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Week Ending: April 5 , 2008
Alan Franciscus
Editor-in-Chief
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This Issue:
March 29th, 2007
Investigator Says Hepatitis C Probe Slowed By Nevada Law
http://www.kolotv.com
LAS VEGAS (AP) - A health investigator says his attempts to collect information about a clinic spread that hepatitis C have been frustrated by laws preventing other agencies from sharing information.
Chief of Investigations Douglas Cooper on Friday told the Board of Medical Examiners that he had been prevented in getting the information for an investigation of the Endoscopy Center of Southern Nevada because laws prevent Las Vegas police from sharing much of their investigative information with him and his staff.
Cooper also says the state Board of Licensure and Certification initially declined to provide him with information identifying patients because of state privacy laws.
Cooper says that it will be some time before his findings are released to the public.
Officials have linked six cases of hepatitis C to the center. Some 40,000 patients have been notified they should be tested to determine whether they had contracted infections. A seventh case was linked to an affiliated clinic.
Board Executive Director Tony Clark says he will ask the Legislature to change laws to guarantee board investigators have access to the information they need.
---
Information from: Las Vegas Review-Journal, http://www.lvrj.com
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Hepatitis C needs study planned in area
http://www.albertalocalnews.com
By Heather Schultz - Red Deer Advocate
The Central Alberta AIDS Network Society received $10,000 in federal money on Friday to compile a needs assessment report for hepatitis C prevention.
“That there are about 3,200 newly acquired cases of hepatitis C diagnosed in Canada each year, and that there are about 1,200 of those here in Alberta, tells you how severe this problem is,” said Red Deer MP Bob Mills. “We want to know how many of those are in Central Alberta (and) what we can do to prevent that.”
The money must be spent by Monday.
Rose Boucher-Blacker, street smarts co-ordinator for the society, said that wouldn’t be a problem. They already have someone lined up.
Boucher-Blacker said compiling the report, the first of its kind in Central Alberta, will include talking to relevant people in the communities, such as drug users and health professionals, and reviewing relevant literature.
“It’s wonderful to get this money,” she said. “I think this will be a fantastic opportunity to actually bring that voice to the table, to fruition, in a needs assessment.”
The research will be conducted over the summer, she said. By the fall, they hope to begin using the information to establish a plan of action with community partners.
Hepatitis C is transmitted through blood-to-blood exchange, such as through shared needles and other shared drug paraphernalia. It attacks the liver.
“Once the liver is impaired, all of a sudden you end up with some vitamin deficiencies and your blood isn’t able to be cleaned as effectively,” Boucher-Blacker said. “And so a lot of health concerns do arise from that.”
Outdated statistics suggest that Central Alberta has the second highest infection rate in Alberta, behind Edmonton, she said.
“I think so much of it is lack of information, lack of knowledge: people just don’t know how they get hepatitis C,” Mills said.
“Rose said it’s preventable — that’s the key thing. So let’s prevent it from happening.”
Contact Heather Schultz at hschultz@reddeeradvocate.com
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March 31st, 2007
Vertex Lifted on Hepatitis C Drug
http://www.thestreet.com
Adam Feuerstein
Schering-Plough (SGP - Cramer's Take - Stockpickr) may not be the formidable competitor to Vertex Pharmaceuticals(VRTX - Cramer's Take - Stockpickr) as previously thought, according to clinical data released Monday on their respective hepatitis C drugs.
The new clinical data, released in advance of next month's European liver disease meeting, pushed Vertex shares up almost 18% to $21.96 in recent trading.
Also aiding Vertex on Monday was new clinical data of its own showing that its drug telaprevir was effective in hepatitis C patients who cannot be treated with currently prescribed drugs.
Schering-Plough's experimental hepatitis C drug boceprevir given in combination with pegylated interferon and ribavirin pushed the virus below detectable levels in 38% of newly diagnosed patients after four weeks of treatment, according to new data from a phase II study released Monday.
In another group of patients who were pretreated with interferon and ribavirin before receiving boceprevir, 62% of patients achieved undetectable viral loads after four weeks.
This antiviral response at four weeks is known as a rapid virologic response, or RVR. It's widely believed that a vast majority of hepatitis C patients who achieve an RVR at four weeks will go on to be fully cured of their disease once a full course of treatment is completed.
