| HOME >> MEDICINE >> TECHNOLOGY |
VANCOUVER, British Columbia, July 10, 2007 /CNW/ - Protox
Therapeutics Inc. (TSX-V:PRX) today announced positive
top-line results from its Phase 1 clinical trial evaluating
PRX302 in patients with localized, recurrent prostate cancer
following radiation failure. The trial results indicate that
PRX302 is safe and well tolerated and shows promising signs
of therapeutic activity following a single intra-prostatic
treatment.
"The completion of the PRX302 Phase 1 trial is encouraging from
two perspectives," said Dr. Scott Coffield, Principal
Investigator from the lead site, Scott and White Memorial
Hospital. "First, there was therapeutic benefit demonstrated
through overall PSA reduction in study patients, as well as a
reduction in the number of positive biopsies after treatment.
Second, there was no significant adverse side effect profile
at the highest dose of PRX302 given to patients in this
trial."
"It is heartening to see promising results at this stage of the
clinical development program in a patient population which
has limited therapeutic options," said Dr. Fahar Merchant,
President and Chief Executive Officer of Protox. "These data
support our heightened confidence regarding the potential of
PRX302 for the treatment of not only prostate cancer, but also BPH,
which is currently being evaluated in an ongoing Phase I
trial."
This study is intended to examine the safety, tolerability
and therapeutic activity of PRX302 in patients with localized
recurrent prostate cancer who show signs of disease
progression as evidenced by rising levels of PSA (prostate
specific antigen) following radiation treatment. Using a
well-established, image-guided technique, PRX302 was administered
directly into the prostate. A total of 24 patients were
treated in this trial. Protox has concluded that despite a
100-fold escalation in dose, the maximum tolerated dose (MTD)
was not reached in this study while e
ncouraging signs of
therapeutic activity were
observed.
No significant safety issues relating to PRX302 treatment
were encountered in this clinical trial. One patient in the
study, who met inclusion criteria in spite of having
borderline liver abnormalities, showed a transient rise in
liver enzymes (Grade 3 on the National Cancer Institute's
5-stage grading scale) that quickly returned to screening levels.
An expanded cohort was enrolled at this dose in order to
collect additional safety data. No safety issues were
observed in any patients within the expanded cohort or in
further cohorts that received higher doses. In summary, no serious
adverse events were reported relating to PRX302 and all other
adverse events reported were mostly associated with the
injection procedure, rating no higher than Grade 1
(mild).
Assessment of potential therapeutic activity was determined by
measuring PSA levels throughout the study and conducting
prostate biopsies at 30 days post-treatment. PSA is one of
the most widely recognized disease markers in prostate cancer
and levels of PSA in the blood are used in the diagnosis of
prostate cancer, monitoring cancer progression and tracking patient
responses to its
treatment.
A comparison of prostate biopsies taken at baseline and at 30
days post-treatment shows that 18 of the 24 patients tested
in this trial had a decrease in the percentage of
cancer-positive biopsies. Three of the patients showed a
complete absence of cancer in their day 30
biopsy.
Two specific measurement indicators, PSA doubling time (PSADT) and
PSA velocity (PSAV), are key parameters in predicting
clinical progression, metastasis and mortality in patients
with prostate cancer. Of the 24 patients tested in this
study, 90 day PSA data is available for 15 patients at this
time. Comparison of PSA levels pre- and post-treatment shows a
clear and desirable trend towards an incr
ease in PSADT (15 of
15 patients) and a decrease in PSAV (11 of 15 patients), both
of which are very positive outcomes for the patient. Results
show that in 10 of 15 patients PSA levels were below baseline
at 90 days or longer post-treatment. In 14 of the 15 patients,
a decrease in PSA levels was observed during at least one of
the, 30-, 60- or 90-day follow-up
intervals.
The company expects that a final report that will include top-line
PSA data with expanded analysis of PSADT and PSAV will be
available for release in October. Plans are underway to
commence a Phase 2 study before the end of the
year.
