Wednesday, June 30, 2010

OctoPlus' PolyActive drug delivery technology gets funded by Novartis

AMSTERDAM, June 30, 2010-OctoPlus N.V. ("OctoPlus" or the "Company") (Euronext: OCTO), the drug delivery company, announces today that it has signed an agreement with Novartis relating to the use of OctoPlus' controlled release technology.



Under the contract announced today, OctoPlus will develop, up to in vivo feasibility, a controlled release formulation of an undisclosed compound using its proprietary drug delivery technology PolyActive®. Novartis will fully reimburse OctoPlus for its activities under the agreement. Further financial terms of the agreement are not disclosed.



Simon Sturge, CEO of OctoPlus, says: "I am delighted to see our technology being evaluated by such a prestigious company as Novartis. This along with the recent data on Locteron® in more than 175 patients continues to build the strong support behind our PolyActive® controlled release technology and our capabilities in this area."

Friday, June 25, 2010

OraQuick® HCV Rapid Antibody Test approved for sale in the US...

OraSure Technologies Receives FDA Approval for OraQuick(R) HCV Rapid Test, the First Rapid HCV Test Approved for Sale in the U.S.

GlobeNewswire - Jun. 25, 2010
BETHLEHEM, Pa., June 25, 2010 (GLOBE NEWSWIRE) -- OraSure Technologies, Inc. (Nasdaq:OSUR) announced today that its OraQuick® Hepatitis C ("HCV") Rapid Antibody Test has been approved by the U.S. Food and Drug Administration ("FDA") for use in detecting HCV antibodies in venous whole blood specimens, making it the first rapid HCV test approved by the FDA for use in the United States.
"The OraQuick HCV test efficiently identifies previously undiagnosed HCV infected individuals who are at risk," said Eugene R. Schiff, MD, MACP, FRCP, MACG, AGAF, University of Miami School of Medicine. "We at the University of Miami found this test to be user-friendly, practical and an important tool for rapid HCV antibody detection."

"We believe that the OraQuick® HCV Rapid Antibody Test, with its simplicity and speed, will be a critical tool in identifying more at risk individuals infected with hepatitis C in the U.S., and thus represents a significant market opportunity," said Douglas A. Michels, President and Chief Executive Officer of OraSure Technologies. "Obtaining FDA approval of our OraQuick® HCV Rapid Antibody Test for venous whole blood represents a major milestone for our Company."

OraQuick® HCV is the only rapid, point-of-care test for the detection of antibodies to the hepatitis C virus in venous whole blood specimens that is approved by the FDA. The test, which utilizes the OraQuick® technology platform, provides results in 20 minutes. The OraQuick® HCV Rapid Antibody Test is the latest rapid test manufactured by OraSure to receive FDA approval. OraSure had previously received FDA approval for its OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test for use with oral fluid, fingerstick and venous whole blood and plasma samples.

In the U.S., there are an estimated 4.1 million Americans, or 1.6 percent of the population, that are or have been infected with HCV. According to the Centers for Disease Control and Prevention ("CDC"), new infections in the U.S. are estimated at approximately 20,000 per year. On a worldwide basis, there are an estimated 180 million people who are chronically infected with HCV, with an estimated 3 to 4 million individuals newly infected each year.

According to the World Health Organization, most cases of HCV infection are currently undiagnosed and up to 80 percent of HCV-positive individuals show no signs or symptoms.

In December 2009, the Company received the CE mark for its OraQuick HCV Rapid Antibody Test for use with oral fluid, whole blood, serum and plasma specimens. The CE mark was required in order to sell the product in the European Union.

As previously announced, OraSure has entered into agreements with Merck & Co. (through its predecessor Schering Plough Corporation) to collaborate on the development and promotion of the OraQuick® HCV test. Under the terms of these agreements, the Company has been and will be reimbursed by Merck for a portion of its costs to develop the test and obtain regulatory approvals. Additionally, Merck will provide promotional support, including detailing the test in the physicians' office market in those countries in which the Company has obtained approval.

Monday, June 21, 2010

Hematide problems to delay NDA...

Not necessiarly HCV-related, but ESAs are commonly used in current HCV therapy.  Shares of Affymax Inc. plunged more than 60 percent this morning after the Palo Alto, Calif.-based firm and partner Takeda Pharmaceutical Co. Ltd. reported much-awaited Phase III data for its ESA alternative, Hematide, in chronic renal failure. Though all four trials met the primary endpoint, secondary analyses turned up results that could be problematic, especially for approval in nondialysis patients. The companies will have to conduct further analysis, likely delaying a new drug application, which is good news for Amgen Inc.'s market-leading ESA franchise. Thanks to BioWorld for the scoop.

Benitec Limited stakes claim for HCV RNA interference patent...

