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Prescient completes Phase I safety study (Canada NewsWire) ...Phase II studies in tumor types where pre-clinical models have shown efficacy (non-small cell lung carcinoma and cervical...... safety and tolerance study of AVLB in patients with advanced solid tumors....... Canadian biotechnology and drug discovery company focused on the rescue and protection of brain cells.... - Aug 14 7:00 AM ET

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Posted on: 08/14/2001

"Yahoo - Prescient completes Phase I safety study"
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Tuesday August 14, 7:00 am Eastern Time

Press Release

SOURCE: Prescient NeuroPharma Inc.

Prescient completes Phase I safety study

-- Anti-Cancer drug moves to Phase II --

TORONTO, Aug. 14 /CNW/ - Prescient NeuroPharma Inc. (CDNX: PRE - news) announced today that it has successfully completed a Phase I clinical trial demonstrating the safety and tolerability of Anhydrovinblastine (AVLB). "The final report on the trial is expected to be available at the end of September," said President and CEO, Anthony Giovinazzo

"Although the class of drug and mechanism of action is similar to other vinca alkaloids, AVLB may have a therapeutic advantage if it demonstrates efficacy with reduced toxicity," remarked H.W. Hirte MD, FRCP(C), Acting Head - Medical Oncology and Chair - Investigational Therapeutics Group, Hamilton Regional Cancer Centre. "As well, the possibility of an oral formulation would make outpatient administration much simpler. Phase II studies in tumor types where pre-clinical models have shown efficacy (non-small cell lung carcinoma and cervical carcinoma) as well as tumor types responsive to vinca alkaloids (lymphomas, leukaemia's, testicular cancer, bladder cancer, breast cancer, and Kaposi's sarcoma) would be warranted."

The Phase I trial was a single center, open label, non-randomized, dose finding, safety and tolerance study of AVLB in patients with advanced solid tumors. Twenty-four subjects received an intravenous infusion over a one-hour period and were monitored for up to 3 weeks following treatment. Clinical examinations and evaluation of symptomatic toxicities were performed within one week of first infusion, and then periodically throughout the study. Plasma was collected from patients and levels of the drug were also measured to provide information on basic pharmacokinetics in man. The study was carried out at the Roswell Park Cancer Institute in Buffalo, NY, under an Investigational New Drug application filed with the FDA in 2000.

The objectives of the study were to determine the maximum tolerated dose (MTD) and the dose limiting toxicity (DLT) of AVLB when given as a 1-hr IV infusion every 3 weeks; these objectives have been met.

The results from this trial demonstrated that AVLB is safe and well tolerated in humans over the dose range studied. AVLB has a manageable toxicity profile, which is consistent with approved drugs in the vinca alkaloid class. The maximal tolerated dose (MTD) is 21.0 mg/m(2). Nausea, vomiting and constipation were dose-limiting toxicities (DLT).

Patients who participated in the trial have refractory malignancies (have not responded to other treatments). A total of 24 patients received AVLB intravenously every 21 days. Enrolled patients with measurable lesions were monitored; 4 of the 21 evaluable patients were assessed with disease stabilization, i.e., no further growth.

The clinical investigators have recommended dose levels and frequencies for future Phase II trials to assess anti-tumor activity. Prescient has completed a preliminary Phase II study outline of AVLB as a second line therapy in patients with non-small cell lung cancer (NSCLC).

The principal mechanism of action of AVLB is believed to be the disruption of microtubules, which arrest cell division.

There are issued patents on the process of synthesizing AVLB as well as the use of AVLB as an anti-cancer therapy for lymphomas. The company has received notice of allowance from the US Patent office for the use of AVLB as an anti-tumor agent against non-small cell lung, cervical, colon and breast cancers.

Cancer is the second most common cause of death in Western developed countries. An estimated 1.2 million new cases and 600,00 deaths from cancer will occur in the United States annually. Lung cancer remains the leading cause of cancer death. Although there has been an increase in five-year survival rates attributable to improved screening, detection and treatment since the 1960's, mortality and morbidity from cancer remains a significant problem.

About Prescient

Prescient NeuroPharma Inc. is a Canadian biotechnology and drug discovery company focused on the rescue and protection of brain cells. Prescient has two lead neuroprotection research programs. One program relates to a proprietary metabotropic glutamate receptor (mGluR) library of small molecules that act on specific mGluRs in the brain, thereby modulating glutamate signals that lead to functional imbalance and/or nerve cell death. The other program involves the discovery of naturally occurring neurotrophic proteins, which sustain the life of brain cells, aimed at slowing disease progression.

The CDNX has not reviewed and does not accept responsibility for the adequacy or accuracy of this press release.


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