This boceprevir data is not as robust as similar results previously presented by Vertex's hepatitis C drug telaprevir. In two phase II studies, 79% and 75% patients given telaprevir achieved so-called rapid virologic in two phase II studies.
Final results from Schering-Plough's boceprevir study, including the percentage of patients cured of their disease, has not yet been released.
The new telaprevir data that Vertex released Monday suggested that the drug may be effective in treating hepatitis C patients who have failed to respond to previous treatment.
These patients are considered the hardest to treat because they either don't respond to drugs like interferon and ribavirin, or their virus returns after treatment.
Vertex treated these so-called null responders and relapse patients with telaprevir plus interferon and ribavirin. Early results suggest that telaprevir was able to suppress the hepatitis C virus in these patients, although final data on cure rates is not yet available.
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April 1st, 2007
InterMune Announces Top-Line Results of Phase 1b Trial of ITMN-191 (R7227) and Provides Program Update
http://www.therapeuticsdaily.com
BRISBANE, Calif., April 1, 2008 /PRNewswire-FirstCall/ -- InterMune, Inc. today provided an overall program update and reported the top-line results from the four dose cohorts of treatment-naive patients in its ongoing Phase 1b clinical trial of ITMN-191, designated R7227 at Roche . ITMN-191 was administered as monotherapy in patients with chronic hepatitis C virus (HCV) genotype 1 infection. InterMune reported that treatment with ITMN-191 resulted in rapid and significant reductions in HCV RNA (see table below).
Cohort |
Dose |
Total Daily Dose (mg) |
Mean Maximum Reduction
HCV RNA Log10 IU/mL (range) |
1 |
100 mg q12h |
200 |
1.6 (0.9-2.2) |
2 |
100 mg q8h |
300 |
2.6 (1.7-3.6) |
3 |
200 mg q12h |
400 |
3.4 (2.4-4.4) |
4 |
200 mg q8h |
600 |
3.9 (3.0-5.0) |
One final cohort consisting of treatment-experienced patients dosed at 300mg every 12 hours will begin dosing next week.
InterMune additionally reported that, based on a preliminary review of the available and still blinded clinical data from the four completed cohorts of the Phase 1b study, ITMN-191 was safe and well-tolerated. No serious adverse events were reported and no subject discontinued the study due to an adverse event. Adverse events were generally mild and transient in nature.
"With rapid and substantial anti-viral effect at twice daily doses and an excellent safety and tolerability profile to date, ITMN-191 has the potential to be the best-in-class protease inhibitor for the treatment of patients with chronic hepatitis C virus infection," said Dan Welch, President and Chief Executive Officer of InterMune. "Strong viral kinetic performance of ITMN-191 was observed at total daily doses of less than or equal to only 600 mg, confirming its exceptional potency."
Mr. Welch continued, "With our partner Roche, we plan to initiate in this quarter a 14-day triple combination therapy trial with Pegasys(R) (pegylated interferon alfa-2a) and Copegus(R) (ribavirin). We also are exploring the combination of ITMN-191 with other small molecule compounds."
ITMN-191 Program Update - Clinical, Preclinical and Formulation Progress
InterMune also provided additional new information regarding the progress of the ITMN-191 program.
InterMune today reported that Clinical Trial Authorization (CTA) applications related to its 14-day triple combination study of ITMN-191 with Pegasys(R) (pegylated interferon alfa-2a) and Copegus(R) (ribavirin) were submitted to the relevant European regulatory authorities in March. InterMune expects the 14-day triple combination study to begin in the second quarter of 2008, assuming timely approvals by the relevant authorities.
Regarding future clinical development approaches, InterMune and its collaboration partner Roche also reported that the companies are actively working together to launch a development program that will investigate the combination of various small molecule compounds for the treatment of patients suffering from chronic HCV infection.
InterMune also announced today that a 13-week chronic toxicology study in monkeys has been successfully completed and that this study supports the intended longer duration of dosing of ITMN-191 planned in the Phase 2 clinical development program, to be conducted by Roche.
Regarding formulation, InterMune reported that Roche has completed development of the tablet formulation of ITMN-191 that will be used in the Phase 2 program. Given the relatively low total daily dose of ITMN-191 required to show substantial antiviral activity, Roche has begun work on a modified-release formulation of ITMN-191 with the goal of optimizing the delivery of ITMN-191, potentially to a once per day administration.
