Maxim Pharmaceuticals Expands Testing of Maxamine in Hepatitis
C
SAN DIEGO---(BW HealthWire)---April 3, 2000--Maxim Pharmaceuticals
(AMEX:MMP) (SSE:MAXM) announced the initiation of a clinical study
to evaluate the safety of triple-drug therapy incorporating the
company's lead drug, Maxamine(R), in patients with chronic
hepatitis C infection.
The study will evaluate the safety of treatment with Maxamine in
combination with the immunotherapeutic agent interferon-alpha and
the anti-viral drug ribavirin in 15 hepatitis C patients who were
nonresponsive to prior therapy. The clinical study is being
conducted at the Kaplan Medical Center, Israel.
Maxim also announced that it expects to commence by mid-year a
clinical study to evaluate the safety of Maxamine in combination
with pegylated (sustained release) interferon for the treatment of
hepatitis C patients. Moreover, the company announced that the
24-week results from its 129-patient dose-ranging clinical study of
Maxamine and interferon-alpha for the treatment of hepatitis C have
been accepted for presentation on April 12, 2000 at the 10th
International Symposium on Viral Hepatitis and Liver Disease
sponsored by the U.S. Center for Disease Control and Prevention to
be held in Atlanta. All three studies are intended to position
Maxamine for the commencement of advanced clinical studies in
hepatitis C by the end of this year.
"The interim results reported late last year from our ongoing
Phase II hepatitis C trial suggest that Maxamine may substantially
improve the efficacy of interferon-alpha in the treatment of
hepatitis C," said Kurt R. Gehlsen, Maxim's vice president,
development and chief technical officer. "Maxamine may have the
potential to benefit a number of existing and proposed treatments
for hepatitis C using immunotherapy, regardless of whether that
treatment consists of interferon, pegylated interferon or any form
of interferon administered in combination with anti-viral drugs.
These two new trials are designed to facilitate more advanced
testing of Maxamine in combination with a broad range of
complementary drugs. We are pleased that as a result of the growing
interest in Maxamine both new safety trials will be funded by our
collaborators."
Maxim is currently conducting a 129-patient, dose-ranging
clinical study of the combination of Maxamine and interferon-alpha
in the treatment of chronic hepatitis C. This ongoing study is
designed to determine the most appropriate dose regimen for
Maxamine, and to evaluate the efficacy of combination immunotherapy
using Maxamine in the treatment of chronic hepatitis C.
In late 1999, the company reported that after 12 weeks of
treatment, 72% of the patients treated with Maxamine in combination
with interferon-alpha attained a complete biochemical and viral
response. Published reports suggest that no more than 20-30% of
patients with similar profiles achieve a complete biochemical and
viral response when treated for 12 weeks with interferon alone.
Maxamine, however, is an investigational drug and safety and
efficacy have not been established at this time. The 24-week
clinical results from the ongoing study have been accepted for
presentation April 12, 2000 at the 10th International Symposium on
Viral Hepatitis and Liver Disease.
Hepatitis C
Hepatitis C is more easily transmitted than HIV and is now the
leading blood-borne infection in the United States. The U.S. Center
for Disease Control and Prevention estimates that over 4.5 million
Americans are infected with the hepatitis C virus. The World Health
Organization and other sources estimate that more than 200 million
people are infected worldwide.
Hepatitis is a disease characterized by inflammation of the
liver and, in many cases, permanent cirrhosis (scarring) of the
liver tissues and mortality. The cycle of disease from infection to
significant liver damage can take 20 years or more. Some experts
estimate that without substantial improvements in treatment, deaths
from hepatitis C will surpass those from HIV. Hepatitis C is the
leading cause of liver cancer and the primary reason for liver
transplantation in many countries.
The standard treatment for hepatitis C is interferon-alpha, an
immunotherapeutic agent often given in combination with the
anti-viral drug ribavirin. The majority of patients do not attain a
sustained response with current therapies.
Maxamine Overview
Treatment with Maxamine is based upon the discovery of a universal
mechanism that suppresses the capacity of the immune system to
detect and destroy tumor cells or virally infected cells in many
patients with cancer and chronic infectious diseases. Maxamine is
designed to reverse this immune suppression, thereby enhancing the
effectiveness of immunotherapy, a class of therapies that employ
the body's immune system to fight cancer and certain infectious
diseases.
Maxamine protects critical immune cells and is administered in
combination with cytokines, a class of proteins such as
interleukin-2 and interferon-alpha that stimulate these same immune
cells. More than 1,000 patients have been treated in the company's
completed and ongoing clinical trials in advanced malignant
melanoma, acute myelogenous leukemia, hepatitis C and renal cell
carcinoma. Clinical trial results to date suggest that Maxamine
Therapy, the administration of Maxamine in combination with
cytokines, is a safe, at-home treatment that may improve patient
survival.
Maxim Pharmaceuticals is developing advanced drugs, therapies
and vaccines for cancer and infectious diseases. The Company's lead
drug candidate, Maxamine, is currently being tested in three Phase
III cancer clinical trials in 12 countries for malignant melanoma
and acute myelogenous leukemia. Maxim expects to file its NDA and
report results for its U.S. Phase III study of Maxamine in the
treatment of malignant melanoma in mid 2000.
Phase II trials of Maxamine are also underway for the treatment
of hepatitis C and advanced renal cell carcinoma. The company is
also developing MaxDerm(TM), for the treatment of medical
conditions for which topical therapy is appropriate such as oral
mucositis, herpes, decubitus ulcers, shingles, burns and related
conditions. The company's third platform technology, MaxVax(TM),
now in preclinical development, utilizes a needle-free mucosal
vaccine carrier/adjuvant system for a broad range of infectious
diseases. The company expects to commercialize its technologies
through a combination of in-house development and collaborative
agreements with pharmaceutical companies.
This news release contains certain forward-looking statements
that involve risks and uncertainties. Such forward-looking
statements include statements regarding the efficacy and intended
utilization of Maxamine and the company's clinical trials. Such
statements are only predictions and the company's actual results
may differ materially from those anticipated in these
forward-looking statements. Factors that may cause such differences
include the risk that products that appeared promising in early
research and clinical trials do not demonstrate efficacy in
larger-scale clinical trials and the risk that the company will not
obtain approval to market its products. These factors and others
are more fully discussed under "Risk Factors" and elsewhere in the
company's periodic and other reports as filed with the Securities
and Exchange Commission.
Note: Maxamine(R), Maxamine Therapy(TM), MaxDerm(TM),
MaxVax(TM), and the Maxim logo are trademarks of the company
Editor's Note: This release is also available on the Internet at
www.maxim.com.
CONTACT:
Maxim Pharmaceuticals
Larry G. Stambaugh or Dale A. Sander, 858/453-4040 or Burns
McClellan; Ethan Denkensohn or Justin Jackson, 212/213-0006
Home | What is HCV | Transmission |
Future |
Complications |
Biopsy |
Treatment
| Lab |
Nutrition |
Patient |
Links | Transplant |
Webrings |
guestbookbook |
Awards |
FAQ
|