Back to News Review
Week Ending: July 16th, 2005
Alan Franciscus
Editor-in-Chief
To download pdf version click here
This Issue:
• Man's Long Wait for Liver Ended in Indianapolis
• Local Tainted Blood Victim Part of Court Victory
• Governor Signs Bills Protecting Missouri Children
• Hep C Virus Produced in Tissue Culture from Cloned Viral Genome
• Panel Upholds Prisoner's Medical Appeal
• MIGENIX and Schering-Plough Sign Agreement for MX-3253 Hepatitis C Drug Development and License Option
• Individualized Versus Standard Treatment in Hepatitis C
• Fergie Frederiksen and Hepatitis C
• US Needle Exchange Programs Declining
• Promising New Drug for Hepatitis C Patients
• Tustin Company Thinks New Drug Could Target Cancer and Multiple Viruses
July 7th, 2005
Man's Long Wait for Liver Ended in Indianapolis
SourceURL:http://www.indystar.com
By Diana Penner
diana.penner@indystar.com
Setrack Nalbandian waited. And waited. And waited. For four years, he waited for a new liver.
But by late last spring, the Troy, N.Y., father of triplets was rapidly failing, and New England Medical Center in Boston was telling him he still faced a long wait. There were about 400 people on that hospital's waiting list and Nalbandian, a former baker, was nowhere near the top, although he didn't have a specific placement.
So his wife and friends turned to the Internet. They found Clarian Transplant Center in Indianapolis and saw that there were only 40 people on the waiting list for a liver. Talin Nalbandian called and explained: Her husband would die soon.
"They were very nice," Talin Nalbandian recalled. "They just said to get his medical records from Boston."
Nalbandian is one of 14 out-of-state residents who had organ transplants at Clarian last year. The reasons include the expertise the doctors can offer, the range of transplants available and the shorter waiting times than patients face at some other hospitals.
Waiting times for transplants are tricky statistics. They are calculated over multiyear periods because some waits for organs can be several years, as Nalbandian's experience shows.
Waiting times can depend on a patient's physical health and characteristics, such as blood type and size; the number of donors; and the willingness of surgeons to transplant less-than-perfect organs. In addition, some transplants centers opt to "list" patients as soon as they are deemed candidates, while others wait to officially list patients who are in more urgent need.
In general, Clarian has increased the number of transplants it performs and reduced waiting times for transplants to less than the typical waits within a three-state region -- Indiana, Ohio and Michigan -- and compared with national wait times.
For example, the median wait for a liver from Clarian between 1998 and the end of 2003 was 10.6 months, according to the Scientific Registry of Transplant Recipients. For livers, the three-state region's comparable number was 19.1 months, and nationally, it was 53.3 months, or more than four years.
That's what stymied the Nalbandians.
They flew to Indianapolis on June 4, 2004, leaving behind their then-7-year-old triplets: Melanie and her brothers, Nazaret and Hrant.
On June 5, Nalbandian was examined and was in bad enough shape that he was admitted to the hospital, his wife recalled. A new scan was ordered for the next day, the same day a liver became available. But that scan showed that Nalbandian's condition had deteriorated.
He had been exposed to Hepatitis B some years earlier, leading to cirrhosis of the liver. But now, his poorly functioning liver also had damaged his intestines. While insurance had approved the liver transplant at Clarian, it balked at the multi-visceral transplant Nalbandian now needed. This time, his wife said she used family political connections to get Nalbandian's insurance company to reverse itself and approve the multiorgan surgery.
At the time, Clarian was seeking federal health officials' approval as an intestinal transplant center, a move that would make insurance coverage almost automatic. That approval came last month.
Nalbandian got his surgery Oct. 17. The operation went fine, but there were some complications in the following months. He and his wife lived in Indianapolis until March so he was close to his surgeons. Since then, they have flown back once a month for checks because their doctors are not familiar with multi-visceral transplants, Talin Nalbandian said. (Her husband couldn't do a telephone interview because he lost his hearing to strong antibiotics he had to take because of an infection during the post-operative period.)
The couple will be back in town soon for a final, minor surgery to close an opening that helps him eliminate waste until his body can handle normal bowel movements.