From the PharmaLive.com News Archive - Jun. 18, 2010
Melbourne, June 18, 2010 - (ABN Newswire<http://www.abnnewswire.net/index.asp?lang=>) - Benitec Limited (ASX:BLT) (PINK:BNIKF) are pleased to announce that US Patent 7727970 "Multiple promoter expression cassettes for simultaneous delivery of RNAi agents targeted to Hepatitis C virus" has been granted by the United States Patent and Trademark Office (USPTO). The granted claims cover the use of an RNA interference construct (with multiple promoters) to inhibit the level of Hepatitis C virus in animal cells, tissues and organs. Moreover, the USPTO has granted Benitec an additional 805 days patent term in recognition of the delays in examining the patent application. Additional related applications remain pending to extend the scope of protection.

Benitec has licensed the rights to use this patent for Hepatitis C exclusively to Tacere Therapeutics, Inc., who recently announced that Pfizer has exercised its option to further develop and commercialise Tacere's Hepatitis C Virus (HCV) compounds.

Benitec's Chief Scientific Officer, Dr Peter French said, "The grant of this patent is an important further recognition of our dominant global position in the transformational DNA-directed RNA interference field and provides increased depth and breadth to our patent portfolio. Benitec's ddRNAi-related patent estate (solely owned or licensed exclusively for humans from CSIRO) currently comprises over 100 patents and patent applications covering 20 jurisdictions, of which more than 30 are granted, accepted or allowed."

Thursday, June 17, 2010

House Oversight panel urges congress to pass bill to boost detection and treatment of viral hepatitis.

Lawmakers on the House Oversight panel on Thursday urged Congress to quickly pass legislation to boost the detection and treatment of viral hepatitis, the leading cause of liver cancer in the United States.

The Oversight and Government Reform Committee held the first hearing in several years on the deadly disease, which disproportionately affects blacks and Asians, and pressed for passage of a bipartisan bill that would boost funding by $600 million over the next five years.

The hearing comes on the heels of an Institute of Medicine (IOM) report that highlighted deficiencies with the federal government's response to the epidemic. The report contains two dozen expert recommendations for improvement, including enhanced screening, physician education and the creation of a coordinated system to identify people who have the disease and refer them to care.

About 5.3 million Americans are believed to have hepatitis — the disease causes 12,000 to 15,000 deaths a year — though many don’t know it.

"The current approach [...] is not working," the IOM report says.
The legislation under consideration, introduced in October by Rep. Mike Honda (D-Calif.), has 52 bipartisan co-sponsors. The "Viral Hepatitis and Liver Cancer Control and Prevention Act" is currently in the Energy and Commerce Committee.

The bill would charge the secretary of Health and Human Services with developing and implementing a plan for the prevention, control and medical management of hepatitis B and C; it would also provide federal funding for state-based screening and early intervention programs.

Honda said the bill would eventually save billions of dollars by identifying sick people early. A study by the research firm Milliman found that without federal leadership, the cost of treating hepatitis C alone could more than triple, to $85 billion a year, by 2024.


"We can do a whole lot better than what we're doing," said Oversight panel chairman Edolphus Towns (D-N.Y.). "I think it's a disgrace to have a problem of this nature and to not commit resources."

The panel heard testimony from Honda and Reps. Bill Cassidy (R-La.) and Hank Johnson (D-Ga.). Cassidy is a hepatologist who co-sponsored the bill, and Johnson last year acknowledged he was undergoing treatment for hepatitis C.


Cassidy applauded former President Bill Clinton's children’s vaccination program and said the Honda bill would "similarly save lives." But debate quickly descended into budgetary politics.

Oversight ranking member Darrell Issa (R-Calif.) said Republicans would not vote for any new directed spending unless it's part of the budget bill, which has stalled.

Meanwhile, Democrats bristled at Issa's description of the word "earmark" to describe the bill.

A coalition of more than 175 public and private organizations launched a print ad campaign on Tuesday to coincide with the hearing. The National Viral Hepatitis Roundtable ad is made to look like a movie poster and reads "Mission: Possible."


"If Congress gets on the case now," the ad says, "the leading cause of liver cancer won't stand a chance."

Patient advocates say the Honda bill will help boost funding for hepatitis prevention efforts, which currently only get 2 percent — $19.3 million — of the budget allocated to the Centers for Disease Control and Prevention's National Center for HIV/AIDS, Viral
Hepatitis, STD and TB Prevention. Advocates hope the Honda bill will eventually allow them to get $150 million a year.

Monday, June 14, 2010

Human Genome Sciences: More bad news on Albuferon approval in the US

 
ROCKVILLE, Md.--(BUSINESS WIRE)--Jun 14, 2010 - Human Genome Sciences, Inc. (Nasdaq: HGSI) today announced that it has received preliminary written feedback from the U.S. Food and Drug Administration (FDA) regarding the Company's Biologics License Application (BLA) seeking approval in the United States to market 900-mcg ZALBIN™ (albinterferon alfa-2b, known in Europe as JOULFERON®) dosed every two weeks for the treatment of chronic hepatitis C. FDA has expressed concerns regarding the risk benefit assessment of ZALBIN dosed at 900-mcg every two weeks. Although the BLA review is ongoing, HGS has concluded that licensure of this dosing regimen is unlikely.

