By Randall Osborne

West Coast Editor

A month after the FDA called AVAX Technologies Inc. regarding problems with its autologous cancer vaccine trials, placing them on ¿clinical hold,¿ the agency has followed up with a list of comments, questions and requests for more information.

¿There¿s a little more in there,¿ said Rich Rainey, vice president of finance and administration for Kansas City, Mo.-based AVAX.

¿What came with the letter was a couple of segments,¿ he said. ¿They told us what we need to get off hold, and there are regulatory hurdles. I guess you could look at this as positive or negative. The issues are on the table, and now we¿re able to deal with them.¿

Wall Street reacted with its usual sensitivity. The company¿s stock (NASDAQ:AVXT) lost 43 percent of its value on the news, closing Monday at 67 cents, down 52 cents.

¿I think the appropriate term [for the market response] could be vigor,¿ but given what¿s been happening over the past three months, I¿m somewhat numb to it,¿ Rainey said. AVAX¿s 52-week high is $13.50, and the 52-week low is 71 cents.

In what AVAX termed ¿a related matter,¿ two company officials have resigned at the request of the company¿s board of directors, and an inspection of the manufacturing facility in Philadelphia is under way by the FDA, while AVAX conducts an internal review.

¿We anticipated [the inspection] was going to happen,¿ Rainey told BioWorld Today. ¿It¿s better sooner than later.¿

In March, Kansas City, Mo.-based AVAX said the delay of trials for M-Vax (for melanoma) and O-Vax (for ovarian cancer) likely would have ¿no long-term impact¿ on the firm. Now, the picture has changed. The FDA is questioning whether the vaccines are developed enough to support applications for marketing approval.

¿The M-Vax trial is designed and powered as a pivotal trial,¿ Rainey said. ¿The O-Vax trial is definitively Phase II.¿

New questions from the agency ¿ which AVAX said will take at least three months to answer ¿ go beyond matters related to sterility of cancer cells, and extend to handling of the cells by AVAX, as well as preparation and manufacture of the vaccines.

Resigning at the board¿s request were AVAX¿s executive vice president Ernest Yankee, and vice president of operations Kamy Behzadi.

¿Basically one was running the clinical trials, and the other was the head of manufacturing,¿ Rainey said.

AVAX said earlier it was investigating how the tumors were handled by hospitals that participated in trials. No strict procedure then had been established, the company told BioWorld Financial Watch, and various facilities had differing rules, so that contamination at the site of surgery was a possibility.

¿Originally, the thought that it was the sterility of incoming tumors,¿ Rainey said. ¿Now we¿re saying, let¿s talk about sterility throughout the process.¿

In March 2000, AVAX raised $25 million in a private placement, saying at the time its main expenditures would be finishing the Phase II pivotal registration study of M-Vax, and the Phase II program for O-Vax. (See BioWorld Today, March 14, 2000.)

The vaccines are made from a patient¿s own cancer cells, modified with a hapten molecule that makes the tumor cells appear foreign to the patient¿s immune system in order to elicit a tumor-killing response.

At the time of the original hold, the FDA said AVAX could continue dosing patients with vaccines proven sterile.

¿That hasn¿t changed,¿ Rainey said.

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