- The Hepatitis Study Center - http://www.hepatitisstudycenter.com/
The Hepatitis Study Center is now participating in the Amgen Clinical
Trial Protocol #980167, Multicenter Randomized Trial of 15 Mcg Infergen
Administered Daily vs. Thrice Weekly in Patients with Chronic Hepatitis
Who Did Not Respond to Interferon Therapy.
Enrollment will be limited to 10 patients, and enrollment ends
This trial is for patients with hepatitis C who have failed previous
monotherapy with any interferon. This includes failures with any of the
pegylated interferons (without Ribavirin).
Those with cirrhosis are NOT excluded from the trial and may participate
if meeting eligibility criteria otherwise.
Other eligibility criteria include:
Hemoglobin >/= 10 gm/dl
Platelets >/= 75,000
Alpha fetoprotein normal within the past year
NO evidence of any decompensated liver disease, such as ascites,
bleeding varices or encephalopathy
Participants will be randomized to receive 15 mcg. Infergen at either
daily or 3x/weekly dosing regimens;
--for those receiving 3x/week dosing, they will continue for 48 weeks
be stopped if virus is detectable at week 12 or 24;
--for those randomized to daily dose, they will continue to week 24 if
virus found at week 12. At week 24, randomization is again done to
continue daily or reduce to 3x/week to a total of 48 weeks.
For more specific info about this protocol, please contact me at The
Hepatitis Study Center by email at gastro_doc@... or phone at
Steve Bonning, PA-C
Sr. Clinical Coordinator, The Hepatitis Study Center
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
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
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
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
"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
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
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
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
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
the ongoing study have been accepted for presentation April 12, 2000 at
the 10th International Symposium on Viral Hepatitis and Liver Disease.
Hepatitis C is more easily transmitted than HIV and is now the
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
Hepatitis is a disease characterized by inflammation of the liver
in many cases, permanent cirrhosis (scarring) of the liver tissues and
mortality. The cycle of disease from infection to significant liver
can take 20 years or more. Some experts estimate that without
improvements in treatment, deaths from hepatitis C will surpass those
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.
Treatment with Maxamine is based upon the discovery of a universal
mechanism that suppresses the capacity of the immune system to detect
destroy tumor cells or virally infected cells in many patients with
and chronic infectious diseases. Maxamine is designed to reverse this
immune suppression, thereby enhancing the effectiveness of
a class of therapies that employ the body's immune system to fight
and certain infectious diseases.
Maxamine protects critical immune cells and is administered in
combination with cytokines, a class of proteins such as interleukin-2
interferon-alpha that stimulate these same immune cells. More than 1,000
patients have been treated in the company's completed and ongoing
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
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
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
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,
a needle-free mucosal vaccine carrier/adjuvant system for a broad range
infectious diseases. The company expects to commercialize its
through a combination of in-house development and collaborative
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
the company's clinical trials. Such statements are only predictions and
the company's actual results may differ materially from those
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
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),
the Maxim logo are trademarks of the company.
Editor's Note: This release is also available on the Internet at
Larry G. Stambaugh or Dale A. Sander,
Ethan Denkensohn or Justin Jackson, 212/213-0006