Back to News Review
Week Ending: May 14th, 2005
Alan Franciscus
Editor-in-Chief
To download pdf version click here
This Issue:
• Peregrine Pharma Submits Tarvacin Antiviral Investigational NDA
• InterMune Announces Hepatitis C Presentations at Digestive Disease Week
• 'Aim for the B' Targets Need to Increase Education and Awareness for Chronic Hepatitis B
• Wimpy Weed? It's a Virus Killer
• Man Who Got Transplant after Ads Dies
• Vertex Pharmaceuticals Reports that VX-950, an Investigational Oral Hepatitis C Protease Inhibitor, Displays Potent Antiviral Activity in Early Clinical Study
• N.H. Sees Big Increase in Hepatitis Cases
• Nonsteroidal Anti-Inflammatory Drugs and Hepatic Toxicity in Arthritis
• Hepatitis Campaign Launched in Belgium
• Preventing Depression in Psychiatric Risk Patients with Chronic Hepatitis
• Deputy Who Died from Disease He Contracted on the Job Buried
May 7th, 2005
Peregrine Pharma Submits Tarvacin Antiviral Investigational NDA
SourceURL:http://www.pharmabiz.com
Tustin, California
Peregrine Pharmaceuticals, Inc. has submitted an investigational new drug application (IND) to the US FDA to initiate a phase 1 clinical trial using Tarvacin to treat patients with chronic Hepatitis C virus infection.
The objectives of the phase 1 clinical protocol submitted in the IND are to evaluate safety, pharmacokinetics and viral load in patients chronically infected with Hepatitis C virus that have failed standard treatment. There are estimated to be 2.7 million people in the US and 170 million people worldwide with chronic Hepatitis C infection.
"This IND filing is an important next step in expanding the potential of Tarvacin. We anticipate this anti-viral IND will be the first in a series of steps to explore the anti-viral potential of Tarvacin," said Steven King, president and CEO of Peregrine Pharmaceuticals.
The new application is the second IND filing for Tarvacin. The first IND allows enrolment of patients with any solid cancer and has been cleared by the FDA to begin patient enrolment.
Pre-clinical studies using Tarvacin for the treatment of viral diseases have yielded promising results in Lassa fever, influenza, and cytomegalovirus, which are included in a viral category called enveloped viruses.
Tarvacin is Peregrine's first product under its anti-phospholipid therapy technology platform. Anti-phospholipid therapy is a novel approach to treating cancer, viral infections and certain ocular diseases. It is based on the finding that aminophospholipids, which are basic components of the inner surface of the cellular membrane, become exposed on the outside of the cellular membrane in response to certain disease states such as virally infected cells and cancer.
Back to top
May 9th, 2005
InterMune Announces Hepatitis C Presentations at Digestive Disease Week
http://www.prnewswire.com
Company to Host Webcast With Clinical Trial Investigators to Discuss Advances in the Management of Hepatitis C Treatment Failure
BRISBANE, Calif., May 9 /PRNewswire-FirstCall/ -- InterMune, Inc. (Nasdaq: ITMN) announced today multiple presentations scheduled to take place in scientific sessions at the Digestive Disease Week (DDW) meeting being held May 14-19 at McCormick Place in Chicago. The company will have a booth in the Exhibit Hall (booth #846).
The company also will host an event with a simultaneous webcast for investors and news media on Monday, May 16 at 9:00 a.m. CDT. Entitled "Advances in the Treatment of Hepatitis C Nonresponders," the event will feature clinical trial investigators who will review and discuss data presented at the conference relating to InterMune's development programs focused on the treatment of hepatitis C (HCV) nonresponders. In addition, InterMune scientists will discuss the company's HCV protease inhibitor program. To access the webcast, please log onto the investor relations section of InterMune's website at www.intermune.com.
The following presentations will occur during the Digestive Disease Week meeting:
Sunday, May 15
8:00 a.m. - 5:00 p.m. CDT
Poster (#S1538): Predictive model and sustained virologic response for PEG IFN-alfa-2 + weight-based ribavirin nonresponders re-treated with IFN alfacon-1 + weight-based ribavirin.
Poster (#S1536): High-dose consensus interferon and ribavirin is effective for treatment of chronic hepatitis C infection in patients who are resistant to PEG-interferon and ribavirin.
Poster (#S1537): Response of chronic hepatitis C PEG INF-alpha-2 + ribavirin nonresponders to treatment with IFN alfacon-1 (15 mcg) and IFN gamma-1b (50 mcg).
Poster (#S1517): Identification of genes responsible for EC50 inhibition of plus-stranded RNA viruses using a genomics approach: implications for monitoring chronic hepatitis C patients receiving IFN therapies.
Poster (#S918): Consensus interferon (IFN alfacon-1) alone or in combination with IFN gamma-1b suppresses replication of a PEG IFN-alpha-2b-resistant hepatitis C virus replicon.
Poster (#S925): The combination of type 1 (IFN alfacon-1) and type 2 (IFN gamma-1b) interferons enhances Th1 and natural killer cell responses: implications for resolution of chronic HCV infection in difficult-to-treat patients.
Poster (#S1541): Daily versus three-times-weekly IFN alfacon-1 in previously untreated HCV patients results in a significantly greater rate of SVR: final results of an international, phase IV study.
Poster (#S923): Novel potent inhibitors of the HCV NS3/4 protease are well tolerated in multiple animal species and display liver concentrations that predict efficacy.
