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VOLUME
03: ISSUE 39
CEL-SCI
joins exciting HIV/HPV initiative.
Perhaps
investors don't remember what can happen when the AIDS community gets behind
a drug or therapy.
CEL-SCI
(AMEX: CVM) announced
today that they has become part of a group that will create The National
HPV Co-Infection Alliance. Other partners include national AIDS organizations,
advocacy groups, the HPV Foundation and pharma company Chronimed (NASDAQ:
CHMD).
The Alliance's mandate, described
in the enclosed press release, is: "to educate the public about the growing
HPV epidemic and to pursue the U.S. government for clinical research support.
Currently, the U.S. government is pursuing no clinical studies for the
treatment of HIV/HPV co-infected women."
Anyone familiar with AIDS treatment
has heard of current therapies encompassing Protease Inhibitors as well
as earlier AIDS drugs still on the market. If it were not for AIDS' community's
activities and the R&D and subsequent availability of these AIDS therapies
would not be anywhere near where they are today. That said, while over
$8 billion is spent on AIDS research annually, nothing is spent on HIV/HPV
co-infection. The Alliance's goal is to get significant dollars allocated
for clinical trials.
Given Multikine's early trial results
and potential efficacy, CEL-SCI stands to not only help drive awareness,
but be on the cutting edge of new therapies targeted at co-infection.
Multikine at the forefront
This
initiative should allow CEL-SCI to further research and develop its flagship
drug, Multikine, which, according to CEO Geert Kersten, "is the only drug
to have shown safety characteristics, as well as activity against both
the cervical dysplasia and the HPV virus causing the dysplasia, in HIV/HPV
co-infected women."
HPV, or the Human Papilloma Virus,
is responsible for the development of virtually all cases of cervical cancer.
HIV infected women especially have shown a statistically relevant increased
risk between that virus and this type of disease, which is second leading
cause of cancer deaths. Condoms have shown little or no effect against
HPV transmission. Education and treatment of this co-infection is the goal
of the Alliance and by lobbying the government through the groups involved,
as well as raising public awareness, it is hoped that new therapies will
garner both funding and faster FDA approval. The official launch of the
Alliance will take place in mid-September, 2003 at the US Conference on
HIV/AIDS in New Orleans. The ultimate goal is to have HPV recognized as
the major public health threat to people with AIDS at the World AIDS Conference
in July 2004.
Education is Power and potential
treatment.
Early Multikine data from CEL-SCI
makes it an integral part of this initiative. CEO Kersten states; "most
other drugs tested so far have failed due to toxicity in these co-infected
women, and because we know of no other drug that attacks both the dysplasia
and the virus simultaneously."
The Alliance's creation an exciting
and augers well for the treatment of HIV/HPV as well as for CEL-SCI. By
raising awareness it will bring potentially effective drugs to the attention
of those who hold the social policy and biotech R&D purse strings.
The ability to combat this scourge which, as the most prevalent sexually
transmitted disease in the world, can occur in up to 75 percent of sexually
active women well deserves serious research and financial attention.
The Alliance intends to bring the
disease from obscurity to a top priority.
Doing so can only be good for those
afflicted with this potent virus, as well as for CEL-SCI's continuing effort
to bring Multikine to market for this and a host of other viral applications.
PRESS RELEASE
VIENNA, Va., July 22 /PRNewswire-FirstCall/
-- CEL-SCI Corporation (Amex:
CVM) has joined with several AIDS organizations and advocacy groups,
the HPV Foundation and Chronimed (NASDAQ:CHMD) to create the "The National
HPV Co-infection Alliance." The Alliance was created to address the
growing epidemic of Human Papillomavirus (HPV) amongst patients infected
with HIV (human immunodeficiency virus). HPV is the world's leading
sexually transmitted virus. HPV is also a growing problem in HIV-infected
women since their damaged immune system is unable to clear the HPV virus,
which in turn leads to serious health complications, including cervical
cancer. Cervical cancer is the second leading cause of cancer deaths
in women worldwide.
HPV is also a growing problem in
non-HIV infected patients. It is estimated that more than 50% of
college age women have been exposed to HPV. Gregory S. Henderson, MD, PhD,
President of the HPV Foundation and author of the book "Women At Risk -
The HPV Epidemic and Your Cervical Health", states that, "HPV infection
is now known to be the cause of the majority of cancers of the female genitalia,
including the cervix, vagina and vulva, and is thus a leading health problem
in non-HIV-infected women. Numerous studies show that up to 50% of
college-aged women and men become infected with HPV. A large concern
among women who have HPV-induced cervical dysplasia (pre-cancerous growth
potentially leading to cervical cancer) is that the treatment of this disease
can require surgical procedures such as hysterectomy or procedures which
can, in some cases, lead to cervical incompetence and the inability to
bear children. This incredibly common sexually transmitted disease
can have devastating consequences, and yet the existence of this epidemic
is essentially unknown to the "
Tony Zappa, Pharm. D., MBA, and Executive
Vice President of Operations of Chronimed, a leading distributor of HIV/HCV
co-infection treatment, said, "Given the high co-infection rate between
HIV and HPV, and the very limited knowledge of and around HPV within the
general public and infected individuals, Chronimed is very interested in
participating in this initiative to provide education and medication support."
