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DSCI:
Used to follow this a 4-5 years ago. Manuka Honey has some very interesting therapeutic properties (if you can get the REAL manuka honey and DSCI does get the good stuff) and they have a product line of bandages that appear to work.
As memory serves, this co. languished for years around $1.50/share and my review of their share price (on Yahoo) doesn't reflect that. Low and behold, they issued a reverse split, 1 for 8 on 2/1/10. split adjusted, their $12/share price is still below what I was watching 5 years ago.
There are some things that will always be a hard sell in our high tech western medicine model. I think one of them is that smearing honey on a wound should be the standard of practice.
aj
NGNM:
I said, "and a slower than expected transformation from providing bulk testing services to other labs"
and you said, "They also lost one of their biggest customers, who took the work in-house"
We're both referring to the same thing. The larger picture is that NGNM had many more bulk service customers in the past and are now rid of all of those customers and the relative decline is now fully out of the earnings and revenue stream. Sequential growth should pick back up to 17-20% YOY now, if not better. The other detail is that mgmt has now trained a whole new cadre of sales reps who were not expected to grow business signficantly in their first year, but that too is now past h(x) and they should be much more productive.
aj
NGNM:From what I can tell, they aren't your typical shady OTC company.
Having been invested in this co. since late '05 I have watched the co. raise cash through one SEDA ('05), one PIPE ('06) and since then, has maintained a balance sheet that has been fairly respectable. They've raised cash since through ABT taking a stake, Van Oort taking a stake, and the recent private purchase from insiders. The co. has grown sales and revenues every quarter since I've been in, but has only had a handful of profitable quarters, usually coming in just under profitability. Mgmt has repeatedly stated that once they hit about $10 million/quarter, they have much greater leverage with cash flow/EBITDA and we will see much more profitability going forward (I do not understand co. finance well enough to be able to explain this, but both Jones, Van Oort and the last CEO all boasted about this.)
Growth has been less than expected for several reasons, including hiring a VP who apparently did very little before he was dismissed (with a generous compensation package I might add) and a slower than expected transformation from providing bulk testing services to other labs, to being a provider to individual pathologists and oncologists. The sales force has essentially doubled since '08 to 26(if memory serves) reps and supervisors. Currently there are three CLIA certified labs and last year, mgmt reported that they anticipated opening/acquiring a 4th sometime this year (which is why I speculate that the insiders raised some cash through the recent insider buy.)
The co. has also played in attempts to get in on early proteomics, with an agreement and potential investment in Power3 Genetics (PWRM.OB now, PWRM.PK just a few months ago; then a longshot microcap co., now a total scam that backwards merged with some other scam co.) which was a complete bust. The co. also attempted to start a CRC contracting business several years ago, to provide genetics testing for pharmaceutical clinical trials, also a bust.
Pcrutch, if I've left out any of the other major details of the co. please feel free to chime in.
Regards,
aj
GSK/IDIX: And it looks like the Oct-Jan move from under $3 to $5 can now officially be labeled a "dead cat bounce"! Dew said this was dead money after the hold and I took any rise as an absolute gift. Glad I got out when I did.
aj
Semi-OT: Re: online publication and my assumptions about NGNM's data publication.
That's an excellent point, Acgood, but don't the journals still have a backlog of manuscripts, that once accepeted, still have to wait until their assigned Vol(no) to be released? If the NGNM data is accepted for a journal that has it's next two issues already laid out, the publication, online or otherwise, will still have to wait until the issue no. has been released, N'cest, pas?
aj
Does anyone know why two directors of NGNM recently resigned?
Can't say definitively, but can provide some background as I've been invested in NGNM for 5 years and have many conversations with Steve Jones in the past about co. growth.
Since the appointment of Doug Van Oort as CEO (with a buy in of 600K shares along with his position announcement), the co. has been trying to build an activist board, well enough connected to move the co. into the retail genetics testing space. They hired and then summarily fired a VP of sales when he underperformed, after just 3 quarters, have managed to get the lab onto most of the provider panels for HMO's (losing some of their margin along the way, but increasing their volume), and recently announced that several insiders bought $3 million worth of shares at $1.50/share when the price was languishing at $1.20 or so. My guess is that Van Oort and Jones are populating the board with individuals who can actually get things done rather than sit around and collect options and attendance compensation.
