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CP - Where I was going with this is – GJH stated that “PS doesn’t stay symmetrical long enough for therapeutic intervention.” However, research shows PS is a specific, accessible, and stable marker of tumors – going back to at least 1998. In fact, in this original patent US 6312694 B1” Cancer treatment methods using therapeutic conjugates that bind to aminophospholipids” filed 1998, it clearly states “The discovery of sufficiently stable PS expression on morphologically intact tumor-associated vascular endothelial cells is important to the targeting nature of the present invention. Should PS translocation to the outer surface of tumor vascular endothelium occur only in dying cells, or should it inevitably trigger cell death, then PS expression would be expected to be transient and PS would not likely be a good candidate target for therapeutic intervention. Surprisingly, the present invention shows that significant stable PS expression occurs in viable endothelial cells in a tumor environment, thus providing ample targeting opportunities.”
GJH - If you give a mouse a cookie - she's going to ask more questions - Can OHPSLSAE act as an anti-phagocytic and can betabody or Bavi bind to it? It's my understanding Betabodies can, but I'm not a microbiologist.
Just got off the phone and the broker stated that the official company name did not change - just the nickname. They couldn't explain why the nickname is now "peregrine pharma new", but they did reassure me that the nickname change had nothing to do with bankruptcy - so at least that's a relief
Good John - is it possible that PS exposure found in malignancies is not apoptic in origin and does not have the same macrophage chemoattractant as PS of apoptic origin and the reason why PS is found as a specific marker for tumor vasculature?
I was logged into my broker account and I noticed pphm is showing up as peregrine pharma new; whereas, normally it shows up as peregrine pharmaceutical - why does it have new now?
Perhaps our bodies don't create PS antibodies because it circulates in the body while the immune system is developing?
Can it be assumed at this point that the poison pill is being repealed? Doesn't it expire in two days?
Entdoc, is it possible that blood tests were taken and the doctors knew which patients were given bavi? If they knew which of their patients were not given bavi, is it possible that they sent control arm patients on to other treatment options to prolong life? I have no idea how this trial was conducted, so these are just general questions.
CP- my thoughts on the arms' overall survival are similar. When I looked at the asco phase 2 poster, while trying the enrollment simulation exercise, I thought Bavi would give a mos somewhere around 13.9 My guess is that the control arm may have beat 11.9 - Didn't opdivo have a mos of 12?
I bought 50% back-in, hoping for a recovery, partnership, merger, patent press release, just about anything that will restore some shareholder value. The earnings showed total assets at 119 million and our current market cap is less than 100million -seems like we should get some reversal soon. Although I know you didn't ask me, I thought I would share my current, a bit clearer, opinion Now, I hope whoever is driving this pps vehicle starts to rev UP the engine a bit and perhaps take a shorter route to get here!
I have been thinking about these comments on this board 1) no restructuring or layoffs 2) management smugness noted 3) worsley (the lead on partnerships discussions) going to avid 4) poison pill not discussed 5) betabody not yet announced 6) little discussion on company plans to finance future trials ... Did I catch most of the CC shareholder thoughts?
Makes me think BCS'S "Family" is in route to take control and perhaps is taking a sideways scenic route to get here.
Any discussion on the poison pill?
Hmm and I thought the family liked tea and milk - 34262 shares after hours. Funny - but - California food and agricultural code 34262 has to do with milk or cream - T101s code for anti-aging. Is it a stretch?
Speaking of your family theory - we currently have 102 institutions and this morn I think I saw that we had a volume of 39103 - which had me wondering if tomorrow 3-9 we would see 103 holders? Maybe that's your family
I was coming to a similar realization this morn - it's not usual trading activity for PPHM and The wiki changes on bavi that you, CP, pointed out have been rattling around in my head also. The two changes I'm confused about that can be seen when you look at the bottom of the page and click on the precise changes made are - in 2016 Bavi "was" their lead candidate - not "is" anymore. The other change - it looks like there was a tag that showed product = drugs, but drugs was removed and the comment states they have no products. Look at the Wikipedia changes made and give thoughts - thanks - need coffee
I hope it's not more tea - the last tea was bitter - big good or big bad - in your opinion? And when?
... in my active imagination I wonder, perhaps, if there was something nefarious that occurred in the trial other than the benign speculation that some control patients went onto other treatment options; further, I wonder if the investigation of the phase 2 sabotage is still active. Would be nice to see a pr and possible indictments if that were the case.
At two dollars I would about break even on my investment with the current shares I'm still holding. However, in the back of my head, rattling around, I'm wondering if anything will come out in a pr on the phase 2 sabotage, now that the sunrise trial is discontinued.
That's what I vote on interpretation too ( study is continued, but the trial is discontinued) but their statements are a tad confusing.
And this statement from the PR is confusing because their website shows they are continuing the study. "Results of the analysis demonstrated that the bavituximab plus docetaxel group did not show a sufficient improvement in overall survival as compared to the docetaxel group to warrant continuation of the study."
Vs their website under bavituximab trials, "As the study continues, data will be collected and will contribute to our understanding of immuno-oncology treatment options."
I think the poison pill expires 3-16
JJ - What 4 new PPHM job positions were opened this week?
I've been wondering the same thing - are they continuing the sunrise study as part of the 2 year rolling bla and is it possible to still get approval?
Is the company recruiting or not recruiting for her negative breast cancer? And is the company continuing the sunrise phase 3 study, but discontinuing the trial? And what exactly does it mean if sunrise is active not enrolling, but the trial is discontinued and the study is continued? See below links. (I may have missed some posts during the week so my apologies if this has already been answered.)
