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Exactly. Thank you FTM for the first relevant remark I've seen in days on this board.
People here don't seem to realize that the more time that goes by now without a PR on 2nd line NSCLC, the better are the prospects for seeing really good data.
SK, together with a committee of investigators, makes the decision on when to unblind the trial. They will continue to wait on lifting the curtain until something like 100 of 120 patients have progressed and only something like 20 patients remain stable, because there are 3 arms to the trial with 40 patients in each arm, and 20 is the median of 40.
If they lift the curtain while there are still 30 stable patients, there will be bias introduced in evaluating the PFS data because all 30 could (theoretically) be in the same arm and the investigators would know who was who when evaluating those last 10 PFS images.
Two other points:
1. The Company is likely to unblind and disclose data from its flagship NSCLC trial the week before ASCO or during Asco, i.e June 1-5, even if there are still 30 stable patients, because that will be 8 full months of data and historical median PFS in this patient group is only 2.7 months.
2. Historical MOS for this patient group is only 7.2 months, so hopefully we will get disclosure in late May of the MOS for the control arm (i.e. docetaxel only). If the MOS data for the docetaxel only control arm comes in normal in late May, i.e under 7.5 months, and the the PFS numbers for the two Bavi arms are something close to 7 months (remember we are already out 7 months and still no unblinding), then the prospect for Bavi MOS numbers that rock will be excellent.
... and we will probably get those Bavi MOS numbers before the July 15 CC because July 6 is the 9 month mark and any Bavi MOS greater than 9 months will be huge when average historical MOS from in these patients is 7.2 months.
FTM-- Thanks for the link to today's new NSCLC Poster.
Please advise if you agree that this is very encouraging data even if a very small sample size.
In your post 77595 on March 25, you showed that the mean ORR in 10 historical trials of first-line advanced NSCLC is 22.5%. The most successful ORR in those 10 trials was 29.8%.
Although our sample size of 5 patients is too small to be statistically meaningful, I note from today's new poster that 3 of 5 patients, i.e. 60% had an ORR and one is not yet evaluable.
Of course this data was submitted to AACR months ago. The Company is reviewing much more recent data from this trial. There may be a reason why Management does not feel pressure to do a premature licensing deal !!!
EBS-- You make a good point about PL's remarks. I felt the same way.
But I disagree with your focus on the six-month horizon. That is the correct date for MOS in the front-line trial, but mean MOS in second-line, from 10 prior historical trials, is only 7.2 mos., which is reached in May (given that enrollment completed in late Sept and was announced Oct 6).
By May/June all the BPs who are conducting serious due diligence right now will have the answer to the second-line MOS question in a double-blinded study. If the 2nd line MOS data is good, I believe a regional Bavi license will be inked by mid-summer.
Likewise, the Bavi + Sorafenib data will be far enough advanced my May/June to see an Asian license for liver cancer as well this summer.
... and believe it or not, it's highly likely the FDA Cotara issues will be resolved this spring as well.
Thanks FTM for emphasizing this point. Bavi's impact on MDSCs appears to be the key to its second MOA, i.e. its immune stimulatory MOA as opposed to its vascular coagulating MOA.
For those who don't know know how to find it, the important poster FTM is discussing from Thorpe's 2011 AACR Abstract #3651 is found on this PPHM Website page as the 3rd item under 2011 AACR Poster Presentations:
http://www.peregrineinc.com/technology/bavituximab-oncology/recent-data.html
C.J.-- Thanks very much for the link to your important post #77185 summarizing SK's encouraging remarks on the Bavi / Sorafenib IST.
On re-reading SK's 3-12-12 comment at the Roth Conference, I was struck by this statement:
"we’ve already made it thru half, the Ph.I portion, of this trial."
I suspect SK started to say that the entire trial was half complete, and then backed off to the lesser statement that the Phase I portion was complete.
I say this because ClinicalTrials.gov has the following two statements about this trial at the top of the page:
"Time Frame: The phase I component is expected to be complete within 3 months."
"Time Frame: The phase II component is expected to be complete within 2 years."