"I keep referring people out there, like when we're at the doctors office in the waiting room, I'll say, 'You know, my husband had his transplant in Indiana. You should look into it,' " she said. "We were even considering relocating there because Indianapolis did save his life."
Call Star reporter Diana Penner at (317) 444-6249.
Back to top
July 10th, 2005
Local Tainted Blood Victim Part of Court Victory
SourceURL:http://www.pentictonwesternnews.com
BOB MUNDAY, Special to the News
We are, basically, just trying to get on with our lives right now and put all this behind us."
That is the sentiment of Peter Gibbenhuck, whose son Jared recently returned home from a day in an Ontario courtroom that ultimately saw the Canadian Red Cross admit guilt on a tainted blood-related charge.
Jared, who will celebrate his 17th birthday one week from today, was one of 10 tainted blood victims to appear in a Hamilton courtroom late last month. The 10 were among 160 victims involved in the case against the Canadian Red Cross.
The remaining 150 victims provided the court with written statements describing how the ordeal had affected their lives. The Canadian blood agency pleaded guilty to one charge of violating the Food and Drug Act.
Jared, like the other victims in the court, helped put a human face on the tainted blood scandal case.
Jared, who contracted hepatitis C at eight weeks of age from a transfusion in Penticton Regional Hospital, told Ontario Supreme Court Justice James Kent that, as a child, he was too sick to do well in school and that he had no childhood friends.
The first 12 years of my life were absolutely terrible ... I wished I could die some days," said Jared to the judge.
Jared's mother, Leslie Sharp, told the court that her marriage broke up under the stress of her son's illness, and that the family is still suffering as it awaits the results of medical tests that will show whether Jared has liver cancer.
That's always the threat from hep C, liver cancer, but he's doing fine," insists Peter, who did not travel to Hamilton with Jared and his mother.
He and his mom just went," said Peter, They went for a day and came back the next day. They just went and made a statement."
Jared will be entering Grade 12 at Princess Margaret secondary school in September.
The Red Cross was fined $5,000 for violating the Food and Drug Act and ordered to establish a $1.5-million fund for scholarships for the children in victims' families and for medical research.
Six other criminal charges were dropped in the plea bargain.
Back to top
Governor Signs Bills Protecting Missouri Children
http://www.infozine.com
Gov. Matt Blunt signed Senate Bill's 74 and 73 both sponsored by Springfield area legislators.
Springfield, Mo. - infoZIne - "Today I am pleased to sign these bills that will have a positive impact on our state," Blunt said. "Sen. Norma Champion's bills will help protect Missouri's children from harmful diseases and elements, will promote efficiency in state government and will make it easier for counties to provide families the tools they need to protect themselves from sexual offenders."
Senate Bill 74, sponsored by Sen. Champion, bans trace amounts of mercury in vaccines given to knowingly pregnant women and children under the age of three. The bill also gives the Department of Health and Senior Services discretion to determine disorders for which the newborn screening program should test, allowing the department to focus state resources on areas that are most beneficial to Missourians. The legislation also expands education resources related to hepatitis C, helping to provide Missourians information on the transmittal, symptoms and effects of hepatitis C.
Senate Bill 74 will capture Blunt's call to maximize personnel productivity, use technology effectively and increase customer service in state government by allowing the Bureau of Vital Records to accept electronic signatures for birth and death certificates.
Senate Bill 73, also sponsored by Sen. Champion, allows Missouri counties to post convicted sex offenders' pictures on their Internet sites, in addition to the name and address of the offender. Adding photos to sex offender websites will make it easier for individuals to identify sex offenders living in their communities.
Back to top
July 11th, 2005
Hep C Virus Produced in Tissue Culture from Cloned Viral Genome
SourceURL:http://www.gastrohep.com
A study in July's issue of Nature Medicine reports on a system that provides a powerful tool for studying the viral life cycle and developing antiviral strategies.
Hepatitis C virus infection causes chronic liver diseases and is a global public health problem.
Detailed analyses of Hepatitis C virus have been hampered by the lack of viral culture systems.
