By: SUE32073
31 Mar 2004, 09:01 AM EST
Msg. 145262 of 145289
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From the 10-K...."We are focusing our clinical efforts on our one ongoing PhaseI/II open-label dose escalation clinical trial being conducted at the Kaplan Medical Center in Rehovot, Israel of AVR118 for cachectic patients with AIDS. Out of 30 total patients contemplated under the protocol for this study, 23 patients are enrolled, 22 of whom have completed the full course of treatment of AVR118, and one is continuing to receive treatments of AVR118, as required under the study. Results from the first 15 patients showed improvement in appetite, weight gain or stability, and enhanced quality of life. None of the first 15 patients reported any serious side effects associated with AVR118 therapy."

Wonder why the company isn't saying anything concerning the 7 additional patients who have completed the full course of treatment. Why was the company so enthused with the results of original 15 patients (enthused enough to put out a PR) and yet they have "nothing to say" concerning the additional 7 patients?????

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By: SUE32073
31 Mar 2004, 09:08 AM EST
Msg. 145264 of 145289
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Does anyone else think that "possibly" the results of the 7 additional patients will be the topic of the Abstract at the ASCO meeting in June in NOLA??
By: mind31
31 Mar 2004, 09:21 AM EST
Msg. 145272 of 145291
(This msg. is a reply to 145262 by SUE32073.)
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Sue, I don't think it means much that they do not report on the additional 7 patients. They would have to crunch numbers again for the 22 vs the 15. I have no doubt 118 makes one hungry. Did't Martin Delaney admit that.
What concerns me is that I see no way for them to finish in the second quarter as stated. I have doubts about 3rd quarter. The longer this goes on without news the more we drift lower. I hope a patent or something happens between now and then.

By: Keith0228
31 Mar 2004, 09:23 AM EST
Msg. 145273 of 145277
(This msg. is a reply to 145267 by taxman221.)
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Think you're wrong taxman. Stock made it's visit to the .12's, so IMO it'll move up today. 10k wasn't that bad. Don't know what you're looking for in a biotech without an approved product, but advr is getting closer, they've still got money, and avr-118 still looks very promising.
By: Ourobouros
31 Mar 2004, 09:36 AM EST
Msg. 145278 of 145291
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What I find interesting is that the semi-timely PR's that Wilner and D'Olympio releasing recently (and which were supporting a rising PPS in addition to sustaining it) seem to be dwindling.

Add to that the fact that we have not heard peep one from our new esteemed CEO.

Are we now back to square one in which the company resorts to releases of SEC documents in communicating with its shareholders??

Sure hope not.

By: qaz121
31 Mar 2004, 09:53 AM EST
Msg. 145284 of 145291
(This msg. is a reply to 145270 by taxman221.)
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The fact alone that company insiders have invested millions of their and their relatives money reflects where we are going. They have no doubt as do I. As I alluded to in my posts, we will do %20 very shortly, we always do....qaz

By: allenadvrlong
31 Mar 2004, 10:13 AM EST
Msg. 145288 of 145291
(This msg. is a reply to 145282 by lunker10706.)
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Today is the end of a quarter
If this CEO cannot send out a Sharholder update
let alone introduce herself within a week then
I think she has a few things to learn about
running this company.


By: tellslikeitis
31 Mar 2004, 10:16 AM EST
Msg. 145290 of 145293
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How come there's two different paragraphs in the 10K relating to the consultant services of Dr. Guarino (Oxford Pharmaceutical Services? One says $61,000 was expended for these services between August-December 2003, the other says $80,000. Other than the dollar amounts, the wording in both paragraphs is identical. So was it two separate payments totaling $141,000 or is one of these reported figures in error?

I doubt that we'll see the completion of the Israel studies by the end of the second quarter. The end of the third quarter is probably a more realistic timeframe to expect the completion of the study, the statistical data analysis and the final study report. And I don't think the company can or will move on an IND for an injectable use in the U.S. until the final report on the Israel trials is available to present to the FDA. This may explain the lack of any action on a U.S. IND we see in the latest 10K news.

The company could, of course, move once again and relatively quickly on the topical IND it has in hand for HPV genital warts. But it seems to have had second thoughts on HPV and does not apparently want to move in that direction. There has been no mention of pursuing this IND in any recent company reports or releases nor has there been action taken to initiate Phase II studies, although the Phase I studies were completed as far back as in early 2002 and we were told that Phase II studies were in the planning stage at that time. The departure of Carol Armenti , supposedly an expert on HPV cervical disease, from the Scientific Advisory Board also seems to indicate that the company has lost interest in pursuing this clinical application. Perhaps they feel that that an injectable use in AIDS patients is a larger application and more likely to be pushed quickly through the FDA.

I personally feel that the company should pursue both a topical formulation and an injectable version of the drug (since the anecdotal data available in patents and publications indicates that the drug is effective in both modes of administration), provided funds are available to conduct both Phase II efficacy studies. If clinical results are good, two different potential big pharma partners could be obtained, one for the topical use of the drug and one for the injectable form of the drug. We have already come this far with the approved topical drug IND and it would be a shame to abandon it at this stage. Unless, of course, the company has some data showing that the drug does not in fact work so well topically in genital warts and has chosen to abandon or defer the study for that reason.