I wanted to take a few minutes to let people here know about a very promising new treatment for advanced non-small cell lung cancer (NSCLC) that's now in Phase III trials. The name of the new therapy is "Lucanix" and it's being developed by a company called "NovaRx" out of San Diego. (http://www.novarx.com). I'm very familiar with the company from having helped them raise money back in 2006.
In brief, Lucanix is a cancer immunotherapy (sometimes erroneously referred to as a "cancer vaccine") that seeks to stimulate the body's own immune system to fight cancer. Unlike other immunoetharpies like Dendreon's "Provenge", which must be custom-made for each individual patient, Lucanix is truly an "off the shelf" therapy.
One of the primary reasons that cancer is able to evade the immune system and take hold is that the great majority of cancer cells have mutated to produce immunosupressive proteins which, in effect, shield the tumor from detection. What NovaRx has done is to take cancer cells from four established NSCLC cell lines and then genetically modifiy them to supress the production of a key immunosuppressive protein, "transforming growth factor - beta" (TFG-. Once the production of TGF-B by these cells has been reduced to below the immunosuppessive threshold, the cells are irradiated so that they can't reproduce and are then injected subcutaneously into the arm of the NSCLC patient, where the dendritic cells of the immune system can come into contact with them.
The idea is that since these are still living cancer cells that are expressing a full range of NSCLC-associated antigens but which have been deprived of their TGF-B cloak of invisibility, the body's immune system can then recognize them as abnormal and mount an attack against them. This immune response will then continue on to attack the patient's own cancer. A very important point to appreciate is that once the effector cells of the immune system have been activated, they are not affected by the TGF-B that the patient's own tumors are still producing.
The therapy hass been tested in two separate Phase II studies in advanced non-small cell lung cancer. In both cases, patients suffering from Stage III-B and Stage IV lung cancer experienced median survival times and two-year survival rates that were approximately double those available with currently available therapies like Paclitaxel, Alimta and Tarceva.
Side effects were mild and generally consisted of flu-like symptoms as well as transient redness and swelling at the injection sites. There were no reported indicents of dose-limiting toxicities, no hair loss, no anemia, no nausea, etc. Here is a link to a summary of the larger of the two studies:
http://www.redorbit.com/news/health/527 ... index.html
A larger Phase III study of Lucanix is now underway in patients with advanced NSCLC who have demonstrated an initial disease stabilization in reponse to front-line treatment with a platinum-based chamotherapeutic agent such as carboplatin or cisplatin. Here's a link to the FDA's official web page for the trial:
http://www.clinicaltrials.gov/ct2/show/ ... nix&rank=1
Here you can find a detailed listing of the inclusion/exclusion criteria for the study as well as a list of their current clinical trial sites.
So far, out of the 150 patients that have been enrolled in the study, only 21 have died. The current survival rate among those who have been on study for at least a year is 70%. The median survival time is now being projected at approximately 23 months, which is about twice the median survival times obtained by both Tarceva and Alimta in this same patient population.