Prescient completes Phase I safety study
...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
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
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
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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