The FDA feedback was provided via a Discipline Review letter, which is a standard vehicle for review disciplines (e.g., clinical) to convey early thoughts on possible deficiencies of an application. In April 2010, HGS announced that Novartis withdrew its Marketing Authorization Application for JOULFERON from the European Medicines Agency.

ZALBIN (JOULFERON) is being developed by HGS and Novartis under an exclusive worldwide co-development and commercialization agreement entered into in 2006. HGS and Novartis are considering development of ZALBIN dosed every four weeks, and HGS previously reported the positive interim results of a Phase 2b study of this ZALBIN regimen.

About ZALBIN (albinterferon alfa-2b)
ZALBIN (also known as JOULFERON) is a genetic fusion of human albumin and interferon alfa created using proprietary HGS albumin-fusion technology. Human albumin is the most prevalent naturally occurring blood protein in the human circulatory system, persisting in circulation in the body for approximately 19 days. Research has shown that genetic fusion of therapeutic proteins to human albumin decreases clearance and prolongs the half-life of the therapeutic proteins.

About Human Genome Sciences
The mission of HGS is to apply great science and great medicine to bring innovative drugs to patients with unmet medical needs.

For more information about HGS, please visit the Company's web site at www.hgsi.com. Health professionals and patients interested in clinical trials of HGS products may inquire via e-mail to medinfo@hgsi.com or by calling HGS at (877) 822-8472.
HGS, Human Genome Sciences and ZALBIN are trademarks of Human Genome Sciences, Inc. Other trademarks referenced are the property of their respective owners.

Sunday, June 13, 2010

FDA Commissioner discusses "Regulatory Science" to speed evaluation of new drugs and medical procdures...

WASHINGTON, June 11 -- The American Association for the Advancement of Science issued the following news release:

Universities, industry, and government must join to develop state-of-the-art "regulatory science" that can speed evaluation of new drugs and medical procedures and bring them more quickly to patients, Dr. Margaret Hamburg, commissioner of the U.S. Food and Drug Administration, told a AAAS audience.

Advanced research and technology are driving remarkable new discoveries, Hamburg said, but the United States' current process of evaluating and approving them for use dates to an earlier era. The resulting gap between new discoveries and older treatments already on the market--some have termed it the "valley of death"--brings risk not only to patients, but to the nation's economy and innovation culture, she said.
"We live in a time when science and technology are changing our world in dramatic ways," Hamburg said. "We are seeing an explosion of knowledge and capabilities emerging from many domains of research and from around the globe. And with that comes a fundamental question of how do we make sure that we fully translate the potential and promise of that research into real-world products and programs that really matter.
"A big part of the answer is by strengthening regulatory science. This is a component of the overall scientific enterprise that is really essential, and yet has been underappreciated and underdeveloped."

Hamburg delivered a luncheon address at the 2010 AAAS Forum on Science and Technology Policy. The Forum celebrated its 35th year on 13-14 May with a selection of programs and events that included talks by John P. Holdren, assistant to the president for science and technology and director of the White House Office of Science and Technology Policy; U.S. Representative Vernon J. Ehlers (R-Michigan); Douglas W. Elmendorf, director of the Congressional Budget Office; Sabine Herlitschka, director of European and International Programmes for the Austrian Research Promotion Agency; and Patrick Gallagher, director of the National Institute of Standards and Technology.

Hamburg has had broad experience, and her influence has ranged from bioterrorism to infectious disease control and U.S. health policy. While New York City health commissioner from 1991 to 1997, she advanced innovative programs for controlling the spread of tuberculosis and AIDS. Between 1992 and 1997, the TB rate for New York City fell by 46%, and by 86% for the most resistant strains.

In 1997, she was selected by President Bill Clinton to be assistant secretary for policy and evaluation at the U.S. Department of Health and Human Services. Beginning in 2001, she served as vice president for biological programs at the Nuclear Threat Initiative, which is dedicated to reducing the threat from nuclear, chemical, and biological weapons. By unanimous voice vote in the U.S. Senate, she was confirmed as President Barack Obama's FDA commissioner in May 2009.

She took charge as the FDA was under broad criticism for its handling of U.S. food safety oversight, its approval of drugs that later were found to pose dangers to some patients, and ties with the pharmaceutical industry that were, in the view of critics, too close.

While the FDA's regulation extends over a quarter of the U.S. economy, regulatory science as discussed by Hamburg at the AAAS Forum is not widely-known. Where research scientists may take years to discover a new drug, regulatory science generally seeks to do its work more quickly; if research scientists develop a new cancer therapy, it is the goal of regulatory science to establish a mechanism that allows for effective evaluation of the therapy, and, if it is safe, allows its use by patients.

Generally, it is a tool used by government, and it is shaped by elected officials and other policy-makers. It is multi-disciplinary, often involving clinical research, epidemiology, statistics, and other fields. It closely overlaps with a growing field of initiatives in translational medicine, which seeks to translate cutting-edge discoveries into regular medical practice. [AAAS and Science last year launched a new weekly journal, Science Translational Medicine (http://stm.sciencemag.org/)]

Hamburg conceded that regulatory science lacks the allure of "discovery science." But without the best possible regulatory science, she suggested, a too-lengthy time may pass before the benefits of discovery find practical use for patients.