The last contact I had with Jones was regarding the publication of data on their MelanoSite melanoma test. I emailed him to ask whether or not the data was in review at a peer reviewed journal and when we could expect to see the data published and his reply was that the data was in review and they expected publication soon. In a presentation at OneMed Forum in San Fransisco on 1/11/11, Jones reported that he expected the publication in 3-4 months (suggesting that the manuscript had been accepted and was simply in cue for publication, based on timeline, IMO.) This is important as the validation of the test (with 98% sensitivity for borderline growths) will likely drive the use of the test. Jones also reported that they planned on launching 2 other specific genetics tests based on their ABT partnership in this next year. Today's announcement of $34.4 should be notable because Jones has gone on record at Both San Fransisco and other places that he expects FY 2011 to have revenues of about $45 million.
So much for my annual pump of NGNM; still officially a penny/BB stock, but slowly gaining momentum and legitimacy.
regards,
aj
GXDX:
The buy price is one helluva pop from the low GXDX hit after disappointing 2 quarters in a row. Had I the guts and foresight, I would have bought but thought of "don't try to catch a falling knife" and stayed on the sidelines. The upshot is, however, that this may bode well for my NGNM holding, particularly since the insiders just pushed the stock price up 20% but buying $3 million worth of shares in an unregistered purchase, well above the trading price at the time. NGNM has something brewing and when the CEO, the largest private owner of shares and another board member pony up, I expect that they are preparing to complete some kind of deal that will grow the co. My guess is that they are close to buying another private CLIA lab with a mix of shares and cash that will add significant revenues and profit. Remember, ABT took a 10% position in this co. last year.
Regards from the road, Austin, TX,
aj
OT:Despite pushing tablets for the past decade, no Wintel tablet has caught on with consumers.
Who needs one (or an Ipad for that matter.) My new HTC Evo (android OS) has a 1 gig ram processor and delivers everything in a screen bigger than an Iphone and still fits into my pocket.
Unless and until tablets show some unique functionality, I suspect the handhend mutitasking netphone/computer will rule for the next 10 years.
aj
With respect to understanding the "junk".... Could Teva obtain approval without understanding the "junk" to the same degree as MNTA? Basically - is MNTA's understanding of the "junk" the bar or the potential ceiling for the FDA?
This is just an armchair quarterback's opinion, but it would seem to me that unless Teva and Amphastar can accurately characterize all the junk, they would need to run the trials to clarify that there are no immunogenicity issues. And....given the complexity of the "junk" and the variability of the molecule, that might mean a cost prohibitive set of trials instead of just one trial. Now that the FDA has had a look inside the rabbit hole (compliments of MNTA) they won't allow "junk" science from either Amphastar or Teva.
The conundrum for MNTA is that if investors don't understand this, there will be an overhang that won't go away. The FDA may say "Gee whiz!!" to MNTA science behind closed doors, but they have neither the mission, motivation nor standing to publicize that MNTA's characterization technology is the next step in complex molecular drug science, one which they now see as the standard. I'm certain that it is governmental policy to allow the "market" to work this out, giving MNTA the opportunity to commercialize their technology. This would be far off as I cannot see either Teva or Amphastar ponying up royalties to MNTA with enough money to cover MNTA's market share loss by allowing new generics to compete.
aj
In other words, the FDA’s five criteria for “sameness” ...are merely a starting point—they are necessary but not sufficient to obtain FDA approval for a generic version of Lovenox.
Right, and isn't MNTA's suit against Teva, in essence, an attempt to prevent TEVA from infringing on MNTA's ability to accurately characterize the molecule (and others) because MNTA has patented the technology to do this in a way that has not been done before? That ability to characterize would also be the primary reason that the FDA went to momenta during the contamination crisis, N'cest, pas?
aj
Placebo effects in pain trials
One of the most difficult and problematic sources of measurement error is the substantial placebo effect in pain trials. Upwards of 60% in some studies and routinely accounting for 30% of variance.
http://symptomresearch.nih.gov/chapter_1/sec2/cmms2pg1.htm
http://www.scientificamerican.com/article.cfm?id=scientists-see-how-placeb
Take away, you better have a darn good pain reliever.
aj
OT:
The quote was more specifically, "If you touch my junk, I'll sue ya!"
