HERPES TREATMENT

Questions and Answers on Recommendation for the Refusal of the Marketing Authorisation for Cerepro

April 30, 2007

LONDON, April 26, 2007-On 26 April 2007, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Cerepro 1 × 1012 viral particles (vp)/ml concentrate for solution for injection, intended for the treatment of patients with operable high-grade glioma. The company that applied for authorisation is Ark Therapeutics Ltd. It may request a re-examination of the opinion within 15 days of receipt of notification of this negative opinion.

What is Cerepro?

Cerepro is a ‘gene therapy’ medicine containing adenovirus-mediated Herpes simplex virus-thymidine kinase gene. It is made up into a solution that is injected directly into the brain during surgery.

What was Cerepro expected to be used for?

Cerepro was to be used in combination with ganciclovir sodium to treat high-grade glioma in patients who are eligible for surgery. Glioma is a type of brain tumour that begins in ‘glial’ cells (the cells that surround and support nerve cells).

Cerepro was intended for use during an operation. After removing as much of the brain tumour as possible, the surgeon would have made up to 70 small injections of Cerepro into the area from where the tumour was removed. Cerepro injection was to be followed by a two-week course of treatment with ganciclovir sodium, starting five days after the operation. Cerepro would only have worked in combination with ganciclovir.

Cerepro was designated as an orphan medicinal product on 6 February 2002 for the treatment of high-grade glioma with subsequent use of ganciclovir sodium.

How is Cerepro expected to work?

Cerepro contains the gene for the enzyme ‘thymidine kinase’ from the herpes virus. The gene is carried within a ‘vector’, a type of virus that has been altered genetically so that it can carry a gene (DNA) into the cells of the body. The virus in Cerepro is an ‘adenovirus’ that has been engineered so that it cannot make copies of itself and therefore does not cause infections in humans.

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When Cerepro is injected into the brain, the modified virus is taken up by the cells near the injection sites. The cells then start to produce the thymidine kinase enzyme. This enzyme helps to convert ganciclovir into a form which can kill cells that are dividing, including any cancerous cells that were not removed during the operation.

What documentation did the company present to support its application to the CHMP?

The effects of Cerepro were first tested in experimental models before being studied in humans.

Cerepro has also been studied in 36 patients with high-grade glioma. The study compared the effects of adding Cerepro and ganciclovir sodium to standard treatment with the effects of standard treatment alone. The main measure of effectiveness was how long the patients survived after the first operation.

What were the major concerns that led the CHMP to recommend the refusal of the marketing authorisation?

The CHMP had concerns over the low number of patients included in the main study of Cerepro, as the small size of the study prevented any benefit of the medicine being demonstrated. The Committee also had concerns over the ways in which the study had been carried out, which made it difficult to interpret the results. In addition, the CHMP considered there to be insufficient information on the safety of Cerepro, and, since any benefit of the medicine has not been shown, that its risks, when used in combination with ganciclovir, could be of concern.

At that point in time, the CHMP was of the opinion that the benefits of Cerepro in the treatment of high-grade glioma did not outweigh its risks. Hence, the CHMP recommended that Cerepro be refused marketing authorisation.

What are the consequences of the refusal for patients in clinical trials using Cerepro?

The company informed the CHMP that there are no consequences for patients currently included in clinical trials with Cerepro. If you are in a clinical trial and need more information about your treatment, contact the doctor who is giving it to you.

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Genital herpes risk increases up to age 32

April 26, 2007

The Department of Preventive and Social Medicine researchers say their findings suggest that current efforts to prevent this se xually transmitted infection should not just focus on the young.

The research, from the long-running Dunedin Multidisciplinary Health and Development Study, found that among men the rate of acquiring herpes simplex virus type 2 (HSV-2) infection when aged 26 to 32 was double what it had been up to age 26. Among women, the rate remained similar.

Taking the number of se xual partners into account, the researchers found the risk was three times higher for men in the later age bracket, and for women, this doubled.

Paper co-author Dr Nigel Dickson says the study, just published in international journal se xually Transmitted Infections, is the first in the developed world able to look at rates of herpes infection in both men and women from their teenage years to their thirties.

“What makes this study unique is that as the study members’ blood had been taken at ages 21, 26 and 32 we were able to detect when new HSV-2 infections occurred,” Dr Dickson says.

By age 32, just over one in five of the women (22.5 per cent) and one in seven of the men (14.6 per cent) in the Study, had evidence of past infection with HSV-2 - the most common virus causing genital herpes. The proportion infected rose with increasing number of se xual partners.

“The most likely reason for the risk to increase with age is that, as a person gets older, there is a tendency for their new se xual partners also to be older and hence more likely to harbour HSV-2. Also, as relationships tend to last longer as people get older, this is also likely to increase the risk of transmission,” he says.

