IDPH? Sure, I own it (well, a very small part of it), and I've had a trading position or two in it as well. I picked it a couple of days ago as a potential "bounce back" for when the sector caught support. Unfortunately, I didn't put more cash where my mouth was. :-)
Couple of nice days.
Obligatory GILD-related comment........... Rachel Leheny of H&Q has been pushing BCHXF due to Glaxo's results with 3TC, the GS 840-competitive product. Read between the lines of the two GILD releases that follow the Leheny story, and you can see that GILD is beginning to look for decent things from GS 840. I've always considered it to be the weak link in their armament, but I'm getting interested in the relative toxicities of 840 and 3TC.
H&Q Says Biochem Pharma's Hepatitis B Data Strong
NEW YORK (Dow Jones)--Biochem Pharma Inc.'s (BCHXF) drug for hepatitis B
shows ''excellent efficacy,'' according to abstracts analyzed by
Rachel Leheny, who covers the biotech company for Hambrecht & Quist LLC.
In a note, Leheny said that the drug, called lamivudine, hit its primary
endpoint, or main goal, and that secondary goals were consistent with
previous trials.
The data showed that 66% of patients taking 100mg of the drug had
improvement in their liver function, compared with 58% in the 25mg group
and 30% in the placebo group. The Phase III study followed 358 Asian
patients over 12 months. The data were statistically significant, she
noted.
The Asian population is particularly difficult to treat, Leheny said,
because the disease is frequently passed from mother to infants. People
born with the infection do not have an immune response to the virus, making
it more difficult to clear away with treatment.
The data will be presented later this week at a major liver scientific
meeting in London.
The analyst said that she anticipates a market launch in Asia by the end of
the year and estimated that at peak the drug would sell more than $1 billion
annually.
Leheny reiterated her strong buy rating on the stock based on the data. She
estimates that the company will earn C$1.44 a share this year on revenue of
C$312.8 million and C$2.61 a share next year on revenue of C$427.7
million.
Monday January 20 7:44 AM EDT
CPCRA Begins Phase III Clinical Trial of Gilead's GS 840
Once-Daily Oral Compound for HIV/AIDS
FOSTER CITY, Calif.--(HealthWire)--Jan. 20, 1997-- Gilead Sciences Inc
announced today that
the Terry Beirn Community Programs for Clinical Research on AIDS (CPCRA),
sponsored by the
National Institute of Allergy and Infectious Diseases of the U.S.
National Institutes of Health (NIH),
has begun enrolling patients in a new multicenter Phase III trial of GS
840 (adefovir dipivoxil).
GS 840 is a broad-spectrum antiviral agent administered orally as a
single tablet once daily and is in
human clinical studies for the potential treatment of human
immunodeficiency virus (HIV) and
hepatitis B virus (HBV) infections, and for the potential prevention of
cytomegalovirus (CMV)
infection.
"The CPCRA's sponsorship of this pivotal study provides an experienced
and broad network of
community-based centers to study the long-term safety and efficacy of GS
840 as an anti-HIV and
anti-CMV agent," said Howard S. Jaffe, M.D., Senior Vice President, Drug
Development at Gilead
Sciences. "The CPCRA's interest and commitment underscore the importance
of developing new
and convenient anti-HIV treatments with broad-spectrum antiviral
activity."
In the CPCRA Phase III study, patients will be randomized to receive
either GS 840 (one 120 mg
tablet) or placebo, in addition to their current antiretroviral therapy,
including combination regimens.
More than 2,000 HIV-infected patients with CD4 counts less than 100
cells/mm3 are expected to
be enrolled in the CPCRA clinical trial. The study will evaluate the
safety and efficacy of GS 840 in
prolonging survival among patients with advanced AIDS and in preventing
the development of CMV
end-organ disease in patients who are co-infected with HIV and CMV.
