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olddogwithnewtrix

05/10/12 2:16 PM

#141733 RE: DewDiligence #141724

it is doable in a small percentage of the population, but their T-cells are basically half why there and just need a little push.

It might be just a matter of time (5-10 years) before they figure out how to do it for most or all of the hiv population.

http://www.aidsmeds.com/articles/hiv_gene_therapy_1667_22347.shtml


April 25, 2012
Report Outlines HIV Cure Research, Important Gaps
by Tim Horn
Three HIV/AIDS activist groups convened a meeting in March with
researchers and representatives of the U.S. Food and Drug
Administration (FDA) to describe the current state of cure research and
identify barriers to moving such research forward swiftly and smoothly.
The proceedings of this meeting, which took place immediately before
the 19th Conference on Retroviruses and Opportunistic Infections
(CROI) that began on March 5 in Seattle, are now available in a report
online.
“A cure for HIV will be essential to ending the AIDS pandemic, but
science that is focused directly on a cure is still in early stages and will
likely require the support of multiple stakeholders to proceed at the
fastest pace,” reads the executive summary of the report, authored by
David Evans, Kevin Fisher, Jeff Taylor and Siegfried Schwarze.
In the past four years, the report notes, there have been signs of
increasing scientific momentum and funding directed toward curing HIV
infection.
The remarkable case of “Berlin Patient” Timothy Brown—a man who all
signs suggest has been cured of HIV—has catalyzed and expanded
what was once a small and somewhat fragmented effort to understand
how HIV persists despite effective antiretroviral (ARV) therapy and to
explore mechanisms to eliminate the hidden pool of virus in people on
ARV treatment (a sterilizing cure) or to enable the immune system to
control HIV without the need for ARVs (a functional cure).
This momentum, the activists write, has been greatly enhanced by the
NIH-funded Martin Delaney Collaboratory projects, partnerships
between academia and industry focused on the possibility of
discovering and developing a safe, effective, feasible and scalable HIV
cure.
Among recent signs of progress, researchers have contributed new
insights into where and why HIV persists despite potent ARV therapy.
In addition, the first controlled clinical trials of drugs to activate cells
harboring archived HIV, such as histone deacetylase (HDAC) inhibitors,
are yielding promising signals, and other types of treatments designed
to teach the immune system to either clear or control the virus on its
own have been initiated.
But central questions remain, the report stresses.
For example, it is still not clear what types of cells and anatomical
compartments harbor HIV, nor is it understood which methods work
best for measuring the latent virus in these reservoirs. Knowledge
regarding how HIV is able to replenish these reservoirs, even when
ARVs with “maximally suppressive” effects on viral load are being used
consistently and correctly, is also needed. Actually, it’s not entirely clear
if modern ARV therapy is, in fact, fully suppressing HIV replication. And
does the immune system play a role in HIV persistence? In addition,
what are the forms of immunologic HIV control that can potentially be
enhanced without major safety issues?
Finally, the report asks, what are “reasonable” risks for the people
living with HIV who will be participating in early—and potentially
dangerous—studies, and how can these individuals be best protected?
To address these questions, members of the AIDS Treatment Activists

Coalition (ATAC), the Treatment Action Group (TAG) and Project Inform
sat down with several industry and academic researchers on March 4
in Seattle, who described their current projects, outlined the obstacles
and facilitators to cure research and offered suggestions for the kinds
of activities that community advocates might undertake to overcome
current obstacles.
Highlights include: an overview of AIDS Clinical Trials Group (ACTG)
clinical trial development by Dan Kuritzkes, MD; laboratory testing for
new compounds, including work being conducted by Romas
Geleziunas, PhD, at Gilead Sciences; the prospects of gene therapy,
notably ongoing zinc finger nuclease work at Sangamo Biosciences,
discussed by Dale Ando, MD; stem cell research after the Berlin
Patient, highlighted by John Zaia, MD, who underscored the importance
of not overselling this approach; and work focusing on the enhancement
of immune responses, reviewed by Pablo Tebas, MD.
The post-meeting report, issued in April, provides a brief synopsis of
each presentation, followed by an outline of areas identified by the
workshop speakers and participants for further exploration,
development and incorporation into a cure advocacy agenda.
“The prevailing view of all the speakers was that we must not raise
premature and unrealistic hopes of a cure for HIV either in people who
volunteer their bodies for cure research, or in the wider community of
people with HIV and their allies,” the authors write. “Critical early steps
have been identified, but we need many more successes in analytics,
basic science and translational research—in both animals and people
—before the cure will be within our grasp.”
Search: cure, research, science, advocacy, activism, treatment action group,
tag, aids treatment activists coalition, atac, project inform, gene therapy,
immune-based therapy, stem cells, therapeutic vaccines
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jellybean

05/10/12 7:12 PM

#141750 RE: DewDiligence #141724

Personally, I think that this is a matter of how to make the system work as proof of concept has occurred. Here are some hard facts that i find relevant to judging this product..

1. only one person has ever been cured of AIDS, meaning that they are virus free without a daily regimen of drugs. That is the Berlin patient who received a bone marrow transplant for Leukemia from a donor that was homozygous for a deletion at amino acid 32 in the CCR5 gene.

2. People who are homozygous for the delta 32 CCR5 mutation do not get AIDs even though they are exposed to HIV and have antibodies to the virus.

3. Clinical trials have looked at what happens when AIDs patients go on 12 week holidays from antiretroviral drugs. On average, during the first 8 weeks of HAART holiday cd4 counts are cut in half and viral load increases on average 3.5 log10.

4. To date SGMO has used their product to alter the cd4+ T cells of 21 AIDS patients. The first 15 were used for safety studies and the data from those show that rhe treatment is safe beyond 2 years now, that the T cells survive and circulate throughout the body including the gut mucosa and that the altered T-cells respond to immune challenges. T cells have been shown to survive anywherer from 1year to >10 years in the body.

5. Six of the 21 treated patients have undergone a 12 week HAART holiday. All patients showed an initial jump in VL, although the timing was delayed compared to historical data. Four of these patients had decreasing viral load starting at week 8-9 and one patients viral dropped to undetectable levels by week 12. The protocol required the patient to return to therapy and be followed for several years.

6. The single patient with undetectable VL was a heterozygote for the delta 32 CCR 5 mutation. Viral load decrease was directly proportional to the number of T-cells that had 2 copies of the delta 32 CCR5 mutation.