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Thanks for the response Thurly and Sunstar. Thats comforting information. My little bit or research after I posted indicates that the FDA may have a test patient population number in mind in the 300 to 600 range in order to support AA data. There was more to it than that but time is short and I have to run. I'm in Beijing and its getting time to find a bus back to the hotel.
FTM - Upon reading the FDA link provided by Thurly the following sentence from the acceleragted approval section sticks out:
"In this example, an approval based upon tumor shrinkage can occur far sooner than waiting to learn whether patients actually lived longer. The drug company will still need to conduct studies to confirm that tumor shrinkage actually does predict that patients will live longer. These studies are known as phase 4 confirmatory trials."
It appears to me that the FDA is saying (or least implying) that AA is only granted on surrogate data generated in phase III studies.
It seems we may have to wait a little longer for FDA acceptable AA data to be generated for sumbittal if required to be based on or, at the least supported by, PIII data.
What is your take on this?
It true that we have to wait until PIII data is generated, then so be it. This doesn't worry me all that much because it doesn't change the facts from what has occured (and still is occurring) in the all the PI and PII studies. Bavituximab has been and continues to be validated as potential BLOCKBUSTER drug for multiple cancers no matter what the red herring fishmongers keep pushing on this board.
It will just make me pay closer attention to the questions being asked of the company re: how they intend to finance the next NSCLC phases. It looks like we may need a partner more than I anticipated. Personally I think the continued strength of the data from the trials will support the share price to a point that would be much more appreciated by us and help fiance some more of the ATM to allow the company to show more strength in the negotiating process when seeking a partner. I would expect that whatever short term price rise we see the company will need to sell shares into it (hopefully later than sooner) to help with this negotiating process.
Does anyone have any guess on what type of money it would take to get PIII data for whatever surrogate data would be used to support AA? I would assume they would be using ORR as a first choice and wouldn't that take at least 8 weeks for eache patient plus a couple of weeks for data collection. Then have to consider enrollment time for the patients but I don't think enrollment time strected out is the real money drain; just the actual patient enrollment and treatment which is bsed on numbers.
Hell, the dilution has already been substantial and at least I have kept the faith and kept buying in the beatdown lows. May not have been the smartest thing but until the trial results start showing me otherwise I can't see how this is a loser even with more near term dilution (based on my belief of what the market potentials are).
If that's the way you truly feel what are you even doing holding this stock? If the only thing you can get from yesterday's information is a paranoid feeling that the company is screwing you then you absolutely shouldn't be owning this stock; no matter how much of a loss you might have. From my standpoint yesterday's information is VERY good indeed - based on historical precedence - and while it might be "as good as it gets" (100% cure rate is "as good as it gets"), its damn good for this stage of the trials. If you can't trust the information what the hell are you doing investing in this stock? You should take this price appreciation as an opportunity to cut your losses before the company "screws" you again and relieve yourself of this worrisome burden. There WILL be someone to buy your shares.
He used the term "majority" most of the time.
However, I still think his words about MOS not being triggered "...for some time yet" and the way he said it and his tone of voice made me believe that he felt the MOS numbers were going to be very good indeed. I might be really wishful thinking here but after hearing all those years of his low key expressions, his voice today answering those questions certainly seemed to me to have a very positive note about it.
"The majority of patients in both arms are still alive and we expect that to continue for time yet." I think that is pretty close to the exact words.
Can you say "EXCELLENT"!!! MOS not reached in either bavi arm and not expected to be reached anytime soon. WOW! FTM what's the new prognosis for the ratio? Thanks
If what Mojo said is correct regarding the the 3 highest PFS trials having no correlation to the PPHM trial then the weighted average for PFS for the remaining trials would be 4.9 months. Just thought I'd put that out there.
If our primary goal is 2nd line NSCLC, why did we take the risk and spend precious funds to pursue the front line at this time? I know this is hindsight but these guys should have perceived this risk and found it not necessary.
I'm not impressed with Garnick being a "call in" -with a poor quality connection- when he's supposed to be handling such an important discussion.
Has SK ever stated in previous CC that companies are performing due diligence?
