By: Tomas Ronolski - AllPennyStocks.com News

Tuesday, October 8, 2013

Acquired Immune Deficiency Syndrome, or AIDS as it is generally known, is still an epidemic that runs rampant throughout the world. Some 33 million people globally are infected with an estimated 2.5 million new cases expected to be diagnosed in 2013. Worldwide, it is still the number one killer of women of reproductive age. In the United States, clade B, one of the subtypes of AIDS, is the most common. A sad fact is that most people don’t realize that they are infected. It’s estimated that in excess of 25 percent of the new cases in the U.S. will be in people aged 13 to 24, with more than half of those people not aware they have the disease. There are some common drugs used to treat HIV/AIDS, such as six drugs from Gilead Sciences (Nasdaq:GILD), including Atripla, Complera and Emtriva, and more in its pipeline. A good portion of Gilead’s $95 billion market capitalization has been built upon its HIV/AIDS franchise.

Taking a different approach is microcap GeoVax Labs Inc. (OTCQB:GOVX), which is focused on developing preventative vaccines for HIV, specifically the major HIV-1 subtypes A, B and C. GeoVax has prioritized vaccines, which can be used standalone or in combination with other drugs, including for subtype B, which is the most common not only in America, but also in Europe, Japan and Australia.

Pre-clinical research has shown the company’s vaccines induce a strong cellular and humoral immunity response in non-human primates against several HIV-1 proteins. Clinical evaluation of GeoVax preventative vaccines have been ongoing since 2003 and established a solid safety and immune response profile. Since inception, more than 90 phase 1 trials have been completed with five advancing to phase 2.

Investors will be on the lookout this quarter for preliminary data from a Phase 1/2 clinical trial testing GeoVax’s DNA/MVA (modified vaccinia Ankara) vaccine evaluating the safety, immunogenicity and ability of the therapy to elicit protective immune responses in HIV patients. Top-line data is expected in the first half of 2014. The vaccine regimen elicits both antiviral antibody that can block infection and antiviral T cells that can recognize and kill infected cells. The DNA/MVA vaccine has been shown to provide up to 78 percent per exposure protection against SIV251, a highly virulent strain of simian immunodeficiency virus. Enrollment was completed in January for the trial enrolling patients at 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.

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 of 2013. The trial is being conducted by the HIV Vaccine Trials Network (HVTN) with financial support from the National Institute of Health and is expected to be completed this quarter.

As with any novel therapy, patent protection is imperative. GeoVax said on Monday that it has protected its property, exclusively licensed from Emory University and the U.S. government, through the U.S. Patent and Trademark Office issuing a patent entitled “Compositions and Methods for Generating an Immune Response,” that broadly covers compositions, methods, and uses of the GeoVax's DNA/MVA vaccine in eliciting cellular and humoral immune responses to an HIV antigen.

"This patent is key to the commercialization of our DNA/MVA HIV vaccine technology," said Robert T. McNally, PhD, President and CEO of GeoVax. "We are pleased that the USPTO has confirmed that the claims in our patent application are patentable over the prior art of record."

There have been plenty of clinical trials and funding that has supported the research of GeoVax. In the first half of 2013, the company reported $1.24 million in revenue related to grants from the NIH. Added to other cash in corporate coffers, GeoVax has $1.8 million in unused grant funds available for use. Investors know full well how lucrative HIV/AIDS therapeutics can be (just take a look at Gilead) and will be looking for some mid-stage trials of second-generation products of GeoVax to try and loft corporate value. Shares have been slumping year-after-year and are sitting near all-time lows, closing Monday at 39 cents, equating to a market cap of only $8.5 million. With only 21.67 million shares outstanding, this low floater could move quickly with additional promising clinical data.

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