Poster (#S1530): A phase I, single-blind, dose-escalating study of the safety and pharmacokinetics of a single injection of pegylated interferon alfacon-1 in healthy volunteers.
Poster (#S915): Biological characterization of PEG-alfacon in vitro: comparison of biological potency to the parent molecule IFN alfacon-1.
Poster (#S1539): Final results of a double-blind, placebo-controlled trial of the antifibrotic efficacy of IFN gamma-1b in chronic hepatitis C patients with advanced fibrosis or cirrhosis.
7:00 - 9:30 p.m. CDT
Symposium: InterMune is sponsoring a continuing medical education satellite symposium entitled "Practical Pathways Towards Improved Management of HCV Treatment Failures." This event will be held at the Palmer House Hilton in the State Ballroom.
Monday, May 16
9:00 - 11:00 a.m. CDT
Event/Webcast: InterMune is hosting an investor and media event and webcast with clinical trial investigators to discuss "Advances in the Treatment of Hepatitis C Nonresponders." This event will be held at The Fairmont Hotel in the Ambassador Room.
About Infergen(R) (interferon alfacon-1)
Infergen is a bio-optimized type 1 interferon alpha indicated for treatment of adult patients with chronic HCV infections with compensated liver disease and is dosed three times a week. Infergen is the only interferon alpha with data in the label regarding use in patients following relapse or non-response to treatment with certain previous treatments. The most common side effects are flu-like symptoms (i.e., headache, fatigue, fever, myalgia, and rigors). Physicians and patients can obtain additional prescribing information regarding Infergen, including the product's safety profile, by visiting www.infergen.com, including the black box warning for all interferon alphas regarding neuropsychiatric, autoimmune, ischemic and infectious disorders.
About Actimmune(R) (interferon gamma-1b)
Interferon gamma is a naturally occurring protein that stimulates the immune system. InterMune markets Actimmune for the treatment of two life-threatening congenital diseases: chronic granulomatous disease and severe, malignant osteopetrosis. The most common side effects are flu-like symptoms, including fever, headache and chills. InterMune is also conducting the INSPIRE Trial, a Phase III study of interferon gamma-1b in idiopathic pulmonary fibrosis and the GRACES Trial, a Phase III study of interferon gamma-1b plus standard of care in ovarian cancer. Physicians and patients can obtain additional prescribing information regarding Actimmune, including the product's safety profile, by visiting www.actimmune.com.
InterMune's Commitment in Hepatology
InterMune is a biopharmaceutical company that is committed to developing and commercializing innovative therapies in hepatology. In addition to the currently marketed product indicated for the treatment of chronic HCV (Infergen(R)), InterMune has a broad and deep late-stage product portfolio addressing HCV, particularly in patients who are considered nonresponders to previous pegylated interferons plus ribavirin. Leading the hepatology portfolio is the DIRECT trial, an ongoing Phase III study of daily interferon alfacon-1 (Infergen(R)) plus ribavirin, and an ongoing Phase II trial of daily interferon alfacon-1 plus interferon gamma-1b (Actimmune(R)) with and without ribavirin for the treatment of HCV patients who do not respond to standard therapy (pegylated interferon alfa 2a or 2b plus ribavirin). In addition, InterMune has an early stage small molecule program targeted at the HCV protease. For additional information about InterMune and its development pipeline, please visit www.intermune.com.
Except for the historical information contained herein, this press release contains certain forward-looking statements that involve risks and uncertainties, including without limitation the statements related to anticipated future financial results and product development. All forward- looking statements and other information included in this press release are based on information available to InterMune as of the date hereof, and InterMune assumes no obligation to update any such forward-looking statements or information. InterMune's actual results could differ materially from those described in InterMune's forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those discussed in detail under the heading "Risk Factors" in InterMune's Form 10-K filed with the SEC on March 16, 2005 and other periodic reports filed with the SEC, including the following: (i) the risk that if physicians do not prescribe Actimmune for the treatment of IPF, an indication for which Actimmune has not been approved by the FDA, or if patient referral rates continue to decline, InterMune's revenues will decline; (ii) risks related to regulation by the FDA and other agencies with respect to InterMune's communications with physicians concerning Actimmune for the treatment of IPF; (iii) risks related to potential increases in Infergen sales; (iv) reimbursement risks associated with third-party payors; (v) risks related to whether InterMune is able to obtain, maintain and enforce patents and other intellectual property; (vi) risks related to significant regulatory, supply and competitive barriers to entry; (vii) risks related to the uncertain, lengthy and expensive clinical development and regulatory process, including having no unexpected safety, toxicology, clinical or other issues; (viii) risks related to achieving positive clinical trial results; (ix) risks related to timely patient enrollment and retention in clinical trials. The risks and other factors discussed above should be considered only in connection with the fully discussed risks and other factors discussed in detail in the 10-K report and InterMune's other periodic reports filed with the SEC.
SOURCE InterMune, Inc.
05/09/2005
CONTACT:
investors, Judy Hayes of InterMune, Inc., +1-415-466-2242, or ir@intermune.com; or media, Jani Bergan of WeissComm Partners, +1-415-946-1064, jbergan@weisscommpartners.com, for InterMune, Inc.
