(By Balaseshan) Dynavax Technologies Corp. (NASDAQ:DVAX : 4.4, 0.24) said the Food and Drug Administration (FDA) has accepted for review the U.S. Biologics License Application (BLA) of its investigational adult hepatitis B vaccine.
The company anticipates submitting a European Marketing Authorization Application (MAA) for HEPLISAV in the third quarter of 2012.
SAN FRANCISCO, Jun 26, 2012 (BUSINESS WIRE) —
Presidio Pharmaceuticals, Inc. announced today successful completion of
Phase 1b clinical testing of its lead HCV NS5A inhibitor in patients
with HCV genotype-1 infection, with positive efficacy and safety
observations supporting advancement of PPI-668 to Phase 2 combination
The randomized, blinded Phase 1b trial of PPI-668 involved sequential
cohorts of treatment-naive HCV genotype-1 patients who received oral
doses of PPI-668 of 40, 80, 160 or 240 mg, once daily for three
consecutive days. Within each 10-patient cohort, patients were
randomized 8:2 to PPI-668 or placebo.
In all of the Phase 1b dose cohorts, PPI-668 was well tolerated with no
serious or severe adverse events, no premature treatment
discontinuations and no apparent pattern of treatment-related clinical
side effects or laboratory abnormalities.
The Phase 1 clinical results indicate that PPI-668 had a favorable
pharmacokinetic (PK) profile that included rapid achievement of high
(micromolar) plasma levels, prolonged maintenance of potentially
effective levels between doses, and achievement of steady-state
pharmacokinetics after the first dose.
The Phase 1b efficacy observations indicated consistently rapid, marked
reductions in patients’ serum viral load (HCV RNA levels), that were
dose-related. Patients’ HCV RNA reductions typically exceeded 3 log10
IU/ml (99.9%) by Day 2. During the 3-day treatment period, mean maximal
HCV RNA reductions for the 4 dosing groups were:
3.2 log10 IU/mL in the 40 mg dose group
3.5 log10 IU/mL in the 80 mg dose group
3.5 log10 IU/mL in the 160 mg dose group
3.7 log10 IU/mL in the 240 mg dose group
There was only one minimal-responder in the trial. A patient in the 240
mg dose group was found to be fully resistant at baseline with 100% of
this patient’s pre-treatment HCV RNA containing 3 genetically linked
NS5A resistance mutations. This patient was excluded from the efficacy
analysis of the 240 mg cohort, since he was pre-resistant and could not
contribute to dose-response inferences.
Five other patients with detectable resistance mutations at baseline,
including those harboring the relatively common L31M variant, responded
well to PPI-668 treatment, with multi-log HCV RNA reductions.
A protocol amendment has been completed to explore the pan-genotypic
clinical efficacy of PPI-668 in HCV genotype-2a/3a patients. Recruitment
is currently underway for this added cohort.
“The rapid 3.5 to 3.7 log10 HCV RNA reductions observed with
PPI-668 at the three higher dose levels and the encouraging safety
profile support advancement of PPI-668 to Phase 2 combination studies
with other promising HCV antiviral agents,” said Nathaniel A. Brown,
M.D., Presidio’s Chief Medical Officer.
“The PK profile of PPI-668
appears to be a major factor in its efficacy profile, with rapid
achievement of potentially effective plasma levels and with inter-dose
plasma concentrations exceeding those needed to inhibit both wild-type
HCV and many naturally-occurring HCV variants.”
Detailed results of the completed trial are expected to be presented at
a scientific meeting in the fall of 2012.
“Speak up,” she writes. “Come out. Tell us your names.”
She goes on: “The secrecy surrounding HCV has big consequences.
Public health officials have long struggled to determine how many
Americans have HCV, but most estimates put the figure somewhere between 3
million and 4 million.”
Heckman, a longtime friend and mentor, knows what she’s talking
about. She contracted hepatitis C through a blood transfusion when she
was an infant. In 2010, she wrote a moving series
about the role the disease plays in her life, her struggle with the
stigma of hepatitis, and her experience in a clinical trial testing
drugs expected to cure it.
RiverStone Health, in partnership with the Yellowstone AIDS Project,
will offer free rapid HIV testing and rapid Hepatitis C testing to the
As part of National HIV Testing Day, testing is
offered in the RiverStone Health trailer from 11 a.m. to 2 p.m. at South
Park, 6th Avenue South and South 30th Street, and again from 3-6 p.m.
at North Park, 1950 8th Ave. N
San Francisco is a clinical hot spot for viral hepatitis infection,
and UCSF is at the forefront in research, public health programs, and
clinical trials to prevent and fight the potentially life-threatening
UCSF faculty and staff in the schools of dentistry, medicine, nursing and pharmacy, the Clinical and Translational Science Institute
(CTSI) and UCSF Medical Center are engaged in a range of efforts,
sometimes joined by students, often with partners in San Francisco city
and county government and in affected populations. They aim to educate
individuals at risk for the disease about prevention and vaccination, to
identify people who are infected and to ensure that those who need
treatment receive it.
TRENTON – A bill sponsored by state senators Joseph F. Vitale and Nia H. Gill that would expand the state’s sterile syringe and needle exchange program to help reduce the prevalence of transmitted bloodborne diseases such as HIV and Hepatitis C through shared intravenous needles was approved by the full Senate Thursday.
“Since its inception in 2006, New Jersey’s sterile syringe and needle exchange program has been a proven success,” said Vitale, D-Middlesex, a member of the Governor’s Advisory Council on HIV/AIDS and Related Blood Borne Pathogens. “Not only has the program been able to reduce the number of intravenous drug users who transmit serious bloodborne diseases such as HIV or Hepatitis C through the sharing of dirty needles, but it has provided drug users with access to treatment options for their addictions. In fact, 25 percent of participants in the exchange program have enrolled in drug abuse treatment programs. I am pleased that we are able to make this program permanent and to allow all municipalities throughout New Jersey to establish needle exchanges.”
In a community battling hepatitis C rates that more than double the
provincial rate, Prince Albert’s Hepatitis C Support Group serves an
“Clients … have lived in silence because of the stigma and
discrimination they fear or have already experienced in their life,”
Crawford said, noting that some of these people avoid treatment.
“As soon as (people) hear hepatitis C they automatically think
injection drugs, and we’d like to encourage people to not think that
way. Lots of our clients have had no risk factors that they know of and
they’re (hepatitis C) positive.”