EyeBuyStox;
Maybe someone should start thinking about the credibility of the Avastin trial data. Having their control arm be lower than actual could only have helped the avastin case. Avastin doesn't seem to be doing all that well after it was approved. Maybe the reasons are starting to show as to why. MCTO
CJ, as always I appreciate your valuable, pertinent and timely summaries. However, I believe your timeline is off by one year for the summary of the 12-10-10 CC. You stated: "[Dec’09 + 2.5yrs = ~June’12].", but the information you quoted is dated December 2010 not 2009. Just wanted to keep the timeline straight.
Mojo, I investigated further on the Inspire web site for the person who posted the message about her father in the Bavituximab trials.
http://www.inspire.com/groups/lung-cancer-survivors/discussion/paclitaxel-carboplatin/
He is in fact in the Paclitaxel/Carboplatin study which based on my understanding of the two trials places here father in the randomized open label study. So I'd say it is valid info regarding how Bavituximab is doing, at least from this person's experience with her father and the people she is aware of.
Good points Mojo. I decided to check on this to remind me exactly how the two trials were structured. I thought that one was an "open label" and the other double blinded. In fact that seems to be the case. The one that is open label is at this link:
http://clinicaltrials.gov/ct2/show/NCT01160601
However, I'm confused on the actual structure of the trial based on this description from the link info:
"Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Open-Label, Phase 2 Trial of Paclitaxel/Carboplatin With or Without Bavituximab in Patients With Previously Untreated Locally Advanced or Metastatic Non-Squamous Non Small-Cell Lung Cancer"
Can someone explain the meaning of "open label" and how it is applied in a "randomized" trial? I thought open label meant you knew what drug you were getting. Does random open label mean that they randomly select which patients get which treatment but whatever treatment arm they are randomly selected for the patients know what the treatment is?
I haven't been following the daily back and forth lately; been too busy and depressed hearing some the SOS. Here is a thread from Inspire, a cancer website. This thread is regarding someone with NSCLC in the Bavituximab trial. This was posted on Inspire on 10-30-11 and I apologize if it has already been posted here and discussed. Here is the thread and the link:
https://www.inspire.com/groups/lung-cancer-survivors/discussion/update-on-my-dad-12/
Thread:
Update on my Dad
Candy3114
By Candy3114 · October 30, 2011 at 6:58 pm · 3 replies
In Non-small cell lung cancer - Stage IV
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After battling a bad chest cold for 3 weeks, Dad went in for his last round of chemo last Friday and they decided he didn't need it. He is anemic and they were afraid the chemo would do more harm than good. I was relieved, as he has been so sick I wasn't sure he could take it. He has been on a trial and will continue that once a week and they will keep an eye on everything. He has been stable for awhile now and some of the smaller tumors have disappeared. We are happy with stable and hoping he will be feeling better soon now that he is off the chemo and once his red blood cells come back. Please continue to keep him in your prayers.
3 replies Reply
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cards7up
By cards7up
Reply 2585933
October 30, 2011 at 9:04 pm
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Praying he'll continue to improve now that he's off chemo. What trial is he in? Take care, Judy
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mar58
By mar58
Reply 2588090
October 31, 2011 at 7:09 pm
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Prayers for your Dad. Hope he get's his strength
back soon.
MARIA
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Candy3114
By Candy3114
Reply 2588156
October 31, 2011 at 7:39 pm
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Thanks. The trial drug he is on is called Bavituximab. It appears to be having good results for those in the trail so far.
golfho - did you mean millions or billions for the peg-interferon market? thanks for your effort.
