FDA OKs clinical trials for cancer vaccine
La FDA accepte que le vaccin soit testé sur des humains.By ROGER TAYLOR Business Columnist
Tue, Jun 21 - 4:54 AM
A small Halifax vaccine development company may be on the cutting edge of the fight against cancer.
Une petite compagnie de Halifax pourrait bien être à la fine pointe de la technologieBy employing a therapeutic vaccine developed from the survivin antigen found in certain cancers, the hope is that the patient’s own immune system can be taught to attack the cancer cells.
En employant un vaccin thérapeuthique développé à partir de la survivin trouvé dans certains cancers, l'espoir est que le système immunitaire du patient pourra apprendre à attaquer les cellules cancéreuses.Immunovaccine Inc. has been given approval by the Food and Drug Administration in the United States to start clinical trials of its DPX-Survivac vaccine, beginning as early as this fall.
La compagnie Immunovaccine a été approuvé par la FDA pour des essais cliniques aux États-unissur son vaccin DPX-Survivac commencant cet automne.DPX is the delivery platform developed by Immunovaccine, while the Survivac part of the vaccine was bought from Merck KGaA in Germany.
DPX est une plateforme developpé par Immunovaccine pendant que la partie du vaccin de Survivac a été acheté par Merck en ALlemagne.Marc Mansour, chief operating officer at Immunovaccine, told me Monday that his company had been working on its own cancer vaccine at the time the opportunity to use Survivac came along.
MArc Monsour chef des opérations chez Immunovaccine m'a dit Lundi que sa compagnie a travaillé sur son propre vaccin anti-cancer dans le temps que l'opportunité d'utiliser Survivac s'est présentée.
Moving a vaccine through the various clinical phases is a very expensive proposition, especially for a small company like Immunovaccine, says Mansour. The Merck product provided the Halifax company with "a lower-risk opportunity" because it is known in scientific literature and there are many academic researchers aware of survivin, he says.
Faire passer un vaccin à travers les diverses étapes cliniques est très couteux spécialement pour une petite compagnie comme Immunovaccine a dit MAnsour. Leproduit de Merck fournit une opportunité à moindre risque parce que c'est connu dans la littérature scientuifique et les chercheurs académiques connaissent la survivine.As a result, Immunovaccine decided to focus exclusively on developing DPX-Survivac.
Immunovaccine a donc décidé de focusser exclusivement sur le DPX-Survivac.The FDA had taken the extraordinary step of simultaneously approving Phase I and Phase II trials for DPX-Survivac.
La FDA a prix le parti d'approuver la phase 1 et 2 en même temps pour les essais avec DPX-Survivac , ce qui sort de l'ordinaire.It had traditionally approved trials one phase at a time, says Mansour, but drug and vaccine development is very expensive, and the U.S. regulatory agency is attempting to make it easier for certain drugs to move through the system quicker.
Traditionnellement les essais sont approuvés une phase à la fois mais comme c'est très cher la FDA est prête a faire des exceptions.Since the DPX system had already been used in trials, he says the FDA felt comfortable that it could be used in clinical trials in this case as well.
In the trials of DPX-Suvivac, ovarian cancer patients will be treated with the vaccine after surgery and chemotherapy treatments.
Dans l'essai ce seront des patientes avec un cancer de qui seront traitées avec le vaccin après la chirurgie et les traitements de chimios.Compared to chemotherapy, which kills healthy cells as well as cancer cells, Mansour says the vaccine is a safer method of battling cancer because it will be employing the patient’s immune system to attack cancer wherever it is hiding.
Le vaccin emploie le système immunitaire du patient pour tuer les cellules cancéreusesThe trials will be on ovarian cancer patients first, but Mansour says there are other types of cancer that carry the critical survivin antigen that may also benefit from such a vaccine. (An antigen is a foreign substance that causes the body to produce antibodies.)
Il y a plusieurs types de cancers pour lesquels le vaccin pourrait être utile.Phase I will be carried out in the United States on about 15 patients, he says. That will be used to evaluate the dosage and other factors before moving to the next step.
La phase I sera sur une quinzaine de patients pour évaluer les doses qu'il faut donner avant d'aller plus loin.The first phase should take about a year to complete, if everything goes well, with safety being the most important factor.
Phase II will be a more stringent examination of the vaccine. It will be a double-blind, randomized test involving 250 patients in 50 hospitals, probably in the United States and Canada.
Immunovaccine, which has been around since 2000, only started working on the DPX-Survivac vaccine in the fall of 2010.
Some people believe a company needs to be in a large centre if it wants to be successful in the clinical vaccine development business, but Mansour says Halifax has its advantages.
"We have great local support from local investors as well as government. Being able to access (Atlantic Canada Opportunities Agency) money, for example, has been really very valuable for us. So there are a lot of advantages to being here."
Nous avons eu un bon support des investisseurs locaus aussi bien que du gouvernement.If the vaccine successfully passes Phase II, he says companies interested in the product usually start calling. That’s when most businesses like Immunovaccine either partner with a much larger pharmaceutical company to take it to Phase III or sell the vaccine outright.
Si le vaccin passe la phase deux ce sont les grosses compagnies de médicaments qui vont appeler.Immunovaccine shares, which trade on the TSX Venture exchange under the ticker IMV, closed Monday at 65 cents, up 10 cents on the news.
Les actions de'Immunovaccine sont à la bourse (au TSX..) et le prix a fermé à .65cents lundi en hausse de 10 cents...