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美國(guó)GeoVax
GeoVax Inc.成立于2001年,致力于研發(fā)人類疫苗,尤其著重于研發(fā)一種HIV、AIDS疫苗,目前正在申請(qǐng)核準(zhǔn)上市。公司位于美國(guó)東海岸,佐治亞州的亞特蘭大市,由艾摩利大學(xué)(Emory University)的兩位教授Dr. Robinson及Don Hildebrand與其它幾位NIH和美國(guó)CDC的學(xué)者共同建立。
GeoVax的艾滋病疫苗技術(shù),已發(fā)展超過(guò)15年,且已完成靈長(zhǎng)類動(dòng)物實(shí)驗(yàn),靈長(zhǎng)類動(dòng)物實(shí)驗(yàn)的結(jié)果顯示,96%有效,且有二十三分之二十二的疫苗接種者,在被可引起AIDS的病毒感染后,仍可受到保護(hù)。
第Ⅰ期的人體試驗(yàn)于2004年圓滿完成。且GeoVax的AIDS疫苗已從2006年4月開始在美國(guó)的多個(gè)城市,進(jìn)行人體臨床試驗(yàn)。GeoVax也在評(píng)估于印度及非洲等艾滋病主要分布地區(qū),擴(kuò)展其HIV/AIDS疫苗試驗(yàn)之試驗(yàn)。
2006年的9月28日,GeoVax Inc. 和美國(guó)伊利諾伊州的Dauphin Technology, Inc.完成合并,兩家公司合并后更名為GeoVax Labs, Inc.。因?yàn)楹喜⒌慕Y(jié)果,GeoVax, Inc.先前的股東,目前大約擁有GeoVax Labs百分之六十九的股權(quán)。GeoVax Labs希望能藉由賣出價(jià)值一千一百萬(wàn)美元的證券繼續(xù)進(jìn)行集資,也因?yàn)橘u出證券,過(guò)去GeoVax, Inc.股東的股份所有權(quán)百分比,將被稀釋到大約67%。艾摩利大學(xué)先前擁有Geovax百分之四十八的股份,在合并之后,仍是最大股東,擁有該公司百分之三十三的股份。
在2004年取得AIDS疫苗的技術(shù)之后,今年GeoVax與Dauphin公司合并使公司資產(chǎn)與股東基礎(chǔ)更加健全。合并后的公司,將更致力于進(jìn)行中的臨床人體試驗(yàn),評(píng)估其AIDS疫苗的成效,以加速AIDS疫苗的發(fā)展,最終,希望能將產(chǎn)品授權(quán)銷售于世界各地,希望能使數(shù)以百萬(wàn)計(jì)的生命,免除HIV-1病毒之威脅。
GeoVax is a biotechnology company developing human vaccines for diseases caused by HIV-1 (Human Immunodeficiency Virus - AIDS) and other infectious agents.
Our goals include: developing AIDS vaccines for global markets, manufacturing and testing these vaccines under GMP/GLP conditions (FDA guidelines), conducting phase 1, 2 and 3 human trials for vaccine safety and effectiveness, and obtaining regulatory approval of these vaccines in the USA and specified international markets.
In 2005, a phase 1 human clinical trial tested GeoVax's DNA vaccine. This trial concluded successfully, demonstrating the safety of our DNA vaccine(details).
After receiving ”Safe to Proceed” status for a new Investigational New Drug (IND) by the U.S. Food and Drug Administration (FDA), a phase 1 trial combining low doses of the DNA vaccine with the MVA vaccine began in May 2006. An additional phase 1 trial began in September 2006 to test full doses of the vaccines. In total, this phase 1 testing included four trials. All tested various combinations and doses of our DNA and MVA AIDS vaccines in human volunteers for their ability to raise Anti-AIDS immune responses as well as for their safety.
Successful results from all phase 1 testing of GeoVax's vaccines supported the initiation of the first phase 2 testing of our product. GeoVax's phase 2 human trial began in January 2009 and involves 225 participants at sites in the United States and South America.
Long term, we expect that GeoVax will enter into agreements to out-license manufacturing technology to major vaccine production companies and distribution rights to key companies in several global markets in return for upfront fees, collaborative development agreements, and royalties on sales and distribution revenues. Internal vaccine manufacture and sale will be considered by GeoVax.