"Americans cannot take full advantage of the breakneck speed of biomedical research unless we also emphasize innovation in regulatory science," Hamburg said. "Just as biomedical research has evolved over the past few decades, regulatory science must also evolve in important and powerful ways."

She cited several fields of medical research where regulatory science will be critical for supporting clinical research--in studies of emerging stem cell and cancer treatments, for example, or in the effort to more tightly control tuberculosis, or TB.

But, she said, TB is a complex challenge. A cure requires multiple drugs administered over many months, and if a TB infection is not eradicated, the disease can evolve so that it's resistant to drugs.

"Fighting TB effectively requires combination products," Hamburg explained. "It will take forever if we have to approve each new drug independently and then look at how they work in combination. But that is how the process would traditionally work. Instead, we have embarked on a new initiative to work with researchers and companies interested in developing combination products which will be reviewed as such."
That's "much more complicated for FDA scientifically," she added, "but it is what patients need and what public health demands."

The effort to develop a more robust regulatory science requires the FDA to build its in-house science capacity, Hamburg said. And, she added, it will seek close collaboration with allied medical and regulatory agencies, such as the National Institutes of Health (NIH). Already, she said, the FDA and NIH recently launched "an important and broad collaboration" in translational and regulatory science.

She said that FDA will continue and expand relationships with academic groups, patient advocacy groups, and industry. International collaboration also could play a critical role in advancing regulatory science.
"There are enormous opportunities to collaborate with scientific colleagues around the world on matters of regulatory science, and also to engage with international sister regulatory agencies to address issues of common concern, share information, and to harmonize standards and approaches," Hamburg said.
"Outreach and collaboration are central to regulatory science efforts. When successful, these collaborative efforts will help predict more swiftly and effectively which discoveries will succeed or fail as actual products, thereby reducing product-development costs and getting better products to patients faster."

President Obama has backed an overhaul of the agency, and Hamburg said that the FDA already is benefiting from renewed attention and new resources. But given the precarious state of the U.S. economy, she predicted that the agency faces a significant challenge in meeting its regulatory science goals in the near future.

"A robust, state-of-the-art regulatory science is essential to the work of the FDA," she insisted in her conclusion. "But more than that, it represents an important driver of our nation's health, the health of our health care industry, and the health of our economy. ... It's vital to our nation's global competitiveness. It is a field of endeavor that must be fully embraced by academia, industry, and government."

Friday, June 11, 2010

ViroStatics and Vichem Chemie Announce Strategic Partnership to Identify and Develop Kinase Inhibitors for the Treatment of HIV/AIDS and Other Chronic Diseases

SASSARI, Italy, PRINCETON, N.J. & BUDAPEST, Hungary--(BUSINESS WIRE)--Jun 11, 2010 - ViroStatics, srl, an Italian-US biopharmaceutical company today announced the formation of a strategic partnership with Vichem Chemie of Budapest, Hungary to identify, synthesize, screen, and develop the next generation of AntiViral-HyperActivation Limiting Therapeutics (AV-HALTs) for the treatment of HIV/AIDS and other chronic diseases.

Vichem Chemie is a Hungarian biotech research company focusing upon the field of kinase inhibitors, one of the fastest growing segments within the pharmaceutical industry with applications in oncology, autoimmune diseases and other unmet medical needs. ViroStatics has brought the first-in-class AV-HALT, VS411, into Phase II development. AV-HALTS are a new class of drugs that combine direct anti-viral activity with a reduction in the chronically elevated immune system activation that is now known to play a major role in the progression of HIV disease, ultimately leading to AIDS.

“We are extremely pleased to be working with Vichem Chemie to discover valuable new AV-HALT drugs,” explained Franco Lori, MD, President and CEO of ViroStatics. “Vichem's expertise, know-how and credibility in the area of in vitro discovery of novel drug families are well-known. Our new partnership brings together both companies' substantial intellectual properties and significant libraries of Kinase Inhibitors."

“The expertise of ViroStatics in translating basic discoveries into clinical applications -from the bench to the bed side – is well appreciated,” added Gyorgy Keri, PhD and CEO of Vichem Chemie. “The Companies' strengths are both complimentary and synergistic. We look forward to a successful partnership to identify new and exciting compounds that ViroStatics will develop into important new therapies against HIV/AIDS and other chronic diseases.”

“The new class of AV-HALTs represents a novel approach to the treatment of HIV based upon the most recent discoveries in the field of viral pathogenesis,” said Richard B. Pollard, MD, Professor of Medicine and Chief of the Division of Infectious Diseases, University of California Davis Health System. “ViroStatics was the first to achieve Proof-of-Principle for the AV-HALTs with the two-drug combination product, VS411. The collaboration between ViroStatics and Vichem Chemie is expected to lead to the second generation of AV-HALTs where both antiviral activity and reduction of excessive immune activation are combined in a single molecule.”

Oppenheimer boosts rating on Idenix based on IDX-184 data.

