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VOLUME
05: ISSUE 58
Trading
Alert: Novelos - Compounds Beat Up On Cancer and Hepatitis.
Before
we detail the amazing potential of the cancer/hepatitis fighting therapies
developed by Massachusetts-based Novelos Therapeutics (OTCBB:
NVLT), we thought that as a reference, it would be of value to
table our past smallcap biotech picks. As you can see, we're extremely
particular as to the companies we follow and are very pleased to welcome
Novelos to that number.
We are confident that investors will
find the Novelos story --which SmallCap readers are among the first
to hear of--unique and, in our opinion extremely profitable as
the company executes its solid plan to bring it's impressive life-saving
therapies through Phase testing and to eventual commercialization.
There's a lot to this story, but
the premise is simple: save and/or improve the quality of patients' lives
afflicted with some of the world's deadliest diseases. Read on...
Salient Investor Points Regarding
Novelos:
Came public June 2005 @ $2.00. Company
well under the radar, for now.
26 million shares outstanding/Market
Cap approximately $80 million.
Proprietary Oxidized Glutathione-based
compounds. Seven patents granted and 30 more filed worldwide.
Oxidized Glutathione-based compounds
simple to manufacture: inexpensive and scaleable.
NOV-002 primarily a therapy for improving
treatment of cancer in conjunction with chemotherapy.
Lung Cancer market alone roughly $1
billion.
NOV-002 clinical data shows effectiveness
in treating platinum-refractory (chemotherapy resistant) ovarian cancer.
HomeLand Security potential as NOV-002
demonstrates effectiveness in the treatment of radiation exposure from
weapons (dirty bombs) or nuclear accidents.
Russian studies completed and NOV-002
product approved under name 'Glutoxim' in Russia (marketed by an unrelated
company). Has been successfully administered to over 5000 patients.
Phase 1/2 US lung cancer study completed
for NOV-002--results pending.
NOV-205 shown in Russian studies to
reduce or eliminate viral loads in Hep-B and Hep-C patients.
Hepatitis C market expected to grow
to $10 billion by 2012.
Solid US Clinical Development plan for
both compounds.
Novelos:
Russian Experience Markedly Reduces Investor Risk
We believe that the potential
for Novelos' products for the treatment of cancer and hepatitis is extremely
compelling and suggest accumulation for long-term investors.
First of all it is important to note
that Novelos owns the intellectual property rights (other than Russia)
related to both of its clinical compounds--NOV-002 and NOV-205--as well as
other pre-clinical compounds based on oxidized glutathione, a natural metabolite.
NVLT's compounds are believed to
act via glutathiolation of critical regulatory immune function, tumor progression
(in combination with chemotherapy), and drug detoxification.
Both
of Novelos' compounds have completed clinical trials in Russia and are
approved for use in that country. In the treatment of Non Small Cell Lung
Cancer (NSCLC) the administration of NOV-002 increased the one-year survival
rate from 17 percent to 63 percent. As the US has a 35 percent one-year
NSCLC survival rate, the Russian study improves on that number by 80 percent.
(see chart below)
Novelos
President Harry Palmin stated: "Taking NOV-002 in combination with toxic
chemotherapy, patients in Russian clinical studies immediately began to
feel better, their blood and immune indices improved, they were able to
take more cycles of chemotherapy, all of which translated into a survival
advantage".
Novelos
has completed a US Phase 1/2 NOV-002 trial and preliminary results will
likely confirm the Russian experience. Novelos plans a Phase 3 trial in
Q2 2006. The lung cancer market in the US is approximately $1 billion.
One really exciting aspect to NOV-002
is its potential effectiveness in increasing the receptivity and sensitivity
of chemotherapy to currently resistant cancers such as ovarian. This $280
million market lacks effective treatments, as do other types of ' platinum
resistant' cancers. NOV-002 could well improve the survival rate for those
patients with these treatment-resistant forms of cancer by improving the
diseases' reception to chemotherapy, which to date has had little or no
effect.
NOV-205 Beats up on Hepatitis
B and C.
Picture, thousand words; you know
the rest.
The following chart below shows the
effectiveness of NOV-205 in the treatment of Hepatitis B and C courtesy
of recent Russian studies. Pay particular attention to the lower
Hep' C' graphic.
Hepatitis
C is a particularly nasty disease. It is a potentially fatal liver infection.
The global treatment market is expected to exceed $10 billion by 2012.
The very few current treatments have vicious side effects and tend to be
very expensive. NOV-205 has shown no toxicity so far and is inexpensive
to produce, thereby giving a significant pricing/margin advantage. Current
drugs are only indicated in 15-20 percent of cases. NOV-205 is anticipated
to be useful in all Hep C cases. Two-month treatments of NOV-205 in the
Russian studies reduced the viral load below the point of detection in
50 percent of patients and substantially improved liver function. Nothing
else, so far, even comes remotely close to this result--especially with
the impressive safety and efficacy profile.
Simple, Inexpensive and Already
Effective...
In our opinion, Novelos represents
a company that has simple, safe and inexpensive proprietary therapies to
treat some of the world's truly devastating afflictions. Investors should
be impressed not only with the technology, but with the in-depth data gained
from years of study, administration and patient success in Russia. As well,
and just as importantly is the strong patent profile the company has secured,
particularly in the US, Japan and Europe.