Now that sounds more like Marth!
Happy Thanksgiving in advance to you all.
MNTA: and FDA work
Can anyone tell us why MNTA did not charge the government, or conversely, why the government didn't pay for the work? Did the govt. offer to pay and MNTA turned them down?
I'm trying to think of a parallel situation. Say the govt needs to find a threat via analysis of huge amounts of internet data and ask IBM, with their Deep Blue computer, to help them with the analysis as they have unique capacity to perform the analysis. IBM certainly has many government contracts also pending with the fed for equipment sales, but complies with the govt's request to help with the threat analysis. Conflict of interest? Appearance of conflict of interest?
Wouldn't it be nice for the fed to address this by sending MNTA a nice check for the work they did?
aj
OT: Hedging against inflation
Just curious how many of those here have established a hedge against the inflation/devaluation risk of the fed printing money.
Disclosure: I have a significant gold/silver position that has done quite well in the last year and I expect it to continue to do so.
aj
OT: HFCS
I'm dating myself, but who ever thought touting real sugar would be seen as sales and health advantages?
My impression is that this marketing approach has/had more to do with taste than anything else and was spurred by Jones Soda (JSDA). They were big on being made with "real cane sugar". The company, which now looks like a flash in the pan, had a helluva run in 2007, with a campaign for marketing in Starbucks. Like most retail products, when they announced that they were negotiating with Walmart, it was clear that they had jumped the shark.
Once a $28/share stock, today is trading at about $1/share.
aj
GXDX:
I've been watching Genoptix (GXDX) getting hammered for more than 6 months. This is a genetics testing lab specializing in Hemonc. They've disappointed on revenues and earnings and recently guided lower (stating that the weak economy is "affecting physician and patient behavior") but is still nicely profitable and now about 60% off its 52 week high.
I'm curious if anyone else follows GXDX, whether or not you have an opinion about their excuse for lowering their estimate (it sounds more like a euphemism for "competition is eating our lunch"), and if this seems to be an emerging biotech value, as their EPS is now looking like it will be single digit, or close to it, in a space that should be growing at a 20-25% YOY clip.
regards,
aj
OT: Foldit
For the non-NPR listeners, this afternoon's broadcast had a short piece on Foldit, solve puzzles for science. The scientist interviewed, Zoran Popovic (I believe) helped design this complex "game" for users to learn how to fold proteins by learning the biophysical "rules". His position is that there are people who have natural talents to "see" how complex proteins should be properly folded (better than computers, actually) and the game has spawned a wide variety of protein folding savants, that are good enough to actually attempt real protein folding conundrums.
http://fold.it/portal/
I'm sure that there are list members who find this absolutely fascinating (and probably are already protein folding masters on this site.)
aj
OT: HFCS
My wife is a food nazi so it is not allowed in our house. The fact that most of it goes to fat is all she needed.
Quietly lurking and thinking about this thread and how little meaningful difference there is (fructose v sucruse v glucose) when you ingest 70-80 grams of one vs the other in a single eating event (think supersized coke).
I quoted Randy because I too have a discerning spouse who keeps the sugar away from the kids (for the most part) but we have a couple of bottles of HFCS in the house virtually at all times because it is an essential ingredient for home made Peanut and cashew brittle, a holiday delight!
aj
Genzyme and Isis Report Results of Two Phase 3 Trials of Mipomersen
(we know that mipomersen works and that a subset of treatment pts will have elevated liver enzymes. ISIS reporting today about liver enzyme elevation appears to be within range from previous studies but we don't know about the dropouts. Does anyone have any comments/opinions about the sustained liver enzyme issue at this point? I suspect that the drug will be approved with the appropriate warnings)
CAMBRIDGE, Mass. & CARLSBAD, Calif.--(BUSINESS WIRE)--Genzyme Corp. (NASDAQ: GENZ - News) and Isis Pharmaceuticals Inc. (NASDAQ: ISIS - News) today announced results of two phase 3 studies of mipomersen in patients who had high cholesterol levels while on maximally tolerated lipid-lowering therapy. In the study of patients with severe hypercholesterolemia, mipomersen reduced LDL-C, the primary endpoint, by 36 percent compared with a 13 percent increase for placebo. In the study of patients with high cholesterol at high cardiovascular risk, mipomersen reduced LDL-C by 37 percent compared with a 5 percent reduction for placebo. Both studies met all of their secondary endpoints. Frequently observed adverse events were injection site reactions, flu-like symptoms and elevations in liver transaminases, as seen in previous studies.
