December 5th 2005
Biocompatibles International plc
("Biocompatibles" or "the Company")
Drug Eluting Bead Programme Update
* Recruitment of first patient in PRECISION V
* Collaboration with Cancer Research UK - Hep-1 trial
* Presentations of further HCC data at the British Society of Interventional
Radiology - consistent with the positive data reported from PRECISION I
* Positive data presented at Radiological Society of North America on
indication of hepatic mestastases.
Biocompatibles International plc, the medical technology company focused on
drug device Combination Products for use in cardiology and oncology, is pleased
to announce four positive developments in its Drug Eluting Bead Programme.
Recruitment of first patient in PRECISION V
On 1st December Professor Johannes Lammer, Head of the department of
Interventional Radiology at University Hospital Vienna, the study's Principal
Investigator, treated the first patient in the PRECISION V clinical trial.
PRECISION V is a prospective randomised trial evaluating Biocompatibles' DC
Bead versus treatment with Conventional TACE, using the products traditionally
used for the technique. Unlike the DC Bead, these have not been specifically
designed for controlled drug release.
PRECISION V is the first significant randomised trial in the emerging field of
Interventional Oncology and builds on the positive results of PRECISION I
(Barcelona) and PRECISION II (Hong Kong). There are three significant
enhancements. The first is the introduction of the control arm. The second is
the use of the EQ5D and EORTC-QLQ-C30 quality of life questionnaires - focused
respectively on patient overall well-being and on changes in quality of life
following cancer treatment - with patients blinded to treatment. The third
enhancement is the measurement of the total cost of the treatment of each arm.
The trial has been prospectively powered to show a statistically significant
benefit in the primary endpoint of tumour response at six months.
Professor Lammer, commented "I have treated my patients with this product and
so far our experience is positive. I look forward to seeing the definitive
evidence from PRECISION V".
Collaboration with Cancer Research UK - Hep-1 trial.
Biocompatibles is supporting Cancer Research UK's (CRUK) "Hep-1" clinical trial
for the evaluation of the treatment of Trans Arterial Chemo Embolisation (TACE)
performed with the Drug Eluting DC Bead, against the treatment of intravenous
administration of systemic doxorubicin. 280 patients with Hepatocellular
Carcinoma (HCC) will be randomised into two equal groups at six UK hospitals -
Royal Infirmary Edinburgh; Freeman Hospital, Newcastle upon Tyne; Addenbrooke's
Hospital and University of Cambridge; Queen Elizabeth Hospital and Institute
for Cancer Studies Birmingham; University of Southampton; Hammersmith Hospital,
London. Other hospitals are expected to join the trial.
The primary end-point of Hep-1 is survival, with secondary end-points of tumour
response (determined by RECIST criteria), time to progression, toxicity,
quality of life, and health economics. To complement the main trial, patients
will also be recruited into two proteomic sub-studies and an immunological
sub-study - to explore the possibility of identifying patients who are likely
to respond to treatment according to proteomic factors, to examine the nature
of the protein released by the tumour following embolisation and to investigate
the frequency and quality of anti-tumour immune response. Recruitment of the
first patients is expected within the next few weeks and is expected to be
complete in December 2008.
There is no treatment that has been proved to be effective for the treatment of
advanced HCC. The Hep-1 trial has been developed by Cancer Research UK on
behalf of the National Cancer Research Institute (NCRI) HCC working party and
the NCRI upper GI cancer clinical studies group,
Crispin Simon, Chief Executive commented "It is a privilege for Biocompatibles
to be able support the work of so many of Britain's pre-eminent cancer
hospitals. It is the first time that oncologists will be investigating our
technology and we look forward to this new challenge."
New Clinical Data
At the recent meeting of the British Society for Interventional Radiology,
Professor Lammer reported on his PRECISION Vienna trial. 21 patients with HCC
were treated with the DC Bead and within six months the tumour response was 43%
complete response and 28% partial response. Complications were reported in
14.3% of cases with 30 day mortality at 4.8%.
