Research & Treatment News
August 31, 2006
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A novel approach to hepatitis C treatment will be presented at this year's annual meeting of the American Association of Liver Diseases. The preliminary results for a new class of drug designed to destroy both HCV viral particles and HCV infected cells show great promise. Bavituximab's recognition at this high-profile and well-respected event signifies this drug's potential.
Peregrine's Final HCV Phase 1a Study Results Accepted for Oral Presentation at AASLD Annual Meeting
- Study Results for First-in-Class Agent Bavituximab Will Be Presented at The Liver Meeting(R), the Leading Scientific Meeting on Liver Disease -
TUSTIN, Calif., Aug. 16 /PRNewswire-FirstCall/ -- Peregrine Pharmaceuticals, Inc. (Nasdaq: PPHM), a biopharmaceutical company with a portfolio of innovative, clinical stage products for the treatment of hepatitis C virus (HCV) infection and cancer, today announced that data from its Phase la study of bavituximab in patients with chronic hepatitis C viral (HCV) infection have been accepted for oral presentation at The Liver Meeting(R) 2006, the premier event in the science and practice of hepatology hosted by the American Association for the Study of Liver Diseases (AASLD).
"We believe that bavituximab represents a potentially valuable new approach for the treatment of chronic HCV infection. Given the novel nature of this approach, we are very pleased that AASLD has selected our clinical data for an oral presentation," said Steven W. King, president and CEO of Peregrine. "The next phase of the HCV clinical program is already underway with patient enrollment in the Phase 1b repeat dose study proceeding well and on track for completion by year-end. The presentation at The Liver Meeting gives us an excellent opportunity to raise awareness of the potential promise of the bavituximab HCV program as we continue clinical development."
Over 5,000 hepatologists and hepatology health professionals from around the world will meet at the 57th Annual Meeting & Postgraduate Course of AASLD -- The Liver Meeting at the John B. Hynes Convention Center in Boston, Massachusetts from October 27-31, 2006. The bavituximab presentation is scheduled for October 30, 2006 at 3:00 pm EST.
About Bavituximab
Bavituximab is the first investigational agent in a new class of anti-phosphatidylserine (anti-PS) immunotherapeutics that targets and binds to cellular components not normally present on the outside of cells, but which become exposed on certain virally infected cells and on the surface of enveloped viruses. Bavituximab helps stimulate the body's immune defenses to destroy both the virus particles and the infected cells. Bavituximab is currently in clinical trials for the treatment of chronic hepatitis C virus infection. Preliminary results from an ascending single dose Phase la trial in HCV patients reported earlier this year indicated that bavituximab was well tolerated, and it showed promising signs of anti-viral activity. A repeat dose Phase 1b HCV trial is ongoing and is expected to be completed by year-end. Similar to their proposed anti-viral mechanism, anti-PS immunotherapeutics also bind to phospholipids exposed on tumor blood vessels in all solid cancers tested to date. Bavituximab is currently in Phase 1 clinical trials for the treatment of advanced refractory solid tumor cancers.
About Peregrine Pharmaceuticals
Peregrine Pharmaceuticals, Inc. is a biopharmaceutical company with a portfolio of innovative product candidates in clinical trials for the treatment of cancer and hepatitis C virus (HCV) infection. The company is pursuing three separate clinical trials in cancer and HCV infection with its lead product candidate bavituximab (formerly Tarvacin) and Cotara(R). Peregrine also has in-house manufacturing capabilities through its wholly owned subsidiary Avid Bioservices, Inc. (www.avidbio.com), which provides development and bio-manufacturing services for both Peregrine and outside customers. Additional information about Peregrine can be found at www.peregrineinc.com.
