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Biotech / Medical : Cel-Sci Corp (AMEX:CVM) (was HIV) -- Ignore unavailable to you. Want to Upgrade?


To: Tom Shutters who wrote (2737)11/4/1999 5:15:00 PM
From: Toni Wheeler  Read Replies (1) | Respond to of 2836
 
Thanks, Tom, for keeping us abreast of the latest research and conferences.

Interestingly, Raging Bull highlighted BCHE today on the site's opening page:

ragingbull.com

<<<Today's Biowatch spotlight is on BioChem Pharma (BCHE), a top-tier biotech organization with a very low profile. Ever hear of miracle AIDS drug 3TC, used in combination therapy with AZT and protease inhibitors to create the now-famous "AIDS cocktail"?...

...BioChem's next-generation AIDS drug is dOTC, which has shown strong efficacy in clinical studies to date. However, results from a study conducted with dOTC in primates showed unexpected toxic effects....

...On Monday, a federal advisory panel rejected Gilead Sciences' (GILD) anti-HIV adefovir dipivoxil pill for fighting resistant strains of the HIV virus that causes AIDS. The panel vote wasn't even close, 13-1 against recommending approval.>>>...

These drugs and their 'cocktails' have their perils. This is even MORE reason to develop an effective VACCINE!

Also noted:

...<<<BioChem was the company that developed 3TC, but many investors think it was co-marketer Glaxo Wellcome (GLX) who created the product...

...However, BioChem does not book 3TC sales, and only receives royalties in the vicinity of 10% to 15%, a terrible deal for BioChem. I guess BioChem didn't realize the potential of this product when it was in early clinical trials.>>>...

It seems Cel-Sci's management doesn't want the same fate!! Which, BTW, I consider a wise decision.

My best,
T.



To: Tom Shutters who wrote (2737)11/12/1999 4:08:00 PM
From: Tom Shutters  Read Replies (1) | Respond to of 2836
 
"CEL SCI CORP files for employee plan."

newsalert.com



To: Tom Shutters who wrote (2737)11/22/1999 11:57:00 AM
From: Toni Wheeler  Read Replies (1) | Respond to of 2836
 
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