Chevynew,
I posted it a couple of weeks ago; and it appears that your post had the same initial problem as mine did regarding the response number. Your post says the response was: "=0.5 log10 reduction)". I believe that if you look at the original data it should be "greater than or equal to 0.5 log10". This website's software can't seem to handle a greater than or equal to sign even when I tried to use the basic ASCII code for the symbol. Something we need to watch out for when posting data here.
http://www1.easl.eu/easl2011/program/Posters/Abstract1116.htm
ESCALATING REPEAT-DOSE STUDY OF BAVITUXIMAB IN PATIENTS CO-INFECTED WITH CHRONIC HEPATITIS C VIRUS (HCV) AND HUMAN IMMUNODEFICIENCY VIRUS
J. Slim1, M.S. Sulkowski2*, J.S. Shan3
1Infectious Diseases, Saint Michael's Medical Center, Newark, NJ, 2Center for Viral Hepatitis, John's Hopkins University, Baltimore, MD, 3Peregrine Pharmaceuticals, Inc., Tustin, CA, USA. *msulkowski@jhmi.edu
Background: Bavituximab, an investigational monoclonal antibody, targets phosphatidylserine (PS) on the surface of virus infected cells and enveloped viruses. Preclinical models show PS-targeting antibodies to bind viral particles and infected cells, inhibit viral replication, and enhance innate immune reponses. In prior studies, single and twice weekly intravenous (IV) infusions up to 6 mg/kg were well-tolerated and showed transient antiviral activity in chronic HCV patients.
Methods: To determine the safety and tolerability and characterize the pharmacokinetics and viral kinetics of bavituximab, sequential cohorts of 6 patients were given up to 8 weekly 90 min IV infusions at 0.3, 1, 3 or 6 mg/kg and followed until week 12. Patients may be replaced if withdrawn prior to receiving 4 doses of study drug. Vital signs, physical exams, safety laboratory parameters, bavituximab levels, HCV and HIV viral titers and T-cell activation profiles were obtained.
Results: Twenty-three patients (13 female, mean age 47) have been enrolled to date. Mean baseline HCV viral load is 4,000,000 copies/mL (100 - 50,000,000) and 6,900 (150 - 280,000) copies/mL for HIV. The majority of patients (18/23) have genotype 1 HCV. Mean CD4 count at study entry is 490 cells/mm^3 (212 - 1239). One patient (0.3 mg/kg) experienced related non-serious grade 3 blurred vision, hypertension and cardiac arrhythmia during the 8th infusion, but extensive cardiac work-up was negative for evidence of thromboembolism. Three serious adverse events have been reported; grade 2 sinusitis (unrelated), grade 3 urticaria (related) and grade 3 hypersensitivity (related), all at the 3 mg/kg dose level. All other adverse events (AEs) were mild or moderate and transient. Preliminary data for the first 3 cohorts exhibit on therapy HIV and HCV antiviral activity (= 0.5 log10 reduction) at all dose levels.
Conclusions: Up to 8 weekly IV doses of bavituximab have been generally well-tolerated to date in HCV/HIV co-infected individuals. No dose-related increase in incidence or severity of AEs are observed. Signs of antiviral activity have been observed at all dose levels analyzed. Enrollment is near completion and pharmacokinetic and T-cell activation data will be analyzed at the end of the study and correlated with antiviral response.
Back
Note: I've tried to update the message to correct the the viral log reduction information but the website doesn't appear to interpret greater than or equal to correctly. The abstract says the viral load reduction at all dose levels was greater than or equal to 0.5 log10
Way to go Chevy, the market is almost two hours from opening and you already state the PR resulted in no PPS increase expect for a minor couple of pennies. We longs sure do appreciate the prompt negative prognostication.
You take a PR that states a deal was made with company in the world's largest potential market and find nothing but negatives and so quickly too.
My concern with this deal is how are the Chinese going to steal the PPHM technology (remember Goldstein and TNT). The specific techonology that I'm concerned about being stolen would be the: "The approach is designed to use our fully-integrated process science capabilities and expertise to efficiently and effectively identify the best cell line that closely matches that of the innovator or reference product." And of course that assumes that this technology is actually effective in its purpose. If PPHM has leading edge capability in this area I would think it would be a much overlooked potential value adder to the company. I don't know how we can find out how PPHM's expertise/technology in this area stacks up against the best in the industry but I would think that the people on this board may want to look into this and attempt to find out.
I must really be getting old. I don't remember any announcement regarding a specific first 1st biosimilar project. I only remember that they are pursuing biosimilars. Can someone please point me to the information re: the first biosimilar project agreement. Thanks.
