Expansion of HIV/AIDS Vaccine Program Announced by GeoVax Labs, Inc.

/PRNewswire/ -- GeoVax Labs, Inc. (OTCQB/OTCBB: GOVX), announced today that it is expanding its preventative HIV/AIDS vaccine development effort in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the U.S. National Institutes of Health (NIH) and the HIV Vaccine Trials Network (HVTN). Specifically, the HVTN plans to clinically test a novel vaccine product developed by GeoVax scientists that expresses human granulocyte-macrophage colony stimulating factor (GM-CSF) in combination with inactivated HIV proteins. The novel vaccine consists of a recombinant DNA vaccine co-expressing human GM-CSF and non-infectious HIV virus-like-particles. The DNA vaccine is used to prime immune responses that are subsequently boosted by vaccination with a recombinant modified vaccinia Ankara (MVA) vectored vaccine. The MVA expresses the HIV virus-like-particles, but does not express GM-CSF. The regimen builds on the GeoVax DNA/MVA vaccine that is currently in Phase 2a clinical testing through the HVTN.

GM-CSF is a cytokine (growth stimulating protein) that serves to expand and mature cells that initiate immune responses and has undergone extensive testing in humans for cancer vaccines. The GM-CSF-adjuvanted vaccine was added to GeoVax's portfolio because of the outstanding ability of the simian prototype vaccine to induce immune responses that prevented simian immunodeficiency virus (SIV) infection. In nonhuman primates, the GM-CSF enhanced vaccine achieved protection against SIV in 70% of the animals. Protection was measured against 12 weekly rectal challenges using a dose of SIV which is estimated to be 30 to 300 times higher than the typical exposure dose of HIV in mucosal transmission in humans.

"For years, the HIV vaccine field has been working with vaccines that elicited immune responses that primarily controlled immunodeficiency virus challenges in infected animals, but did not actually prevent infections. The ultimate goal is to prevent infections. The co-expression of GM-CSF with the SIV proteins is a vaccine design that appears to be a large step towards reaching this goal," said Dr. Harriet Robinson, Chief Scientific Officer at GeoVax. "In our trials in nonhuman primates, GM-CSF enhanced the quality of the SIV-specific antibody response. Antibody is present in blood and tissues and has the potential of blocking SIV before it infects cells. The GM-CSF-adjuvanted vaccine induced the production of antibodies characterized with increased tightness of antibody binding. The tightness of antibody binding, known as avidity, can be expressed as an index. Animals with indices above 40 were protected from infection, whereas animals with lower indices were infected with the number of challenges to infection correlating with their index."

"We are very pleased that the HVTN will be conducting trial HVTN 094 of our GM-CSF adjuvanted vaccine product, which we expect will begin late this year," said Dr. Robert McNally, CEO of GeoVax. "The HVTN, funded by the NIAID, is the largest worldwide clinical trials network dedicated to the development and testing of HIV/AIDS vaccines. We are looking forward to working with an excellent team of HVTN trial investigators."

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Newborn Possibilities Fund Awards Grant to Georgia Health Sciences University Foundation to Support Groundbreaking Pediatric Research

/PRNewswire/ -- The Newborn Possibilities Fund, a grantmaking program established by Cord Blood Registry (CBR), today announced it will provide its first-ever grant to the Georgia Health Sciences University Foundation. The university's medical center is conducting the first FDA-regulated clinical trial evaluating cord blood stem cells as a medical intervention for cerebral palsy. The grant will provide financial support to help curb travel and other expenses for families with a child participating in the trial.

The study will include 40 children, ages 1 to 12 and will begin with a neurological exam. Then, half of the study participants will receive an infusion of their own cord blood while the other half receives a placebo. Three months later, the children will be evaluated without physicians knowing which group received the stem cell infusion. Afterward, children who didn't get their cord blood initially will receive an infusion. Children in the study will return three and six months later for evaluation, where researchers will assess their motor skills and neurological development.

"This is a very well-designed clinical study that will provide new insights into the potential of cord blood stem cells to help children recover from nerve tissue damage to the brain," said Heather Brown, vice president of scientific and medical affairs at CBR. "However, the study design requires a family to make trips at their own expense to the study center. The goal of The Newborn Possibilities Fund is to remove financial barriers that may prevent eligible children from participating in this cutting-edge research and receiving investigational treatments that may improve their quality of life."

The Newborn Possibilities Fund (NPF) was created to help advance clinical research investigating the use of a child's own cord blood stem cells as a treatment for conditions like cerebral palsy and traumatic brain injury. The NPF directs financial grants to non-profit organizations to help cover the cost of travel for families who have the chance to participate in FDA-regulated trials. The Fund is administered by Tides, a public charity, on behalf of CBR.