Safe Harbor Statement: Statements in this press release which are not purely historical, including statements regarding Peregrine Pharmaceuticals' intentions, hopes, beliefs, expectations, representations, projections, plans or predictions of the future are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The forward-looking statements involve risks and uncertainties including, but not limited to, the risk that bavituximab's safety profile in a repeat dose trial or in a combination therapy trial will not be at the same safety level as was found in the Phase 1a trial, the risk that the results of future trials will not correlate to the results from the Phase 1a trial, and the risk that bavituximab will not be as well tolerated at ascending doses. It is important to note that the company's actual results could differ materially from those in any such forward-looking statements. Factors that could cause actual results to differ materially include, but are not limited to, uncertainties associated with completing preclinical and clinical trials for our technologies; the early stage of product development; the significant costs to develop our products as all of our products are currently in development, preclinical studies or clinical trials; obtaining additional financing to support our operations and the development of our products; obtaining regulatory approval for our technologies; anticipated timing of regulatory filings and the potential success in gaining regulatory approval and complying with governmental regulations applicable to our business. Our business could be affected by a number of other factors, including the risk factors listed from time to time in the Company's SEC reports including, but not limited to, the annual report on Form 10-K for the year ended April 30, 2006. The Company cautions investors not to place undue reliance on the forward-looking statements contained in this press release. Peregrine Pharmaceuticals, Inc. disclaims any obligation, and does not undertake to update or revise any forward-looking statements in this press release.
SOURCE Peregrine Pharmaceuticals, Inc.
/CONTACT: Barbara Lindheim, +1-212-918-4949, ir@peregrineinc.com; or Media, Stephen Gendel, +1-212-918-4650, both of GendeLLindheim BioCom Partners, for Peregrine Pharmaceuticals, Inc.
Posted by Editors at 4:41 PM --- Printer-friendly version
August 30, 2006
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Two companies committed to finding a vaccine for hepatitis C have released encouraging news on their progress. Tripep and Inovio's efforts to introduce a genetically engineered medicine through a patented DNA delivery system appear to stimulate immunity against Hepatitis C. As it evolves, this technology represents great hope for controlling the spread of the Hepatitis C virus.
Tripep Produces Additional Positive Data for Its Hepatitis C DNA Vaccine Using Inovio's DNA Delivery System
SAN DIEGO--(BUSINESS WIRE)--Aug. 28, 2006--Inovio Biomedical Corporation (AMEX:INO) announced today that its partner, Tripep AB of Sweden, has achieved additional positive pre-clinical results showing that its ChronVac-C DNA vaccine combined with Inovio's MedPulser® DNA delivery system produced a strong immune response against hepatitis C virus (HCV) in a large animal model. Ongoing toxicity studies of ChronVac-C® delivered using Inovio's electroporation-based system revealed that the combination induces a humoral response in rabbits that is comparable to results previously observed in mice.
"These results provide encouragement that the combination of ChronVac-C with the MedPulser DNA delivery system may work well in humans and indicate that our collaboration with Inovio is progressing very well," said Tripep's CEO, Jan Nilsson.
"We are pleased to see continuing positive data from this program and Tripep's ongoing commitment to the development of this DNA vaccine with the goal of initiating a clinical study using Inovio's MedPulser® DNA delivery system," stated Avtar Dhillon, MD, Inovio's president and CEO.
About Hepatitis C and ChronVac-C
Hepatitis is a disease characterized by inflammation of the liver. Hepatitis C virus (HCV) is a major cause of acute hepatitis. HCV is spread primarily by direct contact with human blood, the major causes worldwide being the use of unscreened blood transfusions, and re-use of needles and syringes that have not been adequately sterilized. As many as 70% - 90% of newly infected patients may progress to develop chronic infection (WHO: 2002). Of those with chronic liver disease, 5% - 20% may develop cirrhosis. About 5% of infected persons may die from the consequences of long term infection (due to liver cancer or cirrhosis). Globally, an estimated 170 million people are chronically infected with HCV, which represents a reservoir sufficiently large for HCV to persist, and 3 to 4 million persons are newly infected each year. In the US, while new incidences of HCV have dropped dramatically, an estimated 4.1 million (1.6%) Americans have been infected with HCV, of whom 3.2 million are chronically infected (Centers for Disease Control and Prevention: 2006).
HCV infections in the liver do not trigger an immune response very effectively. Certain antiviral therapies, while expensive, are somewhat effective in treating hepatitis C, but there is no vaccine currently available to prevent hepatitis C. ChronVac-C® is designed to be a therapeutic DNA vaccine that can stimulate the body's immune system. Animal experiments have demonstrated that ChronVac-C vaccination activates B cells and T-cells (the latter being regarded as the most significant to clearing the chronic infection relating to hepatitis C) that killed cells producing HCV protein. In humans, the ChronVac-C DNA plasmid would be injected into muscle tissue, where vaccinations are usually given, and taken up by muscle cells with the assistance of Inovio's electroporation-based DNA delivery system. These muscle cells would be expected to then produce predetermined proteins that may activate the body's immune system to attack all cells producing HCV proteins.
