Friday, January 23, 2015

Tenofovir showed better efficacy, safety than adefovir dipivoxil in Chinese patients with HBV

In a Chinese cohort of patients with hepatitis B virus infection, therapy with tenofovir disoproxil fumarate was safe and effective in treating the infection compared with adefovir dipivoxil, according to study data published in the Journal of Viral Hepatitis.

Researchers in China randomly assigned 509 patients (83.3% male; mean age, 36.3 years) with HBV to therapy with 300 mg tenofovir or 10 mg adefovir dipivoxil once per day for 48 weeks. The primary endpoint was for all patients to have HBV DNA levels less than 400 copies/mL at 48 weeks.

More patients in the adefovir dipivoxil group experienced adverse events compared with patients in the tenofovir group (4.8% vs. 3.9%).    

Read more...

Wednesday, January 21, 2015

Help available for Peninsula patients with liver disease

Insured patients receiving treatment for the liver disease hepatitis B have access to new funding to help with prescription co-pay relief. The Patient Advocate Foundation, based in Hampton, has announced a new national assistance fund to help with out-of-pocket pharmaceutical expenses.
The foundation's co-pay relief program, which funnels funds to patients in several disease "silos" — cancers, heart disease, etc. — has been providing direct financial support for qualified insured patients since 2004, distributing more than $190 million in assistance to more than 95,000 patients.


The new grant funding will give qualified patients up to $4,000 per year for prescription costs, said Erin Singleton of the Patient Advocate Foundation. She noted that many pharmaceutical companies offer free drug programs and some contribute to co-pay relief, but these are typically restricted to those with commercial insurance and not those with federal benefits, such as Medicare seniors. They may find themselves in the "donut hole," a gap in prescription coverage.

Read more...

Tekmira Initiates Phase I Clinical Trial of TKM-HBV

TKM-HBV, a Leading RNAi Approach to Reduce Hepatitis B Surface Antigen, Has the Potential to Play a Central Role in the Cure of Chronic Hepatitis B Virus Infection

VANCOUVER, British Columbia, Jan. 21, 2015 (GLOBE NEWSWIRE) -- Tekmira Pharmaceuticals Corporation (Nasdaq:TKMR) (TSX:TKM), a leading developer of RNA interference (RNAi) therapeutics, announced today that it has dosed the first subject in a Phase I clinical trial of TKM-HBV, a therapeutic agent designed to reduce hepatitis B surface antigen in patients chronically infected with hepatitis B virus (HBV).

"We are pleased to have reached this important milestone, initiation of phase I studies with TKM-HBV. Since TKM-HBV represents our most important development program, we are testing two LNP formulations, generations three and four, of the product in this study. We expect the results to determine which product formulation we will advance into chronically infected patients later this year," said Dr. Mark J. Murray, Tekmira's President and CEO.

The TKM-HBV Phase I clinical trial is a randomized, single-blind, placebo-controlled study, involving single ascending doses of TKM-HBV. The study will assess the safety, tolerability and pharmacokinetics of intravenous administration of two formulations of TKM-HBV in healthy adult subjects. For each formulation, there are five planned cohorts for a total of 20 subjects (40 in total for both formulations). Four subjects will be enrolled per cohort with three subjects receiving TKM-HBV, and one receiving placebo.

About TKM-HBV
The goal of TKM-HBV is to facilitate hepatitis B surface antigen (HBsAg) loss in patients with chronic hepatitis B. The continued presence of HBsAg in chronic HBV is believed to be responsible for disease pathogenesis and impairing the body's ability to clear the virus. Blocking HBsAg may lead to a functional cure by promoting immune-mediated clearance and control of HBV, potentially through HBsAg seroconversion. TKM-HBV is a novel lipid nanoparticle (LNP) formulated RNAi therapy that uniquely targets three highly conserved regions of the HBV viral genome. Targeting multiple sites on the HBV genome allows for potent reduction of multiple viral antigens, knockdown across a broad range of HBV genotypes, and a decrease in the probability of developing antiviral resistance. Preclinical studies with TKM-HBV have shown reductions of HBsAg and other important viral markers across the most prevalent HBV genotypes, demonstrating that TKM-HBV has the potential to treat patients with chronic HBV.