Web site: http://www.intermune.com
Back to top
'Aim for the B' Targets Need to Increase Education and Awareness for Chronic Hepatitis B
SourceURL:http://biz.yahoo.com
Public Education Program to Take Place During 'National Hepatitis B Awareness Week'
PRINCETON, N.J., May 9 /PRNewswire/ -- In recognition of the need to increase education and awareness for chronic hepatitis B, the Hepatitis B Foundation and Bristol-Myers Squibb Company are partnering to host "AIM for the B: Awareness, Involvement and Mobilization for Chronic Hepatitis B," a public education program designed to elevate the urgency for prioritizing chronic hepatitis B as a serious health issue in the United States. As part of the initiative, a series of local events will take place May 9-16, to coincide with "National Hepatitis B Awareness Week," as designated by the U.S. Senate and House of Representatives.
The "AIM for the B" program includes events held in four U.S. cities where chronic hepatitis B prevalence is high -- Philadelphia, New York, San Jose (Calif.) and San Francisco. During the events, local physicians, chronic hepatitis B patients and third-party organizations will gather to share their experiences with the disease, and discuss the importance of early diagnosis and care. More than one million people in the U.S. have developed chronic hepatitis B infection and an estimated 5,000 Americans die from hepatitis B and hepatitis B-related liver complications each year.
"There is a tremendous lack of awareness for chronic hepatitis B in this country," said U.S. Sen. Dianne Feinstein (D-Calif.). "During 'National Hepatitis B Awareness Week,' programs such as 'AIM for the B' are important because they help raise awareness for the disease and encourage Americans at risk to get tested and physicians and patients to take an active approach to managing chronic hepatitis B."
"We are grateful to Congress for recognizing the need to prioritize chronic hepatitis B as a serious health issue in the United States," said Molli Conti, the Hepatitis B Foundation's vice president of outreach programs. "Less than 30 percent of adults infected with hepatitis B experience symptoms of the disease, which often leads them to think it is not serious and does not require medical attention. As a result, it is estimated that only a small percentage of patients are currently receiving care for the disease. We created the 'AIM for the B' program to educate Americans that this disease can be life-threatening and to encourage screening for the disease if they are at risk and to seek care from a knowledgeable physician."
As part of the "AIM for the B" local events held in Philadelphia, New York, San Jose and San Francisco, Asian and Pacific Islander (API) patients infected with the hepatitis B virus and physicians will speak on their personal experiences with the disease. In the United States, APIs make up more than half of the population infected with the hepatitis B virus. Depending on the country of origin, between five and 15 percent of API immigrants to the United States are chronically infected, and approximately 15 to 40 percent of chronically infected hepatitis B patients will develop liver scarring (cirrhosis), liver failure or liver cancer.
"The 'AIM for the B' program is making progress in helping the U.S. Asian and Pacific Islander community understand the severity of chronic hepatitis B," said Jeffrey Caballero, executive director, Association of Asian Pacific Community Health Organizations (AAPCHO). "We strongly believe increased education and awareness on a national level is the right path to helping providers and patients understand how they can prevent the transmission of the hepatitis B virus and seek appropriate care for the disease."
For more information about the "AIM for the B" program and local events, contact the Hepatitis B Foundation at 215-489-4900 or visit http://www.hepb.org.
About the Hepatitis B Foundation
The Hepatitis B Foundation is dedicated to finding a cure and improving the quality of life for those affected by hepatitis B through a comprehensive program of research, education, and patient advocacy. The organization is committed to raising funds for focused research, promoting disease awareness, supporting immunization and treatment initiatives, and serving as the primary source of hepatitis B information for patients and their families, the medical and scientific community, and the general public. Visit the Hepatitis B Foundation at http://www.hepb.org.
About Bristol-Myers Squibb
Bristol-Myers Squibb is a global pharmaceutical and related health care products company whose mission is to extend and enhance human life. Visit Bristol-Myers Squibb at http://www.bms.com.
Source: Bristol-Myers Squibb
Back to top
Wimpy Weed? It's a Virus Killer
SourceURL:http://www.rednova.com
THERESA MANAVARAN reports
A SHY roadside plant traditionally used as a liver tonic is on the fast track to becoming a drug to treat Hepatitis B.
If herbal entrepreneur N.L. Phang gets his way, he'll be marketing an extract of the plant, Phyllanthus Niruri, as a specific treatment for Hepatitis B, a particularly difficult viral infection to treat.
Phyllanthus Niruri - locally called Dukung Anak - is found throughout Malaysia and is used in traditional communities as a tonic for the liver and as a herbal treatment for jaundice, diarrhoea and kidney trouble.
Malaysians may recognise it as being similar to the dainty mimosa - it closes up when you touch it and relaxes after several minutes. That shy quality is not to be mistaken for being a wimpy village weed. It contains powerful anti-oxidants and anti-viral compounds.
Already, Phang, the founder of Nova Laboratories Sdn Bhd, has begun a collaborative study with the Institute for Medical Research to investigate its performance as a treatment.
In traditional medicine, Phyllanthus Niruri and some its relatives are well-known therapies. Phyllanthus species are found in China, the Philippines, Cuba, Nigeria and Guam where they are used as medicines in different ways. They grow to about 30cm to 60cm.
But it is in India where it is most documented. Indian Ayurvedic practitioners have a number of uses for Phyllanthus, including jaundice, gonorrhoea, problematic menstruation, diabetes, skin ulcers, sores, swelling and itchiness.