Subgenomic replicons of the JFH1 genotype 2a strain cloned from an individual with fulminant hepatitis replicate efficiently in cell culture.
Virus infectivity can be neutralized by immunoglobulins from infected individuals - Nature Medicine
Dr Takaji Wakita and colleagues show that the JFH1 genome replicates efficiently.
The researchers also found that the JFH1 genome supports secretion of viral particles after transfection into a human hepatoma cell line, the Huh7.
The research team report that particles have a density of about 1.15 to 1.17 g per ml and a spherical morphology with an average diameter of about 55 nm.
Secreted virus is infectious for Huh7 cells and infectivity can be neutralized by CD81-specific antibodies and by immunoglobulins from infected individuals.
Dr Wakita's team concludes, “This system provides a powerful tool for studying the viral life cycle and developing antiviral strategies.”
Nature Med 2005: 11: 791-96
Back to top
July 12th, 2005
Panel Upholds Prisoner's Medical Appeal
http://www.thejournalnews.com
BILL HUGHES
whughes@thejournalnews.com
Prison officials' denial of medical treatment for a Sing Sing inmate suffering from hepatitis C amounted to a "cruel and unusual punishment in violation of the Eighth Amendment," a panel of state judges concluded in a ruling issued last week.
Four judges of the state Supreme Court's Appellate Division unanimously upheld a May 2003 order by a judge in Westchester County directing prison officials to provide medication for Angel Domenech, 53, a Bronx man whose condition was diagnosed as hepatitis C after a liver biopsy in February 2002.
Domenech has been in prison since 1999, serving a 16-year maximum sentence for attempted murder. He told prison officials when he was being processed in 1999 that he only used alcohol and sniffed heroin "when (he) was very young," according to court records.
Alexander Reinert, a lawyer representing Domenech, said his client was told by prison officials that to receive treatment for his hepatitis he would have to participate in an intensive six-month drug- treatment program.
Domenech enrolled but dropped out after two weeks because, he said, he hadn't used drugs for 30 years, the program included no useful information about his medical condition and it disrupted his educational classes and work schedule.
"Since he had been in prison at that point for more than two years, where he presumably wouldn't have had access to drugs or alcohol, he didn't see why the state should make this requirement of him in order to get medical treatment," said Reinert, whose law firm took the case pro bono.
While there is no vaccine against hepatitis C, a blood-borne virus transmitted through the exchange of bodily fluids, a combination of the medications interferon and ribavirin can eradicate the virus in up to 80 percent of people infected with certain strains.
Domenech filed an inmate grievance in May 2002 after he was denied the medications and filed a lawsuit on his own behalf after his grievance was denied. State Supreme Court Justice Mary Smith ruled in Domenech's favor more than two years ago, but prison officials have refused to provide the medication while Smith's ruling was appealed.
"In a sense, this is just a way of playing chicken with Mr. Domenech's medical condition," Reinert said. "It's our view that this policy represents a way for the state to routinely release prisoners without having to pay for this treatment, which is very expensive."
James Flateau, a spokesman for the state Department of Correctional Services, declined to comment on Domenech's case while the department was reviewing whether it would appeal the latest ruling to the Court of Appeals, the state's highest court.
According to court documents, lawyers for the department argued that the state court "should not interfere with the Department of Corrections' regulations and that their denial of medical treatment is in full compliance with the law."
Citing Domenech's admitted prior use of drugs and alcohol and his refusal to stay in the drug treatment program, correction officials insisted they were justified in refusing to provide the medication, despite a doctor having written him a prescription for interferon in September 2002.
In her ruling, Smith wrote that while there were limitations to treatments available for hepatitis C, "this Court finds no treatment at all to be repugnant to our standards of decency," and that "failure to provide him with the necessary medical care has subjected him to cruel and unusual punishment in violation of the Eighth Amendment."
Hepatitis C virus, or HCV
Signs and symptoms
About 80 percent of those with the illness show no signs or symptoms, as the disease progresses slowly over many years, but these are most common
. jaundice
. fatigue
. dark urine
. abdominal pain
. loss of appetite
. nausea
Long-term effects
. Chronic infection in 55 percent to 85 percent of the cases.
