HIV breakthrough: European Vaccine enter in Phase I

[John2038]

HIV/AIDS Preventive Vaccine Of Mymetics: Green Light From EU To Start Phase I Human Clinical Study

Mymetics Corporation (OTCBB: MYMX) announces the confirmed success of its preventive vaccine against HIV/AIDS. To this day, these results are the most promising and advanced in the world. They confirm a decisive breakthrough in the HIV/AIDS prevention. To such an extent that European authorities have just authorized the launch of the Phase I human clinical study.

On February 10th, in Montreal, for the 16th Conference on Retroviruses and Opportunistic Infections (CROI), Dr. Sylvain Fleury, Mymetics' Scientific Chief Officer, has presented the results of a second round of preclinical tests, which confirm the success of its preventive HIV/AIDS vaccine.

It is now known that some individuals are naturally resistant to the infection from HIV/AIDS virus, despite a high degree of exposure to this virus, in particular during non protected sexual activities (notably prostitutes in Kenya and Cambodia). Those rare individuals have been identified 20 years ago from diverse populations with different ethnic backgrounds. Despite their high exposure to the virus with different HIV positive individuals, these prostitutes for example, stay HIV negative. The explanation for this natural resistance is the presence, in vaginal secretions of women - or rectal secretions of men - of specific IgA antibodies. Replicating this natural protection, Mymetics' preventive vaccine formulation induces IgA antibodies at the mucosal level, rather than IgG antibodies circulating in the blood.

Thus, Mymetics' preventive vaccine is based on an approach targeting specifically IgA antibodies, whereas all other vaccine projects have opted to target IgG antibodies, or specific cytotoxic cells against the HIV virus. This innovative approach, with mucosal antibodies rather than blood antibodies, explains Mymetics' success compared with the deceptions met by other laboratories, since its vaccine stimulates defence mechanisms blocking the virus entry at the mucosal level, the first entrance door of the virus.

In the last step of the preclinical trials, Mymetics has done a viral challenge with macaques, the species closest to humans when it comes to the development of the pathology. One group is vaccinated and the other one is the control group. Both groups then receive numerous doses of the virus to test the vaccine's efficacy.

Mymetics viral challenge results in Beijing have proven excellent. The vaccinated group is almost completely resistant to the virus and the non vaccinated control group is completely infected. The results obtained with the Institute of Laboratory Animal Science (ILAS) of the Chinese Academy of Sciences were checked (blind test) by an independent lab, the Center for Diseases Control (CDC) of Beijing with the same final outstanding results, using a measuring technique 5 times more sensitive, corresponding to the occidental standards.

On the basis of these results and the excellence of the project, the Belgian Ministry of Health, in the name of European authorities, has authorized (in 16 days) launching the Phase I human clinical study.

What is more, so as to block possible critics, in particular the small number of animals used in the two test groups, Mymetics has presented those extremely promising results to Dr. Chris Miller, of the University of California, whose preclinical research centre on macaques is considered by the scientific community one of the best. Dr. Miller is one of the very few who has already developed a vaccine approach at the mucosal level. Having qualified Mymetics' results as excellent he has confirmed his interest for a joint collaboration, notably for new studies on groups of macaques. These results are unique in the world, and puts Mymetics clearly in a leading position in targeting neutralizing antibodies at the mucosal level versus the approach of most other laboratories which focus on blood antibodies. The goal of the repetitive study that Mymetics plans to do with Dr. Miller is to transform stable results in indisputable results, to be able, at last, to accelerate clinical tests on humans. Because HIV/AIDS prevention is a real issue at world level which calls for an urgent mobilisation.

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[sensual1973]

and how would that help the "already infected" if this vaccine is one day discovered ?

[Ann]

and how would that help the "already infected" if this vaccine is one day discovered ?

By stopping additional infections, the burden on existing services for people with existing infections will be lessened. This will benefit us enormously.

Also, many developing countries infrastructures are falling apart as people of workforce age sicken and die. Positive people need these infrastructures just as much - if not sometimes more - then hiv negative people do.

And that's only two reasons.

Ann

[Inchlingblue]

Innovation and invention in general and especially when it comes to biotechnology are fueled by the prospect of large profits. A preventive vaccine would not only be amazing and wonderful for all of humanity not infected with HIV but the technologies of a preventive vaccine may also lead to better strategies in therapeutic vaccines. That said, there is a legitimate concern that if a preventive vaccine were successfully developed, it could lead to little or no incentive for finding a cure or even for finding better therapeutic options, since the HIV "market" would no longer be a "growth market,' from the point of view of private investors.

[sensual1973]

i personally and as an hiv poz myself wish to see a therapeutic vaccine first,because i know if a preventive vaccine is found we will be left to deal with our hiv with meds only,as we wouldnt be a great source of income to the pharma companies in such a scenario.