Professor Charlotte Paul, another co-author, says while the highest rate of acquiring herpes infection was among those with 10 or more partners between 26 and 32 years, the risk was also high for those with fewer partners.

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“This is also an important finding. Two-thirds of new infections in women actually occurred among those having four or fewer partners in that time, compared to less than 20 per cent for women up to age 26. A similar pattern was seen for men,” Professor Paul says.

Dr Dickson says the results are especially relevant to childbearing women.

“The late 20s and early 30s are now the most common ages for giving birth. This is when the risk of acquiring HSV-2 is higher and women with new infections are most at risk of transmitting the virus to their infants. This can have major consequences,” he says.

“The study has significant implications for public health policy. Prevention in relation to se xually-transmitted infections has tended to focus on young people. Yet, to control the spread in populations where a high prevalence of infection is driving a large number of new cases, it is important to address all factors which contribute to this at any age.

“What’s more, transmission of HIV is enhanced by HSV-2 infection, so controlling the current spread of HSV-2 is likely to reduce the spread of HIV though the population in the future.”

The study was funded by the Health Research Council of New Zealand.

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Study highlights male herpes risk

April 24, 2007

Men in their late 20s and early 30s are in the most danger of contracting genital herpes.

A study from Otago University that has followed a group of people for the last 35 years shows men aged between 26 and 32 have about twice the risk as women of the same age.

Dr Nigel Dickson from the University’s School of Social and Preventive Medicine says in part, the higher risk is because once people contract herpes, they have it for life. Therefore, as people get older and their sexual partners get older, there is an increased likelihood they will be infected.

Dickson says people in their late 20s should get tested to find out if they are carrying the herpes virus.

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Fake flyers fool Univ. students, advertise false Herpes outbreak

April 18, 2007

They look real. Flyers urging students to get tested for herpes after a recent outbreak even bear the University Health Center logo.

But officials at the health center said it’s just a hoax.

“This is not coming from the University Health Center,” said Liz Rachun, health communications coordinator at the health center. “Somebody’s playing a joke.”

The flyers on campus accurately report the facts of herpes such as symptoms like a burning, tingling sensation where a sore is forming, blisters and that 90 percent of individuals may not be aware they have it.

Rachun said herpes is always an issue, but there has been no outbreak on campus.

“We are certainly not seeing an increase in the number of cases,” said Michelle Cohen, sexual health coordinator. “I’m frustrated that someone or some organization is trying to scare people.” Fear tactics, Cohen said, aren’t an effective way to educate people.

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While the jesters remain at large, the theory that the flyers represent contemporary art remains a possibility.

Mark Callahan, a professional at the Lamar Dodd School of Art, often has the students in his Introduction to Art and Technology class display their projects - which sometimes take the form of signs or flyers - around campus.

“The goal of the exercise is to make students aware of the many avenues for communication that exist outside of traditional art galleries,” Callahan said in an e-mail.

After speaking to his students, Callahan found out these flyers were part of the project and told them to take them down immediately.

“I can’t begin to understand why someone would do this,” said Thomas Burke, associate vice president in the Office of the Vice President of Student Affairs.

Health center officials said they will continue to put out accurate information.

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Analysis: Shorter therapy for hepatitis C?

April 17, 2007

BARCELONA, Spain, April 15 (UPI) — Hepatitis C virus patients today face a yearlong, grueling treatment regimen in hopes they can achieve a virtual cure of the disease, but preliminary trial results indicate a drug in development could allow a dramatically shorter treatment course.

“The result of this study has elevated our hopes that we can reduce the time of treatment for this disease,” Ira Jacobson, chief of gastroenterology and hepatology at Weill Medical College of Cornell University, New York, told United Press International.

Jacobson was one of the investigators who treated hepatitis C patients with the oral drug telaprevir, an investigational small molecule that inhibits the protease enzyme of the virus, preventing reproduction.

The interim results of the study were presented at the weekend’s conclusion of the 42nd annual meeting of the European Association for the Study of the Liver, attended by more than 5,600 clinicians in Barcelona, Spain.

The encouraging results with telaprevir were presented by John McHutchison, professor of medicine at Duke University Medical Center in Durham, N.C., who said that a “highly significant” number of patients were able to achieve complete viral suppression — undetectable levels on the most sensitive assay — within four weeks of treatment.

“About 79 percent or 138 of 175 patients infected with genotype 1 hepatitis C virus — the most common and most difficult to treat form of the disease — were able to achieve undetectable levels of the virus after four weeks of therapy with telaprevir plus pegylated interferon alfa-2a and ribavirin compared to 11 percent of patients treated with just pegylated interferon alfa-2a and ribavirin,” he told UPI.

The current standard of care for hepatitis C virus infection is 48 weeks of interferon - a once-a-week injection, plus twice daily oral ribavirin. “By the time a patient gets to the second 24 weeks of this treatment, he or she is often really miserable,” Jacobson said. The drugs have flu-like symptom side effects.