A hot water infusion of the young shoots is used to treat chronic dysentery. No side-effects or interactions with other drugs have been reported.
It was a indirect encounter with Ayurveda that brought pharmacist Phang to Phyllanthus Niruri.
In the late 1990s, Phang's relative was diagnosed with severe Hepatitis B. The country's top liver specialists said there was little they could do and advised the family to take the patient home and help him recover with good care.
Phang became restless. "I found it unacceptable that there was nothing we could do," he says. "We were about to enter the 21st century."
He spoke to his family doctor who told him about an ayurvedic preparation that might help. It was Phyllanthus Niruri, in its dried, pulverised and capsuled form.
With nothing to lose, the patient tried it. Four weeks later, the Phang's relative looked remarkably better. A blood test showed a dramatic drop in the viral load.
"I found this fascinating. I became curious," says Phang. "I wanted to know how this worked."
Phang travelled to India where he met various ayurvedic doctors and a Dr N. Madhanagopal of Madras University, a noted scientist who studied the Phyllanthus plant extensively.
Phang was convinced and began researching the Phyllanthus Niruri plant.
He found several active compounds. Together, they seemed to work like a superpowerful anti-oxidant. When isolated, some showed anti- viral behaviour.
They improve overall immunity and inhibit the replication of the virus by affecting the necessary enzymes in check.
This anti-viral quality has been observed by German researchers who are studying it for HIV.
Phyllanthus Niruri's lipid peroxidation inhibitor quality makes it hugely attractive as a therapy for diabetes, ageing and even cancer prevention. "All these are worth investigating," says Phang.
After much research and development, Phang and his six scientists arrived at a formulation. Farmed Phyllanthus Niruri is harvested at a particular age. Its maturity dictates the ratios of the active compounds and their potency.
"It's that particular combination that makes this plant effective as a medicine," says Phang. "Also, the combination of leaf and stem has an effect. Then comes the extraction process which also has an impact."
In 2002, Phang filed for a patent and soon went into production. Hepar-P was launched two years ago as a liver tonic.
These days, Hepar-P is sold by pharmacists, general practitioners and traditional Chinese physicians.
Last year, Phang opened a factory in Selangor's attractive countryside.
Ensconced in the plantations and brickworks of Sungai Pelek, the RM6 million Nova Laboratories facility enjoys the calm and quiet of a rustic neighbourhood.
"This peaceful environment is actually a magnet for good staff," says Phang. "The 40 staffers are serious about their work. They are doing world-class research here. I'm amazed at their dedication and talent."
The facility makes 22 products, among them formulations of Tongkat Ali, pegaga, gingko, dongquai, royal jelly, hempudu bumi, evening primrose oil and ginger.
The supply of Phyllanthus niruri comes from farmers in Selangor commissioned by Phang to grow it according to specifications.
Phang built the factory on land belonging to the family. His grandfather and father had farmed and grown oil palm trees for more than 50 years in Sepang.
As a teenager, he, too, grew oil palm trees but Phang went on to study pharmacy at Universiti Sains Malaysia, a subject he found fascinating.
He worked four years in government and in 1984, opened a small retail pharmacy in Sungai Pelek, a tiny village near Sepang.
Separately, he started a business selling veterinary products to nearby farms.
Five years later, he began manufacturing some of those products with licence at a plant in Negri Sembilan's Taman Tuanku Jaafar industrial park.
With a small R&D team, he created his own formulations as well.
Hepatitis B is tough to treat. It's a viral infection that involves a complex biochemical labyrinth which hinders drugs from working.
Doctors find it difficult to explain the tricky balancing of enzyme levels to patients when their expensive drugs are not effective.
On top of that, the two drugs of choice for Hepatitis B have problems of their own, including likely relapse. One of them, interferon, is only injectable.
Some day, Phang hopes to take Phyllanthus Niruri further - isolate the very molecules at work, perhaps modify them and create a full- blown pharmaceutical compound.
The biggest hurdle, he says, will be handling the Hepatitis B virus.
"You need high-end labs for that," he says. "So, it will depend on funding."
While he thinks about that, Phang is working on an extension of his lab. He has a five-year plan to open an R&D centre dedicated to herbals and to screening of all kinds of plants, especially those which are not yet in known pharmacopoeia.
theresam@nst.com.my
Source: New Straits Times
Back to top
Man Who Got Transplant after Ads Dies
http://www.ama-assn.org/amednews
By Andis Robeznieks, AMNews staff
His solicitation raised ethical questions, but some say it also raised organ donation awareness.
Most marketing executives can only dream of creating an ad campaign as simple and successful as the one a Houston photographer seeking a liver developed last year.
With a couple of billboards and a Web site, cancer patient Todd Krampitz took his quest around the world. A few weeks and several media appearances later, he received a liver.
Krampitz had a liver transplant in August 2004. On April 20, 32-year-old Krampitz died.
His family has not said publicly if liver cancer played a role in his death. Medical ethicists and transplant officials say they will need time to assess what impact his story will have on public solicitations for organs specifically, and on organ donation in general.
"To see a young person die early, it's tragic no matter how you slice it," Mark D. Fox, MD, PhD, chair of the United Network for Organ Sharing's Ethics Committee said. "If it was from liver cancer, that ought to give us pause about how things unfolded."
