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Biotech / Medical : GEB - Genetronics Biomedical -- Ignore unavailable to you. Want to Upgrade?

To: MAX LLOYD who wrote (3)	5/19/1999 12:51:00 PM
From: Rob	Read Replies (1) \| Respond to of 31

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.