Since 16 months of the 2-year time period for Phase II have been completed, and Phase I safety portion of the trial only lasted 3 months, chances are good that SK wanted to say that "we've already made it thru half of this trial" ... but then decided not to raise expectations and open himself to a host of questions.
Half the trial would be around 28 patients, which is enough to support some interim data.
Thank you FTM for another very useful data set, this time for the liver IST trial being done at UTSMC with Thorpe's home team.
Given that the PR announcing trial initiation was on Dec 1, 2010, this IST will have been running for 16 months when AACR begins next week. ClinicalTrials.gov says December 2012 is the Estimated Primary Completion Date (i.e. final data collection date for primary outcome measures). Thus the trial is now 64% complete, i.e. 16 out of 25 months.
Estimated enrollment in this trial is 56 patients.
Since this is an open-label trial, and since an Abstract about safety data from this trial is being presented at AACR, I think there is a good chance the Company may also elect to put out a PR during AACR week showing interim ORR and TTP data on the first 25 or 30 liver patients, if the data is good.
Based on remarks made by King in recent CCs and Conferences and summarized in a recent C.J. post (help please with C.J.'s Post # ?), it would appear that Bavi plus Sorafenib is generating good results.
How can SK tell already that this interim HCC data is good? Answer: just look at FTM's chart. Historical TTP for Child-Pugh A patients is only 5.5 months. This IST has been running for 16 months. ... Connect the Dots. The Company already knows whether Bavi plus Sorafenib is working in roughly half the trial patients.
From what I can tell, the overall total employment for the Company is only reported once each year in the 10-K which is filed in mid-July. There is no update on total employment in the 10-Q.
Looks to me like we have to wait until mid summer to answer your question.
FTM-- Thanks for this very informative table. Since the PR announcing completion of enrollment in the front line trial was Sept 8, the great majority of patients in that trial would have been randomized and started their MOS time clock by mid August 2011. Thus by early September 2012 we will have replicated the Phase IIa MOS results, i.e. 12.4 months, if no PR comes out before that date.
Thus we have to wait until mid-July to confirm that Bavi has beaten SOC in 2nd line lung, and until mid Sept to confirm that Bavi has beaten SOC in front line advanced lung.
I expect the pps will start moving up in anticipation as we approach those dates and no MOS PR has been issued.
If we get a little help in April and May from AACR abstracts, from Cotara FDA outcome, from interim IST results and from a possible Asian Bavi + Sorafenib liver license , the additional ATM dilution over the summer shouldn't be too bad.
I expect serious BP negotiations for a regional Bavi lung cancer license will start in early summer but won't conclude until the fall when both MOS numbers are known.
I am very encouraged by historical MOS data for SOC products in 2nd line lung trials as shown in C.J.’s post 77309 and FTM’s post 77303? Before seeing this data I spoke with an oncologist friend who obtained virtually the same data from the Package Inserts for three SOC products now being used in the 2nd Line setting. Here is MOS data for SOC from those inserts:
Docetaxel: MOS = 7.9 mo.
Alimta (Pemetrexed): MOS = 8.3 mo.
Tarceva: MOS = 6.7 mo.
This data means that we will know for sure by the mid-July CC whether Bavi plus Docetaxel is better than current SOC. MOS data is measured from the time a new patient is enrolled and randomized. Completion of enrollment in the 2nd line lung trial was announced on Oct 6 so the vast majority of patients in that trial were randomized by mid-Sept.
Thus, if there has been no PR announcing MOS by the mid-July CC, that means Bavi MOS will be at least 10 months, which beats even Pemetrexed.
As SK said in the last CC, when the 2nd line data is unblinded next month, they are expecting to see more consistent readings as between the investigator and independent ORR and PFS data. But the good news is that, no matter what the 2nd line ORR and PFS data shows next month, the Company only has to go four more months, i.e. to mid-July, to have a definitive MOS outcome in the 2nd line trial.
… and if the ORR and PFS data is strong when unblinded next month, BP interest to lock down a regional license will build steadily between the PR in April that unblinds the PFS data and the mid-summer MOS date.
Mojo-- I don't read SK's remark the same way. Since no one, not even SK, has a clue about any of the 2nd line data yet to be unblinded, there is no way that the remark you quote was intended to be a comment on the strength of the blinded data.