With these studies, the companies have completed the four phase 3 studies that are planned to be included in the initial U.S. and E.U. regulatory filings for mipomersen. These filings, expected in the first half of 2011, will seek approval for the treatment of patients with homozygous familial hypercholesterolemia (FH), and may also include patients with severe hypercholesterolemia. The two previous phase 3 studies of mipomersen, which focused on patients with homozygous and heterozygous FH, also met their primary and secondary endpoints.
“We are pleased with the robust efficacy of mipomersen across all four phase 3 trials. These data, along with the emerging safety profile, support our focused approach on patients at highest cardiovascular risk who are in the greatest need of new treatments,” said Genzyme Senior Vice President John Butler. “With completion of these studies, we remain on-track with our plans for mipomersen.”
Phase 3 Study in Patients with Severe Hypercholesterolemia
This double-blind, placebo-controlled trial included 58 patients with severe hypercholesterolemia who were already taking maximally tolerated lipid-lowering medications. Severe hypercholesterolemia patients were defined as those who have LDL-C levels = 200 mg/dL with baseline cardiovascular disease (CVD) or LDL-C levels = 300 mg/dL without CVD. Patients were randomized 2:1 to receive a 200 mg dose of mipomersen or placebo weekly for 26 weeks. This study was conducted at 26 sites in North America, Europe and South Africa.
Patients treated with mipomersen had an average LDL-C at baseline of 276 mg/dL. At the end of the trial, these patients had an average LDL-C level of 175 mg/dL, representing an average LDL-C reduction of 101 mg/dL (36 percent). The reductions observed in the study were in addition to those achieved with the patients’ existing maximally tolerated lipid-lowering regimens. The trial also met each of its three secondary endpoints with statistically significant reductions in apo-B, non-HDL-cholesterol and total cholesterol. Study results are based on an intent-to-treat analysis (full analysis set). Detailed results will be submitted for presentation at a medical meeting.
Of the 39 patients treated with mipomersen, 27 completed treatment; of the 19 patients treated with placebo, 18 completed treatment. Eight of the discontinuations in the mipomersen group were reported as being related to adverse events, the nature of which was generally similar to previous studies. The placebo discontinuation was reported as being related to an adverse event. There was one death in the study due to acute coronary syndrome in a patient treated with mipomersen that was reported as unrelated to treatment.
Elevations in liver transaminases (ALTs) in patients treated with mipomersen were observed that were generally similar in character with those seen in other studies. In this study, 15 percent of patients had persistent ALT elevations above 3X ULN (three times the upper limit of normal) during the treatment period. Persistent is defined as consecutive elevations at least one week apart. No patients had changes in laboratory tests indicative of clinically significant hepatic dysfunction, and there were no Hy’s Law cases.
“There are patients, such as those with familial hypercholesterolemia, who are on maximally tolerated doses of currently available medications and still are very far from appropriate target goals,” said James A. Underberg, M.D., of the New York University Center for Cardiovascular Disease Prevention. “For these high risk patients, there exists a tremendous need for additional lipid lowering therapies.”
Phase 3 Study in Hypercholesterolemic Patients at High Risk of Developing Coronary Heart Disease
This double-blind, placebo-controlled trial included 158 patients with hypercholesterolemia (LDL-C = 100 mg/dL) and at high risk of developing coronary heart disease (CHD) who were taking a maximally tolerated dose of a statin. Patients were randomized 2:1 to receive a 200 mg dose of mipomersen or placebo weekly for 26 weeks. This study was conducted at 43 sites in the United States and Canada. This was the first study of mipomersen designed to evaluate patients with diabetes. More than 50 percent of patients in the study had type 2 diabetes.
