LUCANIX: Very promising new treatment for advanced NSCLC

[Danram]

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.

[Danram]

(I ran out of space in my previous post.)

The phase III trial has been designed as a fully randomized, double-blinded, placebo-controlled study. 50% of the patients in the study will receive Lucanix in addition to supportive care, while 50% will receive a placebo in addition to supportive care. The primary endpoint of the trial is a statistically significant increase in the median survival time of the treatment group relative to the placebo control group.

Normally, it would be considered highly immoral to give a cancer patient any type of placebo and the FDA would never sign off on it. However, the FDA is indeed allowing NovaRx to test Lucanix as "maintenance therapy" in advanced NSCLC patients who have exhibited an initial positive response to front-line platinum-based chemo. The reason for this is that the usual course of action in these circumstances is simply to "watch & wait", since patients can only tolerate a finite amount of a given chemotherapeutic. So the FDA's reasoning is that since these patients will typically not be receiving any treatment at all during this time anyway, it is acceptable to evaluate Lucanix against a placebo in the phase III study.

When NovaRx went back and re-analyzed its phase II trial data looking only at the patients who fit the selection criteria for the phase III study, they found that the median survival time was about 44 months, which is an extremely high number.

Many qualified NSCLC patients have been reluctant to sign up for this trial because there's a 50% chance that they will receive a placebo. However, potential participants should realize that they would, in all likelihood, not be receiving any treatement during this phase of their treatment anyway. So even if they should be ramdonized to the placebo arm, they really aren't any worse off than they would have otherwise been. Patients in the trial are monitored closely and if there is evidence that their tumors have resumed growing, they can immediately drop out of the trial and start treatment with another chemotherapeutic.

If you or anyone you know might be a good candidate for this study, I would strongly recommend that you research the therapy further and discuss the trial with your/their attending oncologist. Alternatively, you can contact NovaRx directly in San Diego.

Lucanix is a very promising therapy that could, if proven successful, help to save untold thousands of lives in the years to come.