About Tripep AB
Tripep AB is a Swedish biotechnology research company that develops and commercialises candidate drugs based on patented and proprietary technologies. Its main focuses are research and clinical development of ChronVac-C®, a therapeutic vaccine against hepatitis C; preclinical research focusing on the development of the therapeutic and prophylactic vaccines against influenza A and HIV; the RAS® technology platform. More information is available at www.tripep.se or contact Jan Nilsson, CEO at +46 8 449 8480 or jan.nilsson@tripep.se.
About Inovio Biomedical Corporation
Inovio Biomedical Corporation is a late stage biomedical company focused on commercializing its proprietary Selective Electrochemical Tumor Ablation (SECTA) therapy. SECTA is designed to target a significant unmet clinical need: a local treatment for solid tumors, with selective killing of cancer cells while preserving surrounding healthy tissue. Inovio is moving its lead product, the MedPulser®, through pre-marketing studies for head and neck cancer and skin cancers in Europe, where it has CE Mark accreditation, a U.S. Phase III pivotal study for head and neck cancer, and Phase I trials for pancreatic and breast cancer. Merck, Vical, University of Southampton, and H. Lee Moffitt Cancer Center are using Inovio's gene delivery technology in clinical studies of novel DNA therapeutics delivered using electroporation. Inovio is a leader in developing human therapeutic applications of electroporation, with the industry's most extensive patent portfolio covering in vivo electroporation. More information is available at www.inovio.com.
This press release contains certain forward-looking statements relating to our plans to develop our electroporation drug and gene delivery technology. Actual events or results may differ from our expectations as a result of a number of factors, including the uncertainties inherent in clinical trials and product development programs (including, but not limited to, the fact that pre-clinical results referenced in this release may not be indicative of results achievable from testing in humans), the availability of funding to support continuing research and studies in an effort to prove safety and efficacy of Inovio's technology as a delivery mechanism, the availability or potential availability of alternative therapies or treatments for the conditions targeted by Inovio or its collaborators, including alternatives that may be more efficacious or cost-effective than any therapy or treatment that Inovio and its collaborators hope to develop, evaluation of potential opportunities, issues involving patents and whether they or licenses to them will provide Inovio with meaningful protection from others using the covered technologies, whether such proprietary rights are enforceable or defensible or infringe or allegedly infringe on rights of others or can withstand claims of invalidity and whether Inovio can finance or devote other significant resources that may be necessary to prosecute, protect or defend them, the level of corporate expenditures, assessments of our technology by potential corporate or other partners or collaborators, capital market conditions, and other factors set forth in our Annual Report on Form 10-K for the year ended December 31, 2005, our Form 10-Q for the six months ended June 30, 2006, and other regulatory filings. There can be no assurance that any product in our product pipeline will be successfully developed or manufactured, or that final results of clinical studies will be supportive of regulatory approvals required to market licensed products.
CONTACT: Inovio Biomedical Corporation
Bernie Hertel, 858-410-3101 (Investor Relations)
or
Porter Novelli Life Sciences
Susan Neath, 858-527-3486 (Media Relations)
SOURCE: Inovio Biomedical Corporation
Posted by Editors at 3:44 PM --- Printer-friendly version
August 18, 2006
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One-third of all HIV positive patients are also infected with the hepatitis C virus. A new diagnostic test allows physicians to quickly identify both viruses with a single blood sample. With this diagnostic tool, doctors can immediately begin tailoring a comprehensive treatment plan.
MedMira Offers New Rapid Diagnostic to Combat “the hidden epidemic” - Co-infection with HIV/Hepatitis C
Multiplo Delivers Simultaneous Rapid Diagnosis of HIV and Hepatitis C - XVI International AIDS Conference
Toronto, ON, August 14, 2006 – An estimated 56,000 Canadians are living with HIV infection (The Public Health Agency of Canada) – and 30% of them don’t know it. Another estimated 251,000 Canadians are infected with hepatitis C and, because of the lack of symptoms, 95,000 of them don't know it. (Public Health Agency of Canada)
Up to 33% of those infected with HIV/AIDS are also infected with Hepatitis C (www.hivandhepatitis.com) - prompting some researchers to describe HIV/Hepatitis C co-infection as “the hidden epidemic.”