Patients who meet the inclusion criteria and are enrolled in the trial at Georgia Health Sciences University will be notified of the Newborn Possibilities Fund and have the opportunity to receive funds to use toward the cost of travel to Augusta, Georgia for the cord blood infusion procedure and required follow up visits.

"The hope for stem cells, really from the beginning, is that they might serve as some type of replacement for cells in the nervous system that have been destroyed or never developed properly," said Dr. James Carroll, professor and chief of pediatric neurology at Georgia Health Sciences University and principal investigator on the study. "The main goal of our research is to try to help improve the lives of children with cerebral palsy and find out if the method we're using is going to help these children in the future."

A growing body of research in animals has shown that infused stem cells help to initiate repair and induce healing in the brain. While the Georgia Health Sciences University is the first controlled clinical trial to be conducted, anecdotal reports from previous studies have shown marked improvement in children with cerebral palsy about three months after an initial infusion of cord blood, which led Dr. Carroll to design his trial.

Through generous donations, the Newborn Possibilities Fund hopes to provide financial support for additional trials already underway at leading research universities across the country. For more information on the program or to donate, please visit www.newbornpossibilities.com/donate.asp

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New Magnetic Resonance Imaging (MRI) Data Show Efficacy of SIMPONI® in Treatment of Rheumatoid Arthritis

/PRNewswire/ -- Magnetic resonance imaging (MRI) analyses from two Phase 3 clinical trials showed that once every four week subcutaneous injections of SIMPONI® (golimumab) 50 mg plus methotrexate resulted in statistically significant improvements in markers of inflammation and structural damage in patients with active rheumatoid arthritis (RA) compared with placebo plus methotrexate. Changes in disease activity were measured using the Rheumatoid Arthritis MRI Scoring (RAMRIS) system, which assesses three components: synovitis, bone edema (osteitis) and bone erosions. Changes in RAMRIS scores were observed as early as week 12 and continued through week 24. These data were presented at the largest rheumatology medical meeting in the United States.

"MRI assessment has previously been demonstrated to show greater sensitivity than x-ray in detecting changes in inflammation and the structural integrity of the bone. The findings from a randomized controlled trial with a large number of patients show the value of this diagnostic tool in its ability to monitor disease progression" said Dr. Paul Emery, head of the Academic Unit of Musculoskeletal Medicine at the University of Leeds and lead study investigator. "The ultimate goals of inhibiting joint damage are to both reduce the symptoms that patients with RA experience and also to preserve patients' functional ability (which is correlated with early structural changes). These findings present important new information for rheumatologists and further support the substantial efficacy SIMPONI demonstrated in multiple Phase 3 registration trials in the treatment of this chronic disease."

Investigators reported that at week 24 of the GOlimumab Before Employing methotrexate as the First-line Option in the treatment of Rheumatoid arthritis of Early onset (GO-BEFORE) study, patients with RA receiving SIMPONI 50 mg plus methotrexate showed significant improvements in synovitis, bone edema and bone erosions [-2.2 (P = 0.011), -2.5 ( p <0.001) and -0.7 (p = 0.016), respectively], compared with patients receiving placebo plus methotrexate (-1.0, -0.3 and -0.2, respectively).

In a second study, GOlimumab FOR subjects With Active RA Despite Methotrexate (GO-FORWARD), patients receiving SIMPONI 50 mg plus methotrexate experienced significant improvements in synovitis and bone edema [-1.9 (p < 0.001) and -2.6 (p < 0.001), respectively] at week 24 when compared with the placebo plus methotrexate group (-0.4 and 0.7, respectively). Minimal changes in bone erosion across all treatment groups (mean change ranging from -1.1 to 0.4) precluded the adequate evaluation of the effects of SIMPONI on bone erosion, which is consistent with previously published radiographic data.

In September 2010, Centocor Ortho Biotech Inc. announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking to expand the SIMPONI physician label to include inhibiting the progression of structural damage in the treatment of moderately to severely active RA.

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'Improving Access to Clinical Trials Act' Passes U.S. House - Heads to President for Signature

/PRNewswire/ -- Today the U.S. House of Representatives passed the "Improving Access to Clinical Trials Act" (I-ACT), in a victory for the Cystic Fibrosis Foundation, its advocates and 120 other health advocacy organizations.

The bill, which passed the Senate Aug. 5, now goes to President Obama's desk for his signature. He is expected to sign it.

This legislation enables patients with rare diseases to participate in clinical trials without losing eligibility for public health care benefits.

