BioSante’s vaccine adjuvant, BioVant^TM, increases the protective effect of vaccines for multiple flu strains

BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) announced today’s presentation of H1N1 vaccine results at the Immunotherapeutics & Vaccine Summit in Providence, RI. BioSante’s vaccine adjuvant, BioVant^TM, increased the protective effect of vaccines for multiple flu strains, including a potential new vaccine against H1N1 (swine flu), which resulted in 100 percent protection from symptoms of illness, including weight loss, and death in animal studies.

The BioSante presentation, “BioVant Calcium Phosphate (CaP) Nanoparticles: An Effective & Safe Adjuvant for Influenza Vaccines including H1N1 and H5N1,” showed that BioVant-adjuvant effectively enhanced the natural immune response to the swine flu, using a BioVant-adjuvanted matrix protein M1 vaccine, and to H5N1 (bird flu), using a BioVant-adjuvanted H5N1 vaccine delivered via intranasal administration.

The studies concluded that swine and bird flu vaccines using BioSante’s BioVant may allow for availability of a greater number of lower-dose vaccines, due to its dose sparing characteristics, and intranasal administration could provide more convenient and wider distribution during a flu pandemic.

“The results of the BioVant-influenza studies suggest that BioVant can increase the efficacy of a potential adjuvant-enhanced H1N1 vaccine,” said Michael Snabes, BioSante’s vice president of clinical development. “The exciting prospect is that BioVant also may allow use of lower doses of H1N1 swine flu vaccines in order to stretch potentially limited vaccine supplies.”

An adjuvant is a substance that, when added to a vaccine, increases the vaccine’s effectiveness by enhancing the body’s immune response. In multiple studies, BioVant has been shown to be safe and cause minimal dose-dependent inflammation at the injection site, and has been shown both to prevent the manifestation of allergic response, and, to effectively ‘switch off’ established Th2-T-cell-associated allergic reactions and potentially to be delivered via alternative routes of administration, e.g. intranasally.

About BioSante Pharmaceuticals, Inc.

BioSante is a specialty pharmaceutical company focused on developing products for female sexual health, menopause, contraception and male hypogonadism. BioSante’s lead products include LibiGel^® (transdermal testosterone gel) in Phase III clinical development by BioSante under a U.S. Food and Drug Administration (FDA) SPA (Special Protocol Assessment) for the treatment of female sexual dysfunction (FSD), and Elestrin^TM (estradiol gel) developed through FDA approval by BioSante, indicated for the treatment of moderate-to-severe vasomotor symptoms associated with menopause, currently marketed in the U.S. Also in development are Bio-T-Gel^TM, a testosterone gel for male hypogonadism, and an oral contraceptive in Phase II clinical development using BioSante patented technology. The current market in the U.S. for estrogen and testosterone products is approximately $2.5 billion and for oral contraceptives approximately $3 billion. The company also is developing its calcium phosphate technology (CaP) for aesthetic medicine (BioLook^TM), as a vaccine adjuvant, including for an H1N1 (swine flu) vaccine, and drug delivery.

Additional information is available online at: www.biosantepharma.com.

©2012 An Inconvenient Woman. All Rights Reserved.

The newly emergent 2009 H1N1 influenza virus is a novel virus with pandemic potential. Consistent with the National Strategy for Pandemic Influenza, HHS is committing funds for the production of pilot lots for clinical studies, as well as a bulk supply of antigen and adjuvant for use in a potential vaccine for the 2009 H1N1 which will become a part of the national stockpile of pre-pandemic influenza vaccines.

A vaccine is made from a virus or bacteria (referred to as an antigen), which causes the human body’s immune system to develop antibodies against a specific virus or bacteria so the body can recognize and fight the virus or bacteria. Adjuvants may be added to a vaccine to help generate a stronger immune response so less vaccine is needed for the body to recognize and fight a virus or bacteria.

Vaccine Development

When the 2009 H1N1 strain was isolated and identified as a novel influenza virus, work began to prepare a virus reference strain. This is a standard practice when new influenza strains are discovered, where a clinical sample of the virus is mixed with another influenza virus that grows in eggs to develop a new virus that has some of the properties of the novel virus and the ability to grow in eggs. This work is necessary in order to create an influenza vaccine using conventional methods.

Once a virus reference strain is ready, it will be made available to influenza vaccine manufacturers in order to create a master virus seed, which prepares a virus to be used in making the vaccine.

Health and Human Services (HHS)Contracting Activities

Since 2004, HHS has contracted with manufacturers that currently hold U.S. licenses for flu vaccine as part of the National Strategy for Pandemic Influenza. In May 2009, HHS issued new orders on these contracts to produce a bulk supply of vaccine antigen and adjuvant and to produce pilot (also called investigational) lots of a 2009 H1N1 vaccine. Most will be stored in bulk, and a small amount will be prepared as vaccine for use in clinical studies to evaluate vaccine safety and the dosage required for a protective effect. This research will include studies with adjuvant to determine its safety and the effect it would have on the immune system’s response.

Orders for Bulk Supply of 2009 H1N1 Influenza Vaccine Antigen and Adjuvant

©2012 An Inconvenient Woman. All Rights Reserved.

“By 1853, Parliament began passing laws to make the untested vaccine compulsory throughout the British Empire. Other countries of Europe followed suit. Once the economic implications of compulsory vaccinations were realized, few dared to
disagree. Then, as now, the media were controlled by the vaccine manufacturers and the government, who stood to make huge money from the sale of these spurious vaccines.”… Tim O’Shea, D.C.

1946:  US Public Health Service was established and EO 9708 (Executive Order) was signed, listing the communicable diseases where quarantines could be used. 1946 and 2003, cholera, diphtheria, TB, typhoid, smallpox, yellow fever, & viral hemorrhagic fevers were added.
April 4, 2003:  EO 13295 added SARS to the list.
April 1, 2005:  EO 13295 added “Influenza caused by novel or re-emergent influenza viruses that are causing, or have the potential to cause, a pandemic.”
EO 13295 also:
The president gave the Sec. of HHS the power to quarantine, his or her discretion.
Sec of HHS has the power to arrange for the “apprehension and examination of persons reasonably thought to be infected.” A cough or a fever could put a person at risk for being quarantined for an extended period of time without recourse.

To read complete paper go to Iconic Downloads “Flu Vaccine Fact Sheet

©2012 An Inconvenient Woman. All Rights Reserved.