The application for AA was locked in before the trial started over a year ago. If it was filed as an AA application, it didn't suddenly change into a non-AA application by osmosis.
Rather, I think he was simply reiterating that the way the AA process works is that a second confirmatory trial will be needed before the conditional AA approval we are all hoping for this summer ripens into full, unconditional product approval.
Your question reminds me of SK's recent emphasis on the fact that there has been a very high level of consistency between pre-clinical / early clinical data, and the current results. For most biotech companies, there is no such consistency and the results of each trial are a crap shoot.
With the confidence the Company now has in the predictive value of their early data, I bet they wait for the unblinding before inking a Bavi deal.
CJ- Another big thanks for re-printing Slide 24.
Key Point: Note that we are being told here for the first time that it is possible/likely we could see interim data from all 4 IST trials as early as April, May and June.
CJ- THANKS SO MUCH. This was a labor of love. It's so helpful to have SK's comments right next to the slides.
The clear statement that they hope to do an Ex-U.S. (i.e. Asian) license of Bavi + Sorafenib to "... fund Phase III and to be able to continue to advance the program" is a very strong indication that the Liver trial is going well. We've already heard several times before that the Company expects to parley the Bavi Ph IIb data into regional licenses and hold on to the U.S. market. There was no reason to highlight the Liver trial as a lead candidate for such an Ex-U.S. license unless the liver data is coming in strong and the dialogue with an Asian partner is already well underway.
Look at how he finished his comments on the current Liver IST;
"Interestingly, this is a Phase I/II study, we’ve now completed the Ph.1 component, and what you’re seeing is that you can safely combine Bavi with Sorafenib, which has been a significant problem anti-angiogenesis agents. So, also some data points to help us fully differentiate this from other antibodies that are on the marketplace in solid tumors."
Sure sounds to me like he is telling us Bavi + Sorafenib has a leg up on the SOC / "other antibodies" in the Liver Cancer market. In other words, Bavi is a unique product that addresses problems other antibodies can't address in an Ex-U.S. market, i.e. Asia, where there is a growing unmet need.
SK gave another encouraging update this morning on the prospects for a regional partnership in Asia for Bavi plus Sorafenib in liver cancer. This is the second time he has talked about liver cancer as a near term prospect for licensing. The liver trial is open label so the pending Asian partner could have access to all the IST data as it develops depending on arrangements.
I don't have time to listen again today, but maybe someone else out there could capture and report exactly what was said about partnering Bavi in Asia for liver cancer. If I heard correctly, SK gave some details on why Sorafenib by itself is not working well on Asian patients ???
My point is that Georgia now has more trial centers than any other state. There are only 13 states participating in the pancreatic trial. Yes, PPHM made an effort to go beyond the initial 10 sites in order to speed the pace of enrollment. But the addition of yet another center in Georgia rather than in one of the 37 states that don't have any centers is very likely to result from buzz in the Georgia medical community rather than from further recruitment efforts by the Company in Georgia.
Eligible pancreatic cancer patients are distributed evenly across the country. If you want to speed enrollment, you don't spend your limited resources recruiting another trial center in a state where you already have 4 centers up and running.
The Pancreatic Buzz. The PR on Jan 5, 2011 announcing initiation of the Pancreatic Trial states: "Peregrine is conducting this randomized, open-label Phase II trial in up to ten clinical sites in the United States."
But when you go to ClinicalTrials.gov you see that there are now 23 sites participating in this trial.
Wow! That's more than twice the number of sites the Company was hoping to work with. With 4 sites already up and running in Georgia before DeKalb Medical Center joined today, it's hard to imagine that PPHM felt the Company needed to recruit yet another site in Georgia to hunt down eligible pancreatic patients in Georgia.
A much more likely explanation is that, after a year of collecting trial data at the other 4 Georgia centers, there is a buzz in the Georgia medical community about how patients are doing in this open label trial and DeKalb didn't want to be left behind.
Drlab- Thanks for this calculation. I'm not sure, but I think ORR scans are done something like 4 weeks and again 8 weeks after last dose. Could someone out there please confirm this? Thank you.