GS 840, which belongs to a new class of antiviral compounds known as
nucleotides, is a potent
inhibitor of reverse transcriptase, an enzyme required by HIV for
replication. GS 840 is convenient
in that it is dosed once-daily as an oral therapy in human studies,
whereas other anti-HIV
compounds consist of multiple tablets or capsules taken several times a
day. In addition to anti-HIV
activity, clinical studies have provided evidence for activity against
hepatitis B virus and CMV.
GS 840 -- Anti-HIV Activity and Ongoing Studies
Data presented in April 1995 and January 1996 from two separate Phase
I/II clinical studies
demonstrated that GS 840, administered as single-agent therapy for two
weeks and 12 weeks,
respectively, was well tolerated and resulted in improvements in
surrogate markers of HIV infection
such as CD4 cell counts and HIV RNA. To date, more than 200 patients have
received once-daily
GS 840 for up to 15 months. Preliminary data from clinical trials suggest
that GS 840 treatment does
not induce early onset of drug resistance.
In addition to the CPCRA Phase III study, a pivotal trial sponsored by
Gilead is ongoing and has
enrolled more than 200 patients to date. This Phase II/III study is
enrolling HIV-infected patients
with CD4 counts greater than 200 cells/mm3. The study is designed to
evaluate the efficacy of GS
840 in combination with approved antiretroviral therapies in patients
infected with HIV. The study is
designed to enroll 400 patients and will determine the anti-HIV activity
of GS 840 as measured by
CD4 cell counts and HIV viral load.
GS 840 -- Anti-HBV Activity and Ongoing Studies
In a Phase I/II study in the United Kingdom, GS 840 demonstrated
significant antiviral activity
against chronic HBV infection. Patients who received a once-daily dose of
GS 840 for four weeks
experienced a 97 percent decrease in HBV DNA levels, compared with a
seven percent increase in
viral DNA levels among patients who received placebo. Gilead Sciences
anticipates commencing
multinational Phase II studies for this indication in 1997.
GS 840 -- Additional Information on Clinical Trials
Patients and physicians who would like more information and enrollment
criteria for ongoing studies
of GS 840 may call the AIDS Clinical Trials Information System (ACTIS) at
1-800-TRIALS-A or
Gilead Sciences Medical Information at 1-800-GILEAD-5 (1-800-445-3235),
press 3.
The CPCRA is a community-based network of clinical trial units in the
United States. The network
was created to extend the opportunity for participation in AIDS research
to community-based
clinicians and their patients, through the establishment of treatment
research programs in communities
where HIV-infected patients live and receive their primary medical care.
A major goal of the
CPCRA is to access HIV-infected populations that are frequently
under-represented in clinical trials.
Studies conducted by the CPCRA are directed toward all people infected
with HIV, although they
specifically target people of color, women, and injection drug users.
HIV causes AIDS by destroying immune cells that help the body fight
disease. According to the
Joint United Nations Program on HIV/AIDS, an estimated 20 million people
worldwide were living
with HIV/AIDS as of the end of 1995, and more than five million people
are estimated to have died
from AIDS. Currently, about 750,000 U.S. adults are infected with HIV,
including 190,000 with
AIDS.
Gilead Begins Phase II Clinical Trials of Oral GS 840 for Chronic
Hepatitis B; Earlier Study Demonstrated that GS 840 had Potent Antiviral
Activity Against Hepatitis B Virus
FOSTER CITY, Calif.--(BW HealthWire)--March 31, 1997--Gilead
Sciences, Inc. (NASDAQ:GILD) announced today that it has begun
enrolling patients in two multinational Phase II studies of GS 840
(adefovir dipivoxil) for the potential treatment of chronic hepatitis B
virus (HBV) infection.
GS 840 is an oral tablet with demonstrated antiviral activity against a
broad spectrum of viruses, including hepatitis B virus, human
immunodeficiency virus (HIV) and herpesviruses, such as
cytomegalovirus (CMV). GS 840 is a member of a new class of antiviral
therapeutics known as nucleotide analogues, which have been shown to be
potent inhibitors of viral replication with long durations of action and
infrequent development of resistance.
