GeoVax starts injections for phase 2...

[Inchlingblue]

from my own anecdotal evidence, most of the people I know who were on AZT monotherapy, including myself, did not develop resistance to AZT; instead AZT was unable to adequately suppress the disease (ie did not adequately reduce the viral load). By only attacking HIV in one part of it's cycle, AZT did not affect enough HIV and HIV was able to continue replicating. It wasn't resistance to AZT, as much as AZT was unable to kill off enough of the rapidly reproducing HIV.

You really believe that NRTI monotherapy does not lead to resistance? If it did not happen in your case you were lucky.

The length of time for HIV to mutate around AZT can vary among individuals and many factors are involved, such as the person's viral load and the extent of immune damage but it will eventually happen (usually in a matter of months).

Keep in mind that resistance is not always "all or nothing.'' There are mutations that still allow some susceptibility to the drug and a mutated virus is usually less fit (i.e. less able to do as much damage). There is still resistance though and the virus will eventually win.

[leatherman]

You really believe that NRTI monotherapy does not lead to resistance? If it did not happen in your case you were lucky.

I don't know about all NRTIs but that quote I posted showed <33% of patients developed resistance to AZT. If the figure had been closer to 100% then there would be a lot fewer LTS around today. AZT monotherapy had more issues of toxicity than resistance. so yes, I believe (and at least this study has shown) that not all monotherapy leads to resistance. At least not for 66% of the people who take took AZT (had to change the tense there, as no one foolishly takes monotherapy anymore since HAART is so much more effective, and so less toxic)

[ElZorro]

I received the following reply from a Dr involved in the trial:

Thanks for your interest in our trial.  

Because of the many visits and close followup required, we are looking to enroll people who live in Atlanta area.  

There are 21 visits, including 4 vaccinations, in the first 32 weeks of the trial.
Then there are an additional dozen or more visits over the next 36 weeks.

We have not entirely excluded the possibility of enrolling people who live elsewhere, but it is a logistic challenge.  Any interest in re-locating to Atlanta for a while?

Also to know whether you might qualify, we would need evidence of seroconversion.  Did you have a negative HIV test followed by a positive within 6 months?  Otherwise, your labs look perfect.

Unfortunately, moving to Atlanta is probably not an option for me.

[Inchlingblue]

One thing I don't get about this GeoVax therapeutic trial (which I think I mentioned above in another post) is that they want people who seroconverted within the past year. Most people have a strong immune reaction to HIV and are able to control the virus for years without meds so how are they going to be able to parse what is an individual's innate immune response versus what effect GeoVax has since everyone is so recently infected?

It would make more sense if the trial was opened to others with HIV who have responded well to HAART, not only to those infected for less than a year.

I don't know about all NRTIs but that quote I posted showed <33% of patients developed resistance to AZT. If the figure had been closer to 100% then there would be a lot fewer LTS around today. AZT monotherapy had more issues of toxicity than resistance. so yes, I believe (and at least this study has shown) that not all monotherapy leads to resistance. At least not for 66% of the people who take took AZT (had to change the tense there, as no one foolishly takes monotherapy anymore since HAART is so much more effective, and so less toxic)

instead AZT was unable to adequately suppress the disease (ie did not adequately reduce the viral load). By only attacking HIV in one part of it's cycle, AZT did not affect enough HIV and HIV was able to continue replicating. It wasn't resistance to AZT, as much as AZT was unable to kill off enough of the rapidly reproducing HIV.

Eventually everyone in the study on AZT monotherapy would have developed high level resistance. You agree that AZT alone is not enough to fully suppress the virus. When the meds are not suppressing the virus to undetectable levels, resistance will eventually happen. This is how mutations work, when there is selective pressure exerted by just one drug (in the case of monotherapy) or by one drug over another (in the case of a failing triple-drug regimen, which is essentially the same as montherapy) so the virus is then able to mutate and replicate, becoming the predominant virus.
 
These are the conclusions to the study you cite:

These data clearly suggest that AZT alone is worse than the other three regimens as initial therapy, in the patient group studied in this trial.

So AZT alone was also worse than the other three regimens for those who had already taken AZT.

In the 90s AZT was a stopgap measure that did save some lives but, putting aside issues of toxicity, it has been proven scientifically that it does not work as monotherapy long term because it is not sufficient to suppress the virus which means that eventually resistance will occur.