Conference call
Protox will host a conference call and live webcast today at 12:00 p.m. E.T. to discuss these results. To access the conference call by telephone, dial 416-644-3414 or 1-800-732-9307. Please connect approximately ten minutes prior to the beginning of the call to ensure participation. The conference call will be archived for replay until August 10, 2007 at midnight. To access the archived conference call, dial 416-640-1917 or 1-877-289-8525 and enter the reservation number 21240373 followed by the number sign. A live audio webcast of the conference call will be available at http://www.protoxtherapeutics.com. Please connect at least ten minutes prior to the conference call to ensure adequate time for any software download that may be required to join the webcast. The webcast will be archived at the above website for 30 days.
About Protox
Protox Therapeutics is a leader in advancing novel, targeted protein toxin therapeutics for the treatment of cancer and other proliferative diseases. The company is actively developing two distinct but complementary platforms, INxin(TM) and PORxin(TM), and currently has four programs in clinical development. A Phase 2a clinical trial evaluating PRX321 (INxin) for the treatment of primary brain cancer has been completed and the product candidate has received Fast Track Designation and Orphan Drug Status from the US FDA. In addition, a Phase 1 clinical trial evaluating PRX321 for the treatment of patients with renal cell carcinoma and non-small cell lung cancer has been completed. Patient enrollment has been completed for a Phase 1 clinical trial evaluating PRX302 (PORxin) for the treatment of localized prostate cancer. A Phase 1 clinical trial evaluating PRX302 for the treatment of benign prostatic hyperplasia (enlarged prostate) is ongoing.
NO REGULATORY AUTHORITY HAS APPROVED OR DISAPPROVED THE CONTENT OF THIS RELEASE. THE TSX VENTURE EXCHANGE DOES NOT ACCEPT RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THIS RELEASE.
Certain statements included in this press release may be considered forward-looking. Such statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from those implied by such statements, and therefore these statements should not be read as guarantees of future performance or results. All forward-looking statements are based on Protox' current beliefs as well as assumptions made by and information currently available to Protox and relate to, among other things, anticipated financial performance, business prospects, strategies, regulatory developments, market acceptance and future commitments. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Due to risks and uncertainties, including the risks and uncertainties identified by Protox in its public securities filings; actual events may differ materially from current expectations. Protox disclaims any intention or obligation to update or revise any forward-lookin g statements, whether as a result of new information, future events or otherwise.
For further information: James Beesley, Director, Investor Relations, Protox Therapeutics, (604) 688-0199, jbeesley@protoxtherapeutics.com; Michael Moore, Investor Relations, Equicom Group, (416) 815-0700 x 241, mmoore@equicomgroup.com
'"/>
Related medicine technology :
1. Protox Announces Publication in Journal of the National Cancer Institute Supporting PRX302 as Treatment for Prostatic Diseases
2. Antisoma Announces Further Data From ASA404 Ovarian Cancer Trial
3. Neose Announces Presentation of Positive Preclinical Data on GlycoPEGylated Factor VIIa at the XXI Congress of the International Society on Thrombosis and Haemostasis
4. Biofrontera AG Announces Clinical Study Confirms Excellent Efficacy of BF-200 ALA In Actinic Keratosis
5. YM BioSciences Announces Secondary Efficacy and Safety Findings in Randomized Phase IIB Aerolef Trial
6. BioSante Pharmaceuticals Announces New Findings for Potential Bird Flu Vaccine
7. Portola Pharmaceuticals Announces Positive Data from a Phase II Study of its Factor Xa Inhibitor at the XXI Congress of the International Society on Thrombosis and Haemostasis
8. Manhattan Pharmaceuticals Announces Results of Phase 2a Studies for Oral Oleoyl-estrone
9. AVI BioPharma Partner Cook Medical Announces Completion of Patient Enrollment for APPRAISAL Phase II Clinical Trial for Treatment of Cardiovascular Disease
10. Inspire Announces Webcast of Presentation at C.E. Unterberg, Towbin Emerging Growth Opportunities Conference
11. NexMed Announces Completion of Patient Enrollment in Two Pivotal Phase 3 Studies for Anti-Fungal Product
| Copyright © 2003-2012 Bio-Medicine. All rights reserved. ABOUT | CONTACT US | DISCLAIMER | PRIVACY POLICY | TERMS AND CONDITIONS |  |