Wow this is some amazing news ADXS is on the verge of a treatment or cure of cervical cancer! Phase 2 Trials
I hope everyone is ready (including bashers).... because I'm about to drop some serious knowledge on your #$%$ The following are points I highlight when convincing friends and family to invest in ADXS.
1) Phase I had 15 people in it, all with stage 4b cervical cancer (VERY SICK PEOPLE). They all received 2 doses of the vaccine when it was known that 3 doses is the actual therapeutic dose. Why only 2? Because the company was scared. This had never been tested on humans before. Still.... with just 2 doses, 3 of these patients lived 3 years and 2 are still living 4 years out! The historical median survival is 6 months! This trial had a median survival of close to 1 year! Imagine the results when 3 doses are given AND given in combination with chemo!!!
2) Provenge extends life an average of 4 months, is difficult to administer, and will cost Medicare $93,000. Yet it was approved!! And for just 4 extra months of life!! Listeria based vaccines are easy to produce, easy to administer, potentially very efficacious, and will cost Medicare 15x (at least) less for reimbursement.
3) Drugs fail to be FDA approved because they are dangerous. We know 72 patients...sick patients... have received the vaccine and no serious side effects were experienced.
4) Provenge is a one trick pony. There are NINE Listeria constructs and who knows how many more cancers this can be applied to? The possibilities are literally infinite. Insert any antigen you desire. The vector (Listeria) will work the same way and elicit the same immune response. This could prove disasterous however if the technology DOESN'T work since one construct will give a glimpse into all the others. Please see point 1 for hints that it DOES work.
5) ADXS management is brilliant. They have a phase 2 going on in CIN (pre-cervical cancer) AND Stage 4b cervical cancer. If it works in both, chances are this vaccine will be approved for ALL stages of cervical cancer. Provenge is only approved for late stage/metastatic prostate cancer.
6) ADXS has collaborative agreements with NCI, CRUK, Dept of Homeland Security, Wister, etc. NCI and CRUK are running trials at their OWN EXPENSE. Organizations of this caliber do not associate with POS companies.
7) Veterinary applications. If this thing ONLY works in cattle to prevent hoof and mouth disease we are looking at a $10 stock. Forget humans. There are millions of cattle worldwide and they are a commodity. Let's not forget about canine osteosarcoma as well.
8) A lesson in pattern recognition. DNDN went as high as $54 and was the first immunotherapy approved. How high will the next approved immunotherapy go? No telling how high ADXS goes with 9 constructs and limitless constructs in the future. Imagine the kind of profit you can make by buying in NOW! And trust me... the cost effectiveness of Listeria based vaccines is a HUGE issue. Let's say ADXS vaccines extend life of prostate cancer patients 3 months and Provenge extends it 4 months. Guess which one will be reimbursed by Medicare. NOT Provenge. Why? Because 1 month of life is not worth an extra $90,000 to the government.
9) Great business model. ADXS has never had a problem raising money. There is minimal dilution. And guess what? They have enough to make it to the end of phase 2. Forget phase 3. After good phase 2 results they license out the technology and collect big time!! Why is this good? Because it means the share price will move FAST and you won't have to wait very long before you are a millionaire.
10) Advaxis has the only immunotherapy that downregulates T-regs. These T-reg cells help protect the tumor from immune attack. No other immune therapy dose this. And this is a big reason why Advaxis vaccines will work.
Keep this post at the top for newbies and feel free to add.
Not sure who this Diana person is but I can assure you I have never heard of them in my life. This is just a small voice in the back of your head telling you to look up ADXS and do some DD on the company see if you think as I do that this stock could explode on Phase 2 results! New VP hired right before the results come out secured 11 million in financing just a month ago things are shaping up for a company that seems really confidant that things are going to work on in these trials!
Welcome to Endocrine Today on PDA.
A great story
Posted on April 21, 2009 n/a
Some years ago, one of my friends jokingly changed his last name from “Kim” to “Kim-ball” in honor of the movie The Fugitive, which was popular at the time. This movie — now 15 years old! — featured not only the “one-armed man” and Harrison Ford’s righteous innocence, but also the potential FDA approval of a fictional drug, “Provasic,” which was actually at the root of the plot.
Earlier in the week, there was a story in the ASCO daily e-mail news summary (a fantastic feature which I urge all of you to take advantage of) about “Provenge” (sipuleucel-T, Dendreon), not quite “Provasic” but with plenty of intrigue nonetheless. As you may know, Provenge is the name of a prostate cancer vaccine. Cancer vaccine research remains a fascinating area of study, as investigators continue to struggle mightily to harness the body’s immune system against invading cancer cells. The potential benefits of this research are tantalizing with almost mythic overtones. All of us know stories of certain patients whose apparently immunogenic tumors have spontaneously regressed, as if an internal triumph of good vs. evil. We hope that there will be successful vaccines that “use the body’s own natural defenses” to offer “personalized and individualized treatment.” There’s a lot riding on the success of these efforts, as the keys to this kingdom will unlock a goldmine.
Unfortunately, cancer vaccines haven’t met with a lot of success so far. GVAX (Cell Genesys), Canvaxin (CancerVax), and MyVax (Genitope), just to name a few, haven’t worked out in phase-3 trials in various disease types. I was just listening to one of Neil Love’s CDs, in which Dr. Brad Kahl discussed the disappointment in the recent follicular lymphoma cancer vaccine trial. He concluded by suggesting that young investigators might want to find other areas of research.
So could it be that a prostate cancer vaccine that actually works is just around the corner? Provenge actually ran two phase-3 studies a few years ago, D9901 and D9902A. Both failed to meet their primary endpoint and failed to achieve statistical significance for other endpoints. Combined, however, there was a suggestion that the results demonstrated a survival advantage. Naturally, the company wanted FDA approval on this basis. In 2007, an FDA advisory committee met, and the application was rejected — more data was sought. Two prominent oncologists had recommended against approval at that time and were subsequently targeted with death threats. At least one needed additional security for personal protection at the ASCO meeting. Though the spin was predictable — vulnerable cancer patients were upset at being denied life-saving treatments — other commentators later speculated that it was actually the stockholders who were the angriest, most vocal, and maybe most threatening group. Sounds a little bit like The Fugitive, doesn’t it?
So it was with interest that I read the recent ASCO e-mail bulletin. In it, I learned that the company announced that the most recent phase-3 results — ie, the additional data that the FDA had requested — was “positive.” Provenge stock subsequently soared, up 150% by the next day. There’s just one problem though — nobody knows the actual results yet. How much did patients benefit? What were the costs and toxicities? Was the methodology in the trial design and the reporting of the results sound? All of this awaits careful scrutiny of the upcoming abstract and publication, but none of it stands in the way of extraordinary excitement and rising share prices in the meantime. What pressure will there be on the FDA, and the experts voting for or against approval this time around? We’ll have to see how this movie ends.