EpiCept Announces Successful Phase I Trial in Brain Cancer for Azixa(TM) (MPC6827) Conducted by Myriad Genetics Monday September 25, 6:23 pm ET First clinical proof of concept for EpiCept's novel apoptosis inducer technology platform
ENGLEWOOD CLIFFS, N.J., Sept. 25 /PRNewswire-FirstCall/ -- EpiCept Corporation (Nasdaq: EPCT; OMX Stockholm) today announced that Myriad Genetics, Inc. (Nasdaq: MYGN - News) has reported positive clinical results for Azixa(TM), a compound discovered by EpiCept and licensed to Myriad as part of an exclusive, worldwide development and commercialization agreement. Based on these results, Myriad intends to initiate Phase II clinical trials for the drug this fall, triggering a milestone payment to EpiCept.
Myriad Genetics has reported that in a Phase I study of Azixa in cancer that has metastasized to the brain, the drug achieved its maximum tolerated dose in patients. Myriad also noted a measured reduction in tumor size in certain patients, suggesting evidence of activity. Myriad has stated that it is finalizing the therapeutic dose and regimen to bring Azixa forward to Phase II trials shortly.
"We are excited that a compound discovered through the application of our proprietary apoptosis screening technology will soon be entering Phase II trials," remarked Jack Talley, president and chief executive officer. "Our researchers continue to identify promising families of compounds with potentially novel mechanisms to induce apoptosis in cancer cells. As this work proceeds, we are also advancing the lead drug candidates that have already been identified. This includes our anticipated IND filing for EPC2407, a small molecule apoptosis inducer for the treatment of certain types of cancer, later this year."
EpiCept's proprietary apoptosis screening technology can efficiently identify new cancer drug candidates and molecular targets that selectively induce apoptosis in cancer cells through the use of chemical genetics and its proprietary live cell high-throughput caspase-3 screening technology. Azixa represents the first confirmed clinical proof of concept for this new technology, which is the basis for the company's oncology drug discovery efforts.
About EpiCept's Apoptosis Modulator Discovery Platform
Cancerous cells often exhibit unchecked growth caused by the disabling or absence of the natural process of programmed cell death called apoptosis. Apoptosis is normally triggered to destroy a cell from within when it outlives its purpose or it is seriously damaged. One of the most promising approaches in the fight against cancer is to selectively induce apoptosis in cancer cells, thereby checking, and perhaps reversing, the improper cell growth.
EpiCept researchers can efficiently identify new cancer drug candidates and molecular targets that selectively induce apoptosis in cancer cells through the use of chemical genetics and our proprietary live cell high-throughput caspase-3 screening technology. Chemical genetics is a research approach investigating the effect of small molecule drug candidates on the cellular activity of a protein, enabling researchers to determine the protein's function. Using this approach with its proprietary caspase-3 screening technology, EpiCept researchers can focus their investigation on the cellular activity of small molecule drug candidates and their relationship to apoptosis. The focus on apoptosis is achieved by screening for the activity of caspase-3, an enzyme with an essential role in cleaving other important proteins necessary to cause cell death through apoptosis.
This combination of chemical genetics and caspase-3 screening technology allows EpiCept's researchers to discover and rapidly test the effect of small molecules on pathways and molecular targets crucial to apoptosis, and gain insights into their potential as new anticancer agents. Our screening technology is particularly versatile and can be adapted for almost any cell type that can be cultured, and it can measure caspase activation inside multiple cell types (e.g. cancer cells, immune cells, or cell lines from different organ systems or genetically engineered cells). This allows researchers to find potential drug candidates that are selective for specific cancer types, which may help identify candidates that provide increased therapeutic benefit and reduced toxicity.
About EpiCept Corporation
EpiCept is an emerging specialty pharmaceutical company focused on unmet needs in the treatment of pain and cancer. The Company has a staged portfolio of product candidates with several pain therapies in late-stage clinical trials, and a lead oncology compound (for acute myeloid leukemia, AML) with demonstrated efficacy in a Phase III trial; the compound is intended for commercialization in Europe. EpiCept is based in New Jersey, and the Company's research and development team in San Diego is pursuing a drug discovery program focused on novel approaches to apoptosis.
Forward-Looking Statements
This news release contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. Such forward-looking statements include statements regarding the efficacy, safety, and intended utilization of the Company's product candidates, the conduct and results of future clinical trials, the sufficiency of the Company's existing capital resources, plans regarding regulatory filings, future research and clinical trials and plans regarding partnering activities. Factors that may cause actual results to differ materially include the risk that product candidates that appeared promising in early research and clinical trials do not demonstrate safety and/or efficacy in larger-scale or later stage clinical trials, the risk that the Company will not obtain approval to market its product candidates, the risks associated with reliance on outside financing to meet capital requirements, and the risks associated with reliance on collaborative partners for further clinical trials, development and commercialization of product candidates. You are urged to consider statements that include the words "may," "will," "would," "could," "should," "believes," "estimates," "projects," "potential," "expects," "plans," "anticipates," "intends," "continues," "forecast," "designed," "goal," or the negative of those words or other comparable words to be uncertain and forward-looking. These factors and others are more fully discussed in the Company's periodic reports and other filings with the SEC.