It is envisioned that the "National
HPV Co-infection Alliance" will encompass municipal health authorities,
pharmaceutical and biotechnology firms, AIDS service organizations (ASOs)
and non-profit entities. Its goal is to educate the public about
the growing HPV epidemic and to pursue the U.S. government for clinical
research support. Currently, the U.S. government is pursuing no clinical
studies for the treatment of HIV/HPV co-infected women.
The initial campaign, dubbed, "Get
Tested, Get Treated", will include a series of public service announcements
(PSAs), treatment education symposiums directed at providers and patients,
presentations at AIDS Education Treatment Centers (AETCs), an HIV Clinical
Education Initiative (HCEI), and other similar programs throughout the
U.S.
"Our immunotherapy drug Multikine(R)
is the only drug to have shown safety characteristics, as well as activity
against both the cervical dysplasia and the HPV virus causing the dysplasia,
in HIV/HPV co-infected women. These findings should put Multikine
at the forefront for testing of drugs geared to these co-infected women
because most other drugs tested so far have failed due to toxicity in these
co-infected women, and because we know of no other drug that attacks both
the dysplasia and the virus simultaneously. We are very pleased to
see that other organizations are willing to join us in this fight for the
search for an effective treatment for these women," said Geert Kersten,
Chief Executive Officer, CEL-SCI Corporation.
Human Papilloma Virus (HPV) is the
most prevalent sexually transmitted infection in the world, occurring at
some point in up to 75% of sexually active women (Groopman 1999).
Although HPV infection is widespread, most women are unaware that they
are infected because they seldom have noticeable symptoms. Almost
all cervical cancers (99.7%) are directly linked to previous infection
with one or more of the oncogenic (cancer-inducing) types of HPV (Judson
1992; Walboomers, et al 1999). Unlike other STDs, barrier protection
such as condoms, is not effective against HPV transmission. There
is substantial evidence that HIV-positive women are at increased risk of
developing cervical cancer as well (Judson 1992). In two studies,
both from areas with high HIV prevalence, a statistically significant association
between HIV and cervical cancer was reported.
Rona Taylor, a member of the New
York City Women's HIV Collaborative, stated that, "HPV expression persists
longer in HIV-1 infected women with rising rates of infection for women
of color. There are indications of a continued measurable rise in morbidity
and mortality in HPV/HIV co-infection. Public awareness and education should
be made a priority if efforts and advances are to be made in this arena."
"Our milestone achievement will be
to have HPV recognized at the 15th World AIDS Conference in July 2004 as
the threat it truly is to the health of people with AIDS," said Jeannie
Gibbs, the Northeast regional campaign director of the National HPV Co-infection
Alliance, who also serves as a board member of the AIDS Action Council
(www.aidsaction.org). "We are actively recruiting regional directors
across the country and planning to ensure that HIV/HPV co-infection gets
the attention it so obviously deserves. Federally sponsored clinical
trials need to receive top priority".
The official launch of the campaign
"Get Tested, Get Treated" is scheduled to take place at a reception at
the seventh annual United States Conference on HIV/AIDS (USCA), sponsored
by the National Minority AIDS Council (NMAC), (www.nmac.org), on September
18-21, 2003 in New Orleans, Louisiana. The USCA attracts over 3,000
service providers, people living with HIV/AIDS, policymakers, public officials,
funders and other leaders each year, making it the largest U.S. AIDS-related
gathering.
CEL-SCI Corporation's drug, Multikine,
a patented immunotherapeutic agent consisting of a mixture of naturally
occurring cytokines, has been tested in over 190 cancer and HIV patients.
It has been shown to be safe, to reduce and/or eliminate tumors and to
render the remaining cancer cells highly susceptible to follow-on radiation
and chemotherapy.
Chronimed, Inc. distributes pharmaceuticals
and provides specialized patient management services nationwide for people
with long-term chronic conditions, including HIV/AIDS, organ transplants
and diseases treated with injectable medications. StatScript Pharmacy
is a nationwide network of community-based specialty pharmacies with 27
retail locations.
When used in this report, the words
"intends," "believes," "anticipated" and "expects" 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
clinical results demonstrated in clinical 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, inability to raise the necessary capital
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, 2002. 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;
HPV Foundation; Chronimed; National Minority AIDS
Council; NMAC
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