I was wrong about 500. It was 300. See press release:
ITHACA, N.Y.--(BUSINESS WIRE)--May 30, 1996--Paracelsian, Inc. (NASDAQ:PRLN)
today announced that as a result of the "very encouraging" results from its
initial compassionate use trial for its PN 27,1, the company is expanding
the trial to encompass 300 patients.
The announcement was made by John G. Babish, Ph.D., vice president and chief
science officer of the company.
According to Dr. Babish, the trial has been expanded as a result of the
strong response that was seen in six of the seven patients who participated
in the trial, as well as the subsequent requests from additional patients
and their doctors for the drug. "We expect that the trial will last through
the fall of this year, and we are hopeful that we will promptly recruit the
300 patients. We have approximately 30 patients who are already enrolled in
the expansion and we expect that we will be able to recruit the additional
patients as news about PN 27,1 and the trial continues to spread among
patients and their physicians."
Dr. Babish noted that in the initial compassionate use trial for PN 27,1,
Paracelsian's anticancer drug, which has been found to effectively block the
secretion of prostate-specific antigen and the growth of prostate cancer
cells in vitro, seven patients took the drug: two for non-Hodgkin's
lymphoma, two for breast cancer and two for prostate cancer. Of these
individuals, five were taking the drug for therapeutic purposes, while the
two prostate cancer patients took the drug to prevent a recurrence of their
illnesses. Since completing approximately three months of therapy, a 75
percent positive response rate has been seen, as measured by such
traditional clinical variables as tumor shrinkage in the case of lymphomas
and CEA values for breast cancer. All patients tolerated the drug well with
no toxic side effects, although one patient did develop what appeared to be
an allergic response to the drug. In addition, all patients reported an
additional significant beneficial effect...it appears that PN 27,1 had an
antidepressant effect on the patients.
According to Dr. Babish, potential participants in the expanded
compassionate use trial may call him at the company, 607/257-4224 to discuss
whether they meet the appropriate criteria for participation. "The
objective of this dose escalation/toxicology study will be to gather
additional data in advance of a submission for an IND with the U.S. Food and
Drug Administration."
Paracelsian is a biotech company engaged in the discovery of pharmaceuticals
from herbal sources and the development and marketing of tests for improved
cancer diagnosis and environmental carcinogens, utilizing the proprietary
technology of the company. In addition to its compassionate use trials for PN
27,1, the company has clinical trials underway at the Bastyr University in
Seattle for its PN 355 compound that appears to work against HIV.
However, I had called the company several months agao, and they acknowledged that they had nowhere near 100. However, folks who have terminal cancer are willing, in some cases, to try just about anything. Like using Taxol. Its only like 20% effective with serious side affects, but you do whats necessary. I think its more that PRLN does not have the contacts in the oncology field to get the drugs out.
SSB, what happens after compassionate testing if successful? Clinical I, or can they market it under that 1994 herbal act? |