. Chronic liver disease in 70 percent of chronically infected people.
. Deaths from chronic liver disease occur in 1 percent to 5 percent of infected people.
Transmission
. Occurs when blood or bodily fluid from an infected person enters the body of a person who is not infected.
. HCV can be spread through sharing needles when injecting drugs, through syringes or sharp-stick exposures on the job, or from an infected mother to her baby during birth.
. People at risk of HCV infection might also be at risk of infection by the hepatitis-B virus, or HBV, or by HIV.
Prevention
. There is no vaccine to prevent hepatitis C.
Treatment and medical management
HCV-positive people should be evaluated by their doctor for liver disease and treated accordingly.
Other treatment
. The drugs interferon and ribavirin are licensed for the treatment of chronic hepatitis C.
. Interferon can be taken alone or in combination with ribavirin.
. Combination therapy, using pegylated interferon, which is interferon with polyethylene glycol, or PEG, and ribavirin, is currently the treatment of choice because it works longer.
. Drinking alcohol can make the liver disease worse.
Statistics and trends
. About 3.9 million Americans (1.8 percent of the population) have been infected with HCV, 2.7 million of whom are chronically infected.
. New infections per year have declined from an average of 240,000 in the 1980s to about 30,000 in 2003.
. Most infections come from sharing syringes associated with illegal drug use.
. Blood-transfusion associated cases had occurred before rigorous blood donor screening began in 1992, but now occur in less than one per million transfused units of blood.
Sources: Department of Health and Human Services, national Centers for Disease Control and Prevention
Back to top
July 13th, 2005
MIGENIX and Schering-Plough Sign Agreement for MX-3253 Hepatitis C Drug Development and License Option
Source: www.migenix.com
Vancouver, BC, CANADA & San Diego, CA, USA - July 13, 2005- MIGENIX Inc. (TSX: MGI; OTC: MGIFF), a clinical-stage developer of drugs for infectious and degenerative diseases, has completed a Material Transfer and License Option Agreement ("Agreement") with Schering-Plough Corporation (NYSE: SGP) of Kenilworth, N.J., related to celgosivir (MX-3253), MIGENIX's first-in-class compound in Phase II clinical development for the treatment of chronic Hepatitis C Virus (HCV) infections.
Under the terms of the Agreement, Schering-Plough will supply PEGETRONTM (peginterferon alfa-2b powder for solution plus ribavirin 200 mg capsules) as well as provide certain technical and laboratory support and other services for MIGENIX's upcoming MX-3253 Phase II combination study in chronic HCV patients. In addition, the Agreement grants Schering-Plough limited periods of exclusivity for data review of clinical trial results and for the negotiation of a license agreement.
"We expect to benefit greatly from Schering-Plough's leadership in the field of HCV and their contribution to our upcoming Phase II HCV combination study," stated Jim DeMesa, M.D., President and CEO of MIGENIX. "With their expertise in HCV, this agreement can help ensure a solid assessment of MX-3253 in combination with PEGETRON for the treatment of HCV patients who have not responded to first-line therapy".
About MX-3253 and the Proposed Phase II Combination Study
MX-3253 (celgosivir) is an alpha-glucosidase I inhibitor and is currently the only oral drug in development that acts through host-directed glycosylation. In preclinical studies, celgosivir has demonstrated strong synergy with interferon-alpha plus ribavirin and has the potential to be included as part of a combination approach to therapy to improve efficacy. Celgosivir is currently being evaluated in a Phase II monotherapy study in chronic HCV patients in Canada.
The Phase II combination study of MX-3253 will be a randomized, multi-center, active-controlled, 12 week evaluation of MX-3253 in three treatment arms of up to 20 chronic HCV patients each: celgosivir plus peginterferon alfa-2b plus ribavirin (3-way combination); celgosivir plus peginterferon alfa-2b (2-way combination); and placebo plus peginterferon alfa-2b plus ribavirin (control). Patients will be selected based on having genotype 1 chronic HCV and having failed to respond to pegylated alpha interferon plus ribavirin therapy (non-responders). Patients who respond to therapy during the trial will also have the option to continue on treatment for up to 48 weeks. The study will measure viral load at various time points as well as a number of safety parameters. The study is currently expected to commence during the third quarter of calendar 2005.
