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Avatar universal

Email I received from AVI Bio Pharma

G'day, Ron:  While our trials continue, there are lots of paths which
are open and/or may develop.  We're not concerned about the "race", for
we're dealing with entirely different approaches to those, like Vertex,
using protease inhibitors or other technology.

Vertex is using a combo approach, in part, because they have to.  They
have a dose limiting aspect to their drug (in other words, toxicity
emerges with higher or prolonged doses), whereas we do not believe our
AVI-4065 will have that.  Perhaps they will get approval with the
combination, especially in non-responsive patients.  Yet we, too, could
experience a more rapid route in non-responsives if we show efficacy.
In both cases, that's because there are no other options for those who
are chronically-infected with HCV and are no longer responding to
either interferon or ribavirin.


But another indication that we do not, at present, believe will plague
us is mutation of the virus around our NeuGene approach.  That cannot
be said for many of the other approaches.


So, once more: While we recognize the market size and opportunity,
we're not as interested in the speed of our course as we are the
quality of the outcomes.  That stated, we are, however, moving as
quickly as we can at our clinical sites and are as anxious as anyone to
see the results.


I hope that this helps a bit.  Cheers, Michael


                                                           Ron

20 Responses
Avatar universal
letter said in part: Vertex is using a combo approach, in part, because they have to. They
have a dose limiting aspect to their drug (in other words, toxicity
emerges with higher or prolonged doses), whereas we do not believe our AVI-4065 will have that.
--------------------------------
Strange letter and to me not all that professional. Not saying it's wrong, but never read about Vertex having a toxity problem with their drug. Any documentation on this?

Also, my understanding is that Vertex is compelled to intially combine with Peg for a number of reasons, including FDA approval -- not because "they have to". Mono trials were of Vertex were still in the planning the last time I checked.
Avatar universal
Was a strange email.  Thats why I thought I would share it. I had not heard of the toxic aspect either.  I was disapointed that vertex was not doing their phase 11 with a mono leg. Sure wish these people were honest with us and not just trying to prop up their stock prices.

                                                      Ron
Avatar universal
I agree with NYgirl about what you read.  I wish some one would study the blood of those who cleared the virus on their own.  The answer may be in their blood.

Beagle
Avatar universal
Maybe it's just an "Aussie" thing. LOL. I was a bit taken aback because you'd never see that type of letter from an American drug company that knocks the compeition.

But let's give them the benefit of the doubt. If this is the "vaccine" approach I'm thinking about (not sure if it is) then potentially it is very exciting, but yet to be proved.

Still, wondering about this "toxicity" problem they're talking about. Every drug has a toxity problem at some level but never heard about it in the context of why Vertex was using combo threapy.

-- Jim
Avatar universal
I just hope their current trials aren't based on studies of crocodile blood.
Avatar universal
I hope your right, it would help all now and in the future.  God, just think how wonderful it would be.

Beagle
Avatar universal
From what I've read and heard, the reason Vertex is trying the combo approach is to ensure that mutations resistant to VX-950 do not emerge. In some of the blood studies on their patients they did in the early trials they found evidence of this possibility.

Resistance is a common problem with protease inhibitors and many have suspected this may happen. But hey, indications are that they can reduce the tx time to say 12 or 24 weeks with a much higher success rate. A vast improvement I would say.

I have no doubt in the future tx will be further improved upon. The knowledge gained from the study of HCV will no doubt help with other harmful viris.
Avatar universal
You know I think the info you can glean from a COMPETITOR might be more realistic than what is said in a press release - even if it's a big unprofessional to leak it out you know that Vertex is not going to as it would hurt its stock share price.

That is why it's good to hear what all fronts have to say about each of these drugs. You know they only market the "good" reports and not the bad. This is not a private company...it's public and therefore the money thing is a big deal.
Avatar universal
I think you nailed the monkey on the head - studying the blood of those who DID clear the virus on their own...how? why? there has to be a great answer in there somewhere.

I wish we had that blood to share with them!
Avatar universal
As I know personally how devastating the Interferon can be to vital organs - the news that Vertex at high doses or for prolonged periods can be toxic reminds me...that is why they do trials and get approval.

Putting any of these poisons into us is such a gamble...I agree it's better to WAIT until all of the unknowns are "known" and the success rate it high rather than they push out to market and find out a lot of people are injured in the interim.

I love that they seem to have conquered (hopefully) the mutation factor that in itself is such huge news.

Thank God we have a slow progressing disease...maybe in our lifetimes there WILL be an easier cure than Int/Riba.
Avatar universal
NEW YORK (AP) - Shares of Vertex Pharmaceuticals Inc. jumped Wednesday after an analyst upgraded the biotech firm citing upbeat views on a long-term mid-stage trial of the company's hepatitis C treatment, VX-950.

Piper Jaffray analyst Rachel L. McMinn upgraded Vertex to "Outperform" from "Market Perform" and boosted her target price to $42 from $38. She said in a client note she now expects the Phase II trial of VX-950 to include an additional patient group that will assess a longer-term dosing of the drug.

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The analyst had said in an earlier note said she "would be more comfortable with a trial that looked at 18 or 24 weeks of dosing" instead of the original 12 weeks, as the shorter treatment may not be as effective.

