Released by FDA: 3/7/00.  Posted by FDA:  3/16/00

Joseph B. Nester 
President 
Ozelle Pharmaceuticals, Inc. 
11825 IH 10 West, Ste 213 
San Antonio, TX 78230

Re:    Anvirzel ^TM
         IND 58,345 
         MACMIS lD# 8776

Dear Mr. Nester:

It has come to the attention of the Division of Drug Marketing, Advertising, and Communications (DDMAC) that Ozelle Pharmaceuticals (Ozelle)  is promoting Anvirzel prior to approval, in violation of the Federal Food, Drug, and Cosmetic Act (the Act) and its implementing regulations (see 21 CFR 312.7).

Ozelle’s website makes numerous claims regarding the safety and efflcacy of Anvirzel. These claims are based solely upon preliminary and inconclusive data since the clinical investigation of Anvirzel is in a preliminary stage; neither the safety nor efficacy of the drug has been demonstrated by substantial evidence (i.e., adequate and well-controlled studies).  Therefore, the information on the website is in violation of the Act and its implementing regulations because it promotes an investigational new drug.

Following are selected statements from the website that promote the drug as safe and/or effective: -

Objective clinical responses in these cases were documented, including complete responses, partial responses, and stabilization of disease.

Anvirzel exerted a very consistent palliative effect on patients treated for four to six weeks.  These patients experienced increased energy, diminished pain, decreased need for analgesia, as well as an enhanced sense of well being.

The drug has shown very positive responses in almost all of these cases.  Particularly evident has been a dramatic increase in patients’ Quality of Life and tumor arrestment. 

Experience shows that Anvirzel is a multi-mechanism drug that uniquely modulates the immune system and has cytotoxic activity that attacks cancer cells.  Additionally, the drug produces yet unexplained pain reduction and/or pain remission.

There have been no perceived negative side effects noted with the use of Anvirzel to date.

Since a New Drug Application (NDA) for Anvirzel has not been approved for marketing by the Food and Drug Administration (FDA), the dissemination of information by Ozelle that represents in a promotional context that Anvirzel is safe and effective constitutes promotion of an investigational drug, in violation of the Act.

DDMAC requests that the distribution and use of materials that promote Anvirzel prior to approval cease immediately, including but not limited to, removal of violative information from the Ozelle website.  Ozelle should submit in writing, on or before March 21, 2000, a description of the steps that will be taken to comply with the above request.

Ozelle should direct its response to the undersigned by facsimile at (301) 594-6771, or by written communication at the Division of Drug Marketing, Advertising, and Communications, HFD-42; Room 17B-20; 5600 Fishers Lane; Rockville, MD 20857. ODMAC reminds Ozelle that only written communications are considered official. In all future correspondence regarding this matter, please refer to MACMIS lD# 8776 and IND 58,345

Sincerely,

Jean-Ah Choi, Pharm.D. 
Regulatory Review Officer 
Division of Drug Marketing, 
   Advertising, and Communications