HIV usually becomes resistant when it is not totally controlled by drugs someone is taking.

LINKS:

http://www.aids.org/factsheets/126-HIV-Resistance-Testing.html#anchor67077

http://www.aids.org/atn/a-231-04.html

Re: AZT
There is substantial scientific evidence and published guidelines that do not (recommend) monotherapy with this drug;

http://www.thebody.com/Forums/AIDS/Meds/Archive/FirstLine/Q123132.html

[leatherman]

HIV usually becomes resistant when it is not totally controlled by drugs someone is taking.

the thing is that we have been mostly agreeing here. Monotherapy, particularly the AZT kind, sucks. It's very toxic, often causes side effects, has sub-par effectiveness, and often results in resistance.

(But as some people took AZT for years without developing resistance, I don't believe that it is conclusive that AZT monotherapy MUST end in resistance. However, I believe that discussion is useless to continue as the data clearly shows that AZT monotherapy sucks canal water when compared to HAART and no one in their right mind has used AZT-mono in years, nor will they in the future.)

If you would take notice when I replied to Borzel, it was because he did not seem to fully understand the multi-drug approach in Atripla, or what actually causes resistance to develop - which is not "monotherapy" but "low levels of med(s) that allow the virus to mutate".

Resistance can happen with bad adherence to HAART (or out-n-out stopping HAART) as easily as it could happen to monotherapy.

I didn't realize that was why there are three drugs in the Atripla that I take (the doctor probably told me and I didn't listen or "get it").

Thanks for clarification. The way my doctor explained it to me - and this was in regard to stopping of medication completely (not missing doses)

[veritas]

Inch,

You said: "Most people have a strong immune reaction to HIV and are able to control the virus for years without meds so how are they going to be able to parse what is an individual's innate immune response versus what effect GeoVax has since everyone is so recently infected?"

I'll guess at this-------- I haven't researched this particular vaccine in any depth, but from little I understand for the purposes of the clinical trial (phase2), they want to give the vaccine every reasonable chance to succeed. With a vaccine that is effective, the viral load should go to ud along with maintenance of a strong immune system (probably cd4% in the 40-60 range among other indications) without HAART. By recruiting the newly seroconverted, they have a strong immune system to help the vaccine work. Then they will go to phase3, where inclusion criteria would probably be relaxed somewhat.
My two cents.

leatherman & Inch,

If it weren't for AZT, I wouldn't be here now. I did not become resistent to AZT,  the side effects  rendered it unusable for me.

v

[Inchlingblue]

 what actually causes resistance to develop - which is not "monotherapy" but "low levels of med(s) that allow the virus to mutate".
 

Low levels of meds do allow the virus to mutate but so does monotherapy (some boosted PIs being the only exception so far). That's the reason that the standard of care is to take three drugs. If monotherapy suppressed virus to undetectable levels we'd all be on it.

Mikie, when you say that AZT was not enough to fully suppress the virus that means there was at least some resistance. When you take one drug, say AZT as an example, if that drug is not suppressing viral load to undetectable levels that means there is resistance. It may not be full resistance, it could be partial resistance, in which the drug is still doing some suppression. If there were no resistance at all then the viral load would go to undetectable.
 
Those viruses that are still replicating despite the presence of the drug (or drugs) are the ones that have mutated around the drugs. Full resistance could take months and maybe even longer with some people but with monotherapy it will happen, guaranteed.

If it weren't for AZT, I wouldn't be here now. I did not become resistent to AZT,  the side effects  rendered it unusable for me.

v

AZT saved many lives (and killed many others). Did you take it alone, i.e., as monotherapy? If so, for how long? If you did for an appreciable length of time then chances are that some resistance must have developed. Maybe, as stated above, not full resistance, but it would be biologically impossible to take AZT for too long without the virus mutating to some degree. And if taken for long enough, it would lead to full resistance.


Re: monotherapy:

usually has only short-term benefits. And it has the primary effect of burning through all available antiviral drugs, helping the virus accumulate additional mutations that reduce the efficacy of any future regimen.

LINK:

http://www.thebody.com/content/art14371.html

[Miss Philicia]

Mikie was diagnosed around the same time I was, and by that time ddi (Videx) was available and AZT was already on the lower doses.  If he started treatment like I did then it wasn't monotherapy but rather dual-therapy of both those medications, but I won't speak for him -- just saying what was standard where I was living at the time.

