Apr 5, 2013

GeoVax is On Track to Advance its HIV/AIDS Vaccine Programs in 2013 - Analyst Blog

HIV Vaccine Infects 172 Patients During Clinical Trials

Via: Nasdaq
Full Year 2012 Financial Results
GeoVax reported revenues of $2.7 million for 2012, related to grants from the NIH. This compares to $4.9 million of grant revenue reported in 2011. As of December 31, 2012, there was approximately $3.0 million in unused grant funds available for use through August 31, 2013 (the end of the grant project periods).
Research and development (R&D) expenses were $3.0 million in 2012, compared with $4.3 million in 2011. R&D expenses include $1.8 million and $3.0 million for 2012 and 2011, respectively, in direct costs funded by NIH grants; and also include vaccine manufacturing costs and costs related to the Phase I/II clinical trial of the Company's therapeutic vaccine, being sponsored by GeoVax. Costs associated with the conduct of a Phase IIa clinical trial of GeoVax's preventative vaccine (completed during 2012) and a Phase I clinical trial of GeoVax's second-generation vaccine (both trials conducted by the HVTN) are being funded directly by the NIH and are therefore not reflected in GeoVax's financial statements.
General and administrative (G&A) expenses were $1.8 million and $3.0 million in 2012 and 2011, respectively. G&A expenses were lower during 2012 primarily due to lower legal costs, patent costs and stock-based compensation expense related to investment advisory fees and investor warrant extensions.
The Company reported a net loss for the year ended December 31, 2012 of $2.1 million, or $0.12 per share, based on 18.3 million weighted average shares outstanding. For the year ended December 31, 2011, the Company reported a loss of $2.3 million, or $0.15 per share, based on 15.7 million weighted average shares outstanding.
Cash balances as of December 31, 2012 was $1.0 million, as compared to $1.2 million at December 31, 2011.
We think the earnings report is a non-event for GeoVax. Investors should be focused on the Company's progress in its clinical programs. In this regard, we think GeoVax has made great progress for its HIV/AIDS programs and is on track to further advance these clinical programs in 2013.
Progress on Clinical Development
Preventive Vaccine - Phase IIa Trial. The Phase IIa trial (HVTN 205) of GeoVax's preventive HIV/AIDS vaccine has been completed. Results of this trial were presented in September 2012 by the HIV Vaccine Trials Network (HVTN) at the AIDS Vaccine 2012 Conference in Boston. HVTN 205 confirmed the Phase I results, with the GeoVax vaccine demonstrating an excellent safety profile and reproducible T cell and antibody immune responses. The Company expects formal publication of the full study results by the end of 2013.
Preventive Vaccine (2nd-generation) - Phase I Trial. Patient enrollment was completed in December 2012 for the Phase I trial testing the safety of GeoVax's second-generation vaccine (GM-CSF adjuvanted). GeoVax expects the Phase I trial to be completed in the second half of 2013.
Preventive Vaccine (2nd-generation) - Phase II Efficacy Trial Planning. Pending successful outcome of Phase I testing of the second-generation vaccine, GeoVax expects to advance this version of its preventive vaccine into Phase II efficacy testing in high-risk individuals, expected to begin in 2014. The Company is currently in discussions with the HVTN regarding protocol development and anticipates knowing more about the trial design and the government funding consortium in late 2013.
Therapeutic Vaccine - Treatment Interruption Study. The Company's ongoing Phase I/II "treatment interruption" clinical trial, investigating the use of its vaccine for treatment of individuals already infected with HIV, completed enrollment at the end of 2012. GeoVax expects to see data readouts from this study during 2013, which might indicate the potential use of its vaccines to treat HIV infection, either as a standalone therapy or in conjunction with an oral drug regimen.
New Clinical Trial Planned for Combination Therapy
GeoVax is collaborating with the NIH and planning is underway for a second therapeutic clinical trial to begin in mid-2013. This Phase I trial will investigate the use of GeoVax's therapeutic vaccine in combination with standard-of-care drug therapy in HIV-positive young adults. The Company expects this trial to be conducted by the International Maternal Pediatric Adolescent AIDS Clinical Trial Group (IMPAACT), a program supported by the NIH. Because of the mechanisms by which current oral drugs work, if the virus is in latent phase (non-replicating), the drugs are not effective, thus it is impossible to totally eradicate the virus. There is hope for a combination approach using the patient's own immune system stimulated by the vaccine, together with oral drugs to eradicate the virus -- thereby potentially offering a cure.
We think GeoVax has made great progress in its HIV/AIDS vaccine clinical programs. We are especially pleased to see that the Company is planning a new clinical trial combining its HIV/AIDS therapeutic vaccine with AIDS drugs in mid-2013. This will provide a new big market for the Company's vaccine.
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Apr 4, 2013

Boost Oregon's childhood vaccination rates by trying Washington's technique |

Via: Oregonlive
Oregon could wait for an epidemic. The state could retain its casual approach to childhood vaccinations and keep its ranking as the nation's worst for protecting children against terrible and preventable diseases.
Or, Oregon could follow Washington's lead and take one simple step to improve its childhood vaccination rates -- and do so without infringing on anyone's religious liberty.

