The only way for cancer-stricken Smith to get back on the list of potential liver recipients is to forego using medical marijuana for a staggering six months while submitting to random drug testing and counseling. For his part, Smith requested that Cedars-Sinai reinstate his name on the list immediately – no report if the hospital responded. Smith told the Los Angeles Times, “It’s frustrating … I have inoperable cancer. If I don’t get a transplant, the candle’s lit and it’s a short fuse.”
Inhibitex, Inc. (NASDAQ:INHX) (the “Company”) today announced several recent clinical and corporate developments, including top-line safety and antiviral data from its ongoing clinical trial designed to evaluate additional doses of INX-189, an oral nucleotide polymerase inhibitor being developed to treat chronic infections caused by hepatitis C virus (HCV), administered as monotherapy or in combination with ribavirin (RBV) for seven days.
“We believe the significant increase in antiviral activity demonstrated with 100 mg INX-189 in combination with RBV, as compared to 100 mg INX-189 dosed as monotherapy, further confirms the antiviral synergy between INX-189 and RBV that we have consistently observed in preclinical and clinical results to-date,” stated Dr. Joseph Patti, Senior Vice President and CSO of Inhibitex, Inc. “We look forward to further exploring this antiviral synergy with 200 mg of INX-189 and expanding the scope of our ongoing and planned Phase 2 clinical trials to include interferon-free combinations of INX-189 with other antiviral agents in HCV genotype 1, 2, and 3 patients in 2012.”
Recent Corporate Developments
INX-189 for Chronic Hepatitis C – The Company today reported top-line safety and antiviral data from an ongoing Phase 1b extension trial of INX-189, which is designed to further evaluate the safety, tolerability, pharmacokinetics and antiviral activity of various doses of INX-189, administered as monotherapy or in combination with RBV, for seven days in treatment-naïve patients infected with chronic HCV genotype 1. In the ongoing trial, 100 mg INX-189, dosed once-daily for seven days in combination with RBV, continued to demonstrate potent and dose-dependent synergistic antiviral activity with a median HCV RNA reduction from baseline of -3.79 log10 IU/mL. Further, 100 mg INX-189 in combination with RBV was well tolerated and there were no serious adverse events. For comparison purposes, in a clinical trial completed earlier this year, 100 mg INX-189 dosed as monotherapy once-daily for seven days resulted in a median -2.53 log10 IU/mL reduction in HCV RNA levels. In this same clinical trial, the Company also reported antiviral data indicating that INX-189, when dosed once-daily at 9 and 25 mg in combination with RBV for seven days, demonstrated dose-dependent, synergistic antiviral activity.
The Company also reported today that, subject to regulatory review, it plans to further expand its ongoing Phase 1b extension trial to evaluate once-daily doses of 200 mg INX-189 in combination with RBV; 300 mg INX-189 as monotherapy; and 200 mg INX-005 (a single isomer of INX-189) as monotherapy, respectively, for seven days. The Company anticipates that the Phase 1b extension trial will be completed in the first quarter of 2012.
Additionally, the Company reported that it plans to submit a protocol amendment this quarter to its ongoing Phase 2 study in genotype 2 and 3 HCV-infected patients to include the evaluation of 100 mg and 200 mg of INX-189 dosed once-daily in combination with RBV for 12 weeks.
Read complete press release here
This facility is the newest hospital at Washington State Penitentiary and no one receives care here unless they are behind bars.
Nonetheless, on this day, Trevor Roberts is happy to get the attention his hepatitis C demands, he said. “I started doing IV drugs when I was way young. I shot meth starting at 16.”
Research into range of mutations provides clues to improve treatment
A team of international researchers, led by Matthias Götte from McGill’s Department of Microbiology and Immunology, believes it has found a key factor in understanding why certain drug-resistant strains of the hepatitis C virus are seen so frequently, while others are rarely detected.
It was already known that humans are not infected by a single species of virus, but rather by billions of different, mutant viruses that sometimes differ from one another only by a single nucleotide, i.e. the basic building blocks of viral RNA. The researchers have now demonstrated that the viral polymerase, the enzyme responsible for copying sequences from RNA, is inaccurate in the way it replicates these sequences and as a result generates mutations when connecting one nucleotide after the other. “The surprising finding we had is that some mutations are much more easily made than others,” says Götte.
On November 28, 2011, the Food and Drug Administration granted a Clinical Laboratory Improvement Act (CLIA) waiver for the first rapid blood test for HCV, the OraQuick HCV Rapid Antibody Test, manufactured by OraSure Technologies, Inc. in Bethlehem, PA.
The OraQuick HCV Rapid Antibody Test is used in clinical settings to test individuals at risk for infection with HCV and individuals who have signs or symptoms associated with hepatitis.
The CLIA waiver will broaden access to the test by permitting more widespread distribution and use of the OraQuick HCV Test to nontraditional laboratory sites, including physicians’ offices, health department clinics and other freestanding counseling and testing sites. The broader availability and easier access to this test may contribute to a higher rate of detection for this disease.
OraQuick is a test strip that is read visually and does not require an instrument for diagnosis. Its 20-minute response time allows decentralized testing of HCV enabling the patient to be referred immediately for further testing.
The test qualifies for the CLIA waiver based on data submitted to FDA that demonstrated that the test is simple, accurate, and reasonably free of harm.
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KARACHI: “Over 10 million people are infected with Hepatitis-C Virus which is about six percent of the total population. Viral hepatitis has affecting about 400 million people, out of which one third cases are due to Hepatitis-C Virus (HCV) alone”. This was stated by Prof Dr Aqeel Ahmad, Director, Biological Research Centre (BRC), University of Karachi Centre.
He was delivering the lecture on ‘HCV: Disease and Prevention’ at Latif Ebrahim Jamal (LEJ) National Science Information Centre (NSIC) here on Saturday.
Hepatitis C virus (HCV) protease inhibitors are not cost-effective for first-time treatment takers with HCV genotype 1 and the IL-28B CC genotype, according to analysis conducted by Ziad Gellad, MD, MPH, of Duke University Medical Center in Durham, North Carolina, and his colleagues. They reported their findings on Monday, November 7, at the 62nd annual meeting of the American Association for the Study of Liver Diseases (AASLD) in San Francisco. According to the study authors, people with the IL-28B CC genotype are more likely to be cured with pegylated interferon and ribavirin alone than people with the IL-28B CT or TT genotypes, for whom the addition of either Incivek (telaprevir) or Victrelis (boceprevir) may be more cost effective.
A 24- to 48-week course of pegylated interferon and ribavirin ranges from $18,000 to $30,000. As Gellad noted, “adding Incivek (telaprevir) or Victrelis (boceprevir)”—both recently approved HCV protease inhibitors—“more than doubles the cost of therapy, to a range of $48,000 to $85,000.”
Seeing an average of 1,600 to 1,800 patients in a one- to two-year time span, the clinic and its five-member staff are in need of more volunteers, including doctors, nurses and other health care providers, but also anyone else.
Patients not only get access to health care, but they also receive free medication, a lifesaving option that’s made available through Community MedShare, an effort sponsored by the clinic that benefits their patients as well as others from the Free and Community Clinic Collaborative, a fairly new consortium of 26 area clinics.