-------------------- Best Regards and Good Trading Posts: 239 | From: Florida City, FL | Registered: Jul 2006
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Wow just got back from late lunch and here we have a major pullback on the pps. The MM no doubt collected many cheap shares when it bottomed at 1.95. Wish I had some more free money to buy in. I cashed out this morning. They will most likely do a late afternoon or EOD run to collect on their shares.
-------------------- Best Regards and Good Trading Posts: 239 | From: Florida City, FL | Registered: Jul 2006
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Looks like you miscalculated that bottom Lootcifer. sanked to 1.81, Why the MMs are playing with this an hour and a half before the closing bell I don't know. Perhaps trying to fill the gap? It seems like it. In just the last 15 minutes they managed to shake down a lot of people into selling over 100 thousand shares.
-------------------- Rule 1: Always Protect Your Capital Rule 2: Earn slow, Don't lose fast Posts: 457 | From: Miami, Florida | Registered: May 2006
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ACOR still holding steady though, no stopping that monster, it was going neck and neck with EPCT this morning at about 30% gain a piece but it seems to be holding more momentum. This positive brain cancer treatment will take EPCT higher though, they're getting substantial revenue from Myriad who conducted the tests on their behalf. And they're in the process of conducting the phase two trial of the drug in anticipation of an FDA approval.
-------------------- Best Regards and Good Trading Posts: 239 | From: Florida City, FL | Registered: Jul 2006
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It's amazing to see how the MMs work a stock when they want cheap shares. I looked at my streamer time and sales, and it shows a lot of mirror trades and small 100, 200, and 300 block trades. The volume barely moves during those trades, but when they get serious with the shake thas when investors get scared and let go of their shares thus increasing the volume but lowering the PPS.
-------------------- Best Regards and Good Trading Posts: 239 | From: Florida City, FL | Registered: Jul 2006
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The good thing about this stock is that they won't have to dilute after this run. According to the PR this brain cancer breakthrough will trigger a milestone payment from Myriad Genetics to Epicept Corporation. How much exactly that is I don't know but it must be a substantial amount since they labeled it as "milestone". The next PR or 8k filing will most likely discuss the profits from this. Could just see it between after hours to maybe a day or two. IMO
-------------------- Best Regards and Good Trading Posts: 239 | From: Florida City, FL | Registered: Jul 2006
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Whats up people I posted a thread on this in the NASDAQ bigboard section but it seemed to got ignored go figure. Anyway I share your thinking about the PR or filing elaborating on the money made from the trial. Phase two trials is on the way too and the FDA will probably give them a thumbs up, if there's no serious side effects which so far there seems to be none. Phase 3 is the pivotal point where we'll see the very last end results of the drug on the patients in the trial. With that said this stock is heading for a major reversal upwards.
-------------------- One risk I enjoy: daytrading stocks Posts: 273 | From: New York City | Registered: Sep 2004
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Next up also is their Ceplene drug for Acute Myeloid Leukemia in Europe. This drug is in pivotal phase three trials right now and is heading towards European aproval based on the fact that a lead oncology compound demonstrated efficacy in this pivotal phase. I'm looking forward to this stock reaching somewhere between $3 to $5 by then.
-------------------- One risk I enjoy: daytrading stocks Posts: 273 | From: New York City | Registered: Sep 2004
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I just picked up 700 shares in the last 15 minutes for tomorrow. todays momentum is definitely not over. There's been an upwards trend since it hit bottom last Friday at $1.65. See you all tomorrow folks.
-------------------- One risk I enjoy: daytrading stocks Posts: 273 | From: New York City | Registered: Sep 2004
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Just noticed the streamer. Wow what a strong end. Bring it on baby. This is the week of the positive clinical trials. OK I'm gone now, a little too excited.
-------------------- One risk I enjoy: daytrading stocks Posts: 273 | From: New York City | Registered: Sep 2004
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To my knowledge, this stock has never seen volume this big. I looked at the charts and the most I see it risen in the past is 300 to 400K. Most days it lingered around an average of 20 to 40K. This is a humungous spike. Something is definitely up on the inside. The usual consensus is that great volume proceeds news. Well I'm banking on that its either improved financials or FDA or European approval. Does anyone have another take on this?
