AL 721 Developer Speaks

The experimental AIDS treatment AL 721 continues to be controversial. Recently we spoke with the principal developer of AL 721, Meir Shinitzky, PhD, a cancer researcher and Professor in the Department of Membrane Research at The Weizmann Institute of Science in Rehovot, Israel. Dr. Shinitzky gave us new information about two trials of AL 721 in Israel, and an additional study beginning in France to compare AL 721 with AZT.
We tape recorded part of the conversation, but we chose to quote most of the material indirectly rather than word for
word, as we could not get back to Shinitzky by press time to verify the changes which would have been necessary to make our discussion clear to readers unfamiliar with AL 721. We used verbatim quotes when we could.
'AL 721' is a trademark of Ethigen Corporation, Los Angeles.

The Compassionate Study In Israel

Shinitzky told us that there were two clinical trials now ongoing in Israel. The first is a compassionate trial started
by Yehuda Skornick, M.D. This trial (now being conducted by other physicians because Dr. Skornick is working in the U.S.) has treated about 60 patients so far.
But this compassionate trial, Shinitzky explained, was not organized for obtaining scientific data; and therefore "the
medical community will never accept such a trial for documentation".
A major problem has been the difficulty in followup. About 80 percent of the patients are from abroad. After
laboratory work and diagnosis, they were given AL 721; the physicians asked them to send back data after they returned home. But most didn't comply and disappeared after they left Israel.
"We have data on only 12 of them. It's hard to make any real statement. But out of this 12 there was a clear-cut
positive effect."

A Scientific Trial

Shinitzky explained that in addition to this compassionate trial, Israeli researchers at the Tel Aviv Medical Center
started a more scientific study with 16 patients about one year ago; the principal investigator is Dr. Yust. Unlike most U.S. studies, which try to select a more uniform groups of patients, this trial included persons with AIDS, persons with ARC, and asymptomatic seropositives within the group of 16.
Nine of the 16 were P24 antigen positive when they started; all 16 were HIV antibody positive of course. "In
these nine, five showed clear-cut reduction to the basal detectable level" (apparently meaning they became antigen
negative) on the Pasteur test kit used. Shinitzky noted that this result seemed compatible with the result of the only U.S.
clinical trial of AL 721 completed so far, the St. Luke's/Roosevelt study in New York, in which about 60 percent of the patients showed a large reduction in reverse transcriptase (an earlier measure of viral activity, used before the P24 antigen test was available).
We asked how often the P24 antigen went negative without any treatment. Shinitzky said such cases were rare and would never happen five times out of nine.
For two of the other four patients who did not respond to AL 721, the researchers started AZT in addition to AL 721.
These patients had a marked decrease in antigen; one, however, had a brain infection and died in two weeks. The other is alive and doing well. Shinitzky noted that while two cases could certainly not provide proof, it seemed that the drugs might be synergistic, working much better in combination than separately. Shinitzky also thought that the AL 721 might be reducing the side effects of the AZT.
The other two patients did not respond at all. Both of them had AIDS.
Of the five who did become antigen negative, three were asymptomatic, one had lymphadenopathy, and the other had KS, which has since disappeared. All of them feel far better than when they started.
We asked about the other seven of the 16, who had been P24 antigen negative at the start of the trial. Shinitzky said
that all responded well to the treatment, but that it was hard to evaluate these cases because there was no biochemical
measure to follow.
We asked if these results would be presented at the Stockholm AIDS conference in June. Shinitzky said the work had
been submitted; if it is accepted the researchers will present it formally, otherwise they will finalize it for scientific
publication elsewhere as soon as possible.

French Study Planned

We asked Shinitzky about reports of an AL 721 study which has just begun in France.
"The French researchers, in particularly Dr. Montagnier of the Pasteur Institute, who is the key figure in AIDS research
today probably in all of Europe, expressed his willingness to participate in such as study. As you know the French won't do it unless they are quite convinced.
"The head of the Israeli AIDS Association went to Dr. Montagnier's lab to learn the latest in antigen monitoring and
so on. They developed good relations and together designed a protocol that later was given to other groups, including one from Marseilles. The study has just started.
"In this particular study a well defined group of people-- 100 to 200, I don't have the exact number--will be divided into
equivalent groups. One will be given AZT for three months, the other will be given AL 721, and then there will be a crossover. With this design we avoid using a placebo for a control group. The results can be analyzed as a comparative study.
"Since AZT is already approved as an effective drug, if you find that our material is as effective or even further, of
course it has the advantage of being nontoxic.
"And after this study is finished, both groups will be kept on AL 721. Some of them will also be given a thymus
hormone, assuming that the virus has been reduced.
"In those people in whom the virus has been reduced after six months of the trial, all will be kept on AL 721, and some
of them will be given a thymus hormone; the one selected was THF, thymus humoral factor, which has been analyzed and characterized at the Weizmann Institute by Dr. Trainin. So it will be a combined-treatment study, even though the beginning and the most substantial part of the study will be our compound."