About RNAi and Tekmira's LNP
RNAi therapeutics have the potential to treat a number of human diseases by "silencing" disease causing genes. The discoverers of RNAi, a gene silencing mechanism used by all cells, were awarded the 2006 Nobel Prize for Physiology or Medicine. RNAi trigger molecules often require delivery technology to be effective as therapeutics. Tekmira believes its LNP technology represents the most advanced and widely adopted delivery technology for the systemic delivery of RNAi triggers. Tekmira's LNP platform is being utilized in multiple clinical trials in various disease areas by Tekmira and its partners. Tekmira's LNP technology (formerly referred to as stable nucleic acid-lipid particles or SNALP) encapsulates RNAi triggers with high efficiency in uniform lipid nanoparticles that are effective in delivering these therapeutic compounds to disease sites. Tekmira's LNP formulations are manufactured by a proprietary method which is robust, scalable and highly reproducible, and LNP-based products have been reviewed by multiple regulatory agencies for use in clinical trials. LNP formulations comprise several lipid components that can be adjusted to suit the specific application.

About Tekmira
Tekmira Pharmaceuticals Corporation is a biopharmaceutical company focused on advancing novel RNAi therapeutics and providing its leading lipid nanoparticle (LNP) delivery technology to pharmaceutical and biotechnology partners. Tekmira has been working in the field of nucleic acid delivery for over a decade, and has broad intellectual property covering its delivery technology. Further information about Tekmira can be found at www.tekmira.com. Tekmira is based in Vancouver, Canada and Seattle, USA.

Forward-Looking Statements and Information
This news release contains "forward-looking statements" or "forward-looking information" within the meaning of applicable securities laws (collectively, "forward-looking statements"). Forward-looking statements in this news release include statements about Tekmira's strategy, future operations, clinical trials, prospects and the plans of management; RNAi as a leading approach in the treatment of HBV; TKM-HBV representing a central role in the treatment and potential cure of HBV; initiation of the Phase I clinical study in human healthy volunteers with two formulations of TKM-HBV comprising a third generation LNP and a new fourth generation LNP, which contains novel lipid chemistry and has shown improved potency in certain pre-clinical studies; and to progress to chronically infected patients later in the year; the effects and potency of Tekmira's product TKM-HBV to reduce hepatitis B surface antigen in patients with chronic hepatitis B infection; and estimations of unmet demands for TKM-HBV.

With respect to the forward-looking statements contained in this news release, Tekmira has made numerous assumptions regarding, among other things: LNP's status as a leading RNAi delivery technology; the effectiveness of RNAi therapeutics in the treatment of hepatitis B virus; and the results of pre-clinical studies. While Tekmira considers these assumptions to be reasonable, these assumptions are inherently subject to significant business, economic, competitive, market and social uncertainties and contingencies.

Additionally, there are known and unknown risk factors which could cause Tekmira's actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements contained herein. Known risk factors include, among others: RNAi based therapeutics may not prove to be effective in the treatment of hepatitis B virus as currently anticipated, compared to other therapeutics, or at all; TKM-HBV may not prove to have any significance in the treatment of HBV; a cure for HBV may never be discovered; Tekmira may not initiate all the clinical trials for TKM-HBV as currently anticipated, or at all; the FDA or other regulatory agencies may refuse to approve Tekmira's products, or place restrictions on Tekmira's ability to commercialize its products; anticipated pre-clinical and clinical trials may be more costly or take longer to complete than anticipated, and may never be initiated or completed, or may not generate results that warrant future development of the tested drug candidate; future operating results are uncertain and likely to fluctuate; economic and capital market conditions; and the possibility that Tekmira may not have sufficiently budgeted for expenditures necessary to carry out planned activities.

A more complete discussion of the risks and uncertainties facing Tekmira appears in Tekmira's Annual Report on Form 10-K and Tekmira's continuous disclosure filings, which are available at www.sedar.com and www.sec.gov. All forward-looking statements herein are qualified in their entirety by this cautionary statement, and Tekmira disclaims any obligation to revise or update any such forward-looking statements or to publicly announce the result of any revisions to any of the forward-looking statements contained herein to reflect future results, events or developments, except as required by law.

Additional Information and Where to Find It
Tekmira plans to file with the Securities and Exchange Commission (the "SEC") and mail to its stockholders a proxy statement in connection with the proposed Merger. The proxy statement will contain important information about the proposed Merger and related matters. INVESTORS AND STOCKHOLDERS ARE URGED TO READ THE PROXY STATEMENT CAREFULLY IN ITS ENTIRETY WHEN IT BECOMES AVAILABLE. Investors and stockholders will be able to obtain free copies of the proxy statement and other documents filed with the SEC by Tekmira through the SEC's website at www.sec.gov and from Tekmira by contacting Investor Relations by telephone at (604) 419-3200 or upon written request addressed to our corporate secretary at Tekmira Pharmaceuticals Corporation, 100 - 8900 Glenlyon Parkway, Burnaby, BC, Canada, V5J 5J8 or by going to Tekmira's Investor section on its corporate web site at www.tekmira.com.