-------------------- Best Regards and Good Trading Posts: 239 | From: Florida City, FL | Registered: Jul 2006
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It is a rarity to hit upon a diamond stock, the one which grows from a few scientists to a multi-billion dollar behemoth, even with sound and diligent research. The very fact that shares of Epicept skyrocketed today proves investing in biotech while volatile, and unpredictable, can be a rewarding game. It gets even better when the positive clinical results come out in Phase 2 and Phase 3.
Look what happened to biotech ACOR between yesterday and today based on their clinical trials, over a 300% gain. It seems likely EPCT will follow the same trend based on their clinical trials. The charts show it in the uptrend and it will most likely settle back to its regular price between $3.00 and $4.00. Can't wait to see the PPS by Friday.
-------------------- Best Regards and Good Trading Posts: 239 | From: Florida City, FL | Registered: Jul 2006
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Morning East Coasters!! Still a little early for me in Cali but gotta go with the money. I noticed this was one the big movers in the Nasdaq smallcaps yesterday along with ACOR and a few others. I don't know how they'll perform today but I still see the momentum in EPCT. The brain cancer results from yesterday looks very promising. I'm banking that this stock will sizzle some more possibly doubling by Friday or Next week Monday. The charts don't lie, at least not when it comes to the Dow and Nasdaq stocks. I'm buying a few thousand shares first thing at the opening bell.
-------------------- Now We Movin On Up!! Posts: 211 | From: Los Angelos | Registered: Oct 2004
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I'm keeping eyes on the Marketwatch site for some great followup news that should make this stock burst even more. If ACOR did it, I think EPCT will also. Biotechs are very competitive in the market.
-------------------- Now We Movin On Up!! Posts: 211 | From: Los Angelos | Registered: Oct 2004
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The MMs had to do a massive pullback yesterday from the opening high of $2.25 in what looked like an attempt to fill the gap. They brought it back up at the End of Day with a very strong close at $2.04. Still a 20% gain for the day. From what I'm seeing there's already premarket movement going on.
-------------------- Best Regards and Good Trading Posts: 239 | From: Florida City, FL | Registered: Jul 2006
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EPCT seems to be moving in a much more positive direction than ACOR in pre-market trade. ACOR is close to $11 per share right now so investors aren't buying as much as when it was at the $2 and $3 ranges. I think the next big mover is EPCT. This is just my opinion of course but I feel good about it. I'm watching the premarket trades to see how I should buy when the market opens at 9:30.
-------------------- Best Regards and Good Trading Posts: 239 | From: Florida City, FL | Registered: Jul 2006
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I have $11,000 I wanna put into this today based on momentum and PPS. I really missed out on ACOT at 2.22 because I was extremely skeptical and blind sided like most other investors. I don't plan on missing the train for EPCT. Its moving well so far but I'm being very cautious. Pre market swings are very crazy. 9:30 will tell if todays gonna be another good day.
Two in a row for ACOR, why not EPCT, LOL
-------------------- Best Regards and Good Trading Posts: 239 | From: Florida City, FL | Registered: Jul 2006
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quote:Originally posted by Lootcifer: I have $11,000 I wanna put into this today based on momentum and PPS. I really missed out on ACOT at 2.22 because I was extremely skeptical and blind sided like most other investors. I don't plan on missing the train for EPCT. Its moving well so far but I'm being very cautious. Pre market swings are very crazy. 9:30 will tell if todays gonna be another good day.
Two in a row for ACOR, why not EPCT, LOL
Holy crap, you are putting in 11K?? I wish I had half of that to play with. I'm buying but can't afford to put in that much. Please send me some, I hear you have a good heart. LOL
-------------------- Now We Movin On Up!! Posts: 211 | From: Los Angelos | Registered: Oct 2004
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BIG NEWS IS OUT for phase 3 trials of LidoPain Pain relieving patch!!!
Press Release Source: EpiCept Corporation
EpiCept Announces Additional Findings From LidoPAIN SP European Phase III Clinical Trial Wednesday September 27, 6:30 pm ET
ENGLEWOOD CLIFFS, N.J., Sept. 27 /PRNewswire-FirstCall/ -- EpiCept Corporation (Nasdaq and OMX Stockholm: EPCT) announced today several important findings revealed from an ongoing analysis of its previously reported Phase III clinical trial results for LidoPAIN SP, the Company's sterile prescription analgesic patch designed to provide sustained topical delivery of lidocaine to a post-surgical or post-traumatic sutured wound. The Company is studying the impact of these findings in conjunction with other data generated from the trial in order determine what changes in trial design could be made to improve the likelihood of a positive result in a subsequent trial.