NEW YORK -- An Oppenheimer analyst boosted his investment rating on Idenix Pharmaceuticals Inc. Friday, citing the market potential for the biotechnology company's hepatitis C treatments.


Oppenheimer analyst Dr. Brian Abrahams upgraded shares to "Outperform" from "Perform" and issued a $7 price target on the stock.

The company's developing hepatitis C drugs include IDX-184 and IDX-320. Hepatitis C is an infection that damages the liver.

"With IDX-184 appearing more impressive, the rest of the hepatitis C pipeline nearing proof-of-concept, and a growing emphasis in the space on STAT-C combos, we believe Idenix is poised to derive greater value from its broad hepatitis C development approach," he said in a note to investors.

He said IDX-184 appears more promising and expects additional midstage study data to confirm its potential. In April, the company said a 100-milligram dose of the drug prompted antiviral activity after 14 days of treatment in patients during a midstage study. The company had previously reported positive results from patients taking a 50-milligram dose of the drug and said it will move ahead with dosing on a 150-milligram version of the drug.

Abrahams said additional positive data from 150-milligram and 200-milligram doses during the second half of 2010 should further strengthen the drug candidate's profile.

Meanwhile, he said, the company's pipeline is maturing, with multiple chances at approval for a hepatitis C drug. He cited potential hepatitis C drugs IDX-320 and IDX-375, which are in the early stages of development.

Thursday, June 10, 2010

Idenix Pharmaceuticals Initiates Proof-of-Concept Study for Protease Inhibitor IDX320 in Hepatitis C Patients

Idenix Pharmaceuticals Initiates Proof-of-Concept Study for Protease Inhibitor IDX320 in Hepatitis C Patients

PR Newswire US - Jun. 10, 2010
CAMBRIDGE, Mass., June 10 /PRNewswire-FirstCall/ -- Idenix Pharmaceuticals, Inc. (Nasdaq: IDIX), a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral diseases, today announced that it has initiated a 3-day proof-of-concept study of IDX320, a protease inhibitor for the treatment of hepatitis C virus (HCV) infection, under a Clinical Trial Application (CTA). The study is evaluating IDX320 in treatment-naive hepatitis C genotype 1-infected patients.

"The potent and multi-genotypic activity demonstrated in vitro, as well as the favorable pharmacokinetics observed in healthy volunteers, suggests a promising profile for further development of IDX320," said Jean-Pierre Sommadossi, Ph.D., chief executive officer of Idenix. "The landscape for combination development in HCV is evolving quickly. Assuming favorable results from the IDX320 proof-of-concept study, we plan to discuss with regulatory agencies a direct-acting antiviral combination strategy with IDX320 and IDX184, our HCV nucleotide polymerase inhibitor."

Douglas Mayers, M.D., Idenix's chief medical officer commented, "We are encouraged by the results seen to date with IDX320 and are hopeful that future clinical studies will allow us to continue advancing this program with the ultimate goal of treating a wide range of patients infected with HCV."

The proof-of-concept trial in HCV-infected patients is a Phase I/II randomized, parallel-arm, double-blind, placebo-controlled study evaluating the safety and antiviral activity of IDX320 in treatment-naive adult patients infected with chronic hepatitis C. The study will evaluate four doses of IDX320, ranging from 50 to 400 mg once-per-day, administered for three days. Each cohort of the study will evaluate eight patients randomized six to IDX320 and two to placebo. 

About IDX320
IDX320, a macrocyclic HCV protease inhibitor, is an inhibitor of NS3/4A proteases from genotypes 1a, 1b, 2a and 4a (IC50 values from 0.8 to 1.9 nM), as well as from genotype 3a (IC50=23 nM). IDX320 did not inhibit nine tested cellular proteases (IC50 > 10 uM) in vitro, suggesting high selectivity. IDX320 bound tightly to the HCV protease enzyme with a long dissociation half-life (> 9 hours). After single 2 mg/kg oral doses of IDX320 in two animal species, favorable bioavailability and a long plasma half-life were observed, with substantial plasma concentrations 24 hours post dose. Comparable drug exposure was confirmed in healthy volunteers (n=6) receiving a single 200 mg oral dose. Further, no significant in vitro inhibition of human drug metabolizing enzymes, CYP450s and UGT1A1, by IDX320 suggests low potential for drug-drug interactions in patients.

About IDX184
IDX184 is a novel, liver-targeted nucleotide prodrug of 2'-methyl guanosine monophosphate, which includes Idenix's proprietary liver-targeting technology. This technology enables the delivery of nucleoside monophosphate to the liver, leading to the formation of high levels of nucleoside triphosphate, potentially maximizing drug efficacy and limiting systemic side effects with low, once-daily dosing. IDX184 in combination with pegylated interferon and ribavirin has demonstrated a generally favorable safety profile and potent antiviral activity in an ongoing Phase IIa study.