What I do know is that once the data is "unblinded" it immediately becomes final. There is no chance to revisit the data later like they are doing in the front-line trial. Thus the Company will elect to wait until the clincial docs are sure there is no further chance for remissions in any patient in any arm of the trial before telling the controllers to unblind the data.
Yes, BP will take notice in a big way if the ORR is even 15% in these hard to treat, second line patients who have failed prior chemo. This is largely because "double blind" trials are the irrefutable gold standard that a drug works and should (or should not) become the new standard of care.
But BP will also notice the fact that this "registration" trial is designed like two trials inside one trial because there are 80 patients receiving Bavi and only 40 patients who receive just Docetaxel. It's like two separate trials built into one. In one Bavi arm 40 patients will receive a 1 mg/kg dose of Bavi and in the other Bavi arm 40 patients will receive a 3 mg/kg dose of Bavi. In the 3rd arm the final 40 patients receive only Docetaxel plus a placebo.
80 patients will receive bavi (i.e. 2/3 of the total) and not just 60 patients (i.e. 1/2 of the total as in most trials). Thus when BP looks at the data, there will be two separate proofs / two separate trials of whether 40 patients receiving Bavi + Docetaxel do better than 40 patients receiving only Docetaxel.
As for the timing when ORR from this "registration" trial will be released, the ClinicalTrials.gov website has this statement:
"Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)"
This statement is consistent with SK's remarks in last CC that they will be compelled for SEC reasons to disclose ORR data from this trial before ASCO, which takes place the first week of June. I expect to see the big PR on this trial in late April or early May.
JR-- Thanks for this article. Very interesting, especially this quote from this week's JPMorgan conference:
"Other areas likely to attract keen takeover attention include oncology specializations such as ovarian cancer, pancreatic cancer and hematology, bankers said."
I strongly believe Mgmt is showing their interim randomized Ph II pancreatic trial data to BP as we speak pursuant to NDAs. Let's remember that trial started enrolling patients in January 2011 and now has a full year of data. IMO
Two big differences between today and 2007.
1. High-quality randomized data is now becoming available. We may only see the six NSCLC data points SK mentioned between now and ASCO, but you can be certain BP is already reviewing all of the interim pancreatic and front line NSCLC data as it comes in pursuant to NDAs. Thorpe's team at UTSW is probably making the interim liver data available as well in that IST.
2. SK's statement in last CC confirming that the Company is actively seeking Bavi regional licenses. I know there has been plenty of prior talk in general about "licensing discussions" and possible Cotara and Hep C licensing, but I don't believe SK has ever before been so direct in acknowledging that the Company is using the current randomized data to advance regional Bavi licenses.
IMO, the Company knows they need to close some regional licenses and bring in some cash and get the share price up before the second line NSCLC data is unblinded-- in order to maximize the potential of that announcement.
I'm not worried about the magnitude of PPHM's rise when this rocket takes off. Consider this:
Little INHX was valued at $2.5 billion by BMS for potentially a lead position in a world-wide HepC market which the is valued currently at $1.7 billion in the article on page B3 of today's WSJ. According to WSJ this HCV market is expected by some to grow as high as $16B by 2015. In November Gilead made a similar bet on Pharmasset and valued that HepC company at $11B-- again, for a HepC market currently totaling just $1.7B and maybe growing to $16B and experiencing 10,000 HCV deaths per year in the U.S.
Now compare the U.S. cancer market where Bavi has a similar shot at being a major player, perhaps even a bigger shot because Bavi is synergistic with the chemo therapies that currently dominate the cancer market, not competitive to them like INHX and VRUS are in the HCV market.
According to this research report, the world-wide cancer market in Dec 2010 was valued at $47.7B: http://www.salisonline.org/market-research/the-cancer-market-outlook-to-2014-competitive-landscape-market-size-pipeline-analysis-and-growth-opportunities/.
According to this research report, the lung cancer market alone had 158,000 deaths way back in 1999. http://www.healthcentral.com/encyclopedia/408/178.html?ic=506048
I don't have projections for the size of the cancer market in 2015, but as of 2010 the cancer market already dwarfed the size of the projected 2015 HCV market by 3 fold.