Phase 1b (MAD) Trial Design
The ongoing Phase 1b placebo-controlled study is designed to assess the effect of multiple doses of ITMN-191 given as monotherapy on viral kinetics, viral resistance, pharmacokinetics, safety and tolerability. A principal goal of the MAD study is to help choose the range of doses of ITMN-191 that when administered in combination with Pegasys(R) (pegylated interferon alfa-2a) and Copegus(R) (ribavirin) would likely offer the optimal protease inhibitor-based triple combination regimen in terms of efficacy, safety and tolerability. The Phase 1b study also will inform the design of future combination studies using small molecule HCV compounds of different mechanisms of action.
In the Phase 1b study, four cohorts of treatment-naïve patients received ITMN-191 in a gelatin capsule every 12 hours or every 8 hours with food for a period of 14 days. In addition, a single cohort of treatment-experienced chronic hepatitis C patients infected with HCV genotype 1 will begin dosing next week at the 300mg every 12 hour dose level.
Conference Call and Webcast Details
InterMune will host a conference call today at 8:30 a.m. EDT to discuss the preliminary Phase 1b clinical trial results of ITMN-191 and the Program Update. Interested investors and others may participate in the conference call by dialing 888-799-0528 (U.S.) or 706-634-0154 (international), conference ID #41908166. A replay of the webcast and teleconference will be available approximately three hours after the call.
To access the webcast, please log on to the company's website at http://www.intermune.com/ at least 15 minutes prior to the start of the call to ensure adequate time for any software downloads that may be required.
The teleconference replay will be available for 10 business days following the call and can be accessed by dialing 800-642-1687 (U.S.) or 706-645-9291 (international), and entering the conference ID #41908166. The webcast will remain available on the company's website for approximately 10 business days.
About InterMune
InterMune is a biotechnology company focused on the research, development and commercialization of innovative therapies in pulmonology and hepatology. InterMune has a research and development portfolio addressing idiopathic pulmonary fibrosis (IPF) and hepatitis C virus (HCV) infections. The pulmonology portfolio includes the Phase 3 program, CAPACITY, which is evaluating pirfenidone for the treatment of patients with IPF and a research program focused on small molecules for pulmonary disease. The hepatology portfolio includes the HCV protease inhibitor compound ITMN-191 (referred to as R7227 at Roche) in Phase 1b, a second-generation HCV protease inhibitor research program, and a research program evaluating a new target in hepatology. For additional information about InterMune and its R&D pipeline, please visit http://www.intermune.com/ .
Forward-Looking Statements
This news release contains forward-looking statements within the meaning of section 21E of the Securities Exchange Act of 1934, as amended, that reflect InterMune's judgment and involve risks and uncertainties as of the date of this release, including without limitation the statements related to anticipated product development timelines. 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 most recent annual report on Form 10-K filed with the SEC on March 14, 2008 (the "Form 10-K") and other periodic reports filed with the SEC, including the following: (i) risks related to the long, expensive and uncertain clinical development and regulatory process, including having no unexpected safety, toxicology, clinical or other issues or delays in anticipated timing of the regulatory approval process; (ii) risks related to failure to achieve the clinical trial results required to commercialize our product candidates; and (iii) 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 Form 10-K and InterMune's other periodic reports filed with the SEC, all of which are available via InterMune's web site at http://www.intermune.com/.
Pegasys(R) and Copegus(R) are registered trademarks of Roche
InterMune, Inc.
CONTACT: Jim Goff of InterMune, Inc., +1-415-466-2228,
jgoff@intermune.com
Web site: http://www.intermune.com/
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Hepatitis May Be Ally Against HIV
http://www.sciam.com
Cynthia Graber reports.
A part of one of the proteins of the Hepatitis C virus shows anti-HIV activity in cell cultures.
Podcast Transcript: The disease hepatitis C might provide a new tool in the fight against HIV/AIDS, say scientists at the Scripps Institute and in the Netherlands. The research was published March 31st online in the Proceedings of the National Academy of Sciences.
A segment of one of the proteins of the hepatitis C virus is called C5A. Ironically, this segment, or peptide, actually actually is deadly to the hepatitis virus. So scientists wondered if it could kill the HIV virus as well. They found that in cell cultures, C5A did indeed damage HIV. It also interfered with HIV’s ability to infect cells such as the immune system’s T cells. And C5A properties are in effect at low pH, which is important if any therapy based on it were to be used by women before sex.