Grappling with ad campaigns
Krampitz's efforts were an inspiration to others in need of transplants, and public solicitations are increasingly common on the Internet. A site called MatchingDonors.com contains 151 ads for patients seeking a donated kidney, liver, lung or pancreas.
Another site, "Links for Life," is a jumping-off point to Web pages for 24 people seeking organs.
Those in medicine, though, are concerned that solicitation for directed donations to individuals bypasses the UNOS organ allocation system and waiting list. It has led to accusations that Krampitz and his imitators "cut in line."
"MatchingDonors has certainly changed the landscape," said Dr. Fox, a physician ethicist at the University of Oklahoma College of Medicine in Tulsa. "They highlight some ways in which the system doesn't work, and I'm sympathetic, but the system has to work as a whole -- even if it may not work ideally for each patient."
Medical ethicists are concerned that solicitations could give an unfair edge to photogenic patients or those with the resources or marketing savvy to create a successful advertising campaign. They also worry that it could reduce public trust in the fairness of the organ donation system.
Consequently, transplant organizations are trying to discourage the practice. Last November, UNOS board members adopted a position statement opposing efforts to solicit deceased organ donors for transplant candidates where no personal bond exists.
On Jan. 20, the American Society of Transplant Surgeons followed with a statement warning that solicitations for organs will "undermine the trust and fairness on which the system of organ transplantation depends."
While some criticized these statements for not going far enough, Dr. Fox said advertising is protected by the First Amendment and directed donation is still a legal practice, so it would be hard for UNOS or other medical organizations to impose a ban.
"The challenge is to help the donating public to have a better understanding of the impacts of directed donation on the allocation system and, more importantly, to understand the allocation system itself," Dr. Fox said.
The AMA does not have an official position on public solicitation or directed donation of organs, said Robert Sade, MD, a member of the AMA Council on Ethical and Judicial Affairs and a former member of the UNOS ethics committee.
"Before CEJA reaches a definite position on solicited donations, we would like to see some scientific evidence of the effect of solicited donations on the organ pool," Dr. Sade said.
If there were evidence that solicited donations increased the number of available organs, he said, "it would be hard to argue this is a bad thing," but there would be concerns about fairness if the solicitations had a negative or neutral impact.
Some patients, though, say Web site solicitations can have benefits to people other than the one needing a donation. Krampitz inspired New York City truck driver Sonny Velez to develop his own Web site. Velez didn't receive a liver through the Web site, but his wife said the site introduced him to a support group that helped his recovery after he received a liver through traditional channels in November 2004.
"Sometimes, you want to talk to someone who went through the same things you are going through," Caroline Velez said. "A lot of people don't understand how it's an emotional roller coaster ride as you move up and down the list."
Organ donation up in 2004
Despite the negative publicity Krampitz received, 2004 was a record year for organ donation.
Some believe that Krampitz helped contribute to organ donation records in 2004 by stimulating conversation and "putting a face" on the dire need for donated organs.
But many in the transplant community say that the records are a result of the U.S. Dept. of Health and Human Services' Breakthrough Collaborative that seeks to teach more hospitals about techniques that are used by hospitals with high donation rates.
"There were many conditions that may have led to the increase in organ donation, such as the collaborative," said ASTS President Richard Howard, MD, PhD. "But anything that brings attention to the great shortage of organ donors can only help to increase the numbers."
Dallas surgeon and liver-transplant recipient Phil Berry Jr., MD, who recently finished a three-year term on the U.S. Advisory Committee on Organ Transplantation, echoed these sentiments.
"In looking back, there were some good things and some bad things, but it certainly stimulated discussion," Dr. Berry said." Anything that puts it on the table and lets folks understand the bottom line -- there aren't enough organs -- is certainly a good thing." Dr. Berry said Krampitz showed the transplant community how it could do better and how it should do a better job of convincing people to be organ donors.
"That's what I would remember him for," Dr. Berry said.
ADDITIONAL INFORMATION:
American Society of Transplant Surgeons' statement opposing solicitation of donor organs, Jan. 20 (www.asts.org/donorsolicitation.cfm)
OPTN/UNOS board of directors' statement opposing solicitation for deceased organ donation, Nov. 19, 2004 (www.unos.org/news/newsdetail.asp?id=374)
Todd Krampitz Web site (www.toddneedsaliver.com)
Sonny Velez Web site (www.saveoursonny.com)
Links for Life (www.linksforlifecampaign.com)
MatchingDonors.com (matchingdonors.com/life)
Back to top
May 10th, 2005
Vertex Pharmaceuticals Reports that VX-950, an Investigational Oral Hepatitis C Protease Inhibitor, Displays Potent Antiviral Activity in Early Clinical Study
Source: http://www.vrtx.com/
— Presentation of Study Results Planned at DDW —
Cambridge, MA, May 10, 2005 -- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced interim results that indicate that the investigational oral hepatitis C virus (HCV) protease inhibitor VX-950 was well-tolerated and demonstrated potent antiviral activity in a Phase Ib clinical trial.
