Adult Stem Cell Product to be Tested in Stroke Trial

28/11/2007

Biocompatibles initiates Phase I/II Stroke Trial for CellBeads™ Product

  • Collaboration with International Neuroscience Institute, Hannover, Germany
  • New Therapeutic Protein slows down Cell Death
  • Stem Cell Delivery System addresses Challenge of Blood-Brain Barrier

Farnham UK, 28 November 2007: Biocompatibles is pleased to announce that the Paul Ehrlich Institute, the regulatory agency of the German Ministry of Health, has granted permission for the start of a clinical trial for the treatment of patients immediately following a haemorrhagic stroke.

Twenty patients will be treated with CellBeads™, a product developed by Biocompatibles’ subsidiary CellMed, in a Phase I/II trial at the world-renowned International Neuroscience Institute (INI) in Hannover. The trial’s primary end-point is safety; and data will be gathered on a number of indicators of efficacy.

Professor Thomas Brinker, the Principal Investigator, commented “Progress in the development of new treatments for stroke has been painfully slow. The CellBeads technology is novel and the pre-clinical data is positive. We expect to recruit the first patient in the next few weeks.”

The first patients will be treated at INI following Ethics Committee approval, expected before the end of 2007. Two other hospitals in Germany plan to join the trial, which, is expected to complete recruitment in 2008 .The results are scheduled to be available in the first half of 2009.

Every year approximately 125,000 people in the US and the five leading European countries suffer a haemorrhagic stroke and fewer than 40% live for more than one year, the lowest survival rate of any form of stroke. Only 20% of these survivors regain functional independence. The cascade of events starts with the sudden rupture of a blood vessel in the brain, causing haemorrhage and pressure inside the skull. Surgery is routinely used to relieve the pressure; but the haemorrhage causes a longer-term process of programmed cell death, or apoptosis, and it is this that causes the lasting neurological damage.

The CellBeads™ will be delivered directly to the injury site during the surgery. They are programmed to deliver CM1, a proprietary version of a naturally occurring protein, GLP-1, which has been shown to have powerful anti-apoptotic effects.

The delivery mechanism is a cluster of adult stem cells encapsulated in alginate beads. The cells are programmed to produce the protein, which is delivered continuously, directly to the injury site. The alginate beads protect the stem cells from the body’s immune system, which would otherwise destroy the foreign cells.

Products designed for the treatment of stroke have up until now been confounded by poor blood-brain permeability and half lives measured in minutes.

Professor Madjid Samii, Founder and President of the INI, commented “I am very proud of INI’s involvement with this exciting programme. INI’s unique focus on neuroscience has allowed us to play an active role in both the basic science and in clinical development.”

Crispin Simon, Chief Executive of Biocompatibles, commented:

“The CellBeads effectively create a local micro-factory; and I congratulate the CellMed-INI team on satisfying the regulators that such a radical approach is now ready for clinical evaluation.

Stem cell science rightly attracts a lot of public interest and many different business models are emerging – including standardised products like ours, modifications of a patient’s own cells, cord blood storage and dedicated treatment clinics. The fundamental challenge for all these models is to show that the technology is safe and effective. That requires solid data from solid trials and is why today’s announcement is so important for us.”

This programme has been supported by grants from the German government and from the State of Bavaria.

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Notes to Editors

Glossary of Terms

Notes:

Adult stem cells Stem cells sourced from adult donors. CellMed’s stem cells were derived from a single adult bone marrow donor and are stored and processed in a GMP-certified facility.

Alginate A biocompatible biomaterial derived from seaweed. CellMed’s proprietary alginate is an ultra-pure form designed to encapsulate and protect the stem cells from the patient’s immune system while allowing the GLP-1 to permeate out into surrounding tissue.

Apoptosis Programmed cell death or “cell suicide”. Apoptosis normally occurs as part of the body’s natural growth, maintenance and tissue renewal processes. Under certain circumstances, e.g. in the tissue surrounding a brain haemorrhage, this process can become uncontrolled and lead to widespread tissue cell death.

GLP-1 Glucagon-Like Peptide-1, a small protein that is naturally produced in the human body and has been shown to have strong anti-apoptotic effects in preventing cell death.

Half-life The time required to eliminate half of a known quantity of a substance from the body.