The researchers say that C5A has a wider range of anti-viral activity than other antimicrobial peptides. Scientists hope that the Hep C peptide research will lead to the development of antiviral therapies that could help prevent the sexual transmission of HIV.
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Desai may be told: ‘Not so fast, Doc’
http://www.lasvegassun.com
By David McGrath Schwartz
If he tries to leave the country, he’ll likely face some questions first
Authorities have “flagged” the passport of the majority owner of the Las Vegas medical center responsible for the hepatitis C crisis, meaning that if Dr. Dipak Desai were to try to leave the country, law enforcement officials would be notified, sources close to an investigation said.
The flagging of Desai’s passport, which authorities arranged after serving a search warrant at the Endoscopy Center of Southern Nevada last month, would not prevent him from leaving the country, according to sources who requested anonymity because their investigation into conditions surrounding the hepatitis C scare is ongoing.
It would allow them, however, to attempt to interview Desai before he left the country.
Metro Police Deputy Chief Kathy Suey said Desai is “absolutely one of the persons we’re looking at in the investigation.” However, that investigation “is not far enough to charge him with something” at this time, Suey added. She would not comment on whether Desai’s passport has been flagged.
It was unclear Monday whether local or federal agencies requested the action in regard to Desai’s passport.
Authorities believe Desai, a native of India who has been licensed to practice medicine in Nevada since 1980, is still in Las Vegas.
Mike Fleming, a spokesman for the Los Angeles field office of U.S. Customs and Border Protection, said airlines regularly provide the federal agency with lists of passengers flying into and out of the United States. Fleming said he could not comment, however, about an ongoing investigation or a specific individual whose travel is being monitored.
FBI officials declined to comment Monday.
Health officials say six people were infected with hepatitis C at the Endoscopy Center of Southern Nevada because of unsafe injection practices. About 40,000 patients have been notified that they should be tested for hepatitis B, hepatitis C and HIV because of the ambulatory surgical center’s practices.
Nurses have told health officials they were directed to reuse syringes and single-dose vials of medicine on multiple patients. It still is unclear who told them to do so and whether that was standard policy at the clinic.
Desai’s attorney, Richard Wright, refused Monday to comment on Desai’s passport being flagged. He also refused to confirm authorities’ belief that his client is still in Las Vegas, saying it is a private matter.
At a public hearing last week attended by 200 people, many expressed outrage that Desai was not under arrest and that he still is allowed to practice medicine, though Desai has voluntarily agreed not to do so for the time being.
Suey said investigators still are examining documents seized from the Endoscopy Center of Southern Nevada.
In early March, Metro Police, FBI agents and state law enforcement officials armed with search warrants seized patient records at several local clinics.
Tens of thousands of pages of medical files were gathered as evidence.
Sun reporter Abigail Goldman contributed to this story.
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April 2nd, 2007
Riverside patient tests positive for hepatitis C
http://www.dailypress.com
By Veronica Gorley Chufo
NEWPORT NEWS - — One Riverside Regional Medical Center patient screened for hepatitis C has tested positive, a Riverside spokesman said.
Riverside started screening patients last week, after officials learned that a nurse anesthetist who worked there last year was suspected of infecting up to 15 patients in Texas in 2004. Jon Dale Jones, 45, worked at Riverside from July 9 to Dec. 22.
Jones has submitted to Riverside officials a lab report stating that his hepatitis C is inactive now, which means it wouldn't spread to another person. "We do not have any reason to believe this one case is linked to the nurse anesthetist," said Peter Glagola, public relations director. The patient who tested positive has been contacted, he said.
Hepatitis C is a virus that's spread through contact with infected blood. But only about 10 percent of people newly infected with hepatitis C show symptoms, which include fever, fatigue and jaundice, according to the Virginia Department of Health.
Odds are that one in 139 people will test positive for hepatitis C in Hampton Roads, according to Health Department statistics. The federal Centers for Disease Control and Prevention estimates that 3 percent to 5 percent of the population would test positive, Glagola said.
The patient will meet an infectious-disease physician, who will compile a complete medical history and try to determine whether the patient was exposed. DNA testing might be used to determine whether the strain of hepatitis C detected in the patient is the same as the one in the nurse anesthetist, said Patrick Haggerty, director of medical education and Riverside's epidemiologist.
As of Wednesday afternoon, 169 patients were screened, and 86 more were scheduled for screenings. Riverside's Ask-a-Nurse personnel were still trying to contact 41 of the estimated 300 who might have come in contact with Jones, Glagola said. Test results were in for 162 patients, he said.