"Collaboratively with our client, we have developed a streamlined approach to expedite the development of biosimilars, and this second biosimilar project will broaden our expertise and capabilities in this complex and exciting market segment,"
Chevy, I see that as the most interesting part of the news release. I believe it means because Affitech gets exclusivity for the USSR using the future generation of treatments (and the risks that go with it) they get the better chance at big revenues quicker than whoever ends up with the currently under test Bavituximab revenue stream. I believe this means the Russian company was impressed with the Georgia and India trials; enough so that they are putting up money for a deal with Affitech for what would be a better expected result from the fully humanized versions. I would bet that under the Russian and CIS systems drug testing life cycles leading to approval are a lot shorter than the US and Europe. I'll have to look into that.
In turn for Affitech getting the USSR countries and the higher probablity for quicker returns on ivestments they allowed PPHM to have more of the pie for the remaining part of the world (or some other unknown portion thereof) for the EXISTING discovered and collaborated drug platforms.
It also seems to me that this is the beginning of the end of the collaborations between Affitech and PPHM for co-developing any future drugs.
This is my quick off the cuff take on this and of course my opinion.
Would like to hear your take on this.
I see this action as being the topping off of the "war chest" funds needed to support the most important ever phase that we are entering into. Its a necessary evil. Thanks to the information provided on this board we were all well aware ahead of time of the large number put options hanging out there. I believe in the philosophy that we retail investors will always being sucking hind t_t. I've been saving for this event and I intend to buy more as soon as I'm sure we're through with this special treatment being handed to the big boys. Based on today's action I would say that its most likely going to end in a very short period.
I believe that people/organizations that have multi-millions of dollars to hand over to PPHM are going to get the sweet deals. They should.
Why would anyone buy that much stock in such a short period of time if they thought it was going to tank even further?
We've seen this action before (although not quite to this level of volume in such a short amount of time; at least from my short 4 year experience). I feel relatively confident that we will recover from this because this action, along with whats been going on with the ATM over the last year, should - I think - remove the going concern clause. Also, I have yet to see ANYTHING that shakes my confidence in the most important factor - the efficacy of Bavi in cancer treatments.
Of course I could be "riding this missle" to oblivion.
TGIF.
discolpati-entdoc-thales-threes: Thanks (especially to discolpati). disco's info provides a pretty good basis for me to put this drug out of my mind as competition in the near term and affecting the government's Bavi broad spectrum anti-viral contracts. I was worried there might be another "promising" candidate out there to share the "broad spectrum" anti-viral money allotments with. I was concerned they could be in a position to get in on the broad spectrum anti-viral government monies and animal rule approval process if they were anywhere near starting phase 1 safety studies.
The following statement from disco's info says what type of progress they are making:
"it took us 4 years just to get to this point from our initial discovery of the compound--it is difficult to convince scientists
when you propose a paradigm shift of how an antiviral should work. "
I like the line about how difficult it is to convince scientists when a paradigm shift in knowledge is involved. Seems to go hand in hand with the Bavi experience and waiting for the Nature article. Must be Barton (et. al) are having a hard time convincing their peers about the science too.
I don't mind as much about convincing peer review scientists when the price is moving nicely upwards.
This appears to be evolving competition. It has given me an uneasy feeling. I would appreciate some feedback from the medical experts on this board regarding this article.
http://newsroom.ucla.edu/portal/ucla/researchers-find-broad-spectrum-153297.aspx
Moby,
Was your following statement intended to indicate that you now only take short positions in PPHM?
"Actually, "own" isn't correct. I'm just renting them these days."
CJ,
Thanks for the post. I can't help but feel that things are going to pop soon (i.e. this year). SK certainly seems to provide much stronger and positive statements in this presentation than I can ever remember reading in PRs or hearing in qtrly CCs. It seems clear to me that they are ready to partner Cortora at the point of maximum benefit and that point seems to be later this year.
One thing that I don't believe has been discussed regarding the last cc: is the following statement made by PL near the beginning:
"This quarter, we saw gov’t contract revenue increase significantly to $6.9mm. This increase was mostly due to the mfg. services provided by our wholly-owned subsidiary, Avid Bioservices, which is ultimately reported as gov’t contract revenue, in accordance with GAAP."
