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VOLUME
03: ISSUE 37
CEL-SCI:
Of Patents, Peer reviews and Milestones met.
At the beginning of 2003, CEL-SCI
(AMEX:
CVM) CEO Geert Kersten outlined a series of corporate milestones
for the year.
Goal: Attract $1 million in grants.
Result: $1.4 million attracted year-to-date
as well as an extensive collaborative research initiative with the National
Institute of Health and the US Army to test CEL-1000 as a treatment for
SARS, West Nile and other diseases, at virtually no cost to CVM.
Goal: Publication of peer-reviewed
studies.
Result: Two articles on applications
and data for CEL-SCIís Herpes vaccine, and cancer immunotherapy
Multikine, have been accepted by leading journalsópublication pending.
Goal: Gain approval from the FDA
for Phase III Multikine trials.
Result: Application process continuing
for approval--hopefully, later this year.
Goal: Deals with distribution partners.
Result: One eastern European partner
announced. Discussions with others ongoing.
Spreading the word in Europe
CEO Kersten and his team have just
finished up a week-long European road trip during which they detailed the
companyís story and product potential to more than 20 major investment
institutions. With the recent announcement of the acceptance of the third
party, peer-reviewed article regarding Multikine in a leading oncology
journal, the institutions can begin a due diligence process-- which could
well result in major share purchase decisions.
Further,
CVM has announced two more patent applications that will protect both the
company and its shareholders once Multikineís efficacy is borne
out. Patents pending give the company a 20-year exclusive on its key therapies
as the application process moves towards, hopefully, full approval. The
press release for the latest Multikine patent application is included below
for your perusal.
CEL-SCIís shares have sold
off recently following their meteoric rise from 20 cents to $1.40 in May.
Currently at 75 cents, the trading activity seems to have settled at this
level after retracing 50 percent of that rise. No doubt, investors are
waiting for Phase III approval, but in the interim the company has demonstrated
it can meet goals and get its story out. The recently announced $10 million
share shelf registration added some potential dilution to the stock and
that has likely muted the share price in the short term. As the timeline
for the sale of those shares--the net proceeds of which will be used for
research and development-- is indeterminate, investors should focus instead
on the bigger picture which, while still speculative, is gaining credibility
with each passing month.
Risk tolerant investors might establish
and/or maintain positions at this level and plan to buy on dips should
they occur. Rallies, short of substantive news, can be used for trading
opportunities, but a core position should be maintained. Timing for the
publication peer-reviewed articles is unknown, but once these pieces appear,
the shares may move higher as the investment and biotech communities review
the data.
Imclone Versus CEL-SCI
In the past, we have compared CVM
to an early stage Imclone (NASDAQ:
IMCL). The latteróstill losing money and primarily banking
almost solely on its cancer drug Erbituxóhas a market cap of $2.6
billion. Its shares trade for $35 a share. CVM also makes no money as yet,
but has a selection of potentially broad-ranging, novel cancer/viral disease
therapiesóany of which could be blockbusters down the road. With
a market cap of $34 million, IMCL shares trade for 75-80 cents. One glitch
with Erbitux--as has happened before-- and IMCL tanks. Given the stage at
which each company finds itself, I leave it to you do decide which makes
more sense to the speculative investor. And which has more potential.
Imclone is on virtually every investorís
radar screen. CVM isnít--as yet. However, CEL-SCI's management is
working effectively to increase the companyís visibility to investors,
the biotech community and potential partners. I would submit that while
that process has only begun, its profile has already improved significantly
evidenced by recent trading volumes and focused corporate initiatives.
Multikine
represents a revolutionary therapy that may lead to improving cancer treatment
without any severe side effects. In essence, Multikine supercharges the
patientís immune system to effectively fight the targeted disease.
Early data has shown, according to the company: ìthat the use of
CEL-SCIís immunotherapy drug Multikine during a two-week period
prior to surgical intervention affected the tumor such that the residual
tumor cells became more susceptible to follow-on treatment with radiation,
and possibly chemotherapy.î The findings will be further refined
and expanded once Phase III trial approval is wonópotentially, later
this year.
For those who want a piece of this
vision and potential, waiting to purchase CEL-SCI shares at year-end may
well be too late. Due to the nature of the biotech business, youíll
likely not receive enough warning before the train leaves the station.
Best to be on it, get comfortable
and wait for the ëall aboardí.
Got questions or comments? Send 'em
here: editor@smallcapnetwork.com
Press Release
CEL-SCI Files Patent Application
for Multikine(R) Drug to Enhance Radiation and Chemotherapy
Monday July 14, 9:01 am ET
VIENNA, Va., July 14 /PRNewswire-FirstCall/
-- CEL-SCI CORPORATION (Amex:
CVM - News) has filed a patent application covering the use of
its immunotherapy product Multikine for the enhancement of the response
to and success of radiation and chemotherapy. The supporting data was derived
from a clinical trial with Multikine in head & neck cancer patients.
That data has recently been accepted for publication by a leading peer-reviewed
oncology journal.
Data from this trial indicated that
the use of CEL-SCI's immunotherapy drug Multikine during a two-week period
prior to surgical intervention affected the tumor such that the residual
tumor cells became more susceptible to follow-on treatment with radiation,
and possibly chemotherapy. This is a very important new finding which may
lead to a better and more effective treatment for many forms of cancer.
Geert Kersten, Chief Executive Officer
of CEL-SCI, said, "This patent should protect one of the largest applications
for Multikine, namely its use to increase the success of radiation, and
possibly chemotherapy, for a long time."
Multikine, a natural mixture of human
cytokines, has to date been tested in over 190 cancer, HIV and HIV/HPV
infected patients with no severe adverse events related to Multikine administration.
It is under clinical investigation for the treatment of head & neck
cancer and for the treatment of cervical dysplasia caused by the Human
Papilloma Virus (HPV). Multikine is an immune adjuvant with direct anti-viral
and anti-cancer activities, assisting in host immune response reconstitution.
CEL-SCI Corporation is developing
new immune system based treatments for cancer and infectious diseases.
The Company has operations in Vienna, Virginia and Baltimore, Maryland.
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
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