Wednesday, June 9, 2010

Pharmasset Announces Submission of Abstracts to AASLD Liver Meeting Including an Interim Analysis of Roche's Phase 2b PROPEL Trial of RG7128

PRINCETON, N.J., June 9, /PRNewswire-FirstCall/ -- Pharmasset, Inc. (Nasdaq: VRUS) announced today that the interim results from the PROPEL study conducted by its partner Roche demonstrate that RG7128 triple combination therapy was safe and well tolerated. In that study, the safety profile of RG7128 (1000mg BID or 500mg BID), when administered for 8 or 12 weeks with Pegasys (peginterferon alfa-2a) and Copegus (ribavirin), the standard of care (SOC), was similar to the safety profile of SOC alone. An interim analysis of the study included all safety data from all 408 patients who had completed the first 12 weeks of the study.  The most common adverse events were no different than those frequently noted with SOC alone. There were no findings related to rash, anemia, bone marrow suppression, or nephrotoxicity across any of the arms. 

The PROPEL study is evaluating the dose and duration of treatment of RG7128 in combination with SOC in patients with chronic hepatitis C virus (HCV) genotype 1 or genotype 4 who have not been treated previously. The interim analysis also included on-treatment efficacy data demonstrating that >80% of patients had undetectable HCV RNA in all cohorts receiving the 12-week triple regimen compared to <50% for the placebo/SOC cohort. The safety and efficacy results from the interim analysis of the PROPEL Phase 2b study of RG7128 have been submitted by Roche as an abstract to AASLD for the Annual Liver Meeting (October 29 to November 2, 2010). The title of the abstract is:

"High rates of early viral response, promising safety profile and lack of resistance-related breakthrough in HCV GT 1/4 patients treated with RG7128 plus PegIFN alfa-2a (40KD)/RBV: Planned Week 12 interim analysis from the PROPEL study" 

"We are encouraged by the reported efficacy, safety, and resistance data from this interim analysis of the PROPEL study," said M. Michelle Berrey, MD, MPH, Pharmasset's Chief Medical Officer. "We believe safety, absence of resistance, as well as antiviral potency will all be important considerations as HCV treatment incorporates direct acting antivirals in combination with interferon, and in potential interferon-free antiviral combination regimens."

No viral rebounds or resistance-related breakthroughs were noted during the first 8 or 12 weeks of triple combination therapy, consistent with the demonstrated high barrier to resistance in earlier RG7128 clinical studies.  In clinical reports to date, the S282T mutation associated with RG7128 resistance in vitro has not been detected at baseline in HCV-infected patients enrolling in clinical trials. A separate abstract has been submitted by Roche including details of the resistance analyses that have been conducted during this study, including sequencing of the HCV RNA from all patients at baseline. The abstract is entitled:
"No evidence of drug resistance or baseline S282T resistance mutation among GT1 and GT4 HCV infected patients on nucleoside polymerase inhibitor RG7128 and Peg-IFN/RBV combination treatment for up to 12 weeks: interim analysis from the PROPEL study."

About the Phase 2b PROPEL Study
The Phase 2b study enrolled 408 patients with HCV genotypes 1 or 4, cirrhotic and non-cirrhotic, who have not been treated previously. The primary efficacy endpoint of the study is the proportion of patients who achieve an SVR, defined as HCV below the limit of detection (<15 IU/mL as measured by Roche TaqMan assay) 24 weeks after completion of all treatment. The study is being conducted in North America, Europe, and Australia. Patients were enrolled into one of 5 arms:
  • 24 weeks of total treatment;  RG7128 500mg BID in combination with SOC for 12 weeks, followed by 12 weeks of SOC ("12+12", RVR guided)
  • 24 weeks of total treatment; RG7128 1000mg BID in combination with SOC for 12 weeks, followed by 12 weeks of SOC ("12+12", RVR guided)
  • 24 weeks of total treatment; RG7128 1000mg BID in combination with SOC for 8 weeks, followed by a further 16 weeks of SOC ("8+16", RVR guided)
  • 48 weeks of total treatment; RG7128 1000mg BID in combination with SOC for 12 weeks, followed by a further 36 weeks of SOC ("12+36", non-RVR guided")
  • A control arm with SOC for 48 weeks.

Patients in the 24-week arms will discontinue all treatment at week 24 if they have achieved RVR, defined as HCV RNA below the limit of detection (<15 IU/mL) at week 4 and maintain these low levels of HCV RNA until week 22, a strategy known as "RVR-guided" treatment. Patients who do not meet these criteria will continue on the standard of care until week 48. 

RG7128 is also currently being evaluated in a Phase 2b study in which RG7128 and SOC are given for a total of 24 weeks each ("24+0", RVR guided). The regimen will be assessed in treatment-naive HCV-infected patients with genotypes 1 or 4.  Enrollment in this study was completed in early May.  In addition, Roche anticipates the initiation of another Phase 2 study in HCV-infected patients with genotypes 2 or 3 by the end of 2010.