Patients treated with mipomersen had an average LDL-C at baseline of 123 mg/dL. At the end of the study, these patients had an average LDL-C level of 75 mg/dL, representing an average LDL-C reduction of 48 mg/dL (37 percent). Half of the mipomersen-treated patients achieved LDL-C levels of less than 70 mg/dL, a recognized treatment goal for high-risk patients. The reductions observed in the study were in addition to those achieved with the patients’ existing maximally tolerated statin regimens. The trial also met each of its three secondary endpoints with statistically significant reductions in apo-B, non-HDL-cholesterol and total cholesterol. Study results are based on an intent-to-treat analysis (full analysis set). Detailed results will be submitted for presentation at a medical meeting.
Of the 105 patients treated with mipomersen, 60 completed treatment; of the 53 patients treated with placebo, 44 completed treatment. Twenty-six of the discontinuations in the mipomersen group were reported as being related to adverse events, the nature of which was generally similar to previous studies. Two of the discontinuations in the placebo group were reported as being related to adverse events. There was one death in the study due to acute myocardial infarction in a patient treated with placebo.
Elevations in ALTs in patients treated with mipomersen were observed that were generally similar in character with those seen in other studies. In this study, 10 percent of patients had persistent ALT elevations above 3X ULN during the treatment period. Persistent is defined as consecutive elevations at least one week apart. In many cases, these elevations were associated with increased hepatic fat content, as measured by MRI. No patients had changes in laboratory tests indicative of clinically significant hepatic dysfunction, and there were no Hy’s Law cases.
“The completion of these phase 3 studies is a significant milestone for the mipomersen program, for antisense technology and for patients in need,” said Isis Pharmaceuticals Chairman and CEO Stanley T. Crooke. “Mipomersen’s lipid-lowering activity demonstrates the value antisense drugs can bring to patients. Our robust pipeline is evidence of the efficiency of our technology and the potential value we can create.”
Late-Stage Development Plan
Genzyme’s initial U.S. and E.U. regulatory filings for mipomersen will seek marketing approval for the treatment of patients with the genetic disease homozygous FH (hoFH). These initial filings may also include patients with severe hypercholesterolemia. In the first half of 2011, Genzyme expects to submit the initial U.S. and E.U. filings, and to have made progress toward filing in other major international markets.
As previously reported, the phase 3 study of mipomersen in hoFH patients met its primary endpoint with 25 percent LDL-C reduction, and results were presented at last year’s American Heart Association meeting. Genzyme and Isis in February reported that the phase 3 study of mipomersen in heFH met its primary endpoint with a 28 percent LDL-C reduction, and data will be presented at the European Society of Cardiology meeting this month. In addition, studies are ongoing and planned to evaluate alternative dosing regimens.
MNTA, IDIX, and JAV:
Just a little wide smiling perspective while on vacation.
When JAV got their competing $2/share bid a couple of months ago, I completely sold out and bought a considerable stake in IDIX and moderate stake in MNTA. While the news is excellent for MNTA (and I agree with most here about how we will see a steady rise in share value as the street start to "get it"), I have to observe that my MNTA value increase is 50% and my IDIX value increase is 111%.
Cheers Due. I'm a small investor, but when one of them makes me $100,000 I'll be looking for your address so I can send you a bottle of champagne (and the rest of you slackers should consider doing the same!)
Happy Daze [;+>
aj
From as long back as 1998, both Lisa Drakeman and her husband (then both at Mederex) always reminded me to con artists. He was kicked out from MDRX, and now, she was conned from Genmab.
Sorry, just a minor nit to pick with your post. Medarex was MEDX. MDRX was and still is Allscripts-Mysis a HIT co. that I've been in and out of over the years.
aj
OT: Response to Idit (and Dew)
OK, this thread has provided me with more smiles than I would ever have expected (and I hope for many of the readers as well.)
DT: my first blush response is to say "it's an acquired taste" but there are just so many ways to address flavoring (and hygiene) that goes way beyond the scope of even this discussion. Suffice it to say that men who enjoy "nibbling" overwhelmingly report on the pleasure they get in pleasing their partners. Personally, I describe it as enjoying the observation of the fireworks going off, a process that is all too infrequent for many women.
Dew, certainly there are about 1/3 of the general female population that do not have a "taste" for the behavior. About 90% of the variance of this subset can be accounted for by religiosity and educational factors (themselves significantly inter-correlated.) I would expect that the nature of this board would have already selected out most, if not all of those who decline for the above reasons, so am fairly confident that readers of my post (of both sexes) appreciate the message.