McHutchison said that an equally important part of the interim results was a small study of 20 patients who tested the theory that they if they could get the virus under control rapidly — by four weeks — and then continued on medication for 12 weeks they could stop taking all medication.

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He said nine patients achieved the criteria for stopping, and 20 weeks after discontinuation of medicine six of those patients remained with undetectable virus levels.

“Even though the number of patients who were able to achieve this was small, we believe we have achieved proof of concept that we can shorten the treatment period using telaprevir,” McHutchison told UPI.

“We have to realize that these are interim results and we have to wait to see if this rapid viral response does indeed become a sustained viral response,” he said. A sustained viral response - undetectable virus six months after ending treatment — has been shown to be tantamount to a durable cure.

“We agree that the data is very encouraging,” said Frank Duff, executive director for virology at Roche in Nutley, N.J., who was not involved in the trial. Roche makes pegylated interferon and ribavirin (Copegus) used in the trial.

“These are still early results,” he said. “We still need to run the data and see how this pans out over the 48 weeks and that it does result in a sustained viral response. But this is all going into a very positive direction.”

He noted that Roche is also investigating ways of shortening the treatment period. He pointed out that patients infected with genotypes 2 and 3 of hepatitis C virus already have a shortened 24-week therapy.

McHutchison said that in his trial, adverse side effects that were associated with telaprevir included rash, nausea, pruritus, diarrhea, anemia and vomiting. He noted that these are the same side effects seen with ribavirin so there maybe some interaction between the two medications.

In the study, now being replicated in Europe and the Americas, researchers randomly assigned 80 patients to the standard of care and 180 other patients to various treatment schedules involving telaprevir plus interferon and ribavirin.

The drug is being co-developed by Vertex of Cambridge, Mass., and Tibotec, Cork, Ireland.

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No Equine Herpes virus threat to UAE horses

April 12, 2007

In the wake of the virus striking race horses in Hong Kong, a senior quarantine doctor at Dubai Racing Club allays any fear of danger to horses here

DUBAI A senior veterinary expert in UAE has played down any possibility of a life-threatening disease attacking horses permanently stationed in UAE.
The animal health expert asserts that UAE has arguably the best health regulations regarding the transportation of animals, which in turn lessens the likelihood of a major outbreak.
Responding to the recent reports of the highly contagious Equine Herpes infection among racing horses in Hong Kong, Dr. Tom Morton, a senior quarantine doctor at Dubai Racing Club, said that there was no risk of the disease spreading to UAE.
“There are very stringent procedures before our horses get in contact with horses from other countries and this has helped to keep most of them healthy,” said Morton.
Over 132 race horses in Hong Kong were recently struck by a mild form of Equine Herpes virus although reports now suggest that their condition has since improved.
Horses from Hong Kong have taken part in racing tournaments in UAE, including the Vengeance of Rain which won the $ 5 million Dubai Sheema Classic at the just-concluded Dubai World Cup.
Dr. Morton said that over the last twelve years, UAE horses have not been exposed to any life-threatening disease due to the strict animal transportation instructions set by the Ministry of Agriculture.

Strict health procedures

Between 3,500 and 4,000 horses are transported in and out of UAE every year and they all have to undergo strict health procedures before contact is made with horses in UAE so as to minimise the risk of infection.
Before a horse is allowed entry into UAE, it must have undergone tests with negative results for equine infectious diseases and Vesicular Stomatitis (a viral disease that primarily affects cattle and horses) in an internationally approved laboratory 30 days before being transported.
The horses must also bear a certificate of vaccination against equine influenza and West Nile Fever.
All horses entering the UAE must be accompanied by an official health certificate issued by a veterinary surgeon approved by the local government to carry out export certification.

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Dr. Morton added that all horses transported to UAE are first held in isolation in an officially approved Isolation Centre for a period of six days to allow easy monitoring of their health status by veterinary officials.
He added that horses may be subjected to further tests at the discretion of the Ministry of Agriculture to ascertain their health status.
He noted that temporarily imported horses can only remain in the UAE for a maximum of 30 days unless otherwise agreed with the authorities especially for horses competing in certain specified international competitions.
The doctor, however, said that to ensure health standards, it is not permitted to upgrade visiting horses from temporary to permanent import status.
He noted that a mild form of Equine Herpes was not life-threatening to horses but affects their performance especially among horses meant for racing competitions.
“The symptoms are mild fever and occasionally mild blood abnormalities. It can cause abortion, respiratory diseases and paralysis,” said Dr. Morton.
He said that the virus can survive for 14-45 days in the environment and that under severe circumstances; a horse may fall off its legs and thus affecting its performance.
But the Eastern equine encephalitis type is among the most serious mosquito-borne viral diseases that can affect the central nervous system and cause severe complications and even death. It is spread to horses and humans by infected mosquitoes.
The veterinary doctor said that there have been limited cases of Equine Herpes among horses in UAE but they have always been tamed at an early stage due to the regular inspections conducted.
He added that horses in UAE are also vaccinated against a range of diseases that might either affect their lives or performance such as West Nile virus, western and Eastern equine encephalitis, St. Louis encephalitis, and LaCrosse encephalitis.
Dubai’s Central Veterinary Research Laboratory (CVRL) is arguably the foremost centre in the region for diagnosing and finding cures for animal diseases especially horses and camels.
The centre also hopes to find a cure to conditions such as grass sickness, which killed one of the UAE’s best-loved horses, Dubai Millennium after the Dubai World Cup in 2000