And yes, I became resistant though without pulling out my genotype tests IIRC my NRTI stuff mostly shows "susceptible" to the entire class, with the exception of viread and emtriva.

[leatherman]

If he started treatment like I did then it wasn't monotherapy but rather dual-therapy of both those medications,

One of the bad things to getting diagnosed in a smaller city back in the earlier days of the epidemic was that it was next to impossible to find a doctor who knew anything about HIV, much less one that was up the on the latest treatment. (hey, when there's only one ID doc in town, you take what you can get LOL)

ddI hadn't even been on the market 6 months, so it  was monotherapy for me to begin with. That was 4 100mg pills every for 4 hrs, 24 hrs a day, for 9 months. Toxic side effects aside, the broken sleep was another awful side effect that doesn't get enough attention. Needless to say I still have quite an aversion to alarm clocks. LOL

Of course, in those days there wasn't such a creature as a viral load test, so all the doc and I had to go on was my tcell count (up from 5 to 125), red/white blood cells count (which showed the anemia in my case, not neutropenia), and how "well" I felt. At first, I did begin to feel "better" and had more energy. However after a while, the occasional barfing became a daily event - several times a day. Though the data showed the med was working for me, with all the puking I began to feel worse - much worse. Eventually I reached the end of my rope (and hope) and developed a 'quality of life' standard that I used with many of those earlier meds. When I realized that I was feeling worse than my partner, who really was quite literally dying, I decided that if I my remaining life was going to be one of throwing up multiple times a day every day, then I would rather just not take the med(s) and die.

Several genotype/phenotype tests throughout the years have proven that, even though my adherence to the AZT was hit-n-miss in the last couple of months before I just quit taking it altogether (against the advice of my doctor), my mutant virus is resistant to several things but not AZT.

And yes, I became resistant though without pulling out my genotype tests IIRC my NRTI stuff mostly shows "susceptible" to the entire class, with the exception of viread and emtriva.

speaking of emtriva, I was recently put on truvada and was worried due to an old genotype test that showed my mutant bug was resistant to epivir (which is very similar to emtriva). Instead I learned that the 184-186 mutations actually make the virus less fit. Eventually, given proper and sustained therapy the versions of this mutated virus can actually die off leaving you without this mutation, which makes those meds viable for therapy use once again. Ain't that cool? A resistance-causing mutation that mutates itself away making your virus not resistant any more.

[J.R.E.]

http://www.medicalnewstoday.com/articles/221740.php


GeoVax Labs HIV/AIDS Vaccine Development Leadership To Be Highlighted During 2011 World Vaccine Congress

Article Date: 08 Apr 2011 - 0:00 PDT



Harriet Robinson, Ph.D., Chief Scientific Officer at GeoVax Labs, Inc. (OTCQB/OTCBB: GOVX), will provide an update on the status of the Company's therapeutic and preventative HIV vaccines at the 2011 World Vaccine Conference at the Gaylord National Hotel and Convention Center in Washington DC on Thursday, April 14. Dr. Robinson's invited talk, which will run from 11:30 - 11:50 a.m., will cover the topic of recombinant viruses as vaccines. The talk will be followed by a Q&A session at 12:30 pm.

GeoVax has a multi-protein clade B HIV/AIDS vaccine in an open-label Phase 1/2 therapeutic trial and in a double-blinded, 300-participant Phase 2a preventative trial. The preventative trial is being conducted and supported by the US HIV Vaccine Trials Network (HVTN). The vaccine was developed in Dr. Robinson's former laboratory at the Emory Vaccine Center in collaboration with Dr. Bernard Moss's laboratory at the US National Institutes of Health and researchers at the US Centers for Disease Control and Prevention. Recently, the Company announced a 70% prevention rate in a non-human primate study using their GM-CSF co-expressing vaccine. This represents the highest successful prevention rate ever achieved in such a non-human model with a preventative vaccine for HIV.