Bon apetit,
aj
PS: Getting a physician to write an adderall prescription for off label use like that is a dicey proposition, at best. Adderall is a class 1 drug, and physicians are quite reserved about prescribing it to adults without a sound clinical rationale. This I know for a fact from clinical practice.
OT: adderall and sexual response + one closing thought.
Roy are you sure that your wife/partner isn't simply responding to not being too tired, which is one of the most common reasons that working women and mothers cite as a barrier to their libido?
Closing thought and I will apologize up front for anyone who finds this either too coarse or sexist (coarse yes, but no sexism intended).
I have a cousin my age who contacted me several years ago to ask my "expert" opinion on how to transform his dreary sex life. To paraphrase, he presented the following scenario:
"My wife is wonderful, she works, she takes care of the house, she ferries the kids around to a dozen different activities every week, makes sure their homework is done and even puts out a great supper by the time I get home on most days. She loves me and says that she wants to please me, but is just too damned tired for sex at the end of the day. What can I do?"
My response was, "learn how to relieve her of such a load. You take care of the house, cook supper, ferry the kids around and help them get their homework done. and do one more thing..
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learn to eat pussy like it tastes like caviar!
Enjoy eachother, otherwise someone else will.
aj
OT: Adderall
Women taking Adderall are 7 times more likely to want to have a 3some then women not taking Adderall
ROTFLMAO
I'd like to see the data from that study. No, wait, I'd like to be a participant in that study, just make sure I'm not enrolled in the control arm.
aj
OT: Yes, I'm a clinical psychologist by training, neuropsychologist in practice.
aj
OT: Female libido, arousal and response to sexual advances.
"It's not you, it's me. I just don't think about it unless you've inspired me to"
So inspire her. Use your skills to make her feel special.
Then, under other circumstances, communicate to her in a nonthreatening way that you too deserve to feel special and that is something that you will appreciate her for when she is able to reciprocate.
Don't make this a "tit for tat" exchange (i.e. "I do this for you so why don't you do this for me.") discuss the issue in a way that makes you both feel like you can grow closer by working out this sticking point.
Nuff said by the shrink, usually free advice is worth exactly what you paid for it.
BTW, Dew's solutions (Adderall or testosterone) may work for some, but there are significant side effects, none the least of which are either a sleepless night or facial hair growth, neither of which work for many women.
aj
JAV: Can this company (or its partners) do anything right??
Javelin Pharma says pain drug withdrawn from UK
Javelin Pharmaceuticals says pain drug Dyloject has ben withdrawn from the United Kingdom
http://finance.yahoo.com/news/Javelin-Pharma-says-pain-drug-apf-3989687850.html?x=0&.v=1
CAMBRIDGE, Mass. (AP) -- Javelin Pharmaceuticals Inc. said Monday its licensee for the pain treatment Dyloject has withdrawn all batches of the drug from the United Kingdom and shares tumbled 25 percent.
The licensee, Therabel Pharma UK Ltd., notified the company of the presence of a "white particulate matter" in some vials of Dyloject. Javelin, said Therabel was cooperating fully with The Medicines and Healthcare Products Regulatory Agency, with assistance from Javelin.
Javelin is the subject of a $145-million tender offer from drug and medical device maker Hospira Inc.
Shares of Javelin, based in Cambridge, Mass., fell 45 cents to $1.35 in Monday morning trading.
Not even y3maxx posted on this today. Thank goodness I am out!
aj
Jennerex: I don't recall ever reading anything on this co. but their data, presented yesterday at ASGCT, was picked up by someone and found on Yahoo news.
Jennerex Reports Positive Phase 1 Results for JX-594 Administered Intravenously
San Francisco, California, May 20, 2010 --Jennerex, Inc., a clinical-stage cancer biotherapeutics company, today reported positive results from its Phase 1 dose escalation study evaluating the intravenous (IV) administration of JX-594 to patients with metastatic cancer. The data presented today demonstrated clear dose-related delivery to solid tumors, cancer-targeted replication and gene expression, and anti-cancer effects of JX-594 delivered IV. Choi (necrotic) responses were more commonly observed in patients treated at higher doses. In addition, intravenous infusion of JX-594 was safe and well-tolerated. These data were presented today at the American Society of Gene and Cell Therapy (ASGCT) Annual Meeting in Washington DC.