[a2z]

i personally and as an hiv poz myself wish to see a therapeutic vaccine first,because i know if a preventive vaccine is found we will be left to deal with our hiv with meds only,as we wouldnt be a great source of income to the pharma companies in such a scenario.

I sometimes share this thought myself, but really the bigger picture is that no one else should have to suffer through this crap.   

Also I think there is enough people in this world who are infected that we will still be a "lucrative market" for quite some time to come.

[freewillie99]

i personally and as an hiv poz myself wish to see a therapeutic vaccine first,because i know if a preventive vaccine is found we will be left to deal with our hiv with meds only,as we wouldnt be a great source of income to the pharma companies in such a scenario.

You guys need to remember that, generally speaking, Big Pharma isn't in the "cure" business.  They're in the treatment business.  A cure, functional or otherwise, is much more likely to come from academia or one of the non profits like the Hughes Foundation, City of Hope, or CHAVI.  Personally, my money's on something related to Gates Foundation funding.

[Inchlingblue]

You guys need to remember that, generally speaking, Big Pharma isn't in the "cure" business.  They're in the treatment business.  A cure, functional or otherwise, is much more likely to come from academia or one of the non profits like the Hughes Foundation, City of Hope, or CHAVI.  Personally, my money's on something related to Gates Foundation funding.

I wasn't referring to "Big Pharma," per se. There are competitors (or wannabe competitors to Big Pharma) that are developing other treatment strategies that can maybe result in a cure. Of course, most of them eventually want to be so successful that they are eventually bought out by Big Pharma. If a preventive vaccine were developed, it wouldn't be a stretch to assume that there would be less incentive for these biotech firms to pursue these better treatments but I think a2z has a point when he says that he thinks HIV will still be lucrative for years to come despite a preventive vaccine being developed, he just may be right (and I hope he is). You do make an excellent point, though, Freewillie, that there are other, non-profit-based entities that are also working on better treatment options. This is an example of the type of (for-profit) company I mean:

bizjournals

As others come up dry, Virxsys hauls in $26M
For a biotech company in this ravaged economy, trying to raise $35 million by the fall seems like a goal that goes beyond naivete and borders on lunacy.

Except when you are already three-fourths of the way there.

Gaithersburg-based Virxsys Corp., which is working on an HIV treatment, has received $26 million so far this year in cash or commitments during a capital market that has been nothing short of a ghost town.

That has left biotechs, some of the riskiest businesses for investors, stranded and starving for money.

But Virxsys is closing in on its final clinical tests for an HIV treatment that causes the virus to essentially commit suicide in a patient’s body. Virxsys hopes that makes it a safer bet as the company tries to persuade longtime angel investors to toss in $9 million more this year.


“We’re in fairly good shape right now,” said Riku Rautsola, the chief executive officer. “But it’s not easy, I tell you.”

Virxsys’ 10-year total has now reached $105 million, including $10 million last year and $5 million thus far this year from Signature Capital Securities LLP, a Naples, Fla.-based network of angel and private equity investors that has been Virxsys’ primary financier. The company also signed commitments with an undisclosed German hedge fund to add $21 million in the next six months.

Virxsys opened this latest financing round, its eighth, before the slow economy turned into a full-blown recession. Originally the privately held company was seeking $25 million but has upped that goal to $35 million to tide it over for a longer time.

The cash will be used to help pay the remaining bills on two sets of second-phase clinical trials for the HIV treatment.

Virxsys plans to embark soon on the last tests required for potential federal approval of the treatment. Like many other local biotechs, it is on the hunt for large partners to help finance those final trials and, longer term, launch an approved product.

Under the Virxsys treatment regimen, HIV patients get an infusion once a year, and biological deliverymen called lentiviral vectors carry new gene sequences to white blood cells, the foot soldiers of the body’s immune system army.

Those gene sequences, engineered to be exactly the opposite of the HIV cell sequences, work to cancel the virus, taking particular aim at the protein that HIV uses to bind itself to white blood cells and spread in a patient’s body.

Although the process doesn’t kill HIV, it disables the virus while bolstering the patient’s white blood cell count.

“We are breaking the cycle of infection,” said Gary McGarrity, Virxsys executive vice president of scientific and clinical affairs. “When we look at the virus, we are seeing it’s highly mutated and has much, much, much less capacity to do anything.”

Virxsys’ model is a combination of its own research and that of Intronn Inc., a local biotech that McGarrity once led and Virxsys acquired in 2007.

That approach is rare biological route to healing patients who now must swallow a chemical cocktail of drugs every day.

“If this one passes a Phase 2 test, it would lay down important groundwork for the next round of new technologies,” said Baek Kim, an associate professor of microbiology and immunology and HIV specialist at the University of Rochester Medical Center. “This is definitely scientifically important.”

