Vacc-4x Makes come back

[sam66]

       Bionor Pharma reverses decision to put Vacc-4x on hold
  
      After further analyses of the international, randomized, double-blind, placebo-controlled multi-center phase IIb study of Bionor Pharma's therapeutic HIV-vaccine candidate, Vacc-4x, the Company reports an unexpected statistically significant reduction in viral load (amount of HIV virus) at the end of the study period for patients on the vaccine compared to the placebo group.

        Due to the new findings, the Company has reversed its decision to stop development of Vacc-4x. Along with upcoming immunological data, these findings are expected to become the basis for the future positioning of Vacc-4x as a viable therapeutic HIV-vaccine.

     “These follow up findings on viral load reduction in the Vacc-4x arm compared to placebo are positive and very encouraging,” said Professor Dr. med. Jürgen Rockstroh, Oberarzt an der Medizinischen Universitätsklinik, Innere-Rheuma-Tropen Ambulanz, Bonn, Germany. “It is therefore important in follow on studies to investigate whether Vacc-4x in combination with ART could reduce the viral set-point and allow extended periods without HIV medicine.”

         http://www.bionorpharma.com/en/Vaccines.9UFRzK58.ips

     I sure hopes this will make it to the finish line  

  sam

[sam66]

  
   Background infomation on vacc-4x  from BBC news report Aug 2008

   "Scientists are testing a vaccine designed to give HIV patients a prolonged break from their regular medication without side effects.

   The vaccine works by stimulating an immune system response, in contrast to standard HIV drugs, which block replication of the virus.

  It has already been tested in two small trials on 11 and 38 HIV patients with promising results.

The majority of patients were able to refrain from taking their usual antiretroviral therapy (ART) for an average period of 31 months.

During this time their level of key infection-fighting CD4+ cells remained high above the level they had before they started taking ART.

At a follow up 44 months after treatment interruption, 34% of the patients were still not back on ART.

Some patients were still off ART five years after the trial was completed."

       http://news.bbc.co.uk/1/hi/health/7541735.stm      ( Aug 2008 )

[wtfimpoz]

EDIT:  I think i answered my own question.  Shoulda read more closely.  Sorry everyone.

[ElZorro]

At a follow up 44 months after treatment interruption, 34% of the patients were still not back on ART.

Some patients were still off ART five years after the trial was completed."

excellent news! Thanks for posting!

[sam66]

      

                      
                                    Clinical Development of Vacc-4x   since 1999

          Phase I – Safety: 11 chronically HIV-infected subjects enrolled at Haukeland University Hospital in 1999 - no serious adverse events occurred.

          Phase IIa - Drug Holiday:  40 chronically HIV-infected subjects enrolled in a single center, open-label study at Oslo University Hospital in 2002.

          Phase IIa - Re-vaccination study: Baseline blood data from 26 subjects from the original phase IIa study conducted in 2002/03 were analyzed showing at least seven years memory and T-cell killing activity in approx. 50% of the patients.

           Phase IIb - Drug Holiday: A randomized, double-blind, placebo-controlled, international multi- center phase IIb clinical study in 135 HIV-positive subjects who were clinically stable on ART.

            http://www.bionorpharma.com/en/Vaccines/HIV_Vacc-4x_Development/


       I hope vacc-4x manage to overcome political hurdles, they have managed most of the medical ones.

[mhs22]

Vacc-4x is one of the most mature therapeutic vaccines in development. 
AIDS treatment activists don't pay enough attention to therapeutic vaccines because the companies in this space have historically been somewhat horrific.  The controversies surrounding the statistical analysis of Remune and management of the Immune Response Corporation and the debacle that GeoVax has become, which seems to be the preferred company for the current management of Bionor Pharma, are disheartening for those of us dependent on a therapeutic vaccine in the near future due to drug resistance from extensive treatment experience.
Tony Fauci's proclamation at the XVIII International AIDS Conference that a therapeutic vaccine will follow a preventative vaccine is absurd.  There is no scientific precedent for this, and the economic model is without rationale.  Who is going to invest in therapeutic vaccine development when a preventive vaccine would halt new infections and the vast majority of patients globally who are not receiving HAART via PEPFAR, The Global Fund, etc. can't afford currently available vaccines without extraordinary public health measures.  Polio is the perfect example of this- we have still not eradicated polio due to a lack of investment in developing a cure since a preventive vaccine became available.
Against reason, some of us continue to hope Bionor will turn around.  Does anyone know who is on their alleged CAB?  I can't find any information on the web.

[wonderful1]

Hello mhs22,

If I am reading it correctly your statement is mixed with both cynicism and hopefulness. The questioning of the companies involved are valid for sure. Please allow me to inject some practicality. Firstly, there is no precedence for HIV period let alone scientific precedence. HIV has, since it's "discovery", been quite the exception in all facets of research and development and global out cry for a treatment and a cure.