The issue of co-infection is one of growing concern for delegates at Toronto’s XVI International AIDS Conference this week. MedMira, a leading Canadian manufacturer of reliable, fast, and easy-to-use diagnostics, is launching a tool to make the important diagnosis of HIV/Hepatitis C co-infection much simpler.
Multiplo™ Rapid HIV/HCV Antibody Test (Multiplo HIV/HCV) is the first rapid test to simultaneously identify both HIV and Hepatitis C (HCV) infections.
Co-infected individuals have a more rapid progression of HCV liver disease. In addition, some studies suggest that infection with certain HCV genotypes may accelerate the progression of HIV. HCV may also result in patients discontinuing HIV antiretroviral treatment due to liver toxicity.
“More health agencies and researchers are recognizing the benefits of testing for both HIV and Hepatitis C in the same three-minute procedure. Multiplo HIV/HCV lets you know more and know quickly, so that you can make the right treatment decisions, right away,” says Hermes Chan, President & CEO, MedMira.
Multiplo HIV/HCV is a product that enables healthcare providers and other users to obtain two test results in three minutes or less in comparison to other tests that may take 10 to 40 minutes to obtain just a single result.
Chan continued, “Multiplo HIV/HCV is the first of a series of combination tests that MedMira will launch under the Multiplo line. Multiplo means that with a single specimen, patients and healthcare providers can receive multiple, instant results, without timers, or specialized equipment. One test, more answers.”
MedMira will be showcasing the Multiplo HIV/HCV at the XVI International AIDS Conference in Toronto, from August 13-18th.
About MedMira
MedMira is the leading global manufacturer and marketer of in vitro flow-through rapid diagnostic tests. MedMira’s tests provide reliable, rapid diagnosis in just 3 minutes for the detection of human antibodies in human serum, plasma or whole blood for diseases such as HIV and hepatitis C. The United States FDA, the SFDA in the People’s Republic of China and European Union have approved MedMira’s Reveal® G2, MiraWell® and MiraCare™ rapid HIV tests, respectively. The MedMira Rapid HIV Test has been approved by Health Canada.
MedMira’s Reveal® G2 and MiraWell® rapid HIV tests are currently used in clinical laboratories, hospitals, and clinics where professional counselling and patient treatment are immediately available.
MiraCare™ is sold through MedMira’s distributor network to pharmacies, hospitals and laboratories in the European Union. It is also available over-the-counter (OTC) in pharmacies throughout Hong Kong and Macao Special Administrative Regions, in the People’s Republic of China.
Multiplo HIV/HCV is the first in MedMira’s line of rapid tests for multiple diagnoses of infectious diseases. Multiplo HIV/HCV simultaneously detects HIV and HCV antibodies in a single specimen in less than 3 minutes.
MedMira delivers rapid diagnostic solutions to healthcare communities around the globe. Its corporate offices and manufacturing facilities are located in Halifax, Nova Scotia, Canada with a representative office and joint venture manufacturing facility in Guilin, China.
This news release contains forward-looking statements, which involve risk and uncertainties and reflect the company’s current expectation regarding future events. Actual events could materially differ from those projected herein and depend on a number of factors including, but not limited to, changing market conditions, successful and timely completion of clinical studies, uncertainties related to the regulatory approval process, establishment of corporate alliances and other risks detailed from time to time in the company quarterly filings.
The TSX Venture Exchange has not reviewed and does not accept responsibility for the adequacy or accuracy of this statement.
For more information visit MedMira’s website at www.medmira.com.
For further information
Dr. James Smith, Investor Relations
Tel: 902-450-1588
E-mail: ir@medmira.com
Andrea Young, Corporate Communications
Tel. 902-450-1588
Email: ayoung@medmira.com
Posted by Editors at 9:35 AM --- Printer-friendly version
August 17, 2006
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While not well known, the condition known as a bleeding esophogeal varice poses a very real threat to those suffering from a compromised liver. Learn what makes this condition so dangerous and learn how best to stop the bleeding and restore normal blood circulation.
by Nicole Cutler, L.Ac.
