Alright Pharma Investors, today I’m going to run through a quick profile of a company that I am constantly asked about: Advaxis. The company’s lead product is a Live Attenuated Listeria Vaccine technology titled ADXS11-001 and its designed to fight cervix cancer—don’t worry I’ll explain all that science garble in the next paragraph without a bunch of scientific jargon. There has been a lot of recent scientific development around this technology, in fact it is brand new, the first study that was published using the live attenuated listeria technology in humans was published as recently as March 2009 (Please see this journal article that has Advaxis’ Phase I results ).
So how does the Technology Work?
The concept works like this: The vaccine is made using Listeria Monocytogenes, yes these are the same bacteria that cause listeriosis which is a food borne infection (just think food poising), however since these bacteria are intracellular (scientist believe they may be a good vector (delivery system) for delivering cancer fighting genes. Ok, that gets the listeria portion out of the way, but what does Attenuated mean? This is just scientific garble for saying that the listeria bacteria that is used in the drug is made to be much less harmful to humans. Advaxis then engineers the less harmful listeria to secrete a “fusion protein” which is comprised of a tumor specific antigen that they use to fight the cancer.
Sounds pretty cool, but does it work?
So far ADXS11-001 has only finished one Phase I clinical trial with the product, the results seem mixed, however there was one partial response out of 15 patients (7%) and given the poor prognosis of the patients in the trial that could be considered good (results here). The more positive aspect of the trial was that 7 patients had obtained stable disease which is also a significant step in the cancer development process.
So what’s Next?
The company has announced that they will be running a Phase II trial with the National Cancer Institute this year in women that have failed prior cytotoxic therapy.
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I think u didnt get the Phase I result at all man!
3 people were still alive after 3 years and fully immune from Cancer! And they are now starting 2 Phase II, one is sponsored by NCI like u mentioned it.
What do you mixed results? The NCI is now sponsoring and paying for a large portion of a Phase II based on these “mixed results”. From the NCI’s own studies, patients like the ones treated with ADXS11-001, had a median life expectancy of from 3 to 6 months whereas with the Advaxis Lm vaccine, the median was 347 days.
It would be very interesting to know what the average survival time was in the NCI studies, and the Advaxis Phase II with 3 of those treated with ADXS11-011 alive after 3 years.
I doubt that you are constantly asked about Advaxis, but I would hope that if anyone dooe ask, he is not put off by your mixed results garbage.