"These data represent a significant milestone for the field of oncology and viral therapy as this is the first time that a viral or genetic product has demonstrated reproducible, biopsy-proven delivery to multiple solid tumor types following intravenous administration,” said David H. Kirn, M.D., president and chief executive officer of Jennerex. "We look forward to extending our experience with IV JX-594 in our planned Phase 3 trial in patients with advanced liver cancer. This pivotal trial will utilize both IV and targeted intratumoral injections of JX-594 to maximize potential patient benefit. We expect to initiate this study in Q4 of 2010.”
“JX-594 represents a promising potential treatment option for patients with multiple types of cancer. As the first intravenous biological immunotherapy to demonstrate safety and tumor-specific delivery, JX-594 may add significantly to the armamentarium for many solid tumors,” stated Andrew R. Haas, M.D., Ph.D., Hospital of the University of Pennsylvania, and investigator on JX-594 Phase 1 trial.
This open-label, dose-escalation study was completed at four sites in the United States and Canada. A total of 23 patients with solid tumors refractory to standard therapy were enrolled. Patients received a single treatment at one of five dose levels, with follow-up at periodic intervals. Six out of eight patients in the higher-dose cohorts evaluable to date (cohorts 3, 4, 5) exhibited disease control as defined by stable disease by RECIST (Response Evaluation Criteria in Solid Tumors) criteria and/or Choi (necrotic) response. Two out of six patients in the low dose cohorts exhibited disease control (RECIST stable disease) but no responses. The primary endpoints of the trial included safety and determination of the maximum tolerated dose given through intravenous administration. No serious adverse events related to JX-594 therapy were reported and no dose-limiting toxicities were reported. A biomarker analysis further strengthened the finding of dose-dependent replication in tumors following IV administration.
About JX-594
JX-594, currently in Phase 2 clinical trials, is a cancer biotherapeutic product from a proprietary breakthrough class of targeted and armed oncolytic and immunotherapeutic poxviruses. Tumor destruction and safety was shown in patients with diverse cancer types in three Phase 1 trials; treated patients were end-stage and had no effective therapies available. JX-594 multiplies selectively within cancer cells, leading to their destruction. These newly created copies of JX-594 are then released and are able to infect and eradicate other tumor cells both locally and in distant sites in the body. This cycle of JX-594 replication, cancer cell destruction, release and spread is then repeated. Normal cells are not affected by JX-594 resulting in safety and tolerability.
The poxvirus strain backbone of JX-594 has been used safely in millions of people as part of a worldwide vaccination program. This strain naturally targets cancer cells due to common genetic defects in cancer cells. JX-594 was engineered to enhance this natural safety and cancer-selectivity by deleting its thymidine kinase (TK) gene, thus making it dependent on the cellular TK expressed at persistently high levels in cancer cells. To enhance product efficacy, JX-594 is also engineered to express the GM-CSF protein. GM-CSF complements the cancer cell lysis work of the product candidate, leading to a cascade of events resulting in tumor necrosis, tumor vasculature shutdown and an anti-tumoral immune attack.
About Jennerex
Jennerex is a clinical-stage biopharmaceutical company focused on the development and commercialization of first-in-class, breakthrough targeted oncolytic products for cancer. The company’s lead product JX-594, currently in an international Phase 2 trial for primary liver cancer and colorectal cancer, demonstrated promising Phase 1 efficacy and safety results in patients with a diverse array of common cancers. Jennerex’s products target, attack and eradicate cancers through a novel and potent oncolytic mechanism that is dependent on highly-specific replication of the company’s poxviruses in cancer cells. These products simultaneously stimulate the body's immune response to the cancer. Of note, this mechanism of action and the results in patients to date put the company’s product class in a leadership position. Jennerex’s therapeutic approach is markedly different from gene therapy and standard cancer vaccine approaches. Jennerex Biotherapeutics was established in San Francisco CA and in Ottawa Canada in 2006 with Dr. David Kirn (CEO) in San Francisco and Dr. John Bell (CSO) from the Ottawa Health Research Institute/University of Ottawa. For more information about Jennerex and the company’s robust pipeline and three clinical-stage products, please visit www.jennerex.com.
