Initial Abbott Labs interferon-free triple combination data released...

Posted 10/15/12 on Trust.org. The pre-AASLD press release parade is in full swing!! This time Abbott Labs checks in with some pretty impressive data (although you never know until you see the full abstract/presentation) with it's 3 drug interferon-free combo + ribavirin (HCV protease inhibitor ABT-450, polymerase inhibitor ABT-333 and NS5A inhibitor ABT-267 + RBV).  Although the numbers are small, 76 out of 77 treatment naive patients and 38 out of 41 null responders achieved SVR12. I believe, however, it was an Abbott's PILOT study looking at a combo of ABT-450 plus non-nuc ABT-072 and RBV where two patients experienced 'late relapse'... one at week 8 post-treatment and one at week 36. We'll have to see if 'late relapse' is a phenomena with just that certain combination or if a more robust 3 drug combination is enough to quash the virus for a true SVR.  I'd also like to see the IL28B genotype and sub-type of this study population, as well as BMI, steatosis and cirrhosis percentages as well. But without the benefit of an in-depth look under the hood,  this initial data looks pretty impressive. 

Mon, 15 Oct 2012 18:27 GMT
Source: Reuters // Reuters

* 99 pct of untreated patients achieve cure, or SVR, at 12 weeks

* 93 pct of previously unresponsive patients reach SVR at 12 weeks

* Abbott shares rise 3.3 percent (Adds analyst comment, updates shares)

By Bill Berkrot

Oct 15 (Reuters) - An all oral regimen of experimental hepatitis C medicines developed by Abbott Laboratories led to high cure rates in both new patients and those for whom prior treatment failed, according to initial results from a midstage study.

Shares of Abbott rose more than 3 percent after the unveiling of the data, which will be presented next month at a major liver disease meeting. The findings should help cement Abbott as a major player in the race to develop an interferon-free treatment regimen for the serious liver disease.

After 12 weeks of treatment with three Abbott direct-acting antiviral medicines plus the older drug ribavirin, 99 percent of previously untreated patients and 93 percent of those who did not respond to older drugs achieved a sustained virologic response (SVR), which is considered cured, according to available data from a brief summary, or abstract, of the study.

Abbott will present much more detail on the Phase II study involving data from more patients at the American Association for the Study of Liver Diseases (AASLD) meeting in Boston.

"The data looks very good on efficacy and I didn't see anything that really caught my eye as far as side effects," Morningstar analyst Damien Conover said.

Based on the results, Abbott said it would test its three drugs, each of which attacks the virus using a different approach, both with and without ribavirin in a large Phase III program aimed at gaining approval for the treatment.

"The ability to show a sustained virological response in these patient populations without the use of interferon is extremely encouraging," Scott Brun, Abbott's head of infectious disease development, said in a statement.

A pair of new hepatitis C drugs approved last year significantly boosted cure rates and cut treatment duration to as low as 24 weeks for some patients. But those must still be taken with interferon, an injected drug that often causes severe flu-like symptoms that lead many hepatitis patients to delay or discontinue treatment.

Several companies, including Gilead Sciences Inc, Bristol-Myers Squibb Co and Vertex Pharmaceuticals Inc , are racing to develop interferon-free treatment regimens expected to bring in billions of dollars in revenue once approved.

Most analysts view Gilead as current leader both on timing and perceived advantages of its experimental hepatitis C program.

"One of the questions lingering here is whether these (Abbott) drugs can be used without ribavirin," Conover said. "Gilead's drug works pretty well without it, so it's going to be a pretty big competitive hurdle if they have to use ribavirin."

While not as onerous as interferon, ribavirin also has side effects that doctors and patients would like to avoid if possible.

The Abbott drugs, a protease inhibitor called ABT-450, a polymerase inhibitor ABT-333 and ABT-267 from a class known as NS5A inhibitors, were given along with ribavirin for just 12 weeks. Patients in whom the virus was undetectable 12 weeks after stopping treatment were considered cured.

Based on available data at the time the abstract was submitted for the liver meeting, 76 of 77 previously untreated patients and 38 of 41 prior null responders had achieved SVR.

Null responders, while a much smaller market than new patients, have been notoriously difficult to treat.

"The data presented so far appear to be very favorable in these early trials and we'll look for more extensive data at AASLD," JP Morgan analyst Michael Weinstein said in a research note, adding that he expects Abbott's hepatitis C program to reach the market by 2015.

One subject in the new patient group had a disease relapse after treatment and three of the prior null responders experienced viral breakthrough, meaning the virus levels rose during treatment after an initial response.