The study enrolled 34 patients with chronic genotype 1 HCV infection who were treated for 14 days with placebo or one of three dose regimens of VX-950. Patients receiving 750 mg of VX-950 every eight hours achieved a median reduction in HCV-RNA of greater than 4 log10, equivalent to a more than 10,000-fold decrease in viral levels, at the end of 14 days of treatment. A median reduction in HCV-RNA of greater than 2 log10 was seen in each of the other two VX-950 dose groups at the end of 14 days of treatment. Every patient receiving VX-950 achieved greater than a 2 log10 reduction in HCV-RNA within the first three days of treatment. Genotype 1 HCV infection is the most difficult strain of HCV to treat and the most prevalent strain in the United States, Western Europe and Japan. Results from the study will be presented by a clinical investigator on May 17, 2005 at Digestive Disease Week® (DDW), a medical conference to be held in Chicago, Illinois. In accordance with the embargo policy of the meeting, the specific data from the trial beyond what is described in this press release will not be disclosed until the DDW presentation.
“Vertex is committed to developing innovative compounds for the treatment of chronic HCV infection. VX-950, one of the most advanced agents in a promising new class of direct antivirals, underscores that commitment,” said Joshua Boger, Ph.D., Chairman and Chief Executive Officer of Vertex. “The demonstration of antiviral activity in this early clinical study is highly encouraging, and we look forward to sharing these data in greater detail at DDW next week.”
Based on the results of the Phase Ib clinical study, the Company plans to explore the development of VX-950 as monotherapy and in combination with other HCV treatments. Vertex plans to consult with the U.S. FDA and European regulatory authorities on the Company’s development plans. Vertex expects to file an investigational new drug (IND) application in the second half of 2005 to support Phase II clinical development of VX-950 in the United States. In collaboration with Vertex, Mitsubishi Pharma Corporation is developing VX-950 in Japan and certain Far East countries.
Trial Design
The Phase Ib clinical trial was a double-blind, randomized placebo-controlled study designed to evaluate the tolerability, pharmacokinetics and effect on viral kinetics of three doses of VX-950 — 450 mg every 8 hours, 1250 mg every 12 hours, or 750 mg every 8 hours — over a period of 14 days, with additional post-treatment follow-up. A key goal of the study was to assess different dosing levels and frequencies for VX-950 to provide insight into dose selection for future monotherapy and combination therapy studies. Thirty-four patients with chronic genotype 1 hepatitis C virus infection were enrolled in the study; six patients received placebo and 28 patients received VX-950. The study was conducted at three centers in Europe. The trial included treatment-experienced and treatment-naïve HCV-infected patients.
VX-950 Demonstrates Antiviral Activity
Interim Phase Ib clinical trial results indicate that VX-950 was well-tolerated across all three dose groups with no serious adverse events reported, and no treatment discontinuations. Treatment with VX-950 also resulted in significant reductions in plasma HCV-RNA. Within three days of treatment, the median reduction in HCV-RNA was greater than 3 log10 in all three VX-950 dose groups. In the dose group receiving 750 mg of VX-950 every 8 hours, there was a further reduction in viral levels between days 3 and 14 of treatment, with mean and median HCV-RNA reductions of greater than 4 log10 at day 14. Trough plasma concentrations of VX-950 were highest in the 750 mg every 8 hour dose group. In the 450 mg q8h and 1250 mg q12h dose groups, maximal effects were seen between days 3 and 7 of treatment. Subsequently, there was an increase of approximately 1 log10 in median HCV-RNA between days 7 and 14 evident in both groups. Full analysis of the study, including a detailed pharmacokinetic and viral sequencing evaluation, is underway.
Web Cast Conference Call on May 17
Following the presentation of VX-950 clinical data at DDW, Vertex Pharmaceuticals will host a conference call on May 17, 2005 at 4:00 p.m. Eastern Daylight Time (EDT). This call will be broadcast live via the Internet at www.vrtx.com in the investor center until end of day on May 30, 2005. Alternatively, to listen to the call live on the telephone, dial (800) 374-0296 (U.S. and Canada) or (706) 634-2224 (International). The archived call will be available via telephone commencing May 17, 2005 at 8:00 p.m. EDT through 5:00 p.m. EDT on May 23, 2005. The replay phone number for the U.S. and Canada is (800) 642-1687. The international replay number is (706) 645-9291. The conference ID number is 6231209 for both numbers.
About Vertex
Vertex Pharmaceuticals Incorporated is a global biotechnology company committed to the discovery and development of breakthrough small molecule drugs for serious diseases. The Company’s strategy is to commercialize its products both independently and in collaboration with major pharmaceutical companies. Vertex’s product pipeline is principally focused on viral diseases, inflammation, autoimmune diseases and cancer. Vertex co-promotes the HIV protease inhibitor, Lexiva®, with GlaxoSmithKline.
Safe Harbor Statement
This press release may contain forward-looking statements, including statements that (i) Vertex’s HCV protease inhibitor VX-950 is well-tolerated and possesses potent antiviral activity; (ii) that Vertex expects to explore development of VX-950 as monotherapy and as part of combination therapy; and (iii) Vertex plans to file an IND during the second half of 2005 to support clinical development of VX-950 in the United States. While management makes its best efforts to be accurate in making forward-looking statements, such statements are subject to risks and uncertainties that could cause Vertex’s actual results to vary materially. These risks and uncertainties include, among other things, the risks that (i) full analysis of the data, or further testing, will not reflect the interim results, or support any or all of the conclusions provided in this press release; and (ii) clinical trials for VX-950 may not proceed as planned due to technical, scientific, or patient enrollment issues, clinical trial results may not be available when expected, or expected regulatory filings may not occur or may be delayed due to adverse clinical or non-clinical trial developments; and other risks listed under Risk Factors in Vertex’s Form 10-K filed with the Securities and Exchange Commission on March 16, 2005.