Maybe these HCV-to-cancer market size comparisons will help some folks here to see the potential price BP will pay for Bavi licenses in multiple regions of the world as high-quality data flows in over the next 6-12 months confirming Bavi's safety and efficacy in multiple tumor types.
Remember, these huge INHX and VRUS deals in the HepC market are being closed on the the basis of Ph II data just like ours. The count down for PPHM's oncology licensing program has started, and these revenues will dwarf what INHX and VRUS were paid because (1) the cancer market dwarfs the HCV market and (2) Bavi's synergistic activity with all chemo therapies assures it a very large market share.
"I think most people have not yet realized how different this approach is, how universal it is, and how
powerful the immune system can be when it is able to unleash its power."
Well said. Couldn't agree more.
Thanks FTM. Your slide brings to mind the importance of SK's remark at the AGM and in CC that Mgmt is very excited by the way in which the data in all clinical trials is proving to be consistent across the board with data from the animal studies. Thus there is every reason to believe that combining Bavi with Sorafenib is having a similar effect in the current liver clinical trial as what is shown in your graph.
My favorite context for day dreaming on this point (i.e. the consistency between clinical and preclinical Bavi results) is the Company's flagship, blinded, 2nd-line NSCLC trial. Several separate preclinical studies showed that a new dose of chemo upregulates PS on a resistant, 2nd-line tumor just the same as it does on a front-line tumor.
If this preclinical fact holds true in the current 2nd-line NSCLC registration trial, it should not be hard to beat the 6% to 9% ORR that docetaxel (i.e. the SOC for drug resistant NSCLC tumors) achieves in a 2nd-line setting. 9% is a pretty low ORR threshold to have to beat if the engine driving Bavi's performance, i.e. exposed PS, is exposed (i.e. upregulated) the same in the 2nd line setting as in front line setting where Bavi's ORR beat front-line SOC results by 50%. See Dec 6 PR.
I believe this is the essence of why Mgmt is so optimistic about upcoming trial results.
With all Dew respect, I think there is some core confusion about the strategy behind the Company's HCV program. In the Sept CC, SK made the following statement about the HCV licensing strategy:
"For the HCV program, if we have positive data and it validates the potential of bavituximab as an immunotherapy in HCV, then that's a program that we might want to just outright license to someone because it's a specialty area, it's an ever-evolving area, and it's a type of indication where a partner wants to customize it for their particular portfolio products in that area."
Thus the goal of this current HCV trial is NOT to show that Bavi plus ribavirin can generate strong SVR results and compete in the current HCV market. Rather the goal, as SK said, is to "validate the potential of Bavi as an immunotherapy" that can replace interferon in various HCV combinations, including combinations with both protease and polymerase inhibitors.
The whole point of SK's Sept CC remarks is that PPHM is first and foremost a cancer therapy company. But since Bavi also appears to be a very effective immunotherapy agent, why not prove in a randomized trial that bavi + ribavirin is just as good as interferon + ribavirin and then make mucho bucks licensing Bavi to the highest BP bidder in the very competitive HCV market.
As long as the Company can demonstrate with randomized data that Bavi's immuno-stimulatory properties are just as good as interferon in the SOC setting (i.e. with ribavirin), then one of the gorillas in the HCV market will pay big bucks to control Bavi, either because it will make that BP's cutting edge therapy work better, or because it will prevent a competitor from staying in the HCV game by combining their product with Bavi.
RR-- Excellent post. Thank you. We see the same opportunities for Bavi as an interferon replacement.
Essentially, interferon and Bavi both do the same thing: they stimulate an inflammatory immune response . The inflammatory immune response (i.e mature Dentritic cells that present cancer or viral antigens to killer T-cells) has been found necessary as an adjuvant to the new line of protease inhibitors (e.g. Vertex) because a small percent of the virons become resistant to the protease anti-viral MOA and an immune response is necessary in order to get a sustained viral response.
It's way too early to know if the new line VRUS and INHX polymerase anti-viral agents will develop the same kind of resistance that caused the protease agents to need an immune system boost from interferon (in order to achieve a sustained response). All of the data reported by VRUS and INHX so far has been for 12 weeks OR LESS, so it too soon to know if the new polymerase agents will benefit from an immunotherapy adjuvant.