"In particular, we have been concerned that the 12-week design was driven more by the state of available animal toxicity data as opposed to a best clinical outcome for patients," she wrote.

The study is now expected to include a group receiving 24 weeks of treatment in addition to the original 12 weeks, the analyst said.

"We have learned that the Food and Drug Administration had actually approved the original 12-week protocol, and therefore assume this change was not driven by regulatory concerns," McMinn wrote. "Initial feedback from investigators is very positive on this design change."

Shares of the Cambridge, Mass., drug developer jumped $2.27, or 6.9 percent, to $34.97 in morning trading on the Nasdaq. In the past 52 weeks, the stock has changed hands between a low of $9.03 and a high of $44.71.

Vertex's gain sent the AMEX Biotechnology Index, a listing of 20 top biotech companies higher by $8.90 to $677.75.

McMinn wrote she expects VX-950 to "ultimately yield a very favorable clinical outcome."
                                                       Ron
Avatar universal
Just think how great that would be if they the cure in the blood of those who cleared on their own.

In case you didn't catch my post today.  My Dr. called and gave me the green light for me to go to the hospital when ever I felt my HGB dropped more.  I will try to hold out as long as I can so the new blood will take me to the end of tx.

I feel good hearing this and know now I will be able to do full meds to the end.

Beagle
Avatar universal
This may be what AVI was talking about.

In particular, we have been concerned that the 12-week design was driven more by the state of available animal toxicity data as opposed to a best clinical outcome for patients," she wrote.

The study is now expected to include a group receiving 24 weeks of treatment in addition to the original 12 weeks, the analyst said.


                                                          Ron
92903 tn?1309904711
<i>From what I've read and heard, the reason Vertex is trying the combo approach is to ensure that mutations resistant to VX-950 do not emerge. In some of the blood studies on their patients they did in the early trials they found evidence of this possibility. </i>

If I recall from the webcast/conference call reviewing phase 1 results, there was a bloom in a particular quasi-species at lower dosing protocols. The bloom was not seen at optimum dose levels.

Vertex reports this wasn't really a mutation, but rather a single quasi-species that was less reponsive to VX-950 at the lower dose, hence that quasi-species gained dominance as other more succeptible quasi-species were eradicated. Vertex noted that the quasi-species in question was particularly responsive to interferon therapy - which may help expain the 1-2 punch.  

Again just from my recollection, phase 2 will implement a new delivery mechanisim (pill vs suspension) that is expected to double the amount of drug actually delievered into the 'battle zone'. Can't remember whether that's doubled serum concentrations or not - and if toxicity isuues do exist, that might not prove viable.
Avatar universal
there ARE some studies been conducted on the subject you mentioned. I know of at least One in the Hepatitis C center in NYC, that collected the blood of SVRs, spontaneously cleared SVRs and still HCV infected subjects. That was a year or so ago. A friend from MH was contacted to "donate" her blood. It was around that time I suggested that one of our members here, Jamie, contacted the center to offer her blood. She cleared both hep b and hep c on her own. They never responded to her, though. I don't know who they finally chose, but I felt Jamie was a great candidate to study.
I think I read somewhere about another such research going on.
If I remember correctly, the conference in SFO last yr, had a presentation on the changes that occured in the blood of SVRs, both the spontaneous and the ones that treated. They found differing immune system changes in the groups. Maybe someone will find the link.
it is getting nice on LI, finally!
Avatar universal
I agree, Jamie would have been the best one for the study as Jamie took no meds.  
I know it's starting to get nice hee in NY, just got back Monday.  How are you doing?

Beagle
Avatar universal
shh! gaining wt from not enough physical activity, other than mandibular! But ok, otherwise!
I admire how far you have made it in your tx with all the anemia problems, you have some system! I am pleased that your body is cooperating with your battle against hcv.
This time next yr, you will helping the new members and encouraging them to join you in the svr club.
stay well
Avatar universal
Thanks, I had just answered your question in the above thread.

Beagle
Avatar universal
Hiya Jim !

I agree with you on your point--it is a rather unprofessional letter. And certainly not very informative.

Vertex chose to combo their drug. It wasn't a requirement. They chose to do so well before the discovery that higher dosing led to problems. The early data I've seen shows that viral clearance has been just about as effective with the high and medium dose as with the lowest at this point in the trials. SVR rates of course are yet to be known. PI have had their share of problems in the past. The shorter the tx the better is the consensus. Bundling makes sense given that fact. Hope all is well Jim.

Best regards,
PK
Avatar universal
I am a little familiar with AVI Biopharma and am posting the link to their trial site:

http://www.clinicaltrials.gov/ct/show/NCT00229749?order=2

With their drug approach, they have had no major adverse effects in over 250 patients treated for a variety of single stranded viruses.  The e-mail sent from Michael was not a put down of Vertex, he was simply stating facts.  VX-950 has had toxicity issues as can be seen in recent articles.  He wasn't sayng they wouldn't work that out.  He only stated that AVI's approach is totally different.  They use a genetic approach programmed to the specific virus using a synthetic backbone for delivery.  This is even very different than the 1st and 2nd generation antisense technologies.  Their preliminary trial results were very promising and i hope whether AVI, Vertex or somebody else, that a reasonable TX is found soon!
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