Occurring in approximately one in every 10,000 people, bleeding esophogeal varices are swollen veins in the esophagus or the upper part of the stomach that begin to bleed. They can be a life-threatening complication of portal hypertension, where there is increased blood pressure in the primary blood vessel leading into the liver. Because veins are not designed to handle high internal pressure, the engorgement of veins causes them to be fragile and bleed easily. If a large volume of blood is lost, signs of shock will develop (pallor, a rapid and weak pulse, rapid and shallow respiration and lowered systemic blood pressure).
Common culprit
Alcoholic and viral cirrhosis are the leading causes of portal hypertension in Western countries. As liver disease progresses, the risk of developing cirrhosis follows. Cirrhosis is the permanent scarring and hardening of liver tissue, which subsequently prohibits hepatic circulation. This hampering of blood flow through the liver increases the hepatic pressure that causes portal hypertension and sets the stage for blood vessels to burst. A bleeding esophogeal varice is the most serious complication in patients with cirrhotic liver disease.
To read the complete article, including how to treat and prevent this serious condition click here.
Posted by Editors at 11:35 AM --- Printer-friendly version
August 16, 2006
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The preliminary results from the Phase 1b study of a compound taken in conjunction with pegylated interferon are expected later this month. This proof of concept milestone indicates progress toward a feasible and functional Hepatitis C treatment. The next step is a Phase 2 trial. We will be anxiously awaiting the results and will report them to you as soon as have them.
ViroPharma and Wyeth Announce Achievement of Proof of Concept Milestone for HCV-796
- Companies Preparing to Initiate Phase 2 Clinical Evaluation -
EXTON, Pa. and COLLEGEVILLE, Pa., Aug. 14 /PRNewswire-FirstCall/ -- ViroPharma Incorporated (Nasdaq: VPHM) and Wyeth (NYSE: WYE) today announced that while the analysis of data from their Phase 1b study of HCV-796, an investigational oral non-nucleoside hepatitis C virus (HCV) polymerase inhibitor, in combination with pegylated interferon, is still ongoing, data analyzed to date indicate that HCV-796 has achieved a "proof of concept" milestone under the companies' agreements. The companies expect that preliminary data from the Phase 1b study will be available for release by the end of August 2006. Based upon the preliminary data reviewed to date, ViroPharma and Wyeth are preparing to initiate Phase 2 combination studies of HCV-796. The companies expect to begin dosing patients in the Phase 2 study in the fourth quarter of 2006.
In connection with meeting the proof of concept milestone, ViroPharma will issue to Wyeth 981,836 shares of ViroPharma's common stock for a purchase price of Ten Million Dollars ($10,000,000), which represents the last of three stock purchases outlined in the companies' agreements. The price per share for the stock was based on a premium to a trailing average price.
"ViroPharma and Wyeth have been partners in hepatitis C antiviral development since 1999; through the years, our goal has been to identify, develop and eventually market drugs to treat hepatitis C patients," said Michel de Rosen, ViroPharma's president and chief executive officer. "HCV-796 is the most promising compound we have developed together to date, and we look forward to announcing the Phase 1b data later this month. The achievement of this milestone and progression toward Phase 2 clinical trials marks an exciting time for us, and a promising opportunity for patients with HCV."
"With HCV-796, we now have for the first time in our collaboration a unique compound with a novel mechanism of action that has achieved proof of concept in combination with pegylated interferon," commented Robert Ruffolo, Ph.D., Wyeth Pharmaceutical's president of research. "We are excited to reach this milestone and to be collaborating with ViroPharma to move this promising compound toward Phase 2 trials."
In December 1999, ViroPharma and Wyeth entered into an alliance to develop and commercialize ViroPharma's lead small molecule antiviral drug candidates for hepatitis C virus (HCV) and to discover, develop and commercialize additional novel inhibitors of HCV. In this agreement, Wyeth agreed to purchase shares of ViroPharma's common stock at the time of completion of certain product development milestones. Under rules promulgated by the Securities and Exchange Commission, ViroPharma is required to publicly file, via Form 8-K, the fact that common stock is being issued in connection with the achievement of the proof of concept milestone.
