Thursday, October 16, 2014

UK: Widower is suing NHS board for £150,000 after his wife caught hepatitis B in hospital and died

A WIDOWER is suing an NHS board for £150,000 after his wife of more than 40 years caught hepatitis B in hospital and died.

Pam Shaw, 61, got the illness from another patient on her ward at Ninewells in Dundee. Dirty equipment has been blamed as the most likely cause.

Her husband John, 66, accuses NHS Tayside of negligence. He wants damages for the grief and sorrow he continues to suffer and for his distress at the manner of Pam’s death.


Wednesday, October 15, 2014

‘Everyday Heroes’ honored in fight against hepatitis B

SAN FRANCISCO – More than 300 people joined the fight against Hepatitis B at the 7th Annual B A Hero Gala, a fundraiser for SF Hep B Free on October 8 at the InterContinental Hotel.

Hep B is the greatest cause of liver cancer and the biggest health disparity for Asian Pacific Islanders.

The event honored 11 everyday heroes for their commitment to raising awareness and educating both the public and health care providers about Hepatitis B infection.

Tekmira Presents Results of Preclinical Studies With Hepatitis B Therapeutic

Demonstrates Robust Knockdown of HBV Surface Antigen

VANCOUVER, British Columbia, Oct. 15, 2014 (GLOBE NEWSWIRE) -- Tekmira Pharmaceuticals Corporation (Nasdaq:TKMR) (TSX:TKM), a leading developer of RNA interference (RNAi) therapeutics, announced today the presentation of preclinical results characterizing TKM-HBV, a therapeutic agent targeting human hepatitis B virus (HBV), at the 10th Annual Meeting of the Oligonucleotide Therapeutics Society. Tekmira's Chief Technical Officer, Dr. Ian MacLachlan delivered a podium presentation titled, "Update on the Preclinical Development of an LNP-Based HBV Therapeutic." The conference is taking place in San Diego, California, from October 12 – 15, 2014.

Among the results reported is the potent and rapid reduction in hepatitis B surface antigen (HBsAg) demonstrated by TKM-HBV in several preclinical models including the chronically infected humanized (chimeric) mouse.

"These results reflect the rigorous approach we have taken to the design and characterization of our novel hepatitis B therapeutic," said Dr. Mark J Murray, President and CEO, Tekmira Pharmaceuticals. "TKM-HBV employs a unique combination of three RNAi triggers, in a third generation LNP formulation, which results in broad and effective knockdown of viral mRNAs and viral proteins including hepatitis B surface antigen, our primary therapeutic target. This data supports the utility of TKM-HBV as a new therapeutic option for treating patients with chronic HBV infection. Our plan is to file an IND, or equivalent document, by the end of this year, and initiate clinical trials in early 2015."


Tuesday, October 14, 2014

Class Action Lawsuit Against Arrowhead Research Corporation Filed By Glancy Binkow & Goldberg LLP

LOS ANGELES, Oct 14, 2014 (BUSINESS WIRE) -- Glancy Binkow & Goldberg LLP, representing investors of Arrowhead Research Corporation (“Arrowhead” or the “Company”) ARWR, -2.49% has filed a class action lawsuit in the United States District Court for the Central District of California on behalf of a class (the “Class”) comprising purchasers of Arrowhead common stock between August 12, 2014 and October 8, 2014, inclusive (the “Class Period”).

The Complaint alleges that defendants made false and/or misleading statements and failed to disclose material adverse facts about the Company’s operations and financial prospects. Specifically, defendants misrepresented the true viral reduction level that ARC-520 can induce in humans, and failed to disclose that data from the Phase IIa study of ARC-520 did not support their assertions concerning the drug’s ability to induce a certain reduction level of hepatitis B surface antigens in humans.

On October 8, 2014, the Company announced the results of its Phase IIa study, revealing that ARC-520 dosed at 2 mg/kg only induced a reduction in hepatitis B surface antigens far short of the levels defendants previously suggested. Following this news, the Company’s stock dropped $5.48 per share, or almost 44% below its previous closing price, to close at $7.03 per share on October 8, 2014, on extraordinary volume.

