Genetronics Biomedical Ltd -
Genetronics Biomedical completes phase II clinical trials
Genetronics Biomedical Ltd GEB
Shares issued 21,646,116 1999-05-18 close $5.5
Wednesday May 19 1999
Mr. Martin Nash reports
Genetronics Biomedical Ltd. has completed its interim data and
results from phase II clinical trials in the United States and Canada
for the treatment of squamous cell carcinoma of the head and neck.
The trials were designed to evaluate the use of the company's
proprietary electroporation therapy (EPT) system, which incorporates
intratumoural injection of a chemotherapeutic agent combined with a
pulsed electric field. The data were presented at the 35th annual
meeting of the American Society of Clinical Oncology in Atlanta, Ga.
Genetronics also announced preliminary data and results from a
similar study conducted in Europe.
A total of 33 patients with advanced head and neck cancer who had
failed conventional therapy with radiation, chemotherapy, or surgery
or a combination of these, were enrolled in two, multicentre phase II
trials conducted at 17 sites in the United States and Canada. One of
the trials was a crossover controlled study; the other was open
label. Twelve additional patients were treated in a similar, open
label trial conducted in Europe.
In each case, the patients' lesions were treated with bleomycin and
the Genetronics proprietary EPT system, which uses the company's
proprietary MedPulser device to deliver pulsed electric fields to the
cells. This treatment increases the permeability of the cell
membranes to the drug, resulting in significantly enhanced
intracellular delivery of bleomycin. In this interim analysis,
clinical response was determined by either complete disappearance of
the tumour or reduction in size by at least 50 per cent.
For the 33 patients in the phase II trials, a clinical response was
achieved in 64 per cent of the 42 tumours. In the 12-patient European
study, preliminary results show that 12 of the 19 tumours treated (63
per cent) demonstrated a clinical response. These interim results are
consistent with the results achieved in an earlier, eight-patient
phase I/II study, where six of the eight (75 per cent) treated
squamous cell tumours manifested a clinical response. These results
are summarized on the chart below, and described further in the
text.
HEAD AND NECK
CANCER CLINICAL RESULTS
Response
Non-
Respon- respon-
Clinical Tumours der der
trial Patients tumours tumours
North
America
phase I/II 8 8 6 (75%) 2 (25%)
North
America
phase II-
01 study
control
group(1) 23 33 0 (0%) 32 (97%)
North
America
phase II-
01 study(2) 15 18 11 (61%) 6 (33%)
North
America
phase II-
02 study 18 24 16 (67%) 6 (25%)
European
study 12 19 12 (63%) 7 (36%)
(1)Four could not be evaluated.
(2)Control group patients received only drug, no electric field.
The two phase II United States FDA sanctioned protocols involved a
total of 42 tumours treated with bleomycin and EPT. Tumours treated
in the trial include squamous cell carcinoma of the face, oral
cavity, pharynx, larynx and sinus. The volume of tumours treated
ranged from less than one cubic centimetre to more than 132 cubic
centimetres. As shown above, the clinical response was 61 per cent in
one study and 67 per cent in the other, for an overall 64-per-cent
clinical response. The clinical response measured in the European
study also was 64 per cent.
In the crossover controlled phase II study, patients initially
received only the drug (the control group). Patients, who did not
respond to drug alone, were then treated with the complete system of
drug and electric field, EPT (treatment group). Of the 33 lesions on
23 patients treated only with drug, none demonstrated a clinical
response. Fifteen of these patients, having 18 lesions, were
subsequently treated with bleomycin and EPT, and 61 per cent achieved
a clinical response. In the open label phase II study, all patients
received full EPT as their initial treatment. Among the 18 patients
(24 lesions) so treated, 67 per cent achieved a clinical response.
In the European study, 19 tumours were treated on 12 patients. A 64-
per-cent clinical response was measured (12 tumours). In the earlier
phase I/II trial with eight patients, which was conducted at Rush
Presbyterian St. Luke's Hospital in Chicago, six of the eight (75 per
cent) tumours treated with full EPT demonstrated a clinical response,
with five of the responding tumours disappearing completely.
"These interim results suggest that electroporation with
intralesional bleomycin treatment is a promising means for the
treatment of squamous cell carcinoma of the head and neck," said Paul
Goldfarb, MD, medical director at Genetronics. "Our EPT treatment for
head and neck cancer potentially offers several significant
advantages, compared with conventional therapies."
Because these are interim results, the absolute values, including
percentage of tumours experiencing clinical responses, are likely to
change upon more complete analysis of data from the clinical trials.
WARNING: The company relies on litigation protection for "forward-
looking" statements.
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