John G. McHutchison, MD, to Join Gilead Sciences as Senior Vice President, Liver Disease Therapeutics

FOSTER CITY, Calif., Jun 08, 2010 (BUSINESS WIRE) --Gilead Sciences, Inc. (Nasdaq: GILD) today announced that John G. McHutchison, MD, will join the company as Senior Vice President, Liver Disease Therapeutics. In this position, Dr. McHutchison will report to Norbert W. Bischofberger, PhD, Executive Vice President, Research and Development and Chief Scientific Officer and will have responsibility for Gilead's research and development efforts supporting the company's programs in liver disease, including hepatitis C. 

Dr. McHutchison will also join Gilead's Executive Committee. 

"John is recognized internationally as one of the leading experts in gastroenterology and hepatology, and I am very pleased to welcome him to the Gilead team," said Dr. Bischofberger. "John's appointment as Senior Vice President is indicative of the strong commitment we have to the therapeutic category of liver disease. His extensive clinical and translational research experience in this area will be of great value as we work to advance promising pipeline programs in hepatitis C and further characterize the profile of our commercial products in hepatitis B." 

Dr. McHutchison joins Gilead from Duke University Medical Center, where he most recently served as Associate Director of the Duke Clinical Research Institute and Director of the GI/Hepatology Research Program. He also held the positions of Professor of Medicine in the Division of Gastroenterology at Duke University Medical Center, Co-Director of the Duke Clinical and Translational Science Award and Director of the Duke Clinical Research Unit. 

"The strength of Gilead's scientific leadership and the unique opportunity to help shape future therapeutic possibilities for many patients with liver disease led to my keen interest in the company," said Dr. McHutchison. "After meeting with the Gilead team, I am very enthusiastic about the company's potential to advance promising treatments for patients with hepatitis C and other liver diseases - areas where there remains a large unmet medical need." 

Dr. McHutchison received bachelor of medicine and bachelor of surgery degrees from the University of Melbourne, Australia, and completed his residency in internal medicine and a fellowship in gastroenterology at the Royal Melbourne Hospital. Dr. McHutchison is also a member of the Royal Australasian College of Physicians. He is a member of several scientific advisory boards, serves on the editorial boards of numerous scientific journals and has published more than 300 peer-reviewed articles and abstracts.

Friday, June 4, 2010

RetroVirox Inc seeking funding to advance it's HCV & HIV proprietary discovery programs...


RetroVirox Inc. is seeking to raise funds to support the company's hepatitis C virus (HCV) and other antiviral programs, including one aimed at Dengue virus. But the San Diego-based firm, which began operating in May 2009, wants to advance its antiviral programs only so far, through the investigational new drug (IND) application process or Phase I.

"We don't plan to be a clinical stage company," Juan Lama, president, CEO and director of RetroVirox, told BioWorld Today.

Instead, he said the company is focused on the early stages of discovery and preclinical development of lead compounds. RetroVirox could go in a few different directions based on that model.
It would work to identify new compounds that could lead to first-in-class antivirals and out-license those compounds, approach potential partners to continue clinical development, or possibly put all of its assets up for sale, Lama indicated.

The company is interested in partnerships, venture capital and also non-dilutive opportunities such as small business innovation research (SBIR) funding, he said.

Founded by a group of scientists and entrepreneurs in the fields of virology and drug discovery, the company's expertise is in utilizing cell-based assays to discover new small-molecule compounds with antiviral activity. To do this, RetroVirox has developed proprietary assays to identify compounds that block viral entry by targeting host factors rather than viral proteins.

RetroVirox employs four to six scientists with expertise in virology, assay development, high-throughout screening and medicinal chemistry.

The company offers its services to other biotech companies, providing antiviral assays and screening of libraries for antiviral compounds. In that regard, RetroVirox would work similar to a contract research organization, providing assays in the virology area and identifying potential new compounds to offset its research and development expenses.

Still, the company's major focus is on advancing its own discovery programs, explained Lama, who has governed the firm since its inception.

The company's platform technology has achieved proof-of-concept in the area of HIV, and based on that technology, RetroVirox is developing proprietary assays to create a platform to discover drugs against other major human viruses, including HCV. The technology potentially could be used to inhibit viral entry for almost any virus containing a lipid membrane, Lama said.

Ideally, RetroVirox would like to advance its HCV and HIV programs first, to an IND or Phase I. "We are actually working in both [programs] at the same time, although given the burden of HCV infection we intend to put more effort in the HCV program," Lama said.

In the U.S. alone, more than 3 million are infected with HCV.

So far, RetroVirox has received a little over $1.1 million in financing, with much of that coming from three National Institutes of Health Small Business Innovation Research (SBIR) awards, and the remaining from early stage investors.

The current SBIR Phase I funds would last for the next 18 months. A Phase II SBIR grant could cover another two to three-year period, Lama said.

Under the grants awarded in the last 12 months RetroVirox received $872,000 to fund development of novel HIV entry drugs that could potentially overcome limitations of current therapies. The company received its last award in May to finance the discovery of anti-HIV drugs that block removal of the virus receptor, the CD4 protein.

RetroVirox believes that the mode of action used in its antiviral programs has never been targeted before and holds some key advantages over other antivirals. The company takes aim at human proteins that are needed by the virus to become infectious and enter other cells.