MuGard: There's nothing special about a non alcoholic mouthwash, the industry is "awash" in them.
aj
OT: My condolences Flobu. Your mourning will be in my thoughts today, and you can be assured that many in this little online community will be thinking of you as well.
Peace,
aj
OT: "Anxiety and depression breed silence"--Bladerunner LOLOL
"If you suffer from depression, take an antidepressant.* Days like today ought to be a time to prospect for bargains, not to mope.
and what do you recommend for anxiety????
I found yesterday's phenomenon such a non issue. I had a busy clinical day with no time to anything but work with patients, so by 6:00pm when I finally turned the radio on, the news cycle had already swallowed it, chewed it up and spit out several analyses. IMO the general market was overbought and ripe for anything to take it down a notch.
JM2C
aj
OT: Worm hacked me.
Sorry DT (and anyone else who got a post "from me" this am), a worm hit my email, hacked my contacts, sent the post and then erased my contact list. Yahoo maintains the list on their servers and won't do anything to reinstate my contact list, so I can't even respond to emails yet.
Dew, you can delete this message after about a day.
aj
OT: Coal consumption. Electricity demand and coal consumption might be down 2 years running in the US, but it's WAY up in China and won't stop growing in the next decade. Same with India. Given these growing markets, the prospect of slowing the global warming trend by cutting carbon emissions seems bleak.
aj
PS: Still have a coal mine to sell if anyone wants it. 70 million tons of metallurgical grade anthracite coal here in AR.
Aricept and ADAS-COG.
Thanks Idit. I must be recalling a slide at a Pfizer investigators meeting about F/U data tracking the same patients. Masterlongevity has it correct, I think, in that the effect resolved sometime after six months and the declines in both populations (treatment vs. control) paralleled eachother from 6 months on. Pfizer presented the data as ultimately providing the patient with an extra 440 days before their ultimate demise.
aj
That's a good question. I ought to get back to my friend, Sue Griffin who is editor of Neuroinflammation. I saw her this week at a funeral and was too busy with caring for the widow and her family to actually have a good conversation with her.
aj
BAX-Gammagard
I would argue that the change in ADAS score are meaningless
No argument on this from me. Indeed, I've posted before that the nature of this disease, with its very insidious onset (I've heard/seen data that plaque and NF bundles are present in brains of 40 year olds), makes finding a true treatment for prevention almost impossible. What Pharma would risk designing a 25 year study of its drug pipeline for DAT prevention?
aj
BAX-Gammagard
Dew, my recall is that for 6 month studies, Aricept maintained less than 2 pt decline vs. 5 point decline for control patients. Given the Gammagard study is 18 months, it would translate into a 3-5 point decline for study patients and 15 point decline for control, patients. I've posted many times, a couple of ADAS points saved do not a good drug make.
Of course, the original Aricept data is now getting a little long in the tooth and as it fades into historical memory stores, all kinds of distortions might be acting on it. No worries about my memory, I'll choose a path of decline that is markedly different than the typical DAT patient if I become struck with the disease; no Aricept for me.
aj
BAX-Gammagard:
I read the results and had a couple of thoughts/questions including:
How frequent are the infusions? (there are several in trials right now, I believe, and the hassle of frequency will be telling.)
BAX provided a very small sample size and I have seen plenty of DAT studies with small sample size stat sig results that just disappear when the larger samples are taken.
This was a PR about results and I want to read the paper to see if/how many dropouts occurred to get to the 14 treated/7 control patients. The PR had general information about SE's but nothing about frequency for the study population.
Cortical atrophy/ventricular enlargement measures have not been part of the standard fare in the past and the data are intriguing, but the decline in ADAS scores for treatment patients are grossly in line with Aricept studies if memory serves. If you can get the same results with a daily oral med, then why go to all the fuss?
aj
IDIX and JAV
What beautiful timing. When JAV popped, I started liquidating and buying IDIX, continued today and am already almost 10% ahead of my morning buys!
Looking like there are real legs to this, the news is spreading about the IDX899 GSK trial (Thanks for spreading the word Dew.)
aj
I agree with both the short and long-term prospects here. Nothing that I put into the market is needed for at least 10 years, but I do have some favorites that I want to trade in and out of.
Drug discovery and development stocks are always a great ride...up or down (and I've done both for sure).
aj