At the recent 91st Meeting of the Radiological Society of North America Dr
Kenneth Coenegrachts of the Institut Gustave Roussy (IGR) in Paris presented
the findings of a recent study of the DC Bead. Dr Coenegrachts and Dr Thierry
de Baere recruited 10 patients with metastases in the liver from
neuro-endocrine (carcinoid) cancer. The six month tumour response was 50%
(RECIST criteria) and there were no major complications.
Dr. Coenegrachts concluded: "In this preliminary study, TACE with doxorubicin
eluting beads is well tolerated and seems to be efficient"
Regulatory Process
The DC Bead received CE Mark approval in November 2003.
In the US, the Company intends to file for FDA approval of the DC Bead product
during the course of 2006. The FDA has provided no guidance that the package of
data that will be available by this time would be acceptable.
Biocompatibles estimates that the market opportunity for the Drug Eluting Bead
products will ultimately be up to $400m. Of this, the majority is in Europe and
Asia.
* End -
CONTACT:
Biocompatibles +44 (0)1252 732732
Crispin Simon, Chief Executive
Peter Stratford, Managing Director, Drug Delivery
Ian Ardill, Finance Director
Good Relations +44 (0)20 7861 3132
Phil Brady
Suzi Nealson
Kathryn Ager
Biocompatibles International plc
Biocompatibles International plc is a medical technology company focused on
drug device Combination Products for use in cardiology and oncology. The
Company's proprietary biomedical polymer systems provide medical devices with
enhanced biocompatibility and offer a platform for drug delivery.
Further information is available at www.biocompatibles.com
NOTE TO EDITORS:
TACE and PRECISION TACE
Conventional Trans-Arterial Chemo-Embolisation - a procedure whereby a
chemotherapeutic agent is mixed into a slurry and injected
TACE via a catheter, locally at a tumour site.
PRECISION Bead Biocompatibles' proprietary Drug Eluting Bead product
containing doxorubicin developed for the treatment of HCC.
HCC Hepatocellular Carcinoma, primary tumour of the liver.
DC Bead Biocompatibles' proprietary drug eluting bead product
developed for loading with the chemotherapeutic agent by
the hospital. This product received CE Mark regulatory
approval in June 2003 for the treatment of malignant
hypervascularised tumours.
PRECISION TACE The use of either PRECISION Bead or DC Bead in the TACE
procedure. PRECISION TACE results in a lower systemic drug
exposure and more drug at the tumour site.
PRECISION A family of clinical trials sponsored by Biocompatibles
Clinical Trials for the evaluation of the PRECISION Bead and DC Bead
products for the treatment of HCC.
IDE Investigational Device Exemption - The approval by the FDA
to carry out a clinical trial in the US with an unapproved
device.
EASL and RECIST
The definition and reporting of response in solid tumours used in the
PRECISION clinical trials are EASL and RECIST. Both criteria are recognised
in the field of oncology and hepatology in reporting data from HCC studies.
EASL (European Association for the Study of the Liver) assesses tumour
response by using the reduction in viable tumour volume. The EASL criteria
define responses as follows:
Complete Response Complete disappearance of all known disease and no
new lesions
Partial Response 50% reduction in viable tumoural area of all
measurable lesions via uptake of contrast in the
arterial phase of a Triphasic CT scan
Progressive disease 25% increase in size of one or more lesions or the
appearance of new lesions
Stable Disease All other cases
Objective Response Complete Response and Partial Response
RECIST (Response Evaluation Criteria in Solid Tumours) assesses tumour
response by using unidimensional measurements of the sum of the longest
diameters of tumours. The RECIST criteria define responses as follows:
Complete Response Disappearance of all target lesions
Partial Response Greater than 30% decrease from baseline
Progressive disease Greater than 20 % increase from baseline, new lesion
(s)
Stable Disease All other cases
Objective Response Complete Response and Partial Response
END
© 2005 PR Newswire