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UPDATE 1-RESEARCH ALERT-UBS raises Pharmasset to buy; shrs up
http://www.reuters.com
April 2 (Reuters) - UBS upgraded its rating on Pharmasset Inc (VRUS.O: Quote, Profile, Research) to "buy" from "neutral," citing the company's promising drug development programs, and said the stock's valuation was attractive again.
Shares of the company rose as much as 5.3 percent in morning trade.
"Share price has contracted since the promising R7128 data emerged, and we believe this creates an attractive entry," UBS analyst Annabel Samimy said in a note to clients.
Pharmasset, which went public in April last year, is developing drugs targeting viruses like HIV, hepatitis B and hepatitis C. The product R7128 is being developed for hepatitis C, a liver destroying virus.
Analyst Samimy, who earlier had a "neutral" rating on the stock, said the company has "two lead programs with best-in-class potential in the hepatitis B and hepatitis C markets, with differentiated safety and efficacy profiles."
"Thus far, R7128 appears most promising," Samimy said.
The analyst added after a meeting of the European Association for the Study of the Liver (EASL) in late April, where the company will present certain R7128 data, the rest of 2008 would be placid for the company, while 2009 would be "pivotal."
Shares of Pharmasset, based in Princeton, New Jersey, were trading up more than 4 percent at $19.89 in morning trade on Nasdaq.
They have more than doubled since they debuted at $9 a share on April 26, 2007. (Reporting by Varsha Tickoo in Bangalore; Editing by Jarshad Kakkrakandy)
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Screening of Patients with Chronic Hepatitis B and C Improves Survival from Liver Cancer
http://professional.cancerconsultants.com
Researchers from Hong Kong have reported that screening in patients with chronic hepatitis improves survival from hepatocellular cancer. The details of this study appeared in the April 2008 issue of Annals of Surgery.
Liver cancer is a major worldwide problem with more than 1 million cases diagnosed per year. In the United States, the incidence of liver cancer is expected to rise because of the relatively large number of individuals with hepatitis C. Liver cancers can be treated with surgery, embolism, chemotherapy, radiation therapy, liver transplantation, and microwave hyperthermia. Because of the relatively advanced stage at presentation, most current therapies are palliative. Researchers from the Virginia Commonwealth Medical Center have recently reported that the quality of surveillance in patients with cirrhosis has an impact on stage at diagnosis of hepatocellular carcinoma and survival from liver transplantation.
The current study evaluated the impact of screening for liver cancer on 1,366 patients with known hepatitis B or C. Patients were divided into two periods: before and after screening was instituted. They compared survival of patients diagnosed by screening with those diagnosed by the presence of symptoms. These authors reported that the median survival of screening patients was 69 months compared with 39 months for unscreened symptomatic patients. Curative surgery was performed in 68% of screened patients and 51% of unscreened symptomatic patients.
These data are similar to results previously published on screening patients with cirrhosis. However, screening patients with chronic hepatitis would affect a much larger group of patients.
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April 3rd, 2007
Clinic Runs Out Of Vaccine For Hepatitis A
http://www.kypost.com/
- Butler Co. Health Dept. Sends Out Alert After Restaurant Worker Contracts Hepatitis A
- Vaccinations Offered To Diners Exposed To Hepatitis A
People fearing they may have contracted Hepatitis A after eating at the P.F. Chang's restaurant in West Chester lined up for vaccinations on Wednesday, but got another surprise.
The vaccination clinic located at a church on Cincinnati Dayton Road ran out of vaccine around 4 p.m. and sent those left in line to an Urgent Care facility on Kingsgate Way.
The Urgent Care was over-run. Some had to wait for up to three hours.
"It's total chaos, wall-to-wall people, no chairs – it was standing room only, and I finally got my shot at 10 [minutes] til 7 [p.m.]"
The clinic was opened for people who ate at the P.F. Chang's in West Chester from March 14 to March 25.
The restaurant funded Wednesday's vaccination effort and will continue to pay for private vaccinations for interested customers.
For more information call (800) 328-7761.