The most common side effects were fatigue and headache in both groups. Of five reported serious adverse events, one - joint pain - was deemed to be possibly caused by study drugs, the company said.

Abbott shares were up $2.29, or 3.3 percent, at $71.57 at midday on the New York Stock Exchange after rising to a new high of $71.99 earlier. (Reporting by Bill Berkrot; Editing by Andrew Hay, Steve Orlofsky and M.D. Golan)

Australia's Benitec Biopharma to purchase Tacere Therapeutics and it's new HCV drug...

Posted 10-11-2012 on www.LifeScience.com.au. Australia's Benitec Biopharma is set to purchase San Jose, CA - based Tacere Therapeutics. Tacere is currently in phase I/II trails with TT-034, an anti-HCV compound developed using Benitec's ddRNAi (DNA-directed RNA interference) technology. TT-034 has been described as a 'cocktail in one drug', containing three seperate RNAi elements targeted against the Hepatitis C virus. The drug is encapsidated in an adeno-associated virus (AAV) protein coat. The drug has so far been shown to safely penetrate hepatocytes - in preclinical animal studies, TT-034 monotherapy targeted and cleaved the Hepatitis C virus itself at the different sites simultaneously without toxicity.

Benitec to buy Tacere and its new hepatitis C treatment drug

Benitec Biopharma (ASX:BLT) will acquire Tacere Therapeutics, which has a phase I/II ready hepatitis C treatment candidate developed using Benitec's ddRNAi technology.

Dylan Bushell-Embling (Australian Life Scientist)11 October, 2012 14

Benitec Biopharma (ASX:BLT) has arranged to acquire US-based Tacere Therapeutics, and its phase I/II ready hepatitis C treatment candidate.

The financial terms of the acquisition include the allocation of just over $1.5 million in new Benitec shares – or around 9.5% of issued share capital – and an agreement to split future potential licensing revenue.

The size of Tacere's cut of this revenue will be between 2.5% and 35% depending on the stage of the product's commercial development at the time a licensing deal is entered into.

For example, if a licensing deal emerges prior to the commencement of phase II trials, the cut will be 35%. But if an agreement does not come until after Biologic License Application is filed with the US Food and Drug Administration, this falls to 2.5%.

Tacere's hepatitis C treatment candidate is the compound TT-034. The program is based on gene-silencing technology owned by Benitec known as DNA-directed RNA interference, or ddRNAi. This technology was originally developed by the CSIRO then exclusively licensed to Benitec.

Benitec CEO Dr Peter French said he expects the acquisition to bring substantial benefits for the company.

“Tacere has been successfully developing programs utilising Benitec's proprietary ddRNAi technology since 2006, and it now makes sense to bring these assets in-house to complement and strengthen our pipeline as we move into clinical development,” he said.

"We believe the preclinical data and safety profile of TT-034 [also] positions the Company to commence clinical trials in hepatitis C at a time when a number of high profile HCV therapies such as nucleotide polymerase inhibitor are encountering safety concerns.”

Tacere, which licenses ddRNAi technology for its hepatitis C program, has been developing the treatment candidate for years.

In 2008, the company entered into a collaboration and licensing arrangement with Pfizer for the program. Pfizer invested in TT-034 development until 2011, when it shut down the UK facility where it was conducting the program during a restructuring. The rights then reverted back to Tacere.

Benitec (ASX:BLT) shares were trading 7.14% higher at $0.015 as of 2:30pm on Thursday.

New HCV Resistance slide deck available from The Center for HIV Identification, Prevention, and Treatment Services (CHIPTS)

The great folks at CHIPTS, in collaboration from The Forum for Collaborative HIV Research have revised and updated their initial HCV resistance slide deck. Great job from this group in leading the charge in this heavily under-publicized aspect of Hepatitis C treatment. 

HCV Drug Resistance Slide Set Now Available
• ResisSS 2012 v1.2 •


Given the rapid pace of HCV Drug Development, the original HCV Drug Resistance slide deck has been revised into four subsets:

HCV Lifecycle, Drug Targets and Mechanisms of Action
HCV Resistance: Barriers, Selection, and Monitoring of Resistance
HCV Treatment Strategies to Reduce Drug Resistance
HCV Patient and Regimen Factors that Maximize Response and Minimize Resistance


Along with incorporating recent data from EASL 2012, the #3 Treatment Strategies set has been subdivided into regimens with or without interferon.

The Drug Resistance Slide Set, a product of the Forum for Collaborative HIV Research’s HCV Drug Development Advisory Group (DrAG) explains drug resistance in HCV, its consequences, as well as mitigating its impact.