This sounds like he is saying the gubment bought themselves at between 3.5 and 6.9 million dollars worth of Bavi juice this past quarter. Does anyone know how many "animal" treatments that equates to? I assume animal doses would be significantly smaller than typical human doses.
Kind of has the smell of some sort of mini stockpiling or PPHM is really selling the stuff at DOD rates. If its not stockpiling then there must be a lot of testing going on or planning to. Doesn't seem like the government would commit to purchasing that much stuff for testing if they weren't planning on continuing with the contract in the near term.
But as I think Moby said, and I agree with all too much, 3 to 6 million dollars doesn't seem to mean much to anyone in the government anymore. So, to them it could just be like throwing pennies to the poor.
Of course its all my opinion.
Again thanks for your good work CJ.
Nuke
I didn't see any posts on this; does anyone know if this "non-binding agreement to pursue a collaboration" may have been the Cotora agreement UMASS was alluding to in post 46707 on 1-10-2010?
CJ, why did you make this statement: "Obviously, he fell back out of CR at some point."
Doesn't OR = PR + CR. They have only been reporting OR since 2-4-09 and a CR can still be included in OR population. What was it that I missed. Thanks.
UMASS,
What a bombshell. I just read your post. Its been there for 40 plus minutes and no response. Thanks for the info. I too wish for the opinions of the boards long time PPHM investors on what the outlook should be from here. Obviously we need more information to assess this. Hopefully the news is released officially soon so that we have the info.
THANKS UMASS!
This is what I believe the order is for:
http://clinicaltrials.gov/ct2/show/NCT00623168
Starting to sound like an advertisement for selling Avid.
Thanks CJ & Tek for your replies. My memory has holes in it. It just seems like I was always able to access the CC link first thing in the morning for a call. I remember being able to register early and get it out of the way. I was beginning to worry that I wouldn't be able to hear the CC real time. I must be watching this stock too closely.
I can't find a link on the PPHM web site for today's conference call and the Best Calls web link requires one to join Best Calls which appears to require one to call in to join and is $50 per year. All previous CC have been available real time for free. Am I missing something here or is the company pulling a fast one here today?
Today's PR seems to have been an updated/revised version of the abstract release of Dr. Gupta's that was discussed on this board on 8-9-09 (see posts 39994 through 40002; especially 40001 posted by entdoc). My read on the differences is that today's info encompassed data results from 10 patients and the 8-9 data encompassed 8 patients. The most interesting thing that sticks out to me is that the progression free survival time and overall survival time for the 8-9 data (based on 8 patients) was 22 and 27 weeks respectively. These same data for today - based on 10 patients - were 33 and 41 weeks.
Seems to me to represent relatively significant improvement as time goes on. Could be even better considering that it appears the earlier survival times were weighted to the shorter side due to 2 deaths occurring very early in the trial. Realizing that the people going into the treatment are already experiencing recurrence and most likely are in late stage recurrence (considering the speed of this cancer and the time it takes to get into a trial) it appears to me that this drug has a much better potential than is being shown by the current survival data.
I'm not sure if I'm interpreting this data correctly because I see some confusing deltas between the 8-9 data and today's. For example the 8-9 report said follow ups ranged from 12-80 weeks and today's info stated a followup time range of 7 to 73 weeks. I don't know how the data points are adjusted for people who die or are removed from the study data.
This has to be the new standard of care soon, how can it not be!
I agree with those who are saying that this should be fast tracked and I certainly won't be surprised if some of the BIG NEWS in the near term is fast track approval. How can PPHM not already be pursuing fast track approval with the safety profile data and survival time results already in hand and the lack of treatments for this cancer. We MUST be near to fast track approval or there is something very wrong with our system.
ALL CONJECTURE OF COURSE.
82090: I'm sorry to hear about your friend. I not qualified to say how this company's product may or may not help your friend. The best thing to do is to contact Peregrine Pharmaceuticals directly using the links below obtained from PPHM website. This info was obtained from:
http://www.peregrineinc.com/index.php?option=com_content&task=view&id=22&Itemid=39
"If you are a health care provider interested in referring a patient or learning more about these clinical trials, please send an email correspondence to Peregrine Pharmaceuticals at
clinicalaffairs@peregrineinc.com
This e-mail address is being protected from spam bots, you need JavaScript enabled to view it or visit
ClinicalTrials.gov.