Dr. Robinson, formerly Asa Griggs Candler Professor of Microbiology and Immunology at Emory University and Chief of the Division of Microbiology and Immunology at the Yerkes National Primate Research Center, is internationally recognized for her work on HIV/AIDS vaccines, her pioneering studies on the use of recombinant DNA for vaccination and her seminal studies on insertional mutagenesis and oncogene transduction in retroviral induced cancers. She received her Ph.D. from the Massachusetts Institute of Technology and her postdoctoral training at the Virus Laboratory, University of California Berkeley. Dr. Robinson is active on several editorial boards and has consulted for the US NIH, the US Food and Drug Administration, the World Health Organization, and the Gates Foundation.

The annual World Vaccine Conference, which attracted over 485 delegates in 2010, provides attendees with the opportunity to hear from North America's leading governmental stakeholders, business leaders and scientific stakeholders as they continue to enhance the scientific and strategic innovation behind a burgeoning vaccine industry.

Source: GeoVax Labs, Inc

[ppp333]

Sounds great...Would a therapeutic vaccine trial require individuals however to get off HAART to see if viremia can be controlled?  Also is there any chance that a therapeutic vaccine would also be a cure, and that the health T-Cells and other parts of the immune system would be trained to kill the infected cells even the ones sleeping or dormant with HIV.  I just wonder if you get off HAART and have a functional cure how much immune activation is going on to take care of the virus that now is active rather than using HAART to do the trick so there isnt so much inflammation and immune activation which can cause other bad things ie cancer etc. 

[Cosmicdancer]

I noticed that Geovax posted a press release on their website on Dec. 13 that they inoculated their first HIV positive patient with their therapeutic vaccine.  I don't recall how many people are enrolled in the Phase1/2 trial, but perhaps we may hear an update from the CROI conference in March.  They're still enrolling people in this trial at several sites.

http://www.geovax.com/newsroom/pr_th_13dec11.pdf

GeoVax Labs’ First Patient Inoculated in Phase 1/2 Clinical Trial
for HIV/AIDS Therapeutic Vaccine Important Milestone in Study of HIV-Infected Individuals Who Started Drug Treatment During Their First 18 Months of Infection
ATLANTA – December 13, 2011 – GeoVax Labs, Inc. (OTCQB/OTCBB: GOVX), an Atlanta-based biopharmaceutical firm (“the Company”) developing vaccines that prevent and fight Human Immunodeficiency Virus (HIV) infections, announced that the first patient has been inoculated in the Phase 1/2 clinical trial for the Company’s HIV/AIDS therapeutic vaccine.  This is the first study using
GeoVax Labs’ vaccines for the treatment of persons who are HIV infected.
The protocol for the Phase 1/2 clinical trial will carefully monitor safety while evaluating the ability of the vaccine to elicit protective immune responses in vaccinated participants.  The trial is based on the achievement of post-vaccine viral control in animal studies conducted in recently infected non-human
primates at the Yerkes National Primate Research Center, affiliated with Emory University.

Robert McNally, Ph.D., President and CEO of GeoVax Labs, stated, “Dosing the first study participant marks a major milestone for our Phase 1/2 clinical trial. We are pleased to  have the AIDS Research Consortium of Atlanta, the Alabama Vaccine Research Center at the University of Alabama, Birmingham, and the AIDS Research Alliance of Los Angeles participating in the trial.  These three trial sites are actively seeking persons who are interested in and fit the criteria for the study.”
To be eligible for the study, persons should have started drugs within 18 months of their last HIV negative test.  Persons who have been infected within the past 18 months, but not started drugs, are also eligible for recruitment into the study.  The first  participant was enrolled at the AIDS Research Consortium of Atlanta.

[ichigo_kun]