About MIGENIX
MIGENIX is committed to advancing therapy, improving health, and enriching life by developing and commercializing drugs in the areas of infectious and degenerative diseases. The Company's clinical programs include drug candidates for the treatment of chronic HCV infections (Phase II), the prevention of catheter-related infections (Phase III), the treatment of neurodegenerative diseases (Phase I) and the treatment of acne (Phase II). MIGENIX is headquartered in Vancouver, British Columbia, Canada with US operations in San Diego, California. Additional information can be found at www.migenix.com.
"Jim DeMesa"
James M. DeMesa, M.D.
President & CEO
CONTACTS
Jonathan Burke
MIGENIX Inc.
Tel: (604) 221-9666
Extension 241
Back to top
Individualized Versus Standard Treatment in Hepatitis C
SourceURL:http://www.gastrohep.com
An improvement in virologic efficacy was not achieved with the available individualized treatment options, reports the latest issue of the Journal of Hepatology.
Dr Stefan Zeuzema and colleagues aimed to increase virologic response rates by individualized treatment according to the early virologic response.
The researchers frequently quantified serum Hepatitis C virus-RNA in 270 patients with chronic Hepatitis C.
The patients were treated with peginterferon alfa-2a 180 μg per week and ribavirin 1000-1200 mg per day.
Virologic response occurred in 60% of the individualized arm vs 66% in the standard treatment - Journal of Hepatology
The team classified patients after 6 weeks as rapid, slow, flat, or null responders.
The researchers subsequently randomized patients within each viral kinetic class to continue therapy either with an individualized or standard regimen.
Individualized therapy comprised peginterferon monotherapy of 48 weeks or a shorter combination therapy of 24 weeks for 171 rapid responders.
Triple therapy with histamine 1mg per day for 48 weeks or prolonged combination therapy of 72 weeks was given to 65 slow responders.
The researchers gave 10 flat responders triple therapy, and 22 null responders received high-dose peginterferon 360 μg per week plus ribavirin.
The team found that overall end-of-treatment and sustained virologic response rates were 77% in the individualized arm and 77% in the standard treatment arm.
The researchers noted that sustained virologic response was 60% in the individualized arm versus 66% in the standard treatment arm.
Histamine in addition to peginterferon and ribavirin did not improve virologic response rates in patients with flat response rates.
In addition, the team observed that high-dose peginterferon plus ribavirin did not improve virologic response rates in null responders.
Dr Zeuzema's team concludes, “An improvement in virologic efficacy was not achieved with the available individualized treatment options.”
J Hepatol 2005: 43(2): 250-7
Back to top
July 15th, 2005
Fergie Frederiksen and Hepatitis C
SourceURL:http://noted.blogs.com/westcoastmusic
Regarding MelodicRock.com, The great AOR vocalist Fergie Frederiksen is sick with Hepatitis C (HCV). After living with the disease since the 80's, it has now become very important that treatment is sought. Fergie may be off the road for a while, but he will be very active in promoting awareness of the condition.
This from Fergie's website: "Fergie has kept this for himself for decades, but did now realize that he needed not only to tell the world about it, but try to do something for the cause as well. Fergie became acutely aware of a lack of public awareness about Hepatitis C. It is for this reason Fergie created the Fergie Frederiksen Foundation for Hepatitis C with the mission to fund research, increase awareness and provide informational resources to support those and their families affected by hepatitis C.
What will happen next? In fact the foundation is setting up a special event to be held in September (25th & 26th). This will be an annual event raising funds for the foundation and it's projects. So join Fergie and friends for the first annual Fergie's Rock 2005 benefiting the Fergie Frederiksen Foundation for Hepatitis C in September.
A lot of great stars will be performing on the event, some names to be mentioned: Alex Ligertwood (Santana), Mike Reno (Loverboy), Pat Travers (Pat Travers Band), Jimi Jamison (Survivor), John Cafferty and "Tunes" (Beaver Brown Band), Joey Molland (Badfinger), Spencer Davis (The Spencer Davis Band) and Jim Peterik (The Ides Of March).
