Locksmith!!!!!! Great Stuff!
HOW DOES ONCONASE COMPARE WITH ANGIOSTATIN/ENDOSTATIN?
There has been considerable discussion in the news media this week about
the anti-cancer potential of two promising anti-angiogenic agents,
angiostatin and endostatin. Although no human clinical trials have been
performed with these drugs, medical and science writers have placed
EntreMed, the drugs' manufacturer, in the spotlight as the company with a
potential cancer cure.
Alfacell Corporation, on the other hand, receives no media attention;
though its flagship product, Onconase, exhibits similar anti-angiogenic
properties, and has demonstrated significant anti-cancer activity in
humans. Moreover, the scope of Onconase's therapeutic value extends
beyond the sphere of cancer.
In fact, the universal and ubiquitous nature of RNA in living systems
offers an array of opportunities for Onconase as a therapeutic agent. By
virtue of its ribonuclease (RNase) character, Onconase has the potential
to destroy living systems that are offensive to human life. Besides its
proven anti-cancer activity, Onconase has demonstrated anti-viral
activity; and it may have potential as both an anti-bacterial and
anti-parasitic agent as well.
Here I present facts about Onconase and Angiostatin/Endostatin. I will
leave it to the reader to weigh the evidence and formulate a judgment
about Onconase's therapeutic value.
HOW DO ANGIOSTATIN AND ENDOSTATIN WORK?
Angiostatin and endostatin block tumor angiogenesis, a tumor's ability to
produce new blood vessels.
Since anti-angiogenic activity suppresses the growth of a tumor's nutrient
filled blood supply, the tumor starves and its development is inhibited.
In fact, the tumor may shrink and disappear.
Indeed, Dr. Judah Folkman has eradicated tumors in mice with these drugs,
and the mice appear to have been "cured" of their cancers. So, some
medical and science editors have prematurely extrapolated these results to
humans, and claim these two agents may "cure" cancer in humans.
Unfortunately, angiostatin and endostatin have not entered human clinical
trials, and there is no evidence to suggest that the results seen in mice
will be replicated in humans. Moreover, the drug cocktail is not
presently being produced in quantity, and may not be available for human
testing until the end of this year. So, it would be unconscionable for us
to draw conclusions about this cocktail's efficacy in humans.
ONCONASE'S PROPERTIES COMPARE FAVORABLY WITH ANGIOSTATIN/ENDOSTATIN
1) In a study of mice bearing the aggressive M109 Madison
carcinoma researchers stated this observation about Onconase
treated mice,
"There has been no evidence in any surviving mice,
at any time, of the onset of ascites or solid tumors.
The 12 survivors of this study appear to have been cured."
(See "Striking Increase of Survival of Mice Bearing
M109 Madison Carcinoma Treated With A Novel Protein
From Amphibian Embryos," Journal of the National Cancer
Institute, vol. 82, No. 2, January 17, 1990, pg. 151.)
2) Moreover, Onconase has demonstrated anti-angiogenic activity;
the same activity observed with angiostatin and endostatin.
(See EXHIBIT #1 below.)
3) Onconase exhibited a consistent and reversible clinical toxicity
pattern in Phase I clinical trials. It did not induce most of the
toxicities usually associated with other chemotherapeutic agents
such as alopecia (hair loss) and myelosuppression (bone marrow
suppression). A study of the clinical symptoms demonstrated that
peripheral edema (i.e. swelling of the appendages due to water
retention) and asthenia (i.e. weakness and fatigue) were the two
main side effects of Onconase treatment. When compared with
conventional chemotherapy, Onconase exhibits an extremely favorable
toxicity profile. So, the quality of a cancer patient's life
improves significantly with Onconase treatment.
4) Onconase is in Phase III human clinical trials for
pancreatic cancer and malignant mesothelioma. In fact, it is
approaching the conclusion of phase III testing, and is being
prepared for a NDA (New Drug Application). The likelihood of
Alfacell receiving FDA marketing approval for Onconase next year
is excellent.
5) Onconase's Phase II human clinical trial data of
pancreatic adenocarcinoma patients are very impressive.
As of October 1995 one human patient had achieved
a complete remission from pancreatic cancer, and was cancer
free for more than 3.5 years after entering the clinical trial.
Seven patients achieved stabilization of their previously
progressive disease. The median survival time for these
seven patients was 575+ days (greater than 1.5 years).
All surviving patients entered the trial study with
Stage IV disease. This means their cancer had spread to distant
sites. By contrast, the median survival rate for most newly
diagnosed pancreatic cancer patients is only 90 days.
(See EXHIBIT #2 below)
NOTE: Tamoxifen alone has absolutely no effect on pancreatic
adenocarcinoma.
(See "Clinical trial of tamoxifen in patients with
irresectable pancreatic adenocarcinoma," British Journal
of Surgery, 80(3):384-386, March 1993.)
6) The Phase II clinical trial of Onconase as a single agent in
patients with malignant mesothelioma (MM) has demonstrated
similar results. Most malignant mesothelioma patients die of
their disease within 6-12 months of diagnosis. However, the
median survival time for patients treated with Onconase was
24.7 months (greater than 2 years) from date of diagnosis.
(See "The use of Onconase for Patients with Advanced Malignant
Mesothelioma," (Meeting Abstract) Fourth International
Mesothelioma Conference, University of Pennsylvania,
Philadelphia, PA, May 13-15, 1997.)
7) Onconase has an extremely broad scope of biological activity.
Since it is a ribonuclease (RNase), it may act as an anti-viral
and anti-bacterial agent also. In fact, the National Institutes
of Health have demonstrated that Onconase is active against the
HIV-1 virus, the causative agent of AIDS.
(See EXHIBITS 3 & 4 below.)
CONCLUSION
Angiostatin and endostatin are unproven anti-cancer therapeutics, and
months away from entering human clinical testing. Onconase; however, has
proven that it can dramatically improve the lives of cancer patients.
So, we ought to ask ourselves this simple question; why should seriously
ill cancer patients be forced to pin their hopes on tomorrow's dream, when
they can embrace the reality of Onconase today?
Our responsibility to humanity is obvious. We ought to make Onconase
available to everyone stricken with cancer. |