Passage of this legislation is particularly important for people with CF, a rare genetic disease. A limited patient population makes it challenging to find enough people to participate in research studies evaluating the effectiveness of promising new drugs.

"Because of this groundbreaking legislation, people with CF and other rare diseases will no longer be forced to choose between critical health care coverage and participation in research that could lead to the development of a cure for our most serious illnesses," said Robert J. Beall, Ph.D., president and CEO of the Cystic Fibrosis Foundation.

We are grateful to our champions in Congress for approving this bill, which will help move new treatments more swiftly from the lab to the patients who need them most."

Congressional Cystic Fibrosis Caucus Co-Chairs, Reps. Edward Markey, D-Mass., and Cliff Stearns, R-Fla., led the effort to pass the bill in the House. The House version of the legislation, H.R. 2866, has 141 co-sponsors.

"No one should have to choose between participating in a clinical trial and accessing the essential benefits they need. Today's bill will open doors of hope and offer the possibility of better health to those with rare diseases like cystic fibrosis. I am proud to partner with my friend and co-chairman of the Congressional Cystic Fibrosis Caucus, Congressman Cliff Stearns, in the passage of this bi-partisan bill, which now will be signed into law by President Obama. I also want to commend the Cystic Fibrosis Foundation for its incredible work on this vital issue. Today represents an important and hopeful milestone in the battle to beat devastating rare diseases that afflict millions of Americans around the country," Markey said.

Added Stearns: "As co-chair and co-founder of the Congressional Cystic Fibrosis Caucus, I commend my colleagues for approving this legislation allowing people with rare diseases such as cystic fibrosis to participate in life-saving clinical trials that provide nominal compensation without the risk of losing their health care coverage. I also deeply appreciate the work of the Cystic Fibrosis Foundation in supporting my legislation."

The Senate version of the legislation, S. 1674, was introduced by Sen. Ron Wyden, D-Ore., with Sens. Chris Dodd, D-Conn., James Inhofe, R-Okla., Richard Shelby, R-Ala., and Richard Durbin, D-Ill., as original co-sponsors. An additional 17 co-sponsors signed on.

Current law prevents many people who receive Supplemental Security Income (SSI) from accepting research compensation because it makes them ineligible to receive government medical benefits. This penalty has stopped significant numbers of people with rare diseases from participating in clinical studies.

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Fluoride Could be Contributing to Early Puberty, Studies Show

/PRNewswire/ -- The medical and public health community is shocked by the news that young American girls are reaching puberty at ages as young as 7 years (1). However, according to Paul Connett, PhD, Director of the Fluoride Action Network, "If fluoride's dangers had not been taken off the scientific radar screen by the US Public Health Service when it prematurely endorsed fluoridation in 1950, maybe key warning signals would not have been ignored for over 50 years."

In 1956, it was reported, after one of the first fluoridation trials (1945-55) had been completed in Newburgh/Kingston NY, that young girls were starting to menstruate on average five months earlier in fluoridated Newburgh compared to non-fluoridated Kingston (2). This result was ignored and there was no follow-up research.

In 1997, Dr. Jennifer Luke in the UK, as part of her PhD thesis (3), reported that fluoride accumulates in the human pineal gland. The pineal gland produces the important hormone melatonin which acts like a biological clock. One of the processes it is thought to control is the onset of puberty. Luke published this work in 2001 but the result has been ignored and no fluoridating country has attempted to repeat her findings, something which would be easy to do if there was the will to do so.

Luke also found that animals exposed to fluoride had lowered melatonin levels and showed signs of reaching puberty earlier. Again this result has been ignored and no fluoridating government has attempted to repeat Luke's work.

Connett says, "We are not saying that exposure to fluoride is a definite cause of early puberty in girls, but not pursuing this possibility is bad for science, bad for medicine and bad for public health."

Simply put: if you don't look, you don't find. The medical community is being kept in the dark on the possibility that fluoride, a highly toxic substance, which is deliberately added to the drinking water of 184 million Americans daily, is causing a variety of harms from the subtle to the serious.

Connett says, "Apparently, it has become more important for the American Dental Association and the Centers for Disease Control and Prevention and other agencies of the US Department of Health and Human Services to protect this outdated, unethical, ineffective and the dangerous practice than it is to protect the health of the American people. Key research is not being done. Doctors are not being warned."

This and other tragic aspects of the US's peculiar obsession with fluoridation are to be documented in an upcoming book co-authored by Connett. The book, titled "The Case Against Fluoride: How Hazardous Waste Ended Up in Our Drinking Water and the Bad Science and Powerful Politics That Keep it There," will be published by Chelsea Green in early October of this year.

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