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Anadys Pharmaceuticals to Present at the CanAccord Adams Hepatitis C Conference
http://www.examiner.com
SAN DIEGO, April 3, 2008 /PRNewswire-FirstCall/ -- Anadys Pharmaceuticals, Inc. (Nasdaq: ANDS) announced today that it will present at the CanAccord Adams Hepatitis C Conference on Wednesday, April 9, 2008 at 3:00 p.m. EDT (12:00 p.m. PDT). The conference is being held at the St. Regis Hotel in New York City.
Steve Worland, Ph.D., President and Chief Executive Officer of Anadys Pharmaceuticals, Inc., will present an overview of Anadys and an update on ANA598, its development-stage product candidate for the treatment of chronic hepatitis C.
The presentation will be simultaneously webcast and can be accessed on the Investor Relations page of the Company's website at http://www.anadyspharma.com. Listeners are encouraged to visit the website approximately five minutes prior to the presentation to download or install any necessary software. A replay of the presentation will be available approximately one hour after the live webcast concludes and will be available through April 23, 2008.
About Anadys
Anadys Pharmaceuticals, Inc. is a biopharmaceutical company dedicated to improving patient care by developing novel medicines in the areas of hepatitis C and oncology. The Company is developing ANA598, a small-molecule, non-nucleoside inhibitor of the NS5B polymerase for the treatment of chronic hepatitis C and ANA773, an oral TLR7 agonist prodrug for cancer.
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Will InterMune's Hepatitis C Drug Compete?
http://www.fool.com/
By Brian Lawler
The wait was a little longer than anticipated, but investors finally got a healthy first look at data from InterMune's (Nasdaq: ITMN) hepatitis C treatment, ITMN-191, on Tuesday.
ITMN-191 is InterMune and partner Roche's antiviral protease inhibitor to treat hepatitis C virus (HCV) infections. It was discovered by Array BioPharma (Nasdaq: ARRY) and subsequently out-licensed to InterMune, which then out-licensed it again to Roche.
Almost six years ago the FDA approved an important new compound to help treat HCV, which is very dangerous and can lead to liver cancer. Without a doubt there will be more in the coming years. With the success of other, similar antiviral compounds in clinical testing, many people have been eagerly awaiting ITMN-191's first study results.
ITMN-191 against the competition
Thankfully InterMune released enough clinical trial data on Tuesday and Wednesday for us to be able to make initial comparisons of ITMN-191 against its brightest competition.
So how strong is the ITMN-191 data? Here's how its 14-day phase 1 study results compare to some other hepatitis C antiviral agents after their phase 1 14-day monotherapy studies in genotype 1 HCV-infected patients.
Company |
Drug |
HCV mean viral
load reduction (VLR) |
InterMune and Roche |
ITMN-191 |
3.8 log* median VLR |
Vertex Pharmaceuticals (Nasdaq: VRTX) |
Telaprevir |
4.4 log** median VLR |
Pharmasset (Nasdaq: VRUS) and Roche |
R7128 |
2.7 log*** mean VLR |
Roche |
R1626 |
4.1 log* median VLR |
Schering-Plough (NYSE: SGP) |
Boceprevir |
2.1 log^*** mean VLR |
*In previously untreated patients only.
**Both previously untreated and treatment-experienced patients. ***In treatment-experienced patients only.
^Not necessarily at end of study.
This is not a full list of top HCV drug treatments in development. Other compounds, such as privately held ViroChem's polymerase inhibitor, have produced similarly strong study data.
Another important factor is that all these phase 1 studies used at least slightly different patient groups in various locations. Differences such as age, sex, or ethnicity affect how well a drug performs. All these drugs were tested in very few patients in these studies; some cohorts had fewer than 10 patients.
It is still too early to guess which drug candidate looks most effective. Based on these results, all I'd be confident to say is that they all exhibit some activity in fighting hepatitis C. Even a 2.0 log reduction in a patient's HCV loads represents a 99% reduction in the amount of the virus in the bloodstream.
The reason I compare ITMN-191 to the other leading anti-hepatitis C treatment candidates is to show that the drug's phase 1 results are at least comparable to other similar compounds that are much closer to approval. (If telaprevir doesn't get approved I will be beyond shocked.) InterMune has now officially validated ITMN-191 as a viable anti-hepatitis C drug candidate at this stage of the game.
InterMune will start testing ITMN-191 in another phase 1b study this quarter, this time in combination with Roche's Pegasys and ribavirin. The real test for ITMN-191 will be in how the drug performs in long-term testing, and whether it can produce HCV cure rates as high as some of its advanced rivals.