Read complete press release here...

Wednesday, October 8, 2014

Spontaneous HBeAg seroclearance increased chances for HBsAg seroclearance

Patients with chronic hepatitis B virus infection and positive for the hepatitis B e antigen had a greater chance of hepatitis B surface antigen seroclearance after experiencing spontaneous seroclearance of the hepatitis B e antigen, according to data from a recent study. 

Clinical data from 775 patients enrolled at the Hepatitis and Liver Clinic of Queen Mary Hospital, Hong Kong, were collected between September 2005 and September 2007 to determine any factors associated with HBsAg seroclearance. Every patient underwent HBeAg seroclearance and were followed until January 2013. Patients were divided into three groups: group 1 consisted of patients that underwent HBeAg seroclearance and did not undergo or require treatment (n=428); group 2 included patients who received treatment-induced HBeAg seroclearance (n=197); and group 3 included patients who experienced spontaneous HBeAg seroclearance but needed antiviral therapy after seroclearance (n=150).

“Spontaneous HBeAg seroclearance without the need for antiviral therapy afterward was associated with the highest rate of subsequent HBsAg seroclearance,” the researchers wrote. “The levels of HBsAg and not HBV DNA after HBeAg seroclearance were predictive of HBsAg seroclearance. Lower HBsAg levels were associated with higher change of future HBsAg seroclearance.”

Read more....

REPLICor to Present Updated Clinical Trial Data with Combination Treatment Using its HBsAg-release Inhibitors in Patients with Chronic Hepatitis B Infection at the 10th Annual Meeting of the Oligonucleotide Therapeutics Society (OTS)

MONTREAL, October 7, 2014 /PRNewswire/ --Updated clinical trial data from REPLICor's three Asian trials using its nucleic acid polymer (NAP) HBsAg-release inhibitors REP 2055 (REP 9AC) and REP 2139 (REP 9AC') will be presented at the 10th Annual Meeting of the Oligonucleotide Society, to be held from Oct 12-16, 2014 in San Diego, CA.

REPLICor has currently tested its HBsAg-release inhibitor technology in three different clinical trials using different treatment modalities: in monotherapy, in combination with short term immunotherapy and in combination with a complete course of Pegasys™.  Data presented will demonstrate 1) the unique ability of REPLICor's NAP compounds to completely suppress HBsAg in the blood 2) the effect of HBsAg clearance on dramatically improving the activity of immunotherapy and 3) when used with a full course of Pegasys™, NAP therapy has resulted in the establishment of long term SVR in 80% of patients.

Link to the 2014 OTS meeting:

For more information please contact:
Andrew Vaillant, Ph.D.
Vice President, Operations and Chief Scientific Officer
Tel.: +1-514-862-2271

SOURCE Replicor Inc

Arrowhead Research Sinks on Disappointing Hepatitis B Drug Data

The specific data on ARC-520 disclosed this morning was contained in a late-breaker abstract for the American Association for the Study of Liver Disease (AASLD) annual meeting, which is being held in November. 

Here is the nut graph from the ARC-520 AASLD late-breaker abstract which caused Arrowhead shares to sink:
ARC-520 activity is assessed by measuring percent change of quantitative HBsAg decline from baseline. For patients receiving ARC-520 in cohort 1, mean nadir HBsAg was -39% (range -22 to -57) with a mean change on day 85 of -31% (range -14 to -39). For patients receiving ARC-520 in cohort 2, mean nadir  HBsAg was - 51% (range -46 to -59) with a mean change on day 85 of -22% (range -7 to -40). For cohort 2, the percent reduction in HBsAg was statistically significant vs placebo for Days 3 through 43 post dose. This is the first time that a reduction in HBsAg mediated through RNA interference has been shown in chronic HBV patients.
There is a formula to convert percent change in quantitative HBsAg decline from baseline into a log reduction. The 51% reduction disclosed in the abstract for the 2 mg/kg dose of ARC-520 equates to a 0.3-log reduction.


Read the Arrowhead Press Release here...