But the main point is that Bavi uses an entirely different MOA than interferon for triggering an inflammatory immune response. Bavi's MOA is based on blocking a whole chain of PS-based immuno-suppressive signals. Apparently it is this very different MOA that allows Bavi to give the immune system a boost without all the collateral damage that interferon causes.
This is why SK emphasized in his CC remarks that the key point here is the randomized comparisons of 33 patients on ribavirin + inf versus 33 patients on ribavirin + Bavi. If Bavi's novel MOA gives the same or better immune boost as interferon in a controlled, randomized setting, WATCH OUT. The "proof of principle" will have been established and the entire interferon market will be up for grabs, not just the HCV market.
swg-- Thanks for the link to the Milken / Dendreon story. It's always good to be reminded of how far some will go in spreading intentionally dishonest misinformation to drive a stock price down.
However, one thing that gives me confidence about the near future is the huge scope and breadth of the Bavi clinical program that is maturing in 7 different trials over the next six months. Anti-PS is truly a platform technology. Randomized clinical data plus IST data is all maturing at once on six separate cancer indications. Add to that HCV (and other anti-viral indications coming soon), then add in Cotara, and you have a constellation of clinical data stories that cannot be manipulated as easily as Dendreon's Provenge, which was a single-shot on goal.
Hats off to PPHM Management for putting together such a monster clinical trial strategy that all comes together at once. This strategy will enable Mgmt, if needed, to argue up the value of the stock if faced with either a Milken-style short raid or a basement-price BP takeover move.
Of course the same clinical strategy also works well for its primary purpose, which is to impress the FDA that Bavi must really be a game-changing new technology if the MOA works in so many different cancer and viral indications.
IMHO.
"I don't think they'd be so talkative on HCV if the data is insignificant."
JR-- Exactly my view as well. Without being asked, SK gratuitously launched into a discussion of the Company's market research showing that immunotherapy, which is currently dominated by highly-toxic interferon, will be around for many years as a big component of the HCV market.
Given the new products of Inhibitex and other companies that are getting some early success with interferon-free therapies, SK felt the need to confirm that, notwithstanding those developments, "we can be a player in the [HCV] marketplace" and "we'll try to consummate a partnership in a reasonable time" if the data is good.
As you point out, that would be an awful lot of unnecessary talk if the data were bad. More likely explanation is that he's seen the data-- and the data is either somewhat good or very good-- and he wanted to communicate why Bavi "can be an HCV player" notwithstanding the early-stage activity of new drugs not using interferon.
PPHMToo Long-- I agree that the HCV data will be the "deciding data point" as you put it.
I found it interesting that during the last Q&A yesterday, SK launched into prepared remarks about the durability of the HCV immunotherapy market that were not part of the question.
The Company has known now for several months how well Bavi anit-viral is working compared to interferon. Unless the HCV results already known to the Company are good, it's hard to imagine why Management would have done market research, and then reported to us yesterday, that "immunotherapy will continue for the foreseeable future to be a significant proportion of the overall marketplace within HCV treatment."
Here's the quote of SK's HCV partnering comments yesterday:
"... we view this as a proof of principle study showing that bavituximab can be an effective immunotherapy in the HCV space. It's obviously a dynamic -- dynamically changing environment within the HCV treatment area with many companies really starting to gear towards can they even completely remove immunotherapy from the treatment regimen. Now what I will say is that in the market analysis we've looked at, it does indicate that immunotherapy will continue for the foreseeable future to be a significant proportion of the overall marketplace within HCV treatment. And we really view again this validating study here as the proof of principle that we can be a player in that marketplace. So I think, strategically, because we do have quite an oncology focus ... I think we view the HCV program as one we would outsource or out-license to someone for continued development. As far as timing goes, I mean it's impossible to guess timing. I think it's -- obviously, we have interested parties. This is exactly, again, the type of data, randomized clinical data, that really establishes the proof principle. So I think once we have the data in hand, of course, we'll push forward if that's positive and try to consummate a partnership in a reasonable timeframe."
If Bavi's efficacy is at least as good as highly-toxic interferon when the HCV data comes out in a few weeks, then SK's message is clear: The Company will use this data to "try to consummate a partnership" a.s.a.p. with one of the large HCV players. "Obviously, we have interested parties."