http://finance.yahoo.com/news/geovax-labs-presents-findings-potential-173000972.html
ATLANTA, March 7, 2012 /PRNewswire/ -- Harriet L. Robinson, Ph.D., Chief Scientific Officer at GeoVax Labs, Inc. (OTCQB/OTCBB: GOVX), a biotech company specializing in the development of HIV/AIDS vaccines, announced the results of a study suggesting that scientists may be one step closer to a vaccine that protects against multiple exposures to HIV infections. The study results were unveiled by Dr. Robinson during a presentation in Seattle at the 2012 Conference on Retroviruses and Opportunistic Infections (CROI).
Dr. Robinson, working alongside Rama Rao Amara, Ph.D., Associate Professor of Microbiology and Immunology, Yerkes National Primate Research Center, and member of the Emory Vaccine Center, tested a novel vaccine against HIV/AIDS for the ability to protect non-human primates against a series of 36 exposures to simian immunodeficiency virus (SIV) given in three clusters of 12 each over more than 2.5 years. The serial exposures were initiated using the SIVE660 virus that is genetically distinct from the vaccine, followed by exposure to SIV251, the most potent strain of SIV used in non-human primate studies.
The high protective activity of the vaccine is achieved by co-expressing granulocyte-macrophage colony-stimulating factor (GM-CSF) in the DNA vaccine used to prime the vaccine response. GM-CSF is a normal human protein that promotes the initiation of immune responses. By co-expressing GM-CSF and HIV proteins in the DNA vaccine, GM-CSF is present at the site of vaccination where it enhances the ability of the vaccine to elicit blocking antibodies for the virus. Blocking antibodies can stop a virus before it infects cells.
The vaccination regimen consisted of two DNA inoculations at months 0 and 2 to prime the vaccine response and then two booster inoculations at months 4 and 6. The booster vaccine was MVA, a recombinant poxvirus expressing HIV proteins. Six months after the last vaccination, both vaccinated and unvaccinated animals were exposed to a primate version of the HIV virus SIVE660 to see if the vaccine was protective. An 87% per exposure vaccine efficacy was achieved against a 1st series of 12 weekly exposures to SIVE660 with 5 out of 7 vaccinated animals being protected and none of the 9 animals in the unvaccinated group being protected. The 5 uninfected animals were rested for a year, boosted once with the MVA vaccine, rested for a half year and again exposed to 12 challenges with SIVE660. For this 2nd series of exposures, an 82% per exposure vaccine efficacy was achieved with 4 out of 5 animals being protected whereas unvaccinated animals had become infected. At this point the 4 uninfected animals were rested for 6 more months and then serially exposed to the highly potent SIV251 simian version of the HIV virus. For this last challenge, an 84% per exposure vaccine efficacy was achieved with 3 out of 4 animals not acquiring infection until the 11th or 12th challenge. Protected animals did occasionally show low indications of virus, but these were transient, seen at only one bleed, and appear to have represented locally controlled infections or false positives. No other HIV vaccine candidate currently in human clinical testing has achieved this level of preclinical success in non-human primates.
"Repeated virus challenges in animals are used to mimic sexual transmission," explained Dr. Robinson. "The hope is that the results in the non-human primate models will translate into vaccine-induced prevention of infection in humans."
"Excellent results like these give the industry hope that an effective HIV vaccine with long-lasting protection is not far from reality, and bolster our confidence that we are on the right track," says GeoVax's CEO, Dr. Robert McNally.
CROI is a scientifically focused meeting of the world's leading researchers working to understand, prevent, and treat HIV/AIDS and its complications. The goal of CROI is to provide a forum for translating laboratory and clinical research into progress against the AIDS epidemic. Over 4,000 leading researchers and clinicians from around the world convene in a different location each year for the conference.
The first generation GeoVax vaccine that does not co-express GM-CSF has shown excellent safety and reproducible vaccine responses in Phase 1 and Phase 2a clinical trials in over 400 uninfected people. These trials, supported and conducted by the U.S. National Institutes of Health HIV Vaccine Trials Network, set the stage for the 2nd generation GM-CSF co-expressing vaccine to move from its initial Phase 1 safety testing (slated to start in March of this year) to a Phase 2b efficacy trial in participants who are at high risk of exposure to HIV. The vaccine is designed for the "clade B" version of the HIV virus prevalent in the Americas. Since 1989, the United States, despite education and availability of drugs, has consistently suffered about 55,000 new infections per year. And according to a 2010 study by the U.S. Centers for Disease Control (CDC), of those individuals in the United States who are diagnosed with HIV, only 35% ultimately achieve viral load suppression through drug treatment. Thus, there is an obvious need for therapies to complement drug treatment.
About GeoVax Labs, Inc.
GeoVax is a biotechnology company developing human vaccines for diseases caused by HIV. Our goals include developing HIV/AIDS vaccines for global markets, overseeing the manufacture and testing of these vaccines under GMP/GLP conditions (FDA guidelines), conducting clinical trials for vaccine safety and effectiveness, and obtaining regulatory approvals to move the product forward. GeoVax's vaccines are unique in expressing virus like particles that display the trimeric membrane bound form of the HIV-1 envelope glycoprotein. All preventative Phase 1 human clinical trials conducted to date tested various combinations and doses of our DNA and MVA vaccines, their ability to raise anti-HIV humoral (antibody) and cellular (cytotoxic T cell) immune responses, as well as, the vaccines' safety. Successful results from Phase 1 testing supported Phase 2 testing in an ongoing, fully enrolled, 299 participant trial in North and South America . GeoVax is also enrolling volunteers in a Phase 1/2 therapeutic trial for individuals already infected with HIV. For more information, please visit www.geovax.com.

