Important note: Information in this article was accurate in 2005. The state of the art may have changed since the publication date.
PRNewswire - June 9, 2005
The scale of the AIDS crisis now surpasses even the worst-case scenarios of a decade ago. Around the world, approximately 40 million people are living with HIV/AIDS. The predominant mode of HIV transmission worldwide is via heterosexual contact, and women appear to be at greatest risk for HIV infection. The need to develop a simple, cost-effective, female-controlled preventative against heterosexual transmission of HIV in women is urgently recognized by both the WHO and NIH.
Osel, Inc. is pursuing an innovative and women-initiated strategy to prevent the heterosexual transmission of HIV worldwide. This strategy is based on Osel's therapeutic platform technology, known as MucoCept. The MucoCept approach involves the use of proprietary technology designed to harness the natural Lactobacillus flora and its associated biofilm on the mucosal surface -- the site of HIV entry -- to neutralize HIV particles before infection of the host. The MucoCept bacterium, a genetically enhanced human vaginal isolate of Lactobacillus jensenii, is designed to colonize the vaginal mucosa and prevent bacterial vaginosis (BV) and associated sexually transmitted infections (STIs) through production of lactic acid and hydrogen peroxide, and in addition, to further prevent HIV transmission by secreting potent protein-based microbicides into the mucosal environment. Over the past several years, under the support of multiple NIH grants, Osel has made substantial progress towards design and development of this novel topical microbicide. An expression cassette has been stably integrated into the bacterial chromosome with retention of wild-type phenotype of the host bacteria. "We are moving ahead with our business plan to develop genetically enhanced lactobacilli as a delivery vehicle for protein-based microbicides to complement our product candidates utilizing naturally occurring mucosal bacteria." said Dr. Peter P. Lee, the inventor of the MucoCept concept and a co-founder of Osel, Inc.
Osel's MucoCept technology and approaches offer a unique means of generating a topical therapeutic barrier to HIV transmission. Though a number of substantial tasks remain in the development of MucoCept HIV for human clinical testing, Dr. Qiang Xu, Principal Investigator of the funded study and Director of MucoCept Research at Osel, Inc., said "my thanks and gratitude at this announcement must go to our project team and scientists at multiple institutions for jointly advancing the development of our MucoCept bacteria as a potential topical microbicide."
The microbicide field has built significant momentum in recent years, with the introduction of the Microbicides Development Act in the U.S. Senate on March 8, 2005 and several first-generation candidates entering large-scale human clinical trials around the world. To be used globally, microbicides need to be inexpensive to manufacture, safe, and effective at reducing the transmission of HIV.
BV is a common syndrome that afflicts over 16 million women every year, in the U.S. and EU alone. It is characterized by a depletion of vaginal hydrogen peroxide-producing lactobacilli and a dramatic increase in organisms associated with BV. A deficiency of hydrogen peroxide-producing lactobacilli has been associated with an increased risk of STIs, including HIV and Herpes Simplex Virus-2 (HSV-2).
About Osel
Osel, Inc. is the leading company in the emerging field of Bacterio-Therapeutics. The company's business is based on exploiting recent scientific discoveries demonstrating the central role of naturally occurring mucosal bacteria in the maintenance of health and the prevention of disease. Osel's technologies are focused on harnessing the mucosal microflora in two complementary ways. First, we identify the most appropriate naturally occurring bacteria to treat and prevent diseases caused by disruptions in the protective microflora. Second, we develop technologies to genetically enhance the capabilities of these bacteria to combat disease-causing organisms, represented by the MucoCept line of second-generation products. Osel is conducting two Phase II clinical trials of LACTIN-V (a vaginal capsule containing a natural human Lactobacillus crispatus), one for the treatment of recurrent urinary tract infection (RUTI), and a second for recurrent bacterial vaginosis (RBV). Osel is also preparing to take to the clinic its in-licensed CDACTIN-O bacterial product candidate for the prevention of antibiotic associated diarrhea (AAD).
Contact: Ralph Levy
President, Osel Inc.
Phone: 408-986-0012 ext. 206 -- Cell: 415-699-0135
Email: rlevy@oselinc.com
SOURCE Osel, Inc.
Web Site: http://www.oselinc.com
050609
PR050614
Copyright © 2005 - PRNewswire. All rights reserved. Reproduced with permission. Reproduction of this article (other than one copy for personal reference) must be cleared through PRNewswire, Permissions, 810 Seventh Ave., 32nd Floor, New York, NY 10019 http://www.prnewswire.com.
AEGiS is a 501(c)3, not-for-profit, tax-exempt, educational corporation. AEGiS is made possible through unrestricted grants from Boehringer Ingelheim, Bridgestone/Firestone Charitable Trust, Bristol-Myers Squibb Company, Elton John AIDS Foundation, the National Library of Medicine, Roche and Trimeris, and donations from users like you. Always watch for outdated information. This article first appeared in 2005. This material is designed to support, not replace, the relationship that exists between you and your doctor.
AEGiS presents published material, reprinted with permission and neither endorses nor opposes any material. All information contained on this website, including information relating to health conditions, products, and treatments, is for informational purposes only. It is often presented in summary or aggregate form. It is not meant to be a substitute for the advice provided by your own physician or other medical professionals. Always discuss treatment options with a doctor who specializes in treating HIV.
Copyright ©1980, 2005. AEGiS. All materials appearing on AEGiS are protected by copyright as a collective work or compilation under U.S. copyright and other laws and are the property of AEGiS, or the party credited as the provider of the content. .