The choice is clear. Oregon should pass a Senate bill under consideration that would require parents who withhold mandatory vaccines from their children to get a doctor's signature showing that they have been informed of the risks and benefits. As Washington has proven, this requirement is surprisingly effective at boosting a state's childhood vaccination rate virtually overnight.

Today in Oregon, children entering kindergarten need to show proof of immunization against numerous serious diseases, including polio, whooping cough and measles. Vaccines help protect the individual child, build "herd immunity" for the community and reduce the risk for those who are too young or sick to be safely vaccinated.

Oregon does offer two exceptions to its vaccination rule: Parents can get a medical exemption by bringing a letter from a doctor explaining the child's medical condition, or they can get a religious exemption by merely checking a box. Since Oregon defines religion as any belief system, parents use this option quite liberally. About 5.8 percent of Oregon kindergartners skip vaccines for nonmedical reasons, which is the nation's highest rate.
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Apr 3, 2013

Hep B Vaccine Damages The Liver It Is Supposed To Protect

Hepatitis B Vaccination Causing Liver Damage

Research and Links
Via: Greenmedinfo

Startling new research published in the journal Apoptosis indicates that hepatitis B vaccine, which is designed to prevent Hepatitis B virus-induced damage to the liver, actually causes liver cell destruction.

In the study titled "Hepatitis B vaccine induces apoptotic death in Hepa1-6 cells," researchers set out to "...establish an in vitro model system amenable to mechanistic investigations of cytotoxicity induced by hepatitis B vaccine, and to investigate the mechanisms of vaccine-induced cell death."1

They found the hepatitis B vaccine induced a "loss of mitochondrial integrity, apoptosis induction, and cell death" in liver cells exposed to a low dose of adjuvanted hepatitis B vaccine. The adjuvant used was aluminum hydroxide, which is increasingly being identified as a contributing cause of autoimmune disease in immunized populations.

The discovery that the hepatitis B vaccine damages the liver (hepatotoxicity) confirms earlier findings (1999) that the vaccine increases the incidence of liver problems in U.S. children less than 6 years old by up to 294% versus unvaccinated controls.

Another study published in the journal Hepatogastroentology in 2002, observed that Hepatitis B vaccination was statistically associated with gastrointestinal reactions including: hepatitis, gastrointestinal disease and liver function test abnormalities in comparison to other vaccine control groups.

This, however, is only the tip of the iceberg...

In a revealing study published in June 2011 in the journal Molecular Biology Reports, researchers demonstrated that hepatitis B vaccine alters the expression of 144 genes in the mouse liver within 1 day of vaccination, 7 of which are related to inflammation and metabolism. The authors noted:

"Pharmaceutical companies usually perform safety testing of vaccines, but all requirements of the World Health Organization and drug pharmacopoeias depend on general toxicity testing, and the gene expression study of hepatitis B vaccine is not done routinely to test vaccine quality."
Could the gene-expression altering affects of hepatitis B vaccine be one reason why there are over 60 serious detrimental health effects associated with the vaccine as documented in the peer-reviewed and published biomedical literature, including sudden infant death?

Other potential mechanisms of action behind hepatitis B vaccine's dangerous side effects, are as follows...

Hepatitis B vaccines may contain Hepatitis B Virus polymerase as a contaminant, which may trigger an auto-immune process against the myelin (protective coating on the nerves) in some vaccinated subjects.
Hepatitis B vaccine may induced autoimmune demyelinating disease through the molecular mimicry that exists between the vaccine antigen, Epstein-Barr virus and human myelin.
Why Are They Vaccinating Infants For Hepatitis B Virus?

The real danger here is that universal vaccination against Hepatitis B virus may be causing far more harm than good. It is actually our youngest -- infants -- who are most at risk of being irreparably harmed, as the CDC's vaccine schedule requires Hepatitis B vaccination at birth, 1-2 months, and then again at 3-6 months of age.

Universal hepatitis B vaccination was recommended for U.S. newborns in 1991, despite contradictory safety findings. Perhaps not coincidentally, the prevalence of autism today is 1500% higher than that occurring in the period immediately before their introduction. While there is no such thing as a "genetic epidemic," in the traditional inheritable sense of the word "genetic," there is such a thing as environmentally induced gene-expression changes, as described above. In other words, vaccine adjuvants (e.g. mercury and aluminum) and vaccine antigens are capable of profoundly affecting the stability of the genetic infrastructure upon which our health depends.

According to one review published in the Journal of Toxicology and Environmental Health in 2010, male newborns vaccinated with hepatitis B prior to 1999 had a 3-fold higher risk for parentally reported autism. Why before 1999? On 8/27/99 the CDC, in tacit acknowledgment of the profound neurotoxicity associated with the use of thimerosal (organomercury), approved the first thimerosal-free hepatitis B vaccine. Sadly, even after the removal of mercury (which was replaced by another neurotoxic agent aluminum hydroxide), autism prevalence is still several orders of magnitude higher than it was before the CDC's increasingly overwhelming vaccine schedule (60+ by age 6) reached its present-day proportions.