The educational slide deck’s intended audience ranges the spectrum from health care providers evaluating, diagnosing and treating HCV, health care educators, HCV patients who want to learn about the disease and treatment options, and HCV advocates who may use the slides in their community education outreach efforts.

Aethlon Medical releases HCV treatment protocol details for Hemopurifier medical device...

Posted 10/2/2012 on Fox News.com. Aethlon Medical, Inc, whose Hemopurifier filtration device is being studied in India for a variety of indications including HCV, has released their HCV treatment protocol and inclusion/exclusion criteria for their compassionate-use commercialization program. The hope is that the Hemopurifer can be used in combination with Peg/Riba and perhaps future Direct Acting Antivirals to accelerate the decrease of HCV RNA, time on drug therapy as well as increasing the likelihood that patients achieve SVR.  This protocol is targeting null, partial and relapsers to previous Peg/Riba therapy. Further information on therapy pricing is to be released in coming weeks.

The treatment objective will be to accelerate the rate and increase the likelihood that patients achieve undetectable HCV RNA.

Aethlon Medical Releases Hepatitis C Virus (HCV) Treatment Protocol and Inclusion/Exclusion Criteria Underlying Compassionate-Use Commercialization Program

SOURCE Aethlon Medical, Inc.

SAN DIEGO, Oct. 2, 2012 /PRNewswire/ -- Aethlon Medical, Inc. (OTCBB: AEMD), the pioneer in developing selective therapeutic filtration devices to address infectious disease, cancer and other life-threatening conditions, today released the treatment protocol underlying a program that will provide hard-to-treat HCV-infected individuals with expanded access to Hemopurifier® therapy. The Company also disclosed inclusion and exclusion criteria for candidate patients as well as details on the physicians who will administer the program, which is expected to generate first product sales of the Aethlon Hemopurifier®.

The Aethlon Hemopurifier® is a first-in-class medical device with broad-spectrum capability to address infectious viral pathogens and immunosuppressive exosomes underlying cancer and other life-threatening conditions.  In the expanded access program, Hemopurifier® therapy will be administered to selectively target the rapid clearance of HCV from the entire circulatory system to improve benefit, dose, duration and tolerability of standard-of-care drug therapy.  The program is being initiated with support from the Institutional Review Board at the Medanta Medicity Institute (Medicity) to allow compassionate usage of the Aethlon Hemopurifier® for individuals who previously failed or subsequently relapsed standard-of-care drug regimens.  The Medicity is a leading center for medical tourism in India.

In addition to offering Hemopurifier® therapy to the citizens of India, HCV-infected individuals from the United States, European Union and other regions of the world may pursue treatment through the expanded access program.  It is estimated that approximately 170 million people worldwide are infected with HCV, which leads to chronic liver disease or cirrhosis, and is a leading cause of liver transplantation.

"We are grateful for the opportunity to provide hard-to-treat HCV-infected individuals with access to Hemopurifier® therapy," stated Aethlon Chairman and CEO, Jim Joyce.  "Beyond advancing our therapeutic objectives, the resulting Hemopurifier® product sales will augment the government contract revenue stream we established this past year."

The Medicity Expanded Access Treatment Protocol

The Medicity expanded access program will offer HCV-infected individuals the option of either a 3-day or 7-day Hemopurifier® therapy regimen. Under each regimen, Hemopurifier® therapy will be administered continuously for a period up to six hours on each treatment day. While there will be a difference in cost, Hemopurifier® therapy underlying both regimens will be initiated in combination with standard-of-care drug therapy. The treatment objective will be to accelerate the rate and increase the likelihood that patients achieve undetectable HCV RNA. Details related to therapy pricing and candidate patient enrollment processes at the Medicity are anticipated in the coming weeks.

Candidate Patient Inclusion Criteria
Males or females 18 years of age and older testing positive for any HCV genotype
HCV-infected individuals that have relapsed after completing a previous course of standard-of-care drug therapy
Null responders or individuals who previously were unable to achieve > 2 log viral load reduction at month three of standard of care drug therapy
Candidate patients must be willing to submit to temporary vascular access catheterization
Ability to tolerate blood volume losses of up to 150 ml per week
Stable clinical condition, including stable hematocrit
Individuals on ACE inhibitors must suspend ACE inhibitor administration for a minimum of six days prior to initiating therapy
Karnofsky score = 60
Details of blood chemistry inclusion criteria will be provided to candidate patients who meet the above criteria
Candidate patients will be required to sign a written informed consent prior to enrollment in the treatment access program