Novelos is focused and well capitalized
(release below). We are also awaiting the results of its Phase 1/2
NOV-002 trial, which are expected to support the previous Russian findings.
The company appears to know exactly what it wants to do, when it will do
it and is executing on schedule.
As we mentioned in our previous
piece, Novelos, as a Phase1/2 company should be higher in the $70-$100
million market cap range represented in other companies. As the company
progresses through the regulatory requirements and moves to commercialization,
we believe that the share price will rise in concert. In essence, NVLT
is currently at the lower end of that range, so we see lots of room for
share price growth.
Novelos' products work, as noted
by the extensive Russian experience and studies. Investors who want to
participate in the amazing potential that we feel Novelos represents should
accumulate at current levels. We expect great things from Novelos and look
forward to bringing you opinion and commentary as this unique and exciting
story unfolds.
We suggest that investors strongly
consider a position in Novelos in the biotech portion of a portfolio for
what we feel will be superior long-term gains.
NB: EDEN ENERGY (OTCBB:
EDNE) shareholders/traders need to go to the SCBLOG
for an important trading announcement regarding the recent run-up in the
EDNE share price.
Press Release
NOVELOS THERAPEUTICS
COMPLETES $4 MILLION FINANCING
NEWTON, Mass., August
1, 2005 -- Novelos Therapeutics, Inc. (OTCBB:
NVLT), a biotech company focusing on oxidized glutathione for use in
fighting cancer and hepatitis, announced today that it has completed a
private offering of $4,150,000 to accredited investors.
The Company sold a total
of 166 Units, each Unit consisting of 20,000 shares of common stock and
a three-year warrant to purchase 10,000 shares of common stock at an exercise
price of $2.25 per share, at a purchase price of $25,000 per Unit.
The proceeds from this transaction will be used for general corporate purposes,
including clinical trials, research and development. vFinance Investments,
Inc. and Mercer Capital, Ltd. were the placement agents for the offering.
About Novelos Therapeutics,
Inc.
Novelos Therapeutics,
Inc. (OTCBB: NVLT) was established in 1996 to commercialize two promising
oxidized glutathione based compounds, NOV-002 and NOV-205, for the treatment
of cancer and hepatitis. Both compounds have completed clinical trials
in humans and have been approved for use in the Russian Federation where
they were developed. NOV-002, marketed in Russia by an unrelated
entity under the trade name GLUTOXIM®, has been administered to over
5,000 patients, demonstrating clinical efficacy and excellent safety data.
The U.S. based Phase 1/2 clinical trial of NOV-002 for lung cancer has
been completed. The Company plans to file an IND with the FDA for
NOV-205 as a mono-therapy for hepatitis C in 2005.
About the Products
NOV-002, the lead compound,
is being developed to treat non-small cell lung cancer (NSCLC). NOV-002
is designed to act as a cytoprotectant and an immunomodulator. When
used in combination with chemotherapy, NOV-002 increased the one-year survival
rate from 17% to 63% in a Russian study, a result that also represents
an 80% improvement above the U.S. 35% current standard of care. A
U.S. Phase 1/2 clinical study has been completed.
NOV-002 is also being
developed to treat refractory (that is, not responsive to chemotherapy)
ovarian cancer. Two additional clinical indications, radiation protection
and psoriasis, will also be investigated for NOV-002.
NOV-205 is being developed
to treat chronic hepatitis C in the U.S. NOV-205 is designed to act
as a hepatoprotective agent with immunomodulating and antiviral activity.
In Russian clinical studies, when used as mono-therapy for one month in
hepatitis B and for two months in hepatitis C, NOV-205 has been shown to
greatly reduce or eliminate viral loads and to vastly improve liver function
relative to existing drugs on the market.
COMPANY CONTACT
Harry S. Palmin, President
and Acting CEO
Novelos Therapeutics,
Inc.
One Gateway Center,
Ste. 504
Newton, MA 02458
Ph: 617-244-1616 ext.11
Fax: 631-574-3130
Email: hpalmin@novelos.com
INVESTOR RELATIONS
Stanley Wunderlich,
CEO
Consulting for Strategic
Growth
800 Second Avenue
New York, NY 10017
Ph: 800-625-2236
Fax: 212-337-8089
Email: CFSG1@aol.com
This news release contains
forward-looking statements. Such statements are valid only as of
today, and we disclaim any obligation to update this information.
These statements are subject to known and unknown risks and uncertainties
that may cause actual future experience and results to differ materially
from the statements made. These statements are based on our current
beliefs and expectations as to such future outcomes. Drug discovery
and development involve a high degree of risk. Factors that might
cause such a material difference include, among others, uncertainties related
to the ability to attract and retain partners for our technologies, the
identification of lead compounds, the successful preclinical development
thereof, the completion of clinical trials, the FDA review process and
other government regulation, our pharmaceutical collaborators' ability
to successfully develop and commercialize drug candidates, competition
from other pharmaceutical companies, product pricing and third-party reimbursement.
Consulting For Strategic
Growth I, Ltd. ("CFSG") has a June 1, 2005, contract to provide Novelos
with consulting, business advisory, investor relations, public relations
and corporate development services for a three-month period. In connection
with these services, CFSG prepares press releases, corporate profiles,
and other publications on behalf of the Company. Independent of CFSG's
receipt of cash compensation from the Company, CFSG may choose to purchase
the common stock of the Company and thereafter liquidate those securities
at any time it deems appropriate to do so.
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