Another glaring problem with Hep. B vaccine in infants is that Hepatitis B virus is only transmitted through blood or semen by those who are infected, which are two routes of exposure an infant -- certainly not one born in a hospital -- should ever be exposed to; unless, of course, the mother is a carrier, and therefore can transmit it vertically to her offspring. But hospitals can and should screen mothers for Hepatitis B preemptively, therefore making it unnecessary to vaccinate every infant blindly. In addition, there are no randomized controlled trials that have assessed the effects of hepatitis B vaccine during pregnancy for preventing infant infection, despite the fact that pregnant women are being given the vaccine for exactly this reason.2 There is also research indicating that immunization for Hepatitis B does not guarantee protection against becoming infected with it; i.e. it may not truly fall within the category of a vaccine-preventable disease.3
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Apr 2, 2013

Two Autistic Children Awarded Millions by Vaccine Court

Autism Rates 1 in 50 Kids are Vaccines Responsible?

Research and links
Via: TheHealthyhomeeconomist

This is the favored approach the government and tow the line pundits in mainstream media take when it comes to the issue of whether vaccines cause autism.

Newspaper and magazine headlines and TV talking heads repeat the anthem ad nauseum that no link between vaccines and autism has been found and that parents need not be concerned about the uneducated, nonscientific “rumors” swirling on the internet that claim otherwise.

You have to wonder how the pro-vaccine lobby with its head hopelessly stuck in the sand is going to squelch this news.

Just days ago, the Vaccine Injury Compensation Program (VICP) also known as “vaccine court” awarded millions of dollars to two children who rapidly regressed and became autistic after a round of routine childhood vaccinations.

The first case involved a child named Emily who suffered a severe vaccine reaction to DTaP at 15 months old. MMR, HiB and Prevnar were also given at that time.

The second case involved 10 year old Ryan Mojabi of California in which the government admitted that the MMR vaccine caused the brain encephalopathy or brain dysfunction Ryan suffered within five to fifteen days of receiving the shot.  Encephalopathy is considered a “vaccine table” injury, in other words, a compensable adverse reaction to vaccination.

Likely key to the prosecution was the testimony of family, friends, and neighbors of the children who testified under oath that the children were normal and perhaps even advanced for their age before autism took hold after routine immunizations.

Seizures, spiking fevers, a measles like rash of red spots all over the body and ultimately brain encephalopathy were reported following the shots.  The witnesses said that the children never fully recovered from the adverse vaccine reactions they experienced, losing eye contact, language, and social skills – all hallmark symptoms of autism.

These are not the first cases of autistic children receiving compensation from vaccine court.

In two other cases (Polling and Banks), the government conceded that encephalopathy triggered after immunization did result in permanent brain injury and ultimately autism.

How Much Longer Can the Obvious Be Denied?

Very, very quietly and without any media attention to the matter, the cases keep piling up of vaccine court awarding compensation for children who became autistic after routine vaccination.

Vaccination proponents will no doubt argue that the autism that resulted was unrelated to the post immunization encephalopathy the children suffered which is the vaccine table injury that permitted the compensation to be awarded.

Those with any common sense will note that the encephalopathy or brain dysfunction suffered from the immunizations no doubt played a huge role and was most likely a key factor in the rapid, regressive autism these children experienced.

No matter whether you are for or against vaccination, one thing can be agreed upon:  childhood vaccinations can and do indeed result in brain encephalopathy and permanent brain damage.

Whether or not this vaccine induced brain damage is called autism or not is nothing but a game of semantics.

Autism is as autism does.

Sarah, The Healthy Home Economist


Apr 1, 2013

Nano Patch Vaccination Funded by the Gates Foundation

Via: The Verge
Researchers have proved that "injection-free" vaccines are an effective tool in the fight against diseases. The team, based in King's College London and funded by the Bill & Melinda Gates Foundation, used dried sugar to create a microneedle array — a tiny disc that only lightly perforates the skin. The dried sugar, which was laced with a proposed HIV vaccine, dissolves when inserted in to the skin, effectively delivering the vaccine and kick-starting an immune response. The method is far less invasive than conventional vaccines that are delivered via a hypodermic needle.

Other benefits to the microneedle array include preservation; many traditional liquid vaccines need to be kept at extremely low temperatures, which is a major barrier to transportation. The researchers' dried vaccine, however, remained as stable and effective at room temperature as the same dose of liquid vaccine preserved at minus 80 degrees Celsius.
The team's findings, which expand on years of research across the globe, could help lower the cost of vaccinations across the globe. Dr Linda Klavinskis of Kings College says the work "could potentially reduce the cost of manufacturing and transportation" as there would be no need for refrigeration, as well lowering the risk of transmitting diseases through contaminated needles and syringes. The team hopes to one day use the method to vaccinate against HIV, malaria, and tuberculosis; three global issues that the Bill & Melinda Gates Foundation is focused on fixing.
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