While conventional viral entry inhibitors block binding between the viral envelope and receptor proteins, RetroVirox's approach targets intracellular intracellular proteins, which may not bind directly to viral factors. The company believes that those intracellular host factors could display higher barriers to the emergence of resistant virus, one of the major hurdles in antiviral therapy.

Unlike other entry inhibitors such as the FDA-approved CCR5 blocker maraviroc (Pfizer Inc.'s Selzentry), which act on one of the HIV receptors, RetroVirox's molecules are efficient at blocking entry of all HIV strains, regardless of the co-receptor used by the virus, Lama said.

Online article in the journal "Hepatology" looks at IL28B effect on Telaprevir response

Just published online from the journal Hepatology: A small Japanese study looks to see if amino acid substitution in the HCV core region in conjunction with genetic variation near the IL28B gene can predict viral response to a  12 or 24 week regimen of Telaprevir + P/R in a similar way to how it predicts response in good ol' fashioned peginterferon and ribavirin. 

Investigators looked at 72 of 81 Japanese adults infected with HCV genotype 1b. Authors conclusion's cut n' pasted from the actual study below. Looks very positive, but needs a trial with larger numbers in different genotypes and ethnicities to really be sure.

Overall, sustained virological response and end-of-treatment response were achieved by 61% and 89%, respectively. Especially, sustained virological response was achieved by 45% and 67% in 12- and 24-week regimen, respectively. Multivariate analysis identified rs8099917 near IL28B gene (genotype TT) and substitution at aa 70 (Arg70) as significant determinants of sustained virological response. Prediction of response to therapy based on combination of these factors had high sensitivity, specificity, positive and negative predictive values. Efficacy of triple therapy was high in the patients with genotype TT who accomplished sustained virological response (84%), irrespective of substitution of core aa 70. In the patients having genotype non-TT, those of Arg70 gained high sustained virological response (50%), and sustained virological response (12%) were the worst in patients who possessed both of genotype non-TT and Gln70(His70). In conclusions, this study identified genetic variation near IL28B gene and aa substitution of the core region as predictors of sustained virological response to triple therapy of telaprevir/PEG-IFN/ribavirin in Japanese patients infected with HCV genotype 1b.

Wednesday, June 2, 2010

Boehringer Ingelheim starts STAT-C combination study...

According to Clinical Trails.gov, Boehringer Ingelheim has initiated a STAT-C combination study looking at their compounds BI 207127 (Non-nucleoside polymerase inhibitor) and BI 201335 (Protease inhibitor) plus Ribavirin. This study does not have an interferon component.

They are recruiting 302 naive patients who will be randomized to the following arms:
4 weeks of high dose TID BI 207127 + QD BI 201335 (protease inhibitor) + RBV
4 weeks of low dose TID BI 207127 and QD BI 201335 + RBV
24 or 48 weeks of high dose TID BI 207127 and QD BI 201335 + RBV
24 or 48 weeks of high dose BID BI 207127 and QD BI 201335 + RBV
24 or 48 weeks of high dose TID BI 207127 and QD BI 201335

The primary outcome measures are RVR and SVR. All sites are in the EU

http://clinicaltrials.gov/ct2/show/NCT01132313?term=hepatitis+OR+hep+OR+HCV&lup_s=05%2F01%2F2010&lup_d=30

Tuesday, June 1, 2010

Can-Fite's CF102 reports significant decrease in HCV viral load in patient with HCC...

Can-Fite BioPharma reported that a significant decrease in HCV viral load was noted in a patient with liver cancer treated daily, orally with CF102, within the framework of a Phase I/II clinical study in liver cancer (hepatocellular carcinoma, HCC) patients.

The Phase I/II study is enrolling patients with advanced or treatment-refractory HCC. As chronic viral hepatitis is one of the most important causes for HCC, patients in this trial are tested at entry for infection with HCV. Although not part of the primary trial objectives, those patients who are HCV-positive are retested periodically to gauge the effect of CF102 on HCV infection in this population. In the first, lowest-dose, cohort of the trial, 1 patient was found to be HCV-positive with a circulating viral load of >106 IU/mL at entry. Over the course of treatment with CF102, the viral load fell by >1.4 log10 in the absence of any other intervention, providing a very strong indication for a significant effect of CF102 in suppressing viral replication in the liver.

Can-Fite CEO, Dr. Pnina Fishman said, “these results are especially encouraging for 2 reasons. First, they validate our extensive pre-clinical data indicating CF102’s effectiveness in treating liver disease in general, and HCV infection in particular. Second, this result is encouraging for Can-Fite’s other ongoing CF102 trial, a Phase 1/2 study in patients with HCV infection. We are optimistic that CF102 can become part of the treatment arsenal for the millions of people worldwide who suffer from HCV.”

Previously, the company reported that preclinical studies have suggested that the drug is active against HCV via inhibition of NS5, RNA dependent RNA polymerase. CF102 was also found to trigger programmed cell death (apoptosis) of liver cancer cells. The company had announced the successful completion of a Phase I clinical study with CF102 under an IND in the US, showing a safety profile and a linear pharmacokinetic behaviour of the drug.