Many small biotech investors wait impatiently for the day that their chosen company's pivotal Phase III data is released. Good results almost always translate into a rising share price, sometimes spectacularly so. Negative results quickly lead to despair. This is the allure that brings people into the exciting world of small biotech investing. All or nothing...usually. It might not be so with the biotech, Keryx.
Keryx Biopharmaceuticals is focused on the acquisition, development and commercialization of medically important pharmaceutical products for the treatment of life-threatening diseases, including cancer and renal disease.
Keryx's number one compound is called Perifosine. It is a novel, oral AKT inhibitor, potentially the first in it's class. It is in two Phase III Trials with SPA's and Fast Track Status for both refractory advanced colorectal cancer and multiple myeloma, and in Phase 1 and 2 clinical development for several other tumor types.
The Colon Cancer Trial results are very near their release point as Keryx CEO Ron Benstur has stated in early March that the Trial unblinding should occur in March with data compilation and release following four to six weeks later. The data release has been revised back from Quarter Four 2011 to sometime in Quarter One 2012. Most analysts, yours truly included, have perceived this as a positive indicator because the unblinding delay means that the trial patients as a whole have lived longer than expected, either through the placebo control arm somehow outperforming historical norms or....Perifosine working to extend the active arm patient's lives. Whichever the reason, we will know the answer within a few, short weeks.
Earlier in paragraph one, I wrote that negative results usually result in devastation of the share price for small bios. I do not believe this would be the case should Perifosine unexpectedly stumble. Keryx has a second compound called Zerenex in Pivotal Phase III with SPA and Fast Track Status for hyperphosphatemia (elevated phosphate levels) in patients with end-stage renal disease.
Zerenex has already demonstrated a highly significant dose response in the short term portion of the Phase III Trial and is now more than six months through the long term safety portion of the Phase III Trial. Most telling is the company's scheduling of an extended safety, compassionate use study for those patients of the Pivotal Trial who have reached the end of their study participation. These people would have returned to using whatever treatment they had been using before their trial participation. According to Keryx IR, doctors and patients both, requested that some mechanism be established to allow the patients to remain taking Zerenex until approval. This bodes well for the outcome of the Zerenex Phase III Trial. Zerenex serves as a parachute for Keryx' share price in the unlikely event of a Perifosine delay as it's trial results will be known in October of this year.
Premarket and After Hours trades in both Keryx and it's Perifosine partner AEterna Zentaris have been in the tens of thousands of shares this week. This is very unusual for these stocks. Interest is definitely picking up heading into the Perifosine moment of truth.
In conclusion, whether you take the plunge yourself or like to watch the excitement of other stocks behaving wildly, keep an eye on Keryx in April. It should be an interesting month.
Disclosure: I am long KERX.