Candidate Patient Exclusion Criteria
Clinically significant infection, other than HCV, defined as any acute viral, bacterial, or fungal infection, which requires specific therapy (Anti-infectious therapy must have been completed at least 14-days before entry into study)
Co-infections with Hepatitis B virus and Human immunodeficiency virus (HIV)
Received any investigational drug agent(s) within 28-days of entry into study
Any known pre-existing medical condition that could interfere with the subject's participation in the protocol, including serious psychiatric disorders, CNS trauma or active seizure disorders requiring medication, poorly controlled diabetes mellitus, significant cardiovascular dysfunction within the past 6 months (e.g., angina, congestive heart failure, recent myocardial infarction, severe hypotension, or significant arrhythmia)
Subjects with ECG showing clinically significant abnormalities
Need for frequent blood transfusions.
Recent History of bleeding or bleeding disorders requiring the restriction in use of anticoagulants during study treatments.
Active immunologically mediated disease (e.g., inflammatory bowel disease [Crohn's disease, ulcerative colitis], rheumatoid arthritis, idiopathic thrombocytopenia purpura, systemic lupus erythematosus, autoimmune or inherited hemolytic anemia, scleroderma, severe psoriasis)
Any medical condition requiring, or likely to require during the course of the study, chronic systemic administration of steroids or other immune-regulatory medications
Substance abuse, such as alcohol (~80 gm/day), IV drugs, and inhaled drugs (If the subject has a history of substance abuse, to be considered for inclusion into the protocol, the subject must have abstained from using the abused substance for at least 2 months
Any cancer requiring systemic chemotherapy
Any other condition that, in the opinion of the principal investigators or treating physicians, would make the subject unsuitable for enrollment, or could interfere with the subject participating in and completing the expanded access protocol

Current HCV Studies
In addition to the forthcoming expanded access program, Aethlon has been conducting a study at the Medicity which is evaluating the capability of the Aethlon Hemopurifier® to accelerate HCV RNA depletion at the outset of standard of care peginterferon+ribavirin (PR) therapy.  Specifically, HCV-infected individuals are enrolled to receive up to three, six-hour Hemopurifier® treatments during the first three days of PR drug therapy.  Aethlon recently reported that two HCV-infected patients who received Hemopurifier® therapy in combination with PR drug therapy achieved undetectable viral load at day-7, which is rarely reported in drug therapy alone.

A primary clinical endpoint of the Medicity protocol has been to increase the incidence of rapid virologic response (RVR), defined as undetectable HCV RNA at day 30 of therapy.  RVR represents the clinical endpoint that best predicts treatment cure, otherwise known as sustained virologic response (SVR), defined as undetectable HCV RNA 24-weeks after the completion of PR drug therapy. As a point of reference, the landmark IDEAL Study of 3,070 HCV genotype-1 patients documented that only 10.35% (n=318/3070) of PR treated patients achieved a RVR.  However, patients that achieved a RVR had SVR rates of 86.2% (n=274/318) versus SVR rates of 32.5% (n=897/2752) in non-RVR patients.  While the incidence of undetectable HCV RNA at day-7 is not reported in the IDEAL study, the study did reveal that just 4.3% (n=131/3070) of patients achieved undetectable HCV RNA at day-14, which equated to a 91% (n=118/131) SVR rate.

Aethlon reported that Hemopurifier® therapy has been well tolerated and without device-related adverse events in ten treated patients.  Of these ten patients, seven patients were infected with HCV genotype-1; two patients were infected with HCV genotype-3; and one patient was infected with HCV genotype-5.  At present, undetectable HCV RNA is reported in eight of the 10 treated patients.  Of the two patients with detectable HCV RNA, one discontinued PR therapy as a result of a diabetes related condition.  HCV RNA is undetectable in all patients (n=4) that have been monitored for 48 weeks since receiving Hemopurifier® therapy.  Among the 10 treated patients, Aethlon reported that six genotype-1 patients received the three treatment Hemopurifier® protocol, which resulted in four (67%) patients achieving a RVR. The IDEAL study predicts it would normally require approximately 40 PR treated patients to achieve 4 RVR outcomes.  Both patients who achieved undetectable HCV RNA at day-7 also achieved a RVR. Beyond the high likelihood of a SVR, genotype-1 patients that achieve a RVR also have the opportunity to reduce the duration of PR drug therapy from 48 weeks to 24 weeks.

About Medanta – The Medicity

Medanta – The Medicity is one of India's largest multi-super specialty institutes located in Gurgaon, a bustling town in the National Capital Region. Founded by eminent cardiac surgeon, Dr. Naresh Trehan, the institution has been envisioned with the aim of bringing to India the highest standards of medical care along with clinical research, education and training. Medanta is governed under the guiding principles of providing medical services to patients with care, compassion and commitment.