Lexiva® is a registered trademark of the GlaxoSmithKline group of companies.
Vertex Contact:
Lynne Brum, VP, Corporate Communications and Financial Planning, (617) 444-6614
Michael Partridge, Director, Corporate Communications, (617) 444-6108
Lora Pike, Manager, Investor Relations, (617) 444-6755
Zachry Barber, Specialist, Media Relations, (617) 444-6470
Back to top
May 11th, 2005
N.H. Sees Big Increase in Hepatitis Cases
SourceURL:http://www.newsday.com/
By DAVID TIRRELL-WYSOCKI
Associated Press Writer
CONCORD, N.H. -- Drug abuse is helping fuel a dramatic increase in Hepatitis A cases in New Hampshire, prompting health officials to recommend that drug users be vaccinated.
"This is an important situation for us," said acting state Epidemiolgist Dr. Jose Montero. "Historically, we have 16 to 20 case per year. This year, we have had 21."
About half of the cases involved people who used drugs, or people in close contact with someone who used drugs, Montero said.
"We are strongly advising anyone who uses drugs to get a Hepatitis A vaccine," he said.
His comments came Wednesday as the state confirmed the latest Hepatitis patient, a Salem restaurant worker. Montero did not say how the worker became ill. The liver disease also is transmitted through unprotected sex or fecal bacteria in food.
The restaurant worker's family members and close acquaintances are being treated, but public health officials said they do not plan vaccination clinics for restaurant customers.
"There is no substantial risk to customers of the establishment," said Public Health Director MaryAnn Cooney, who said the state was not identifying the restaurant because of the low risk.
"We don't expect any (customers) to come down with the disease," she said.
Last year, the state set up clinics and vaccinated about 2,500 people after they were possibly exposed to hepatitis A at a Taco Bell restaurant in Derry.
Cooney and Montero said the latest diagnosis was confirmed Tuesday. Public health officials determined there was little risk because of the times the patient worked and the times he was most infectious. Also, when he did work, he followed proper food preparation precautions.
The man was hospitalized, Montero said, and was expected to recover.
The restaurant case, Cooney said, highlights the need for food service workers to be vigilant in handling and preparing food. The precautions include wearing gloves. But she said everyone else can help avoid the illness by washing hands frequently and washing fruits and vegetables.
"Anyone really is at risk of getting it," she said.
The state has set up a hotline to answer questions about the illness. It is 1-800-852-3345, extension 4496
Back to top
May 12th, 2005
Nonsteroidal Anti-Inflammatory Drugs and Hepatic Toxicity in Arthritis
SourceURL:http://www.gastrohep.com
Diclofenac and rofecoxib have higher rates of aminotransferase elevations than other nonsteroidal anti-inflammatory drugs but none have increased rates of liver-related serious adverse events or deaths, finds May's issue of Clinical Gastroenterology and Hepatology.
Nonsteroidal anti-inflammatory drugs (NSAIDS) might cause hepatic side effects, but the frequency of these laboratory and clinical side effects is uncertain.
Dr Laine and colleagues conducted searches of bibliographic databases MEDLINE and EMBASE.
The investigators also conducted searches of public archives of the Food and Drug Administration.
The team identified randomized controlled trials of diclofenac, naproxen, ibuprofen, celecoxib, rofecoxib, valdecoxib, or meloxicam in adults with osteoarthritis or rheumatoid arthritis.
The researchers included those trials that provided information on aminotransferase elevations more than 3 times the upper limit of normal, liver-related discontinuations.
Diclofenac had higher rates of aminotransferase more than 3 times the upper limit of normal - Clinical Gastroenterology and Hepatology
In addition, the team assessed hepatic serious adverse events, liver-related hospitalizations, or liver-related deaths.
The proportion of patients with each of the hepatic toxicity outcomes was calculated separately by using sample size weighted pooling for each nonsteroidal anti-inflammatory drug.
The researchers reported that 67 articles from the bibliographic database and 65 studies from the Food and Drug Administration archives met inclusion criteria.
The team found that diclofenac and rofecoxib had higher rates of aminotransferase more than 3 times the upper limit of normal than placebo and the other nonsteroidal anti-inflammatory drugs.
The researchers noted that the 95% confidence intervals for liver-related discontinuations of all nonsteroidal anti-inflammatory drugs, except diclofenac, overlapped with placebo.
Only 1 liver-related hospitalization among 37,671 patients and 1 liver-related death among 51,942 patients occurred with naproxen.
Dr Laine's team concluded, "Diclofenac and rofecoxib had higher rates of aminotransferase elevations than placebo and other nonsteroidal anti-inflammatory drugs studied.
"No nonsteroidal anti-inflammatory drugs studied had increased rates of liver-related serious adverse events, hospitalizations or deaths."
Clin Gastroenterol Hepatol 2005: 3(5): 489
Back to top
Hepatitis Campaign Launched in Belgium
SourceURL:http://www.expatica.com
BRUSSELS --More than 90 percent of Belgians are aware of the health risks posed by hepatitis, but only 15 percent are vaccinated against the disease, a new survey has revealed.
Conducted by the IPSOS institute and based on data gathered in March 2005, the survey has spawned a new nationwide public awareness campaign called 'Vaccination against hepatitis A and B: I’m signing a contract for life', the RTL news site reported on Thursday.
