblast's FDA-compliant manufacturing conditions. Initial batch manufacturing will be outsourced to a world leading company specializing in GMP production of cells meeting FDA requirements for human therapy. Angioblast will oversee all technology transfer and process development, culminating in validation runs on the suite of procedures needed to produce MPC suitable for clinical trials in cardiovascular diseases.

MPC Proof of Principle Models

Angioblast has used well-characterized in vitro and in vivo models to assess the therapeutic potential of MPC.

MPC can be isolated from bone marrow, fat, skin and a variety of other sites in human adults and grown to large numbers relatively quickly using simple, inexpensive culture techniques.

The MPC can differentiate under the right growth conditions in vitro into heart muscle and blood vessels, enabling broad development of this platform technology for a number of conditions that would benefit from tissue regeneration.

Specific results from the pre-clinical studies demonstrate that:

• human MPC can differentiate generate large numbers of blood vessels;
  
• MPCs induce growth of new arterioles in the heart, suggesting that MPC may enhance regeneration of damaged heart muscle and result in sustained improvement in measures of cardiac function.

In addition to direct transformation into a variety of tissue types in vivo, MPC can secrete factors that trigger the animal's own tissues to start to regrow. Moreover, since they can give rise to new blood vessels, MPC may have a unique ability to enhance tissue regeneration by increasing blood flow necessary to stimulate cell growth and division in regenerating tissues.

Preparatory to making application to the FDA to commence clinical trials, Angioblast are conducting studies in sheep for cardiovascular conditions to assess the safety and efficacy of the cells, different delivery methods, and the optimal dosage for use in clinical applications.

MPC Clinical Trials – Autologous

Using patient's own cells

Angioblast has initiated an early clinical trial to evaluate the safety of a patient's own MPC (autologous) in those with cardiovascular conditions. Autologous MPC will be isolated and grown up in culture using the proprietary platform technology.

MPC Clinical Trials - Allogeneic

Using cells from an unrelated donor

On completion of FDA-approved antibody production and MPC manufacture under GMP conditions, Angioblast will each initiate controlled clinical trials examining the safety and efficacy of allogeneic MPC (i.e. derived from universal donors and used in unrelated recipients) for patients with cardiovascular conditions.

Establishing the safety of allogeneic MPC will enable development of 'off-the-shelf' products available for immediate use where speed is critical, such as for patients with heart failure, heart attacks, or peripheral artery disease

Off-the-shelf products would have the commercial advantages of reducing the cost of goods sold as a result of economies of scale and presenting an attractive option for partnering with international pharmaceutical companies.