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| BioOncology
Investing .... Understanding Anti-Cancer Drugs in the
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Ed Wijaranakula, Ph.D.
Chief Investment Strategist, Infotix
Systems, Inc. - July 15, 2004
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According to
the U.S. National Center for Health
Statistics [1], heart disease,
malignant neoplasms (cancer) and cerebrovascular diseases
(stroke) are the three leading causes of
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death in the United States, representing 58.6 percent of
the total deaths reported in the year 2001. While the leading
cause of cancer death for both men and
women is lung cancer, prostate cancer is the second
cause of cancer death in men, behind lung cancer.
The Phase III clinical trials of
potential oncology drug candidates, Tarceva™
and Provenge®,
are underway to evaluate the safety and potential effectiveness
in treating patients with non-small cell lung cancer (NSCLC) and prostate cancers. Successful development and commercialization
of these two new drugs could mean significant
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generation for the biotechnology and
pharmaceutical companies involved. The National
Institutes of Health estimates that Americans
spend $61 billion in direct medical costs for
cancer treatment each year.
Non-Small Cell
Lung Cancer Drugs - NSCLC is a disease in which malignant cells form in the tissues of the
lung, accounting for almost 80 percent of the total lung
cancer cases.
This
year, the American Cancer
Society estimated
173,770 new cases and 160,440
deaths from lung cancer in the United States
alone [2]. According to the National Institutes of Health,
the present standard treatments, including radiation therapy and chemotherapy, do not cure the
cancer in most patients with NSCLC. However, patients who have relapsed after standard
therapies can be subject to treatment options that are currently in clinical
trials.
One of the treatment options is a target drug, taken
orally,
called Erlotinib. Erlotinib works by attaching itself to
the epidermal growth factor receptor (EGFR), a protein
found on the surface of cells, and thereby inhibiting
the attachment of the EGFR to the epidermal growth factor
(EGF). In cell biology, an attachment of the EGFR to the
EGF activates the enzyme tyrosine kinase, which causes
the cell to grow and multiply. Hence, an EGFR inhibitor
will cause cells to stop growing. Human epidermal growth
receptor 1 (HER1) is one of the several proteins which
are found on the surface of many tumor cells.
Tarceva™ (Erlotinib
HCl),
co-developed and commercialized by OSI Pharmaceuticals,
Inc. (NASDAQ: OSIP), Genentech (NYSE:DNA), and
Switzerland's Roche Holdings, is a small molecule HER1/EGFR
inhibitor. The drug is designed to inhibit the tyrosine
kinase activity of HER1 and stop tumor cell growth. Last
month at the American Society of Clinical Oncology (ASCO)
annual meeting, OSIP presented the results based upon
731 patients with advanced NSCLC
whose disease had progressed after one or two courses of
chemotherapy. It was found that the median survival
among patients who took Erlotinib was 6.7 months
compared to 4.7 months for those on a placebo. At one
year, 31 percent of the patients taking Erlotinib were
still alive compared to 22 percent of those taking the
placebo.
Prior to the
ASCO meeting, the company released a preliminary finding
which then sent the OSIP share price to an all-time high
of $98.70 on April 26. Without any additional exciting
news, the OSIP share price could fall back to a support
level of ~ $55. The mean 12-month price target for OSIP
shares, based upon Thompson/First Call, is ~
$107.00. |
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Last month, Tarceva™
was
accepted into the U.S. Food and Drug Administration's Pilot 1 Program for Continuous Marketing Applications. The Pilot 1 Program is designed for products that have been designated Fast Track status and have demonstrated significant promise in clinical trials as a therapeutic advance over available therapy for the disease or condition.
Prostate Cancer Drugs
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Prostate cancer is a malignant
tumor that begins most often in the outer part of the
prostate, affecting men aged 50 and older. In the
United States, prostate cancer affects over one
million men with an estimated 220,000 cases diagnosed and
28,900 deaths reported in 2003. Standard treatments for
prostate cancer patients are surgery, radiation therapy using high-energy x-rays,
and hormone therapy to block testosterone
in the prostate in order to stop
the cancer cells from growing.
A combination of standard treatments and hormone
therapy for early stage prostate cancer using designer
drug "Casodex 150mg", has
shown to be effective in reducing the risk of tumor progression by almost a half
[3]. Casodex 150mg,
which is manufactured by London,
UK-based AstraZeneca
(NYSE ADS :AZN) is however, not approved by the U.S. Food and Drug Administration.
If the
standard treatments fail, patients
may have other treatment options that are currently in clinical
trials. One of the treatment options is biotherapy or
immunotherapy. Immunotherapy is the cancer
treatment that uses the patient’s own immune system to fight
cancer when standard therapies have failed. Provenge®, developed
by Seattle, WA-based Dendreon
Corporation
(NASDAQ:DNDN), and
DCVax-Prostate, developed by Bothell,
WA-based Northwest Biotherapeutics, Inc. (NASDAQ:NWBT),
are two
potential immunotherapy vaccine candidates submitted
into the Phase III clinical trials. The DCVax-Prostate vaccine
clinical trials were suspended in
November 2002 due to financial constraints [4].
Provenge®
is
a vaccine candidate designed to stimulate the immune system to attack cells that express prostatic acid phosphatase (PAP), a protein expressed on approximately 95 percent of prostate cancer cells.
Provenge®
vaccine
works by activating the patient's antigen presenting cells (APCs)
with small pieces of the PAP protein delivered to the
patient's APCs using Dendreon's proprietary Antigen Delivery Cassette technology.
Fully activated APCs, cells of the immune system that
engulf dead or foreign cells and other material, alert
other cells of the immune system, including T-cells, a
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type
of white blood cell or leukocyte, to seek out and destroy PAP-containing prostate cancer cells.
A Phase III clinical trial of Provenge®
(Trial P-11), is now underway to evaluate the safety and potential effectiveness of
Provenge®
in treating men with early stage, androgen dependent prostate cancer. Men whose prostate cancer is responsive to hormone treatment are considered androgen dependent.
Dendreon has research and development alliances with Genentech, Inc., Abgenix, Inc.
(NASDAQ:ABGX) and Dyax Corp (NASDAQ:DYAX). DNDN is now
trading at a support level of ~ $10.55, with a 12-month
price target of ~ $17.00, based upon Thompson/First
Call.
REFERENCES
[1]
U.S. National Center for Health Statistics, National Vital Statistics Report, vol. 51, no. 5, March 14, 2003.
[2] American Cancer Society: Cancer Facts and Figures 2004. Atlanta, Ga: American Cancer Society, 2004.
[3] AstraZeneca's Press Release, AstraZeneca responds to FDA
Action on Supplemental New Drug Application for Casodex
150mg for Early Prostate Cancer, June 21, 2002.
[4] PRNewswire, Northwest
Biotherapeutics, Inc. October 9, 2002.
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About
NMS Research Analysis:
NMS Research Analysis is a service of Infotix Systems, offering
in-depth research analysis of high-tech companies and emerging
technology in sectors ranging from semiconductors, biotech,
nanotechnology, IT hardware and data storage to wireless, Internet
and consumer electronics. Dr. Wijaranakula's portfolio holds long positions
or controls in ABGX, DNA and DNDN.
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