About HCV-796
HCV-796 is an investigational non-nucleoside polymerase inhibitor compound for the treatment of hepatitis C that is being evaluated in ongoing clinical trials in combination with PEG-Interferon by ViroPharma and Wyeth.
About Hepatitis C
Hepatitis C is a blood-borne virus recognized as a major cause of chronic hepatitis worldwide. The World Health Organization estimates that 170 million persons worldwide are chronically infected with HCV, and three to four million persons are newly infected globally each year. According to the U.S. Centers for Disease Control and Prevention (CDC), about four million people in the U.S., or 1.8 percent of the population, are infected with HCV.
Currently, there is no specific antiviral agent directed against HCV that is commercially available, and no vaccine for prevention of HCV infection. Several interferon (IFN) products are available worldwide, but there are substantial limitations to the use of these products when given as monotherapy or in conjunction with ribavirin in the treatment of chronic HCV infection. In addition to the relatively poor treatment response in patients infected with genotype 1 HCV, the most common strain in the U.S., Western Europe and Japan, the considerable side effects frequently associated with the use of IFN can lead to discontinuation of therapy in approximately 20 percent of patients.
About ViroPharma Incorporated
ViroPharma Incorporated is a biopharmaceutical company dedicated to the development and commercialization of products that address serious diseases treated by physician specialists and in hospital settings. ViroPharma commercializes Vancocin(R), approved for oral administration for treatment of antibiotic-associated pseudomembranous colitis caused by Clostridium difficile and enterocolitis caused by Staphylococcus aureus, including methicillin-resistant strains (for prescribing information, please download the package insert at http://www.viropharma.com/docs/pulvules_pi.pdf). ViroPharma currently focuses its drug development activities in viral diseases including cytomegalovirus (CMV) and hepatitis C (HCV). For more information on ViroPharma, visit the company's website at http://www.viropharma.com.
About Wyeth
Wyeth is one of the world's largest research-driven pharmaceutical and health care products companies. It is a leader in the discovery, development, manufacturing, and marketing of pharmaceuticals, vaccines, biotechnology products and nonprescription medicines that improve the quality of life for people worldwide. The Company's major divisions include Wyeth Pharmaceuticals, Wyeth Consumer Healthcare and Fort Dodge Animal Health.
Certain statements in this press release are forward-looking statements that involve a number of risks and uncertainties, including those relating to anticipated continued development of HCV-796, clinical development and data release timelines and ability to find an effective small molecule antiviral treatment for HCV disease. Actual results could differ materially from those results expressed in, or implied by, these forward-looking statements. The development and commercialization of pharmaceutical products is subject to risks and uncertainties. There can be no assurance that estimated clinical development and data release timelines will be achieved, Wyeth and ViroPharma's additional HCV studies will yield positive results, or that ViroPharma and Wyeth will be successful in gaining regulatory approval of any of HCV product candidate. These factors, and other factors, including, but not limited to those described in ViroPharma's quarterly reports on Form 10-Q for the quarters ended March 31, 2006 and June 30, 2006 filed with the Securities and Exchange Commission and Wyeth's periodic reports filed with the Securities and Exchange Commission (particularly Item 1A. RISK FACTORS of Wyeth's 2005 annual report on Form 10-K) could cause future results to differ materially from the expectations expressed in this press release. The forward-looking statements contained in this press release may become outdated over time. ViroPharma and Wyeth do not assume any responsibility for updating any forward-looking statements.
SOURCE ViroPharma Incorporated
CONTACT:
ViroPharma Incorporated Contacts:
William Roberts,
Director, Corporate Communications,
+1-610-321-6288,
or Robert Doody,
Manager, Corporate Communications,
+1-610-321-6290;
Wyeth Contacts:
Media:
Gerald Burr,
+1-484-865-5138,
or Douglas Petkus,
+1-973-660-5218,
Investors:
Justin Victoria,
+1-973-660-5340
Web site: http://www.viropharma.com
http://www.viropharma.com/docs/pulvules_pi.pdf /
(VPHM WYE)
Posted by Editors at 12:36 PM --- Printer-friendly version