Yes, he did mention "later this year" again for HCV results.
I found it interesting that SK allowed the premise of the final HCV question, which was that this randomized HCV trial will be sufficient (if the results are good) to generate an HCV license.
SK talked in terms of "lets see the data before we guess at how many months the HCV license negotiations will last."
It's very good that he did NOT respond in terms of this being a first HCV study and we'll have to do more studies in combination with other new HCV products before we can figure out how to off-license Bavi in the HCV market.
Thanks RR for the thoughtful post. I agree completely with your analysis. I have been glued to the INHX screen the past few weeks exactly because it is such a good comparison. I'm delighted that INHX has been able to hold on to its 7-fold gain. Given that PPHM's imminent news pipeline is so much deeper, i.e randomized cancer data in addition to randomized HCV data, December could be a very big month.
I also agree that big mistake most retail investors will make is selling too soon, without any understanding that good randomized clinical data will signal the start of serious and widespread institutional buying over the next six months as yet more IST and company data comes out and the company approaches release at ASCO in June of double-blind 2nd line NSCLC data for its flagship registration trial. The front line NSCLC data released this week will be a very strong indicator of whether PPHM is lining up to receive FDA Accelerated Approval of Bavi this summer for 2nd line NSCLC.
For the record, I am predicting that the 3 big December PRs will happen as follows:
Dec 7 before market opens:: Randomized frontline NSCLC data will be released just before Thorpe speaks at the big IBC Antibody Therapeutics conference.
Dec. 12 before market opens: The Company will report on the outcome of the Cotara FDA meeting, which I speculate is happening this week.
Dec. 12 after the market closes: The Company will report randomized HCV data and then discuss during the call the implications of this HCV data for partnering in this very hot HCV market.
I know this is an optimistic scenario, but I am one who believes PPHM management is also very frustrated by being so undervalued-- and the related unnecessary ATM dilution-- and is now ready to be more market-savy in telling the PPHM story. I know many others who post here think the PPHM Board is inept or seeking cheap options. I think they have simply been waiting for the arrival of randomized data before they start beating their drums.
Clinical testing is still at an early stage with the Direct-Acting Antiviral Agents (VRUS and INHX), but my guess is that the BP Old Guard in the Ribavirin and PegInterferon game, as well as the newcomers with protease inhibitors that need interferon, have all dramatically increased their interest in our Bavi-Ribavirin trial.
The HCV Old Guard is not going to be quick or easy to see their market share slip away to startups like VRUS and INHX. Surely they will want to see if they can keep their drugs in the game by partnering with a safe replacement for interferon.
I bet SK is getting more calls, not fewer calls, now that VRUS and INHX have upped the anti for finding an interferon replacement.
Excellent point Mojo. And let's not forget the preceding paragraph where Garnick linked good results in the front line randomized lung trial to ramping up investment for Phase III production in the event FDA gives accelerated approval for second line lung results. Here's the quote:
"We're also conducting a front-line non-small cell cancer trial, which is designed to replicate and confirm the promising data from our prior Phase II single-arm trial. In addition to confirming the prior data in a randomized trial setting, the purpose of this open label trial is to use the interim data to help determine our investments, which we would need to make shortly in preparing for future Phase III [accelerated approval] development."
I believe he is saying that the one- two punch from getting front line trial data just before the double blinded second line trial data has been designed to give the Company in 1Q12 the confidence it needs to invest in manufacturing as if accelerated approval will be granted for second line NSCLC. The big reason why Company would need interim data to "help determine our investments" would be to prepare for scenario where accelerated approval is granted for the second line Phase III trial.
DJohn-- Thanks very much for this catch. This 8-K disclosure confirms that Dart/Eastern Capital was one of the investors in the current $7 million placement.
Moreover, it appears that MLV is the firm that introduced Dart to PPHM because MLV gets the lions share of the commission earned on Dart's investment amount. Note especially this statement:
the Company shall pay an amount equal to 5% of the gross proceeds received by the Company from the sale of the Securities to EC to McNicoll, Lewis and Vlak (" MLV ")
So Dart is averaging down on his investment. That's great news. He is obviously still a believer and has a great nose for smelling opportunity. Plus his team does serious due diligence. Clearly Dart has connected the dots in ways most people on this Board have not.