If you are a patient interested in participating in one of these trials, please have your personal physician send an email correspondence to Peregrine."
RE: Use of unapproved drugs in emergency situations. Has this regulation already been discussed on this site? It allows use of drugs still under investigation to be used during government declared emergency situations of which I believe that a viral pandemic might fit into. If previously discussed, I apologize for bringing it up again.
http://www.cdc.gov/eid/content/13/7/1046.htm
Honestabe: I don't think a 3 billion dollar market cap is too preposterous at all. I think its way too low. I'm basing that on Bristol Myers Squibb's offer to purchase Medarex for $16 per share (source Wikipedia and matches current share price). That would be ~2.1 billion for what appears to be a single drug pipeline for melanoma and prostate and still in trials. Reading about the trial results in Wikipedia doesn't appear to be all that impressive although the drug seems be doing well for prostate cancers. PPHM is testing their drugs in the two largest cancer populations - breast and lung - and are having very good results to date. I would think that any deal for PPHM's pipeline less than established deals like the BMS offer for Mearex would be ridiculously under priced.
I don't know how to price a company but this example would seem to be a good starting point.
I think PPHM's problem is their pipeline is too good and no one can afford them. Boy will I probably hear back on that statement. Probably the kind of statement that will provide me and education - wanted or not.
My take on things: So far this recent news cycle appears to be fitting in with the event line that FireFox and I were discussing starting in post 40704.
The projection was that the Haynes paper would be coming out in the Sept print issue (to be released on or about Sunday Sept. 6) and this week would see a series of PRs that would be issued as cover to any trading made by people (especially the press and their associates) with prior knowledge of the release. The press has access to papers a week before release - per Nature Journal website.
I don't know why PPHM would want to cover this type of advance knowledge trading other than to reduce the "stink" that would be associated with a company whose stock has the appearance of being associated with trading on insider information. Therefore, it would seem prudent for the company to try and provide cover to reduce the appearance of insider trading even if it isn't due to company insiders and due to a process they have no control over. Obviously pure conjecture here.
If this projected time line for the Haynes paper is correct then the R&R presentation date would provide the company a very nice venue to present their side of the Haynes research story. The story that the company has been saying that they can't present per agreements with Duke until after the release of the paper. Of course this is pure conjecture.
This of course wouldn't have much bearing (I would think) on inking any partnerships before the NASDAQ deadline but it could help provide a much better public perception of PPHM's pipeline. And good public perception is certainly helpful for getting share prices up.
Also, wouldn't an increasing share price help prod a BP on the fence to accelerate a deal agreement?
All conjecture.
Thanks for the information co3aii.
It certainly appears to be pertinent information that we should keep in mind when assessing the location and ethnic makeup of a trial population. It would seem to me that the US FDA would especially be looking at this issue due the wide ethnic diversity of this country.
I would also assume this issue is known to the US FDA. If so then the regulators should be looking for data from drug trials to address this issue. If regulators are looking for this issue to be addressed by drug trials then the regulators would almost certainly have provided regulatory guidance/requirements on the ethnic diversity in the makeup of clinical trial populations.
Therefore, I believe that the planners of the PPHM trials would have to know about this issue (if applicable to PPHM's trials) and have or, will have, the necessary plans to address it when and if necessary; or they would have no business in this business.
I would think that once past the issue of safety (usually occurring in phase I) this issue would most likely be addressed in a Phase III study where the largest patient population is required, which would allow the best opportunity to evaluate a drug's actions on a variety of ethnic populations.
They do mirror the world's second largest population; soon to be largest. They also are a significant emerging market.
Do you have any data or know of any articles detailing genetic differences and the importance of these differences when doing cancer (or other medical research)on single ethnic populations and how the results from these medical studies using a single ethnic group would or should not be considered applicable to other ethnic groups? It would be nice to have that information in mind when evaluating these trials in India.
Thanks.