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Herpes hits 132 racehorses in Hong Kong

April 10, 2007

HONG KONG: A strain of equine herpes has infected 132 racehorses in Hong Kong, host of equestrian events at the 2008 Olympics, the South China Morning Post has reported.

Equestrian events were switched from host city Beijing to Hong Kong because of difficulties in establishing a disease-free zone in mainland China and this outbreak is certain to raise concerns about the suitability of Hong Kong.

For now, containment measures at the Hong Kong Jockey Club in Shatin in the New Territories appeared to be working and there was no obvious threat of the outbreak worsening, the newspaper quoted Brian Stewart, head of veterinary regulation and international liaison, as saying.

“The horses are showing elevated temperatures but they seem to have recovered after a couple of days of rest. Overall, the symptoms are very mild,” Stewart said.

The club was not immediately available for comment.

The viral outbreak comes as Hong Kong police investigate a device that was found embedded in the city’s other horse track turf in Happy Valley in late March.

The device, which was uncovered during a routine check, was designed to shoot poison darts into horses at the start of a race.

The plot shocked the city and the Beijing Olympics equestrian chief in Hong Kong quickly pledged that security would be tight for the 2008 Games.

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Equine Herpes Virus Confirmed in Maine

April 5, 2007

AUGUSTA -— On March 28, 2007, a horse housed in a private stable in Rome was diagnosed with the neurologic form of Equine Herpes Virus Type 1 (EHV-1). The three-year-old gelding had been euthanized on March 19, after exhibiting severe neurologic signs over a 24-hour period.

A 17-year-old horse at the same location had died of similar signs one day earlier.

According to the State Veterinarian, Don Hoenig, this is the first reported case of the neurologic form of EHV-1 in Maine. Additionally, an eight-year-old horse in Wales, previously housed for a short time at the stable in Rome, is currently under treatment for neurologic signs consistent with EHV-1. The Department of Agriculture has placed both stables under quarantine.

EHV-1 is primarily a respiratory pathogen in horses which can cause respiratory illness and abortion, but it can also cause a paralytic neurologic disease. The virus is contagious and can be spread by direct contact with infected horses, respiratory secretions, and contact with contaminated objects, such as feed and water buckets and other barn tools and tack. Following initial exposure, EHV-1 has the ability to develop into an inapparent latent infection which can provide a reservoir of virus for continual transmission. This disease is not contagious to humans.

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Prior to 2003, the U.S. reports of neurologic EHV-1 were sporadic with typically none to few outbreaks identified annually. In 2005, seven outbreaks of neurologic EHV-1 were reported in five different states. In 2006, the numbers grew to 11 and involved eight states. These outbreaks are primarily concentrated in the eastern U.S., with a few mid-western and western states experiencing outbreaks.

Over the past two years, the Department of Agriculture, in consultation with equine veterinarians and representatives from the equine industry, including racetrack officials, has strongly recommended that racetracks, agricultural fairs, and equine training facilities in Maine require that horses entering their facilities be vaccinated for EHV-1 not more than six months or less than 14 days before entry. Department animal health officials are also encouraging all horse owners to consult with their practicing veterinarian on recommendations concerning vaccination and monitoring for the disease.

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Equine herpes virus kills two horses in Maine

April 3, 2007

The deadly equine herpes virus has appeared in the state of Maine in the US, and has already claimed the life of two horses in the Rome area.

A 17-year-old horse died on March 18 of suspected equine herpes virus Type 1, and a three-year-old gelding was euthanized a day later. A third horse in Wales is being treated and is responding well.

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All three of horses had been at the same premises in Rome. Both the Rome and Wales stables are now under quarantine.

Over the past two years, the Department of Agriculture has recommended that racetracks, agricultural fairs, and equine training facilities in Maine require that horses entering their facilities be vaccinated for EHV-1 not more than six months or less than 14 days before entry.

Department animal health officials are also encouraging all horse owners to consult with their practicing veterinarian on recommendations concerning vaccination and monitoring for the disease.

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