The multicenter, randomized, double blind, placebo controlled, Phase III trial of patients undergoing inguinal herniorraphy allowed the subcutaneous infiltration of intra-operative lidocaine by the surgeon just prior to closure of the skin. Such infiltration was not permitted in the Company's earlier Phase II clinical trial. The post hoc analysis of the data indicated that the patient's perceived pain intensity score was directly influenced by the amount of lidocaine infiltrated by the surgeon. That is, the greater the amount of lidocaine administered by infiltration, the more difficult it was to show an analgesic effect with the candidate LidoPAIN SP patch. The strongest results for self-assessed pain intensity between 4 and 24 hours, the primary endpoint of the trial, were achieved when the least amount of lidocaine was infiltrated.
Second Finding
The choice of anesthetic technique affected patients' pain scores. Patients given general anesthesia showed less of an analgesic response than those given spinal anesthesia. Spinal anesthesia is increasing in popularity as the technique of choice for this surgical procedure.
Third Finding
The endpoint of the frequency of narcotic analgesic rescue reached statistical significance for certain time points during the course of the study. Reduced narcotic consumption is the primary clinical benefit sought for this product.
Michael Damask, MD, Chief Medical Officer and Vice President for Medical Affairs of EpiCept commented, "Clearly the use of intra-operative subcutaneous lidocaine infiltration had markedly affected the patients' ability to discern an analgesic effect with the active patch vs. placebo. The active patch was expected to show an analgesic effect above the background provided by lidocaine infiltration in all patients. This raised the hurdle to demonstrate an analgesic effect. We believe this finding reconciles the differences in the Phase III results from the Phase II results, which did not permit intra- operative subcutaneous lidocaine infiltration at the end of surgery. Patients receiving the active patch consistently showed numerical improvements over the placebo patch patients in pain intensity and rescue medication requirements regardless of the volume of the subcutaneous lidocaine infiltration and the anesthetic technique. Additionally, the preferential numerical analgesic response in spinal anesthesia patients is consistent with the standard of care for these procedures, as this technique is growing increasingly popular. Lastly, we are encouraged that the critically important endpoint of reduced narcotic consumption did reach statistical significance for certain time points. The main benefit of this patch is intended to be effective pain relief for post-operative patients with reduced narcotic consumption. The efficacy signal in this regard is consistent between the Phase III and the earlier Phase II results."
Jack Talley, President and CEO, stated, "A second pivotal study in post- operative pain can be implemented quickly and at a comparatively low cost. These are among the important factors we will consider in our analysis as we chart the best course forward for LidoPAIN SP. We will communicate other significant findings from our analysis of this trial as they become available."
About EpiCept Corporation
EpiCept is an emerging specialty pharmaceutical company focused on unmet needs in the treatment of pain and cancer. The Company has a staged portfolio of product candidates with several pain therapies in late-stage clinical trials, and a lead oncology compound (for acute myeloid leukemia, AML) with demonstrated efficacy in a Phase III trial; the compound is intended for commercialization in Europe. EpiCept is based in New Jersey, and the Company's research and development team in San Diego is pursuing a drug discovery program focused on novel approaches to apoptosis.
Forward-Looking Statements
This news release contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. Such forward-looking statements include statements regarding the efficacy, safety, and intended utilization of the Company's product candidates, the conduct and results of future clinical trials, the sufficiency of the Company's existing capital resources, plans regarding regulatory filings, future research and clinical trials and plans regarding partnering activities. Factors that may cause actual results to differ materially include the risk that product candidates that appeared promising in early research and clinical trials do not demonstrate safety and/or efficacy in larger-scale or later stage clinical trials, the risk that the Company will not obtain approval to market its product candidates, the risks associated with reliance on outside financing to meet capital requirements, and the risks associated with reliance on collaborative partners for further clinical trials, development and commercialization of product candidates. You are urged to consider statements that include the words "may," "will," "would," "could," "should," "believes," "estimates," "projects," "potential," "expects," "plans," "anticipates," "intends," "continues," "forecast," "designed," "goal," or the negative of those words or other comparable words to be uncertain and forward-looking. These factors and others are more fully discussed in the Company's periodic reports and other filings with the SEC.
-------------------- One risk I enjoy: daytrading stocks Posts: 273 | From: New York City | Registered: Sep 2004
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It seems the rest of the biotechs are learning a lesson from ACOR.
EPCT scientists did what ACOR did. They went back in the lab and re-examined their phase III trials of the LidoPain drug. They discovered that the drug worked much better on patients who used it compared to those who used the placebo. They also discovered that the effectiveness of the patch created much better pain killing effects when doctors administered less Lidocaine, a narcotic used in conjunction with their drug patch during surgery.
This is great news, I had a feeling this was coming. Tomorrow will be huge for the stock.
-------------------- One risk I enjoy: daytrading stocks Posts: 273 | From: New York City | Registered: Sep 2004
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