[Cosmicdancer]

Geovax provided an update on their therapeutic and preventative vaccine trials.  They should have preliminary results on the therapeutic vaccine trial with 9 HIV positive subjects later this year.  It involves a short treatment interruption.

GeoVax Reports Financial Results for the Second Quarter and First Half 2013 and Provides Clinical Development Update

8/12/2013
 
GeoVax Labs, Inc. (OTCQB: GOVX), a biotechnology company developing vaccines to prevent and treat HIV/AIDS, announced its financial results for the six months ended June 30, 2013 and provided a clinical development update.

Financial Review

GeoVax reported a net loss of $526,284 ($0.02 per share) for the three months ended June 30, 2013, compared to $497,763 ($0.03 per share) for the same period in 2012. For the six months ended June 30, 2013, the Company’s net loss was $1,223,081 ($0.06 per share) as compared to $1,228,276 ($0.07 per share) in 2012.

The Company reported revenues of $441,561 and $1,238,601 for the three-month and six-month periods of 2013, respectively, related to grants from the National Institutes of Health (NIH) in support of its HIV/AIDS vaccine development efforts. This compares to $705,698 and $1,559,761 of grant revenue reported for the comparable periods of 2012. As of June 30, 2013, there is approximately $1.8 million in unused grant funds remaining and available for use.

Research and development (R&D) expenses were $553,199 and $1,435,187 for the three-month and six- month periods of 2013, respectively, as compared to $712,416 and $1,784,770 for the comparable periods of 2012. R&D expenses include direct costs funded by NIH grants, as well as vaccine manufacturing costs and expenses related to the Phase 1 clinical trial of the Company’s therapeutic HIV vaccine. Costs associated with the ongoing Phase 1 clinical trial of GeoVax’s preventive HIV vaccine, being conducted by the HVTN, are funded directly by the NIH and are not reflected in GeoVax’s financial statements. General and administrative (G&A) expenses were $415,784 and $1,028,727 for the three-month and six-month periods of 2013, respectively, as compared to $492,316 and $1,005,134 for the comparable periods of 2012.

GeoVax reported cash balances of $1,881,393 at June 30, 2013, as compared to $1,035,925 at December 31, 2012. Summarized financial information is attached. Further information concerning the Company’s financial position and results of operations are included in its Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission.


Clinical Development Update

Therapeutic Vaccine Program

Phase 1 "Treatment Interruption" Trial - In 1H2013, GeoVax reported that patient enrollment for GV-TH-01, a Phase 1 “treatment interruption” clinical trial, was completed. The Company expects preliminary data in in the second half 2013, and should report final results and evaluation of trends in the first half 2014. The primary endpoint of this 9-patient study is to document the safety and immunogenicity of GeoVax’s vaccine in HIV-positive patients with well-controlled infections who are being treated with oral HIV medications. Following the vaccination series, the trial includes a short period of drug treatment interruption to evaluate the vaccine’s ability to control the infection in the absence of continuing drug therapy. The combined vaccination period, treatment interruption period and treatment reinstitution period for each patient is approximately 11 months.
Phase 1 "Combination" Trial - As previously disclosed, GeoVax has been in discussions with the International Maternal Pediatric Adolescent AIDS Clinical Trial
Group (IMPAACT) regarding a potential Phase 1 clinical trial investigating the treatment of HIV-positive young adults with GeoVax’s vaccine in combination with standard-of-care antiretroviral drug therapy. However, IMPAACT has recently conducted a review of its core resources in light of current budget constraints and has now informed GeoVax that it will be unable to support this trial with its available resources. This decision by IMPAACT has no effect on NIH’s support for GeoVax’s preventive vaccine program. GeoVax intends to explore other options for advancing and financing its vaccine + antiretrovirals therapeutic vaccine program.
Preventive Vaccine Program