There are few viruses, including Polio, that once contracted requires a life long adherence to medicinal therapy to stay alive. It is true that there are no "cures" to almost all viruses I am aware of except for Hep C in some cases. The sheer cost to keep people with HIV alive with only everyday, life long drugs is a huge economic drain that usurps any previous precedence as well as the companies involved. The idea of a therapeutic vaccine that can be used to halt the advancement of HIV for several years at a time in an infected person can not be held back by economic or business models even if we were to assume those models have no rationale. However they do hold rationale. There is no doubt that the race is on for both a therapeutic and preventative vaccine and that there is a viable ROI and economic rationale behind both as well as it is the only humane alternative. If a preventative vaccine is found to stave off HIV in infective individuals, well then, that cat will have no way of staying in the bag! And I will defer to two of several arguments for that:

1- http://www.technologyreview.com/biomedicine/25563/
"Douglas Richman, a virologist at the University of California, San Diego, who has cared for HIV-infected people for years, now has patients who have kept the virus completely in check with drugs for up to 17 years. "They're going to outlive me," says Richman, who is 67 years old. "They're not going to die of AIDS. That's wonderful, but do we have to have tens of millions of people on lifetime treatment?"
Such treatment has rising costs, both monetary and medical. In wealthy countries, annual drug expenses run into the thousands of dollars per HIV-infected person. Much cheaper generic versions of the drugs have been given to four million patients in poor countries, but the rich governments footing most of that bill are now cash-strapped and worried about sustaining the charity. And an estimated five and a half million more people urgently need treatment but have no access.
What's more, living with HIV for decades can be medically problematic. Even low levels of the virus can leave patients more susceptible to diseases of aging: heart attacks, malignancies, disorders of the central nervous system. Some of these ailments are side effects of the drugs themselves. People on treatment can have damaging surges of virus, too, when they occasionally stop their drugs or develop resistance to the compounds. "There are five million new infections a year, and three million deaths," says Richman. "So we're just going to have more and more people living with HIV."

2 - By Martin Delaney "Another thing typically overlooked is the lifetime cost of treatment which currently averages between $12,000-$25,000 a year for relatively healthy people with HIV, and much more for those in advanced stages of disease. While these costs have been met in the short-term, we're only beginning to look at the lifetime costs of being on regimens for up to 50 years. It's simple: do the math! And what about the developing world, where roughly 90% of the world's cases of HIV occur? Despite massive infusions of money, and despite reducing the costs of drugs to virtually that of their raw materials, efforts still only reach a modest percentage of the people worldwide who need treatment.

The US committed more than $15 billion to HIV treatment in developing countries over the last five years through the PEPFAR program. The World Health Organization, Global AIDS Fund, Clinton Foundation and many smaller groups along with support programs from the pharmaceutical industry have made enormous additional contributions. The reach is still too small and the amount of money needed must be increased many times over to reach even the most vulnerable parts of the infected population.

It has long been hoped that this would only be temporary; that we would have a vaccine and the numbers of people infected each year would finally begin to drop. Sad to say, but the search for a vaccine hit a wall in the last year. In many ways, we may now be no closer to a vaccine than we were 20 years ago. Some of the most prominent scientists in the world are warning us that a vaccine may never be possible due to HIV's unique properties.

At the very least, if there is to be an HIV vaccine, we currently have no idea how to make one. Similarly, great hope was invested in using microbicides -- gel-like compounds applied to the areas of sexual contact that hopefully block HIV infection. But so far these have proven about as effective as vaccines, which is to say "not at all."

Thus, when we take a sober look at the fight against HIV in the developing world, the prospects of lifetime therapy don't look so good either. First, the expenditures by wealthier nations will have to drastically increase, and then these sums must be sustained for the next 50-100 years, assuming there's no vaccine in the near future. We must ask: how likely will developed nations continue this level of support for as long as it's needed?

Sadly, the answer is not very likely. For one, there's little precedent for sustained medical effort in developing nations, let alone one as expensive, difficult and lasting as fighting HIV is. Secondly, the costs are so large they may not be sustainable at all. Even the great private funds like that of Warren Buffet will be bankrupted over time by this fight.

In short, lifetime therapy is not a realistic solution for HIV disease even in the US and Europe let alone the developing world. The situation can only worsen if unexpected long-term side effects appear over time.

It should be abundantly clear: the only way to effectively conquer the epidemic is to cure the disease. We cannot coddle the virus with a lifetime of drugs. People with HIV should be enormously grateful to all those who have contributed to developing the drugs we have today. Millions more would have died without them. But their utility is limited and they're not a true long-term solution. The goal of fighting HIV for the first 25 years was to create and distribute effective anti-HIV drugs. The goal of the coming years must be to get people OFF the drugs and back to a state of normal health."

Best to you..

[John2038]

refrain from taking their usual antiretroviral therapy (ART)  ?

[mbpoz6]

Any news on when the next phase is or whats next for this vaccine? It seems very promising....

For the patients to stay off meds for 31 months is remarkable! I wish the article would be more specific on the viral load info, (if it was undetectable, <500, etc.). Hopefully they can speed things up. I can't seem to find any recent information anywhere.

[sam66]

   An article by Jeannie Gibbs on A&U Magazine
     
   "If therapeutic vaccines such as Vacc-4x and AGS-004 (a promising Phase IIa HIV therapeutic vaccine made by Argos Pharmaceuticals) continue to show the benefits they have thus far, it may be possible to significantly decrease the need for HIV antiretrovirals, postponing treatment, and/or reducing the amount of time spent on HAART. The benefits of this would be enormous in many aspects."

       http://aumag.org/wordpress/?p=1319