Investors shouldn't forget that other HCV antivirals from Wyeth (NYSE: WYE), Achillion, and Gilead Sciences (Nasdaq: GILD) have been derailed due to negative safety signals. ITMN-191's long-term safety in humans is still unknown.
Quality, not quantity
ITMN-191 is not InterMune's only exciting pipeline candidate, and investors will hear more about its potential idiopathic pulmonary fibrosis treatment, pirfenidone, by January next year when InterMune releases phase 3 results for the drug.
InterMune doesn't have the biggest drug pipeline; only two compounds are in clinical stage testing. Its two drug candidates don't treat the biggest potential markets in the world. But I can say with confidence that InterMune does have two very viable shots on goal with ITMN-191 and pirfenidone, and both have produced very exciting data so far.
If InterMune can manage its $235 million in cash wisely and grab additional funds when appropriate, all it would need is one of these compounds to make it to market for its current market capitalization around $700 million to look cheap.
Pirfenidone will represent InterMune's first shot on goal with its phase 3 study results coming out so soon and a potential marketing application around the middle of next year. Investors won't have to wait long to see whether InterMune can score a goal.
Fool contributor Brian Lawler does not own shares of any company mentioned in this article. The Fool has an A+ disclosure policy.
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April 4th, 2007
Pegylated interferon alpha-2a advantageous in dialysis patients with hepatitis C
http://www.therapeuticsdaily.com
Reuters Health
By Scott Baltic
NEW YORK (Reuters Health) - Once-weekly treatment with pegylated interferon alpha-2a is both more effective and safer than standard interferon alpha-2a three times a week for interferon-naive dialysis patients with chronic hepatitis C virus (HCV) infection, according to a report by Taiwanese researchers published in the April issue of Gut.
The researchers note that the standard of care for HCV infection in dialysis patients is monotherapy with standard interferon, while mainstay therapy for patients with HCV infection and normal renal function is pegylated interferon and ribavirin. Ribavirin is considered contraindicated in dialysis patients because of the risk of severe hemolytic anemia.
For their study, Dr. Jia-Horng Kao, of National Taiwan University Hospital, Taipei, recruited 50 patients 18-65 years of age (mean 48.8) receiving regular dialysis who also had detectable HCV RNA for more than 6 months.
These participants were randomized on a 1:1 basis to receive either 135 µg subcutaneous pegylated interferon alpha-2a once a week or 3 million units of subcutaneous standard interferon alpha-2a three times a week. Each regimen was given on an outpatient basis for 24 weeks, after which patients were followed up for an additional 24 weeks.
Patients who received pegylated interferon alpha-2a had a significantly higher end-of-treatment virological response (p = 0.02) than those who had received standard interferon alpha-2a.
Fever was more common among patients receiving standard interferon alpha-2a than in those receiving the pegylated version (44% vs. 12%, p = 0.03). The treatment-related withdrawal rate of patients receiving standard interferon alpha-2a (20%) was significantly higher than the 0% rate among patients receiving the pegylated version (p = 0.04).
"This is a relatively small study with preliminary but promising results," Dr. Kao told Reuters Health. "Therefore, further large-scale studies are awaited to confirm our findings."
Clinicians who care for HCV patients on dialysis, he added, might consider a lower dose of pegylated interferon monotherapy for 24 weeks for those with active hepatitis or advanced fibrosis. He cautioned, however, that "attention must be paid to the adverse effects from the use of interferon, and on-treatment virological response such as the rapid virological response (HCV RNA undetectable at 4 weeks of therapy) should be monitored to predict the sustained virological response."
Gut 2008;57:525-530.
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Idenix Pharmaceuticals to Present at the Canaccord Adams Hepatitis C Conference
http://www.earthtimes.org
CAMBRIDGE, Mass., April 4, 2008 /PRNewswire-FirstCall/ -- Idenix Pharmaceuticals, Inc. announced today that Idenix management will present an overview of its Hepatitis C program at the upcoming Canaccord Adams Hepatitis C Conference on Wednesday, April 9, 2008 at 1:30 p.m. ET at the St. Regis Hotel in New York, NY.
The live and archived webcast of the company presentation can be accessed under "Calendar of Events" in the Idenix Investor Center at http://www.idenix.com/ . Please log in approximately 5-10 minutes before each event to ensure a timely connection. The archived replays will be available on the Idenix website for two weeks following the conference.