And financially important to Virxsys, which hopes this year’s fundraising round is the last it needs.

Good clinical results mean better chances for a potential initial public offering when the markets recover in the next three years, and, ultimately, a profitable sale of the 67-person company.

“The question is when is the right time,” Rautsola said. “This will end up being a platform technology within a big pharma company in the next five to seven years.”

[freewillie99]

There are competitors (or wannabe competitors to Big Pharma) that are developing other treatment strategies that can maybe result in a cure.

My point stands.  If you're anticipating Big Pharma is going to step up to the plate with a cure for HIV you're most likely going to be waiting a long, long time.

Btw, as interesting as I find the work Vrxsys is doing, I've yet to read anyone, Virxsys included, make the claim that their work is going to lead to anything more than a potential therapy.

[bmancanfly]

It would be interesting to see how much funding went into "curing" those already infected with Polio after Jonas Salk invented the preventative vaccine.  I bet not much.

An HIV preventative vaccine would be great news for humanity,  but aweful news for anyone already infected.

The only reason this country funds HIV care is because there is a fear that the disease might spread to "their" community if left totally untreated.  Remove that potential threat and say bye-bye the HIV funding.

[John2038]

and how would that help the "already infected" if this vaccine is one day discovered ?

My two cents is that such vaccine would protect those already infected from superinfection and allows them (if the results are confirmed in human trial), to get a normal sexual life with HIV-negative partners, or HIV-positive infected partners having a different strain and/or mutations (outside of any others STDs considerations).

It will probably help to prevent the mother to child transmission.

It will allows to make the life of some already infected people more easy, this disease becoming a disease as any others, without the "dirty label" probably associated to it.

HIV would probably receive less founding, but it will be also the end of HIV.
Now, with less newly infected people, we will need less founding as well and others disease from which others people are also suffering will get also more funding.

Now, it hasn't been said that such discovery, if confirmed in human trial, won't help people already infected fighting this disease.
My personal opinion is that it might be a path to the purge of the latent reservoirs and reduce greatly the fitness of the virus.

I also believe that the meds aren't the path to a cure and that the others directions will this time get more funding.

HIV is still a huge business, and many small sized labs would love to find a cure to HIV faster (before we die) to get the money that the big pharma are currently doing.

John

[MitchMiller]

I agree that a true, long-lasting HIV vaccine would probably limit future research in treatments (as history has proven).  I see a race between two competitors, prevention and treatment.  The finish lines are "long-lasting vaccine" and a cure, respectively.  When the race is over, the spectators go home. 

One point I would make is that so many seem to think a cure is like a vaccine and wouldn't be profitable for drug companies.  My take is completely the opposite.  A cure could be something like Hep C or TB treatment.  This means you could "catch" HIV again and again.  I believe the cure would be patented and lead to a huge multi-billion dollar monopoly for the foreseeable future for the drug company that finds it.  In fact, I think a cure would mean a LOT more HIV infections.  Therefore, I doubt a cure would actually save any $$$ for the health care system because it would be very expensive (like Hep C treatment) and there would be a lot more infections, hence potential patients. 

The absolute worst case scenario for Big Pharma would be that a "cure" is a one-time treatment, like a genetic modification of the immune system.  I'm happy to see genetic engineering beginning to make noise because it will probably spur Big Pharma to search for a cure that is really just a course of drugs that erradicate the virus, but not prevent its reoccurence.  The trials required for genetic engineering would take probably 10 years so Big Pharma isn't threatened yet, but I wouldn't be surprised if they suddenly "pull a rabbit out of a hat" and "stumble" across that elusive treatment just in time to ensure their profits and squash any further research into genetic engineering to make cells HIV resistant.

A "long-lasting" (meaning at least 10-20 years) vaccine would eventually lead to the eradication of HIV among humans (like polio).  Therefore, new treatments would have an ever shrinking number of patients.

[HALOO]

I am not sure that which one I fear more, preventive vaccine or AIDS....I think preventive vaccine.

There is a lot of $$$ investing in HIV research, more better treatment is coming near future and many excellent research is going on in labraboratory.

But if preventive vaccine is found.Within 7-10 years after that,  no body will remember about AIDS.Vaccine will bring end to the AIDS epidemic.Next generation born will have no idea how awful this virus are.

So I pray that HIV Gene Therapy/HIV SiRNA move forward as quick as possible before preventive vaccine is found.

BUT every week I heard more and more $$$ going for preventive vaccine trial, microbide but hardly hear any $$$ going to Gene Therapy, Elite Controller Study or flushing latent infected cell.

I am just 20 and I have no idea what will happen after this 15 years.It is 50/50, Neither Head nor Tail.So let enjoy every moment we have now.