Go to www.rockhepc.org to learn more
Back to top
US Needle Exchange Programs Declining
SourceURL:http://www.reutershealth.com
NEW YORK (Reuters Health) - Some needle exchange programs in the US have ceased operations in recent years, and public funding for these programs has declined, according to a report released today.
Needle exchange programs help prevent transmission of HIV and other bloodborne infections by increasing access to sterile syringes among injection drug users (IDUs) and safely disposing of used syringes. Exchange programs also offer social services, such as provision of condoms, referrals for substance-abuse treatment, and testing for HIV and hepatitis.
In 2003, Dr. C. A. McKnight, from New York's Beth Israel Medical Center, and colleagues conducted surveys among 148 exchange programs known to the North American Syringe Exchange Network.
"In 2002, for the first time in 8 years, the number of exchange programs, the number of localities with exchange programs, and the amount of public funding for exchange programs in the United States decreased," the authors note in the Morbidity and Mortality Weekly Report, a publication of the Atlanta-based US Centers for Disease Control and Prevention.
Specifically, the number of needle exchange programs declined from 154 to 148 from 2000 to 2002, primarily through loss of small programs, while the number of states and territories with exchange programs fell from 35 to 32. Public funding decreased 18 percent.
At the same time, the number of syringes exchanged increased 20.2 percent and total budgets increased 7.4 percent.
Such programs "provide health and social services to IDUs who might not otherwise be reached," the authors conclude. "Continued monitoring of exchange programs in the United States is necessary to evaluate the long-term effects of this public health intervention."
SOURCE: Morbidity and Mortality Weekly Report, July 15, 2005.
Back to top
Promising New Drug for Hepatitis C Patients
By JANET ST. JAMES / WFAA-TV
"Superstar" Billy Graham took home the Worldwide Wrestling Federation title in 1977. But one thing that happened in the ring brought him a challenge he never expected.
"We cut our foreheads to produce blood to make the match look more authentic," he said, adding that he thinks that may be how he contracted hepatitis C.
The disease is most commonly spread through blood.
"Hepatitis C is a virus that can infect the liver and cause cirrhosis if it is untreated," said hepatologist Dr. Vijayan Balan of the Mayo Clinic in Scottsdale, Arizona.
Right now, patients must take medication once a week that can induce days of flu-like symptoms. A new drug—albuferon—is only taken once a month and causes fewer side effects.
Albuferon is a combination of interferon (which helps fight infection) and albumin (which lets the medication stay in the body longer).
"You don't have the peaks and valleys with this new drug," Dr. Balan said.
The first phase of a research study showed albuferon is safe and well-tolerated by patients. Soon it will be tested in up to 1,000 people across the country.
Graham said a drug that's easier to handle would have had him back in the gym sooner.
E-mail jstjames@wfaa.com
Back to top
July 16th, 2005
Tustin Company Thinks New Drug Could Target Cancer and Multiple Viruses
SourceURL:http://www.rednova.com
Jul. 16--What if someone told you they had a drug that could fight cancer and nearly every human virus from HIV to hepatitis C, and from Ebola to the common flu?
You might be a little surprised, a little curious, a little excited -- and more than a little incredulous.
But Peregrine Pharmaceuticals, a small Tustin company, is making a big bet on a new drug that it says could be just such a panacea.
The drug, Tarvacin, is in the early testing stages. So far, it has shown promising results against cancer in mice and against at least two viruses, including one that causes a kind of hemorrhagic fever related to the deadly Ebola.
Peregrine recently received federal approval to begin initial testing of Tarvacin in humans for solid tumors and for hepatitis C. It's also being tested at lower trial levels -- not on humans -- against the HIV virus, which causes AIDS, and many others.
A government agency recently asked Peregrine for permission to test the drug against some 30 viruses considered to be potential agents of bioterror. The company hopes those tests could lead to early approval of Tarvacin for use in the case of a bioterror attack -- a move that would make the drug an earner before it got formal approval from the U.S. Food and Drug Administration for wider distribution.