MoJo-- Thanks for this terrific insight. Amazing how a few posters drop nuggets of gold on this Board and the same old posters just keep blathering away, obscuring the nuggets and preventing the discussion they deserve.
Your ECOG insight gives one far more confidence that yesterday's PR is indeed a forecast of good data to follow this winter from the randomized trials.
This is one more piece of hard evidence that the PPHM scientific team is conservative and understated, just like the PR team. All this bodes very well for duplicating the impressive Phase IIa results in the pending randomized Phase IIb trials.
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After thought: Regardiing RRDog's insightful post just now, I am inclined to agree with much of what he says, especially if his advice had been acted on by the BOD a year ago. But with randomized Phase IIb results only a few months away for the front line NSCLC trial, and the HCV viral results coming by January, it will be a lot cheaper to hire the banker and do the secondary offering in Q1 of 2012.
Has anyone else noticed this headline at top of the PR: "MOS Data Show Consistent Trend With Earlier Tumor Response Rate."
I think CJ's post comparing all three signal seeking trials is the key to understanding this statement. If you look at CJ's post 67265, you will see that in the lung trial where ORR was 43%, MOS was 12.4 months.
In the breast trial where ORR was 61%, the MOS announced today was 20.7 months.
In the frontline breast trial where ORR was 74%, MOS has not yet been reached !!!
This trend is entirely consistent with the scientific articles posted here about a year ago (I can no longer find them-- a little help please) that say ORR is a very good predictor of MOS.
C.P. Thanks for your post on Garnick’s CC remark that Cotara “looks as good as anything else out there, in particular with the 8.8-month median overall survival and long-term survivors.”
I see this remark as being consistent with SK’s remark in the June 3 PR that “We know of no other recurrent GBM therapy that has achieved comparable median overall and long-term survival using a single administration of one drug.”
In SK’s remark he added the ease-of-administration criterion (i.e. “using a single administration of one drug”), so with this qualifier SK was able to say no other GBM therapy has achieved comparable results.
Garnick’s remark did not include the ease-of-administration criterion, so he was limited to talking about only the efficacy results, which are “comparable” or “as good as anything else out there.”
Obviously, if Cotara’s raw efficacy results are “as good as anything else out there” (i.e. we match Avastin’s results), but our safety profile and our ease-of-administration are much better, than Cotara is a drug that the FDA will allow to move into the market place.
Comparison of 10-K this year with last year shows that full-time employees as of 04.30 increased from 139 in 2010 to 154 in 2011, which is a 10.8% growth in human resources.
Just another little factoid, like the arrival of Garnick and Masten, that shows the Company is gearing up.
My understanding of the Quality Assurance function at the Jeff Masten level is that it has to do with the final round of QA associated with actually launching a product into the market place.
This is not the same thing as the QA needed for good cell culturing practices. Yes, I agree that there is already a QA team in place at Avid responsible for the Company's GMP status that gives them the FDA's green light to produce proteins for PPHM and third-party clinical trials. And it's quite possible that some of the people in that department got fired over the screw up last quarter.
But that is separate from QA for filling, packaging and labeling of finished products that Masten directed while at Genentech.
Also note that Masten was hired as a VP at Peregrine, not at Avid.
As SK said in the 5.31 PR at time of Masten's arrival: "Jeff's leadership will help us become commercial-ready for our product candidates."
Thanks CJ. Excellent lead.
"Quality Assurance" is about filling, packaging and labeling products professionally as they go out the door to the public.
It would be one thing if Jeff Masten were a solitary hire. It could be explained away as a futuristic move to grab a top flight candidate now who happened to be available. But when Dr Masten then turns around and hires a No. 2 Quality Assurance executive to work under him, it really does start to look like Peregrine is seeing data in the pending Phase II trials that make them want to prepare seriously for a product launch.
Note that the new hire will "manage a team of direct reports" underneath him.
... Connect the dots, guys. They are building a whole Quality Assurance department. This is a huge signal.