Tekmira and its executive officers and directors may be deemed to be participants in the solicitation of proxies from the stockholders of Tekmira in connection with the proposed Merger. Information regarding the interests of these executive officers and directors in the transaction described herein will be included in the proxy statement described above. Additional information regarding these executive officers and directors is also included in Tekmira's Annual Report on Form 10-K, which was filed with the SEC on March 28, 2014, and is supplemented by other public filings made, and to be made, with the SEC by Tekmira. The Annual Report on Form 10-K and other public filings are available free of charge through the SEC's website at www.sec.gov and from Tekmira by contacting Investor Relations by telephone at (604) 419-3200 or upon written request addressed to our corporate secretary at Tekmira Pharmaceuticals Corporation, Tekmira Pharmaceuticals Corporation, 100 - 8900 Glenlyon Parkway, Burnaby, BC, Canada, V5J 5J8 or by going to Tekmira's Investor section on its corporate web site at www.tekmira.com.

CONTACT: Investors

         Julie P. Rezler

         Director, Investor Relations

         Phone: 604-419-3200

         Email: jrezler@tekmira.com

         

         Media

         Please direct all media inquiries to media@tekmira.com

Monday, January 12, 2015

FDA places Arrowhead Hepatitis B drug on partial hold, shares plunge

(Reuters) - Drug developer Arrowhead Research Corp said the U.S. Food and Drug Administration placed the company's experimental hepatitis B treatment on partial clinical hold, seeking additional data from the drug's mid-stage study.

The company's shares plunged 22 pct premarket on Monday after the FDA also asked the company to reduce the dosage of the drug, ARC-520.

The FDA requested Arrowhead to begin the multiple-dose trial for the drug at 1mg/kg - much lower than the company's proposed 2 mg/kg and 4 mg/kg.

Read more...

Arrowhead Provides Update on IND for ARC-520 Phase 2b Study

PASADENA, Calif.--(BUSINESS WIRE)-- Arrowhead Research Corporation (NASDAQ: ARWR), a biopharmaceutical company developing targeted RNAi therapeutics, today announced that the U.S. Food and Drug Administration (FDA) verbally informed the Company in a preliminary call of a partial clinical hold, under which the Company is cleared to begin a modified multiple-dose study of ARC-520 in patients with chronic hepatitis B infection. The FDA requested that the Company start the multiple-dose study at 1 mg/kg of ARC-520 rather than the proposed parallel study design of 2 and 4 mg/kg, and requested additional information be provided to the agency. The additional information includes a final study report from the single-dose Phase 2a study in patients who received 1-4 mg/kg ARC-520, which is ongoing and has not reported any serious adverse events or evidence of end organ toxicity to date. The FDA also requested a final study report from an ongoing multiple-dose non-clinical study, which has shown ARC-520 to be well tolerated with no evidence of end organ toxicity to date. The FDA committed to provide the Company with a letter detailing its thoughts and requests within 30 days. The ongoing Phase 2a study continues as planned, and the Company expects to file with Asian and European agencies to begin additional Phase 2b studies in coming weeks.

"Over the next 30 days, Arrowhead will begin preparations for the multiple-dose Phase 2b study," said Arrowhead President and CEO, Dr. Christopher Anzalone. "We will work closely with the FDA throughout this process while we continue to seek approval to proceed with other planned studies in Asia and Europe."

About ARC-520
Arrowhead's RNAi-based candidate ARC-520 is being investigated in the treatment of chronic HBV infection. The small interfering RNAs (siRNAs) in ARC-520 intervene at the mRNA level, upstream of the reverse transcription process where current standard of care nucleotide and nucleoside analogues act. Arrowhead is investigating ARC-520 specifically, to determine if it can be used to achieve a functional cure, which is an immune clearant state characterized by hepatitis B s-antigen negative serum with or without sero-conversion. Arrowhead has completed a Phase 1 single ascending dose study in normal volunteers and the company is conducting a single dose Phase 2a study in chronic HBV patients. Approximately 350-400 million people worldwide are chronically infected with the hepatitis B virus, which can lead to cirrhosis of the liver and is responsible for 80% of primary liver cancers globally.

About Arrowhead Research Corporation
Arrowhead Research Corporation is a biopharmaceutical company developing targeted RNAi therapeutics. The company is leveraging its proprietary Dynamic Polyconjugate™ delivery platform to develop targeted drugs based on the RNA interference mechanism that efficiently silences disease-causing genes. Arrowhead's pipeline includes ARC-520 for chronic hepatitis B virus, ARC-AAT for liver disease associated with Alpha-1 antitrypsin deficiency, and partner-based programs in obesity and oncology.

For more information please visit http://www.arrowheadresearch.com, or follow us on Twitter @ArrowRes. To be added to the Company's email list and receive news directly, please visit http://ir.arrowheadresearch.com/alerts.cfm.