The survey found that while 90 percent of Belgians were aware of the disease only 75 percent were aware that they could catch it, 50 percent thought about getting vaccinated and 15 percent were actually vaccinated.
"Patients wait for their general practitioners to talk to them about hepatitis, but they do not suggest getting vaccinated because they think their patients will find it too expensive," said Professor Van Damme of Ghent University.
Only 3 percent of Belgians mistakenly believe that a vaccination will offer them total protection from the disease and only 2 percent believe the vaccination is without risks or side effects, he added.
Hepatitis A can be transmitted through fecal matter, food or water. Travelers should be warned that the virus is present in Italy and northern Africa.
Hepatitis B can be transmitted through sexual contact, blood or saliva kills 2.5 million people annually across the globe. In 10 percent of adult patients it can lead to cirrhosis of the liver or cancer, Van Damme warned.
More than 70,000 people in Belgium are carriers of the hepatitis B virus and the numbers of hepatitis A cases rose by 13 percent in just one year (from 2002 to 2003).
Belgian authorities launched a hepatitis B vaccinations campaign in 1999 and some 15,000 children have been vaccinated against the disease annually since then.
More needs to be done, however, to vaccinate groups particularly at risk, as well as all travelers, against hepatitis A, said Van Damme.
One full vaccination guarantees protection for life, he added.
Back to top
May 13th, 2005
Preventing Depression in Psychiatric Risk Patients with Chronic Hepatitis
SourceURL:http://www.gastrohep.com
Research in the most recent Journal of Hepatology issue clearly indicates that interferon-alpha induced depression in psychiatric risk patients can be ameliorated by both the use of antidepressants as well as by intensive psychiatric care.
Interferon-alpha-induced depression is a major limitation for the treatment of chronic Hepatitis C, especially for patients with psychiatric disorders.
Dr Schaefer and colleagues from Germany prospectively studied the efficacy of a pre-emptive treatment with the antidepressant citalopram to prevent depression during hepatitis C treatment with pegylated interferon-alpha-2b plus ribavirin.
The team reported that 14 Hepatitis C-infected patients with psychiatric disorders received a prophylactic medication with citalopram of 20mg/day before and during therapy with interferon-alpha.
The incidence of major depression was compared with 22 Hepatitis C-infected patients divided into groups.
The team reported 11 patients with psychiatric disorders in group B and 11 patients without psychiatric risk factors in group C.
The patients underwent interferon-alpha treatment without a pre-emptive antidepressant therapy and depression was diagnosed according to criteria of the Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition.
Major depression occurred in 14% of the controls versus 64% with Hep C infection and psychiatric disorders - Journal of Hepatology
The researchers found that pre-treatment of psychiatric patients with citalopram significantly reduced the incidence of major depression.
The reduction of the incidence of depression was seen during the first 6 months of antiviral treatment as compared to the 2 control groups.
The team noted that the incidence of major depression in control group A was 14% versus 64% and 55% in group B and group C, respectively.
The investigators observed that patients who developed symptoms of major depression during interferon-alpha-therapy could be also improved by antidepressive treatment.
Dr Schaefer's team concludes, "Our open label pilot study, although small, clearly indicates that interferon-alpha induced depression in psychiatric risk patients can be ameliorated by both the use of antidepressants as well as by intensive psychiatric care."
"However, larger, double blind placebo controlled trials in other patient populations are required to confirm these preliminary findings."
J Hepatol 2005: 42(6): 793
Back to top
Deputy Who Died from Disease He Contracted on the Job Buried
SourceURL:http://news.yahoo.com
The turnout was huge Thursday for the funeral of Orange County Sheriff's Deputy Mariano "Rocky" Lemus Jr. who died from complications associated with an on-the-job exposure to hepatitis C.
The funeral was held at the First Baptist Church of Orlando. Afterward, mourners processed to Woodlawn Memorial Park in Orlando, where Lemus was buried with full honors, WESH 2 News reported.
Lemus is the first deputy in Orange County to die in the line of duty from this disease. Officials would not say exactly how he contracted the disease.
People who knew Lemus said he was someone who could be counted on. His partners said he could talk to anyone and that he was a great teacher and mentor to deputies in the field.
"His death should serve as a reminder to all of us that this job exposes us to hidden dangers on a daily basis. Gone are the days of planning just for the gun battle or the ambush," Orange County Sheriff Kevin Beary said in his eulogy.
Beary said that today's officers must be more cognizant of silent killers like diseases than they were in the past.
Officers are given latex gloves to protect themselves from bodily fluids that could be contaminated, but many say there's not enough time to put the gloves on and get the job done.
"It's the officers option of utilizing it or not. If it's a 4- or 5-year-old kid that got hit by a car, you're probably not thinking about that," said Sgt. Cliff Matthews, of the Lake County Sheriff's Office.
"(Lemus) showed me that with an easygoing nature, a quick wit, and the power of words, coupled with a mind moving a million miles an hour, staying three steps ahead of the bad guy, that was the way to do it," said Rolf Cappers, Lemus's former partner. "Rocky and I made so many arrests, we could have used a paddywagon."
Family members say although it was his job that ultimately took his life, he loved what he did.
Lemus had been an officer with the Orange County Sheriff's Office since 1994. He is survived by his wife, Robyn, his daughter, Rachel, and his son, Jon
Back to top
Back to News Review
|