About Idenix
Idenix Pharmaceuticals, Inc., headquartered in Cambridge, Massachusetts, is a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral and other infectious diseases. Idenix's current focus is on the treatment of infections caused by the hepatitis C virus and HIV. For further information about Idenix, please refer to http://www.idenix.com/ .
Idenix Pharmaceuticals' Contacts:
**Media: Teri Dahlman (617) 995-9905
**Investors: Amy Sullivan (617) 995-9838
Idenix Pharmaceuticals, Inc.
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Pharmasset to Present at the Canaccord Adams Hepatitis C Conference on Wednesday, April 9th
http://www.earthtimes.org
PRINCETON, N.J., April 4, 2008 /PRNewswire-FirstCall/ -- Pharmasset, Inc. management will present at the Canaccord|Adams Hepatitis C Conference being held on April 9, 2008 at the St. Regis Hotel in New York, NY. Schaefer Price, Pharmasset's Chief Executive Officer, will provide an overview of the company's clinical and preclinical hepatitis C virus (HCV) programs at 11:15 AM (ET).
To access a simultaneous webcast of Mr. Price's overview via the internet, log on to the "Events & Presentations" section of the Investor Center on Pharmasset's website at http://investor.pharmasset.com/events.cfm. Please connect to the website at least ten minutes prior to the start of the presentation to ensure adequate time for a reliable connection and any software download that may be necessary for the webcast.
A replay of the webcast will be available on Pharmasset's website for thirty days following the conference. The investor presentation will be available for download in PDF format immediately following the presentation in the "Events & Presentations" section of the Investor Center on Pharmasset's website at http://investor.pharmasset.com/events.cfm.
About Pharmasset
Pharmasset is a clinical-stage pharmaceutical company committed to discovering, developing and commercializing novel drugs to treat viral infections. Pharmasset's primary focus is on the development of oral therapeutics for the treatment of hepatitis B virus (HBV), hepatitis C virus (HCV) and human immunodeficiency virus (HIV).
Pharmasset is currently developing three product candidates. Clevudine, for the treatment of chronic HBV infection, is enrolling Phase 3 clinical trials for registration in North, Central and South America and Europe. Clevudine is already approved for HBV in South Korea and marketed by Bukwang Pharmaceuticals in South Korea under the brand name Levovir. R7128, an oral treatment for chronic HCV infection, is in a 4-week Phase 1 clinical trial in combination with Pegasys(R) plus Copegus(R) through a strategic collaboration with Roche. Racivir, which is being developed for the treatment of HIV in combination with other approved HIV drugs, has completed a Phase 2 clinical trial.
Pegasys(R) and Copegus(R) are registered trademarks of Roche.
Contact
Alan Roemer, Vice President
Investor Relations & Corporate Communications
alan.roemer@pharmasset.com
Office: +1 (609) 613-4125
Pharmasset, Inc.
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No Charges Filed Against Doctors Weeks After Hepatitis C Investigation
http://www.ktnv.com
It has been six weeks since the public learned of the mass hepatitis exposure at local Endoscopy centers.
But no doctors are facing charges.
A lot of patients are wondering what is being done.
Action News reporter Kristine Harrington is live with the details.
Patients worried about their health are now facing a fatal disease wonder if and when arrests will come.
"I do not have an attorney. I am not looking to sue anyone I just want these people in jail," explained Howard Platzer.
Howard Platzer knows what it is like to be scared and sick.
He was infected with Hepatitis C through a blood transfusion in 1985 and for the past four years has been a patient at the Endoscopy Center of Southern Nevada.
"Nobody really sees the big picture you can give it to your family your friends and it can continue to spread and spread and spread," explained Platzer.
To date, the health district has tied seven cases of Hepatitis C to the Endoscopy Center of Southern Nevada and its unsafe medical practices.
"Something like this should have never happened," explained Platzer.
Now more than a month later, patients are outraged that these doctors and nurses are able to go about their life without yet having to answer the question why.
"As far as I am concerned it is terrorism they performed pre-meditated murder and they need to be held accountable," said Platzer.
Metro says their criminal investigation is continuing and pepending on the outcome, attorneys say these doctors could face anything from neglect to attempted murder charges.
Metro is still sorting through patient records and test results.
In the meantime, patients are patiently waiting for that day in court.
Stay tuned to Action News as we watch for new developments in the Hepatitis C investigation.
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