1. Clinical trial site shows her2-negative trial is recruiting :
Taxane Therapy With or Without Bavituximab for the Treatment of HER2-Negative Metastatic Breast Cancer this study is currently recruiting participants. (see Contacts and Locations) masking: open label
https://www.clinicaltrials.gov/ct2/show/NCT02651610?term=bavituximab&rank=3
2. This shows her2-negative trial is not recruiting http://www.peregrineinc.com/clinical-trials/bavituximab-trials.html
3. This states that the sunrise phase 3 study continues and the Status is Active not Enrolling "As the study continues, data will be collected and will contribute to our understanding of immuno-oncology treatment options," http://www.peregrineinc.com/clinical-trials/bavituximab-trials.html
4. This PR states that the sunrise phase 3 trial was discontinued "today announced that it is discontinuing the company's Phase III SUNRISE trial of bavituximab."
Well 101T - is the IP for peregrine still in big demand - the King's tea tasted bitter.
Thank you CP - the two things I found promising in the PR were 1) no mention of layoffs or restructuring 2) the focus on io combos including clinical trial combos with AZN's durvalumab.
I sold my shares at . 41 and bought back a small amount at . 35 Book value in the mlv doc stated.41 so that was a value buy.
Much appreciate your thoughts.
Thank you - much appreciated for your sincere advice.
I'm perplexed on the actions. I took a huge loss selling partially out - then I bought partially back in because the stock was less than book value, now I'm still thinking to buy more back as yesterday's press release for the CC held more promise than the initial pr terminating the trial and putting all chemo trials on hold, but I can't find the nerve to hit the buy button!
I'm thinking good news - I mean really - we are already below book value... How much farther can it drop?
Realist, how about Pfizer with Tremelimumab?
On April 2, 2008, Pfizer announced that it has discontinued a Phase III clinical trial for patients with advanced melanoma after the review of interim data showed that the trial would not demonstrate superiority to standard chemotherapy.
On October 4, 2011, MedImmune LLC gained worldwide rights on Tremelimumab to develop and commercialize the drug for treatment of cancer, while Pfizer retains all rights for combination therapies.
Wernaaa, I was going by past biotech stocks that I have invested in that had a failed trial. Such as exelixis on 9-2-2014 they announced comet-1 phase 3 trial not meeting end points and in the same PR stated a workforce reduction. Pphm has had zero PR stating a workforce reduction and it's been a week, so I see that as currently encouraging.
Looks like the AZN collab is still on, that's a relief. "One specific component of this I-O combination strategy includes planned clinical trials of bavituximab in combination with durvalumab, AstraZeneca's investigational anti-PD-L1 immune checkpoint inhibitor, in a range of cancer types under a clinical collaboration. "
No layoffs yet is actually giving me hope
Looks like PPHMP is up today slightly and still no PR of layoffs that normally come immediately after a trial is stopped. This is the most confusing stock ever. Does anyone know if the company can use IRRC criteria from the ongoing phase 3 study in conjuction with phase 2 to file for the BLA?
This Wikipedia article - explains how irRC was created - which I found interesting.
https://en.m.wikipedia.org/wiki/Immune-Related_Response_Criteria
Why did they use conventional response criteria instead of irRC to gain FDA approval? Is irRC still an option at this point?
Wern- in case you missed this post by gpuppy- this is what the poster wrote:
"I have been a PPHM shareholder since 1998 and practicing internist for 30 years. I have been following the science and have a few comments of note. Firstly, CTX/XRT have been the traditional choices in oncology for the last three decades and that is why PPHM chose to pursue the Sunrise trial after the reworking of the PII trial. I/O was not an approved treatment option at that time. Only in 2013 did I/O jump onto the radar. Sunrise was already set in motion and should and could not be stopped at that time. With the advent of the I/O molecules of Bristol Myers and Merck products being introduced to the market for melanoma and lung cancer, CTX and XRT lost significant steam as these forms of therapy were much less profitable. I know of two patients that were enrolled in the Sunrise trial that were terminated from the trial and treated with I/O therapy because they were doing poorly clinically in Sunrise. Give the stage and ECOG status in both the control and treatment arm were to be one and the same, I suspect these two patients were in the control arm. Any responsible oncologist is not going to allow his/her patient to die without a fight for the sake of a trial. Hence, they were terminated from the trial. If this decision was made for all patients who were doing poorly in the control arm, it is understandable to see why the control arm survival was much greater than historical data. Both the control and treatment arm survival is a bell shaped curve and if you remove the early deaths from the control arm, the curve shifts toward the treatment arm. Remember the treatment arm was performing as expected and hence the control arm was artificially skewed in that direction. If practicing oncologist had no I/O options things would have looked very differently. The I/O market will be the only market until the costs of therapy dictate otherwise. If PPHM does not understand that and pursue accordingly, we will all be losers. "
Only going by what the internist gpuppy stated on this board - and it seemed logical- but you have an excellent point- there is no pr yet stating why the control arm did dramatically well.
Biopharm - I initially sold 80% of my position because my investment thesis was thrown a curveball. I bought 5% back today on my belief that if I took everything out of the equation the company is currently going for less than book value. Now I'm wondering, if some in the control arm did in fact get further io treatment and Bavi is known to work safely and has therapeutic value, then shouldn't the government protect this baby biotech from harm?
True - I was going by the mlv doc 8-7-2015 -the offering was to push the bv to . 41 - this is not including proceeds from expanded avid or the Eastman deal -the current price appears undervalued. Would love to see insiders supporting now. At work - sorry so choppy.