"Adefovir dipivoxil appears to differ from other oral agents being
developed for hepatitis B infection because it does not require
processing by one of the host enzymes to become active," said Clinical
Investigator Teresa L. Wright, M.D., Chief of Gastroenterology at the
Veterans Administration Medical Center in San Francisco. "Adefovir
dipivoxil may be an important option both for use as primary therapy and
for use in combination with other hepatitis B drugs. Combination therapy
may reduce the resistance to drugs seen in some patients with hepatitis
B."
More than 1.5 million people in the United States and Europe, and more than
300 million people worldwide are chronically infected with hepatitis B
virus. Long-term HBV infection can lead to severe complications,
including cirrhosis, liver failure and liver cancer. Current Phase II
Studies -- GS 840 for HBV
The two Phase II HBV studies are randomized, double-blind,
placebo-controlled clinical trials evaluating oral GS 840 at one of
three dose levels given once per day for 12 weeks. Both studies are
designed to enroll patients in the United States, Canada, the United
Kingdom and Australia. One study is designed to enroll 60 patients with
normal liver enzyme levels, which is frequently observed in patients
with long-term hepatitis B infection who contracted the virus at birth.
The other study is designed to enroll 60 patients with elevated liver
enzyme levels, which is frequently observed in people infected with HBV
as adults. To determine the drug's safety and efficacy, researchers will
compare changes in HBV viral load in blood and other markers of the disease
among patients receiving different doses of GS 840 to those who receive
placebo. Prior Phase I/II Data - GS 840 for HBV
Previously, data from a Phase I/II human study demonstrated that
treatment with GS 840 was well tolerated and provided significant and
sustained antiviral activity against HBV. Patients who received GS 840
once daily for four weeks experienced a mean decline of 97 percent in viral
load measured by HBV DNA in blood, compared to a seven percent viral load
increase in patients who received placebo. All patients treated with GS
840 experienced a greater than 90 percent decrease in HBV DNA during
dosing. These data were presented at the 36th Interscience Conference on
Antimicrobial Agents and Chemotherapy (ICAAC) in September 1996 and at
the 47th Meeting of the American Association for the Study of Liver
Diseases in November 1996. Other Ongoing Studies - GS 840 for HIV
Treatment and CMV Prevention
GS 840 also is in pivotal studies in combination with approved anti-HIV
agents as multi-drug therapy for the potential treatment of HIV, the
cause of AIDS. One Phase II/III study, which will enroll up to 400 people
infected with HIV, will determine the safety and efficacy of GS 840 when
administered in combination with antiretroviral therapies, including
protease inhibitors currently approved for the treatment of patients
infected with HIV.
In addition, The Terry Beirn Community Programs for Clinical Research on
AIDS (CPCRA), a National Institutes of Health sponsored organization,
is conducting a Phase III study in up to 2,000 patients to determine GS
840's ability, when administered with approved anti-retroviral
therapies, to prolong survival and prevent CMV end-organ disease in
patients with advanced AIDS.
Gilead Sciences is a biopharmaceutical company dedicated to the
discovery, development and commercialization of treatments for human
diseases. The Company's business and scientific endeavors are focused
on making new therapies available to patients, physicians and the
healthcare system. Gilead's expertise has resulted in proprietary
therapeutics for important viral diseases, including a currently
available therapy for cytomegalovirus retinitis, and products in
development to treat diseases caused by human immunodeficiency virus,
hepatitis B virus, herpes simplex virus, human papillomavirus and
influenza virus. Gilead's research programs seek treatments for these
and other viral infections, vascular diseases and cancer. Gilead common
stock is traded on The Nasdaq Stock Market under the symbol GILD.
CONTACT: Gilead Sciences, Inc.
Lana Lauher, 415/573-4858 (Investor Inquiries)
Laurie Hurley, 415/573-4894 (Media Inquiries) |
