Tom, along the lines of your 11/3 post...
<<The problem with peptides is that they are large molecules that have difficulty getting into the mucosa of the gut. Right now, these molecules are administered by injection. Once researchers get them into a "...soluble form that is orally available...I think you're going to have something that is really hot."...>>
Cel-Sci Corp. has news today that indeed is looking promising, IMO:
CEL-SCI Announces Data from Phase II HIV Vaccine Study
<<<HGP-30W Is the Only AIDS Vaccine in Human Studies Designed to Work Against Subtype C, the Most Prevalent HIV-1 Subtype in the Developing World
VIENNA, Va., Nov. 22 /PRNewswire/ -- CEL-SCI CORPORATION (Amex: HIV) (Berlin Stock Exchange: LSR), in response to media questions in advance of World AIDS Day, releases the following statement. Frequently asked questions and answers are as follows:
** Do you have any results from your phase II HIV vaccine study?
The HGP-30W preventive HIV vaccine for HIV-1 subtype C is nearing the end
of a phase II human study in The Netherlands. The volunteers have
completed their vaccinations and follow-up period. Preliminary results
suggest that the vaccine is safe and that it induces both cellular (e.g.,
T-cell) and humoral (antibody) immune responses. Further analyses of the
data for these immune responses are in progress in both the U.S. and the
Netherlands. The Company intends to present the final results at an
appropriate HIV/AIDS conference and/or publish them in a peer-reviewed
scientific journal.
** You have stated before that you want to develop a HIV vaccine for the
developing countries. What have you done that would give your vaccine
a greater chance of working in these countries?
We have never reported this, but our vaccine is based on the HIV-1 subtype
C, which is the most prevalent subtype (about 50% of all HIV infections)
in the world and is dominant in Southern Africa, India and China. Subtype
C seems to spread aggressively in heterosexuals and may in the future
become a problem in the developed world as well. Right now, our sole
focus for the vaccine is to help the developing countries control
infection from HIV-1 subtype C.
** Are there other HIV vaccines in human studies directed against subtype
C?
Not to our knowledge. Several HIV-1 vaccines have been tested or are
currently being tested in the developing world, but all of them are
reportedly based on subtype B, the prevalent subtype in the U.S. and
Western Europe. Only one company has made a vaccine specific to subtype
E, prevalent in Thailand. The HGP-30W HIV vaccine is the only HIV-1
subtype C based vaccine in human studies. This places CEL-SCI several
years ahead of others in the development of a potential preventive HIV
vaccine for countries such as South Africa, India and China, about half of
the world's population.
** Some HIV vaccine studies are being conducted in the developing
countries. Are those vaccines based upon the HIV subtypes of the
developing world or on subtype B, prevalent in the U.S. and Western
Europe?
As noted earlier, all the vaccines we know of, except the one for
Thailand, use the HIV-1 subtype B as the basis of the vaccine. Most
scientists believe that it will be very difficult, if not impossible, to
use a HIV-1 subtype B based vaccine to also protect against HIV-1 subtype
C.
** Does this raise serious ethical questions?
Yes. Serious ethical questions have been and continue to be raised on why
Western researchers and pharmaceutical companies are conducting human
studies in the developing world with HIV-1 vaccines designed for the U.S.
and Western Europe. When we reviewed this question several years ago, we
could not justify the use of a vaccine based on the HIV-1 subtype B for
clinical trials in Africa or Asia. Therefore, once we made the decision
to design a vaccine for the developing countries, we redesigned our HGP-30
HIV vaccine to work primarily against their biggest threat, HIV-1 subtype
C.
** Who will pay for the vaccine in the developing world?
Earlier this year, the World Bank announced that it was planning to set up
a $5 billion fund to help developing countries purchase those HIV vaccines
proven to be effective.
Background on HGP-30W AIDS Vaccine:
The HGP-30W AIDS vaccine is a synthetic peptide vaccine that is based
on a relatively well-conserved (non-mutating) region of the HIV core
protein p17. The amino acid sequence of HGP-30W contains at least 2 CTL
epitopes as well as T- and B-cell epitopes, which elicit both cytotoxic
and helper T-cell immune responses directed towards HIV-1. CTL responses
against one of the epitopes found in the HGP-30W HIV vaccine have also
been found to be present in HIV-infected long-term non-progressors. This
indicates a possible correlation between the presence of these specific
CTLs and the lack of disease progression.
In contrast to vaccines based upon an outside piece of the virus (the
envelope) which mutates rapidly, making protection very difficult to
achieve, the HGP-30 region of HIV is relatively well-conserved
("non-changing target").
The vaccine is designed to preferentially induce cellular (e.g. T-cell)
immune responses that can kill and remove virus-infected cells, while the
envelope-based vaccines primarily induce neutralizing antibodies that bind
free virus circulating in the blood, but cannot kill virus within the
infected cell.
In a study published in the January 1999 issue of Vaccine, researchers
at the University of Nebraska Medical Center reported that the HGP-30 AIDS
vaccine demonstrated 78% protection against HIV infection in an in vivo
human surrogate virus challenge model (SCID mouse).
The vaccine had previously been tested in two human studies in the U.S.
and U.K. and was found to be safe and immunogenic. In June of 1998,
CEL-SCI started a phase II clinical trial in The Netherlands with a HIV
vaccine targeted towards the HIV-1 subtype C (HGP-30W). This vaccine has
been designed to work best against the virus subtype prevalent in Southern
Africa, India and China.
More information on this vaccine is available at cel-sci.com.
When used in this report, the words "intends," "believes," "anticipated," "expects" and "suggest" and similar expressions are intended to identify forward-looking statements. Such statements are subject to risks and uncertainties which could cause actual results to differ materially from those projected. Factors that could cause or contribute to such differences include an inability to duplicate the clinic results demonstrated in preclinical studies, timely development of any potential products that can be shown to be safe and effective, receiving necessary regulatory approvals, difficulties in manufacturing any of the Company's potential products and the risk factors set forth from time to time in CEL-SCI Corporation's SEC filings, including but not limited to its report on Form 10-K for the year ended September 30, 1998. The Company undertakes no obligation to publicly release the result of any revision to these forward-looking statements which may be made to reflect the events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.>>>
SOURCE CEL-SCI Corporation
CO: CEL-SCI Corporation
ST: Virginia
IN: MTC
SU:
11/22/1999 09:01 EST prnewswire.com |