Source: Arrowhead Research Corporation

News Provided by Acquire Media
http://ir.arrowheadresearch.com/releasedetail.cfm?ReleaseID=890676

Friday, January 9, 2015

Viral Hepatitis Prevention Coordinators, a Vital CDC Program Helping to Achieve the Goals of the Viral Hepatitis Action Plan

Viral Hepatitis Prevention Coordinators (VHPCs) are vital to the implementation of the nation’s Action Plan for the Prevention, Care, & Treatment of Viral Hepatitis, and ultimately, achievement of 3 of the national goals of reducing viral hepatitis transmission and disease:
  • Increase the proportion of persons who are aware of their hepatitis B virus (HBV) infection,
  • Increase the proportion of persons who are aware of their hepatitis C virus (HCV) infection, and
  • Reduce the number of new cases of HCV infection. 
Funded by the Centers for Disease Control and Prevention (CDC) and positioned within state and local health departments, VHPCs serve over 50 jurisdictions around the country including 48 states and several major cities. Because each community is unique, VHPCs evaluate local data to tailor prevention activities for their jurisdictions and seek local partnerships and resources to implement these activities where they are most needed.  Since the program began more than a decade ago, the coordinators have improved the effectiveness of viral hepatitis prevention activities, identifying ways to integrate viral hepatitis prevention vaccination, testing, and linkage to care within existing public health, clinical care, and community settings. A recent report on the VHPC program, “Accomplishments of the Viral Hepatitis Prevention Coordinator Initiative, 2008-2012,” outlines the program, describes the scope of activities, and highlights examples of outcomes. 

- See more at: http://blog.aids.gov/2015/01/viral-hepatitis-prevention-coordinators-a-vital-cdc-program-helping-to-achieve-the-goals-of-the-viral-hepatitis-action-plan.html#sthash.BMDb736x.dpuf

Thursday, January 8, 2015

Hepatitis B Patients Benefit from New Co-Payment Assistance Fund

Patient Advocate Foundation's Co-Pay Relief Program adds financial assistance for Hepatitis B patients

HAMPTON, Va., Jan. 8, 2015 (GLOBE NEWSWIRE) -- Patient Advocate Foundation (PAF) is pleased to announce the addition of a new assistance fund to their Co-Pay Relief program dedicated to assisting insured Hepatitis B patients with out of pocket pharmaceutical expenses. PAF's Co-Pay Relief program has been providing direct financial support for pharmaceutical co-payments to qualified, insured patients since 2004.

Approved patients will receive up to $4,000 in assistance per year, representing groundbreaking financial relief for Hepatitis B patients. The new grant joins Co-Pay Relief's Hepatitis C fund, building on PAF's existing support platform for patients affected by critical liver infections.

"Research shows us that if a patient feels they can't afford their prescribed medication they won't attempt to retrieve it, despite the potential health risks incurred. Every day we are working with patients to try and prevent this from happening. We hope that with this new fund, qualified Hepatitis B patients will reach out to us for financial assistance at the point they need help." stated CEO Alan Balch, Ph.D. of Patient Advocate Foundation.

The Hepatitis B silo will launch and begin accepting patient applications on January 8, 2015. Individuals are required to meet financial and medical criteria prior to acceptance into the program. Interested Hepatitis B patients, their caregivers, or their providers may contact a PAF Co-Pay Relief specialist at 1-866-512-3861 or visit http://www.copays.org/diseases/hepatitis-b for help with their application or to learn more about the program. Live Spanish language assistance is also available.

Since PAF's Co-Pay Relief program was founded more than a decade ago, it has provided more than $190 million in financial assistance to more than 95,000 patients who would have been otherwise unable to afford their pharmaceutical co-payments.

About the Patient Advocate Foundation (PAF) Co-Pay Relief Program (CPR)

The Co-Pay Relief Program, a division of Patient Advocate Foundation and provides direct financial support for pharmaceutical co-payments to insured patients who financially and medically qualify.

The program offers innovative technology tools for patients, providers and pharmacy representatives including 24 hour web based application portals, electronic signature, document upload and bar code fax routing capabilities, increasing the speed with which an approval can be granted and expenditure can be paid. Keeping with Patient Advocate Foundation's emphasis on excellent patient service, the program also offers individualized service to all patients through the use of call counselors who personally guide each patient through the enrollment process.

For more information or to contact Patient Advocate Foundation's Co-Pay Relief program visit www.copays.org or call 1-866-512-3861.

Erin Singleton, 757-952-0561

- See more at: 
http://www.globenewswire.com/news-release/2015/01/08/696000/10114714/en/Hepatitis-B-Patients-Benefit-from-New-Co-Payment-Assistance-Fund.html#sthash.TDrZlvWH.dpuf