Zadaxin to increase CD4s

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On 12/7/04 JM Friedman posted a message about importing drugs which included mention of an imported immunomodulator, Zadaxin, to which he attributed a substantial increase in his CD4 counts. Intrigued, I subsequently contacted the company, SciClone Pharmaceuticals, to find out why this drug, being tested in hepatatis and cancer patients, isn't being investigated in HIV patients. I got the following response from the company, which I'll reprint below for anybody who might be interested. They mention a Compasssionate Access Program. (At present, I'm trying low dose IL-2 to boost my T cells, so I'm not attempting to get Zadaxin). I don't know whether Zadaxin has been discussed at length before on this group - searching the archives beyond more than a few hundred past postings is simply too cumberson for anyone with a slow 26K dial-up connection. (Hopefully, Yahoo will improve it's group archives search function so that

at least 1000 past messages are searched per attempt). Anyway, here's the message from SciClone. (If anybody needs the pdf file which is mentioned, contact me and I'll try to forward it to you)

:

Dear Mr. Kara,

Our drug ZADAXIN (thymalfasin, thymosin alpha 1) is currently approved in 33 countries worldwide for the treatment of hepatitis B, hepatitis C, as an adjunct to chemotherapy in cancer patients, and as a vaccine adjuvant in immunocompromised patients.

In the US, ZADAXIN is being tested in 3 trials. The largest, 1000 patient phase 3 trial is for the treatment of hepatitis C non-responders. This study is fully enrolled and is expected be finished in the latter part of 2005. We also have 2 phase 2 trials underway for the treatment of hepatocellular carcinoma (liver cancer).

In Europe, another 550 patient phase 3 trial is underway for treating hepatitis C non-responders as well as a 320 patient phase 2 /3 program for the treatment of malignant melanoma.

ZADAXIN has been tested in HIV patients in pilot studies in combination with antiviral agents with positive results. I do not expect a large scale trial in this area however until we have finished our US and European hepatitis C non-responder studies and our cancer studies due to the high cost of running all of these trials. Hopefully, at the conclusion of these major studies, approvals will come in both the United States and Europe and the incoming revenue will allow us to branch out to do more clinical trials.

I have attached a pdf file that outlines the mechanism of action of ZADAXIN. I hope you will find this helpful in understanding the way that the drug works to improve immune response, including increasing levels of CD4 cells (T-helper cells), CD8 cells (cytotoxic T-cells), and NK (natural killer) cell activity as well as other mechanisms.

As you have read, the US FDA and Customs Department do allow US residents to import non-approved drugs for their own personal use, and especially in the case of life-threatening illnesses such as cancer, HIV, and hepatitis. If you would like further information on this Compassionate Access Program, please let me know.

Sincerely,

Randy McBeath

SciClone Pharmaceuticals

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