Executives at Peregrine know it's still early. But they think -- and hope -- that they might just be on to something big. When they ponder the best-case scenario, they get stars in their eyes -- and more than a few dollar signs.
"This could be the biggest science discovery of my lifetime if it works against all these viruses and cancer at the same time," says Paul Lytle, Peregrine's chief financial officer. "If you went out and tried to develop vaccines for all these viruses, it could take hundreds of years." When Lytle and his colleagues think of role models, they point to Genentech Inc. in South San Francisco, whose pioneering anti-cancer drug Avastin has posted sales of $640 million since its approval early last year.
"You want to model yourself on the people who have been successful," says Steven King, Peregrine's chief executive officer. If the early claims about Tarvacin are borne out, he sees no reason Peregrine couldn't be catapulted from money-losing research mode into the pharmaceutical big leagues.
"I see that as a way the market has actually responded to a product such as the one we're developing," King says. "I think Tarvacin represents what could be termed a blockbuster type drug." Scientists who are working on the drug with Peregrine are also excited, but they urge caution. They warn that hypotheses often crumble in the laboratory for reasons that weren't even imagined beforehand -- and that tests in humans don't always turn out the way they did in animals.
"There are no guarantees, but it's an interesting idea and it looks promising," says Preston A. Marx, a virologist at the Tulane University Primate Center in Covington, La., who's working as a paid consultant to Peregrine. "There's a lot of additional work until you realize this." Philip E. Thorpe, a professor of pharmacology at the University of Texas Southwestern Medical Center in Dallas and a paid Peregrine consultant -- whom executives at the company call "the father" of Tarvacin -- notes that recent tests of the drug in mice have shown almost complete abolition of cancer growth and metastasis. But "we need to demonstrate efficacy in humans," he says.
The reason Tarvacin appears to have such a broad range of uses is that it targets not any specific cancer or virus, but rather a substance found in the membranes of all cells. When cells become malignant, or are infected by a virus, the substance -- known as a phospholipid -- moves from the inside of the membrane to the outer surface, allowing Tarvacin to bind with it.
The binding marks the cell, raising a red flag that alerts the immune system to the presence of a foreign body. With viral infections, the body's white blood cells attack the viruses. With cancer, the immune system appears to destroy the blood vessels of a tumor, depriving it of the nutrients it needs to grow.
"The concept is almost so simple it's hard to believe no one picked up on it before," says King, the CEO.
In cancer, Tarvacin might prove particularly effective in combination with chemotherapy and radiation, Thorpe says. That's because those more traditional treatments appear to enhance the movement of phospholipids to the surface of the membrane, giving Tarvacin a bigger target.
Scientists say Tarvacin could have an advantage over other anti-viral drugs, because viruses probably won't be able to evade it by mutating.
"Mutation won't affect it because it's targeting a substance which is not intrinsic to the virus itself but to the host cell -- so that substance will be there no matter what new form the virus takes," says Stephen M. Smith, a paid Peregrine consultant and chief of infectious diseases at the Seton Hall school of Graduate Medical Education in New South Orange, Jersey.
Peregrine executives say that even if Tarvacin doesn't pan out, there are still other lines of business that could help make the company profitable.
They are fairly far along with testing of Cotara, a drug that has shown some effectiveness against a certain type of brain tumor. And they receive royalties from the licensing of intellectual property to other, more established drug firms.
In addition, Peregrine's wholly owned manufacturing subsidiary, Avid Bioservices, has a contract to produce an eye drug for another company -- a deal that could mean significant new revenue.
But clearly, Tarvacin is the 800 pound gorilla in Peregrine's board room these days. And while company executives soak in the headiness of a potentially revolutionary new discovery, the scientists are whispering in their ears a mix of excitement, caution and good old-fashion scientific curiosity.
"I don't know where it's going to lead us, but the approach is clearly unique," says Seton Hall's Smith. "As I tell my fellows, empiricism rules.
But from a theoretical point of view, it's really fun to think about."
PEREGRINE PHARMACEUTICALS INC.
Headquarters: Tustin
CEO: Steven King
2005 revenue: $5 million
2005 net loss: $15.5 million
Stock price: $1.00
Back to top
Back to News Review
|
