Just wanted to call afficiandos' attention to some information about COCN, a company I have mentioned a couple of times before on the thread. In a recent news release they just announced they ammended a royalty agreement on a drug they had in trials for migraine. Interestingly enough the company reported results on the migraine trial in November and the results appeared less than spectacular. However, I discovered (through NeuroInvestment, not the company) that the trial results were problematic due to absorption problems and that among those who had absorbed enough of the drug, 20 of 23 experienced pain relief from migraine.
Migraine effects about 23MM Americans anually, so it is a HUGE market. And there are very few effective treatments. It is believed the drug works by reducing inflammation in brain lining. Of course the drug still has another P2 and P3 ahead of it, but is probably worth watching the company, since it has just multiplied its market potential many times (the other indication for the drug is epilepsy). Below is some trial info and analysis from NI on the COCN thread:
>>1)"Early in November, CoCensys released data from a trial of ganaxolone in 252 women suffering from migraine. The trial was placebo-controlled. On the surface, the data were not reassuring; none of the four dosage groups showed a statistically significant improvement in pain over placebo, though there was a trend in that direction. However, the data did show that if one could reach a certain threshold in terms of plasma level for ganaxolone, that at the two assessment points (two hours and four hours after ingestion), patients did show a significant improvement in pain (at p values of .04 and .02 respectively). It appears that the problem was one of absorption: the suspension medium used for ganaxolone may have been responsible for the lackluster results. It was poorly tolerated by patients already nauseous from their migraines, and precipitated vomiting in several (which obviously prevents absorption of the drug). Its adhesion to the esophagus also complicated the process of reaching and being absorbed in the gut. Interestingly, 7 of 8 patients who achieved significant plasma levels (greater than 80 nanograms/ml) at two hours also tended to report pain relief just 30 minutes after ingestion. This indicates that threshold plasma levels of ganaxolone lead to rapid-analgesia. CoCensys believes that the absorption solution is to administer ganaxolone in a tablet form. Tablets are more easily tolerated by migraine patients, and preclinical studies in dogs indicate much more consistent and rapid absorption, reaching desired plasma levels in 30 minutes. Since a rapid and sharp onset of therapeutic onset is vital in a pain condition like migraine, this is highly encouraging. In January CoCensys will conduct a small study of ganaxolone in tablet form with healthy volunteers to confirm that the animal absorption data holds true for humans as well. By the end of February it will be completed, with the subsequent step likely to be another Phase II in a mixed gender migraine group, using much higher doses (400-1600 mg instead of 20-500mg) in order to delineate optimal dosing for a Phase III. CoCensys does not plan to launch this Phase II on its own, and it is possible that a partner could move directly into a massive Phase III dose-ranging study, if they have the money and are so inclined. It should be noted that, thus far, the cardiovascular effects seen with sumitriptan and its chemical cousins have not been found with ganaxolone, and the sedating effects seen with benzodiazepines have not emerged save at the highest doses (e.g. some of the epilepsy subjects receiving 625mg three times in a day experienced some sedation)."<< |