Phase 1 HVTN Trial - Patient enrollment for HVTN094, a Phase 1 clinical trial testing the safety and immunogenicity of GeoVax’s second-generation vaccine, was completed in the first half 2013. This vaccine co-expresses granulocyte-macrophage colony-stimulating factor (GM-CSF) as an adjuvant and in non-human primate testing achieved a much higher level of prevention of infection than the Company’s first-generation unadjuvanted vaccine. HVTN094 is being conducted by the HIV Vaccine Trials Network (HVTN) with financial support from the NIH. This trial is ongoing and will be completed in 2013.

Phase 2 HVTN Trial - GeoVax is actively engaged in discussions with the HVTN regarding the design of a Phase 2 clinical trial of GeoVax’s second-generation preventive HIV vaccine. The Company expects trial initiation in 2014, following successful completion of HVTN094.

Robert McNally, PhD, GeoVax’s President and CEO, commented, “With the recent discontinuation of HVTN 505, a 2500-patient Phase 2b trial conducted by the National Institutes of Allergy and Infectious Disease (NIAID), our confidence in GeoVax’s vaccine technology has been strengthened. The vaccine studied in HVTN 505 used an adenovirus vector, or carrier, of genetic material from the HIV virus, similar to the vaccine used in the Merck trial (STEP/Phambili) that was halted in 2007. In contrast, GeoVax’s boosting vaccine uses a poxvirus vector (modified vaccine Ankara) which has been associated with clinical success. Our superb preclinical data and excellent safety profile give us reason to be enthusiastic about the prospects for our vaccine, which is now the leading preventive vaccine candidate for Clade B HIV.

“Our relationship with HVTN and NIAID continues to be strong,” Dr. McNally continued, “and we look forward to advancing our HIV vaccine to the next stage of clinical development with their guidance and support.”

View Financials (pdf)

About GeoVax Technology
GGeoVax’s unique, two component vaccine, a recombinant DNA and a recombinant modified vaccinia Ankara (MVA), is designed to stimulate both anti-HIV T cell and anti-HIV antibody immune responses. GeoVax’s DNA and MVA vaccines are used in a prime/boost protocol in which priming is done with the DNA and boosting with the MVA. Both the DNA and MVA express the three major proteins of the AIDS virus: Gag, Pol, and Env, and produce non-infectious virus-like-particles. GeoVax’s vaccines are unique in expressing virus-like particles that display the trimeric membrane bound form of the HIV-1 envelope glycoprotein. In GeoVax’s second generation vaccine, the DNA prime co-expresses GM-CSF with the virus-like particles, delivering a normal human protein that stimulates immune responses to the site of vaccination. All preventative Phase 1 human clinical trials conducted to date tested various combinations and doses of our DNA and MVA vaccines, their ability to raise anti-HIV humoral (antibody) and cellular (cytotoxic T cell) immune responses, as well as the vaccines’ safety.

About HIV/AIDS
AIDS can affect anyone, regardless of race, gender, age or sexual orientation. 33 million people are currently infected globally and it is estimated that there will be 2.5 million new infections this year. Since the beginning of the epidemic, over a million people in the U.S. have contracted the virus. Every 9½ minutes, someone in the U.S. is infected with AIDS. Globally, HIV is the top killer among women of reproductive age. HIV is a worldwide disease with different subtypes (or clades) of the virus predominating in different regions of the world. Clade B is the predominant subtype in North America. Globally, most infections involve Clades AG, B, and C. GeoVax most advanced vaccines under development are designed to function against Clade B.

For more information, please visit www.geovax.com.



http://www.geovax.com/news/financial/geovax-reports-financial-results-for-the-second-quarter-and-first-half-2013-and-provides-clinical-de.html

[NYCguy]

So does anyone know what's up with this?

http://clinicaltrials.gov/ct2/show/NCT01909414?term=p1082&rank=1

It seems that the therapeutic trial with the 'second gen' vaccine (the one using their much-trumped new adjuvant) has been scrapped.  Does this have something to do with as-yet unreleased results from the second-gen preventative trial?  This makes me nervous.  Any insight or further info would be great.