ECYT - Endocyte Inc.
5 hours 5 minutes ago - PMZ via Comtex
Endocyte, Inc., (Nasdaq:ECYT), a biopharmaceutical company developing targeted small molecule drug conjugates (SMDCs) and companion imaging diagnostics for personalized therapy, today announced its plan to prepare two marketing authorization applications to the European Medicines Agency (EMA). These two marketing applications are for the company's lead drug candidate EC145 for the treatment of platinum-resistant ovarian cancer and its companion imaging diagnostic EC20 for patient selection. The filings will be based on the results of the randomized Phase 2 PRECEDENT trial and supported by a Phase 2 single agent EC145 clinical trial.
"We've been in consultation with the EMA regarding our PRECEDENT results and the design of our Phase 3 trial, PROCEED," said Ron Ellis, president and CEO of Endocyte. "As part of this consultation, we explored the possibility of seeking conditional marketing authorization in the EU based on Phase 2 results. As a result of our interaction with the EMA, including a meeting with the Scientific Advice Working Party and written advice from the Committee for Medicinal Products for Human Use (CHMP), we will prepare marketing applications for both EC145 and EC20. The CHMP welcomed the use of EC20 to select patients with the targeted receptor, so we plan to seek conditional marketing authorization in patients with platinum-resistant ovarian cancer who are EC20 positive. We will discuss these developments during our first quarter conference call scheduled for May 5, 2011."
The PRECEDENT trial, a randomized, multi-center, international Phase 2 study, investigated EC145 in combination with standard chemotherapy, pegylated liposomal doxorubicin (PLD), for treatment of women with platinum-resistant ovarian cancer and evaluated the utility of EC20 for patient selection. The study met its primary endpoint; the combination of EC145 and PLD showed an improvement in the time to disease progression or death compared to PLD alone. This improvement was more substantial in patients who were selected with the companion imaging diagnostic EC20.
Conditional marketing authorization may be granted in certain situations for medical products which treat life-threatening diseases and provide earlier access to patients in areas of high unmet medical need. Conditional marketing authorizations must be renewed annually and require completion of ongoing or new clinical trials to confirm that the risk-benefit balance is positive.
Endocyte cannot predict with any certainty at this time when it will file the marketing applications nor give any assurance that the applications for conditional marketing authorization for either EC145 or the companion imaging diagnostic EC20 will be approved by the EMA.
EC145 is a conjugate of the vitamin folate and a super-potent vinca alkaloid. Folate is required for cell division and rapidly dividing cancer cells over-express folate receptors in order to capture enough folate to support cell division. By attaching a chemotherapy drug to folate through proprietary chemistry, EC145 targets cancer cells while avoiding most normal cells. This targeted approach is designed to provide treatment with super-potent drugs while lowering toxicity compared to standard chemotherapy
I'm keeping a close eye on this stock and doing some research on the company over the next few days. A -65% sell off from their "inconclusive" preliminary trials seems a tad oversold to me. From what I've read, it looks like they had other positive results from other portions of their clinical trials.
Plus, it's hard not to root for these guys as their primary studies involve innovative ways to treat cancer.
Edited by RagingBull - 12/13/11 at 6:20pm
Just a quick update (if anyone cares) on some information that I've manage to dig up. Endocyte has $0 commercial revenue and has been burning cash since its inception. It looks like the entire company is based around it's one treatment "EC145" which failed in preliminary trials. Patients appear to live longer when NOT on the drug according to the statistical results.
The fact that this stock is even trading at $3.42 per share right now is mind boggling. Several failed attempts to make it over the daily 50 DMA looks to be keeping even short term buyers out of the stock.
Hmmm... I've been following this for the last few days and it's starting to show signs of life down here at the 3.20 level. It just broke above of the 200 DMA during actual intraday trading rather than the big pops in the morning. I think I'm going to jump in here at $3.24 and see where it leads me.
Here's a great chart from another guy following the stock as well over on StockTwits. He's seeing heavy accumulation each morning that's looking positive.
Did his "Balance of Power" indicator really give a signal on the 14th? Man at this rate that indicator would've cost somebody like 60-70 cents on entry for a 3.00+ stock.
To be honest with you, I don't even know what a "Balance of Power" is. All I know is I'm not touching ECYT until they show some signs of improvement and I definitely would not hold long term. I'm really just using this stock as a learning experience.
Just checked back in on ECYT. I had totally forgotten about this stock after watching it and studying it for months. At the beginning of March I got tired of following it thinking it would never move. I wish I would have been more patient and held on to my shares at $3.24. I would have been up like 60% right now.