Spread across 43 acres, the institute includes a research center, medical and nursing school. It has 1250 beds and over 350 critical care beds with 45 operation theatres catering to over 20 specialties. Medanta houses six centers of excellence, which provide medical intelligentsia, cutting-edge technology and state-of-the-art infrastructure with a well-integrated and comprehensive information system.  The Medicity brings together an outstanding pool of doctors, scientists and clinical researchers to foster collaborative, multidisciplinary investigation, inspiring new ideas and discoveries; and translating scientific advances more swiftly into new ways of diagnosing and treating patients and preventing diseases. A one-of-its-kind facility across the world, Medanta through its research integrates modern and traditional forms of medicine to provide accessible and affordable healthcare.

The Medicity Expanded Access Program Physicians

Dr. Vijay Kher - Chairman, Division of Nephrology, Kidney & Urology Institute
Dr. Vijay Kher is currently Chairman, Division of Nephrology, Medanta Kidney & Urology Institute. Dr. Kher has established Academic & Clinical departments of Nephrology at Shere-Kashmir, Institute of Medical Sciences in Srinagar, SGPGIMS Lucknow, Apollo Hospitals, New Delhi, Fortis group of hospitals NCR, Delhi & now at Medanta. His research interests are kidney transplantation (clinical immunosuppression, pre emptive kidney transplantation & steroid free immunosuppression, cost-containment), progression of renal disease, acute kidney injury and glomerulonephritis. An astute clinician, a teacher par excellence and a keen researcher, Dr. Kher combines these assets with a friendly and inclusive demeanor to inspire the Nephrology fraternity in India by his professional dedication, academic excellence and social responsibility. He has been awarded fellowships of National Academy of Medical Sciences, Royal College of Physicians Edinburg & Indian Society of Nephrology. Dr. Kher has published more than 150 papers in peer-reviewed journals, 24 book chapters and has edited 5 books.

Dr. Randhir Sud - Chairman, Medanta Institute of Digestive & Hepatobiliary Sciences
Dr. Sud is Chairman of The Medanta Institute of Digestive & Hepatobiliary Sciences, which is a dedicated facility for patients with gastrointestinal, liver, pancreatic and biliary diseases, There are multiple treatment options for a disease and to provide the best available treatment to patients, this Institute has devised protocols where medical, surgical and allied teams jointly decide patient treatments and management.

About Aethlon Medical, Inc.

The Aethlon Medical mission is to create innovative medical devices that address unmet medical needs in cancer, infectious disease, and other life-threatening conditions. Our Aethlon ADAPT™ System is a revenue-stage technology platform that provides the basis for a new class of therapeutics that target the selective removal of disease enabling particles from the entire circulatory system. The Aethlon ADAPT™ product pipeline includes the Aethlon Hemopurifier® to address infectious disease and cancer; HER2osome™ to target HER2+ breast cancer, and a medical device being developed under a contract with DARPA that would reduce the incidence of sepsis in combat-injured soldiers and civilians. For more information, please visit www.aethlonmedical.com.

Certain statements herein may be forward-looking and involve risks and uncertainties.  Such forward-looking statements involve assumptions, known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of Aethlon Medical, Inc. to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. Such potential risks and uncertainties include, without limitation, that this expanded treatment program will augment the company's current government contract revenue stream, that the FDA will not approve the initiation of the Company's clinical programs or provide market clearance of the company's products, future human studies whether revenue or non-revenue generating of the Aethlon ADAPT™ system or the Aethlon Hemopurifier® as an adjunct therapy to improve patient responsiveness to established cancer or hepatitis C therapies or as a standalone cancer or hepatitis C therapy, the Company's ability to raise capital when needed, the Company's ability to complete the development of its planned products, the Company's ability to manufacture its products either internally or through outside companies and provide its services, the impact of government regulations, patent protection on the Company's proprietary technology, product liability exposure, uncertainty of market acceptance, competition, technological change, and other risk factors. In such instances, actual results could differ materially as a result of a variety of factors, including the risks associated with the effect of changing economic conditions and other risk factors detailed in the Company's Securities and Exchange Commission filings. The Company undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.

Contacts:

James A. Joyce
Chairman and CEO
858.459.7800 x301
jj@aethlonmedical.com

Jim Frakes
Chief Financial Officer
858.459.7800 x300
jfrakes@aethlonmedical.com

Marc Robins
877.276.2467
mr@aethlonmedical.com

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