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geocappy1
Very valid questions that possibly could explain control arm survival. When the data comes out perhaps this will be reflected in the trail.
Wouldn't you agree that when the Opidivo trial was going on their was no where for the patients to go who progressed. Please give me an idea as to what approved drug they could go.
Wouldn't you agree that during the bavi Sunrise trial was a bit of bad timing with both Keytruda and Opidivo being available for progressing patients to go to. Also, if the control arm patients progressed sooner that would affect the control arm more. Also, isn't possible an abnormal amount of patients made a move to the IO drugs early, maybe even before progression due to all the publicity.
JCNJ
Interesting logic. I wish it were that simple.
If a control arm patient is progressing and leaves the trial for a third line option, as some have suggested, shouldn't the date of their leaving count as an event for purposes of comparison?
Otherwise, how could this trial ever reach its endpoint? The control arm would always win, given the efficacy of the third line. So either this trial had a flawed design, which I do not believe given RG, or this trial was to gain evidence to negotiate/convince FDA. The latter seems logical given the moving targets and changing landscape of the treatment options
ALL IMO
GEO,
My BIO investments in the large caps has never compelled me to
improve my understanding of this process until I invested in this micro cap stock.
Help me out here. Pardon any ignorance. Are you suggesting some patients from the control arm began to progress so they were switched to a different treatment regimen and thus that could have a barring on the out performing arm. If so how can we get a comparative analysis if another i/o is introduced. Of coarse it would be best for the patient.
Pretty simple even for a layperson. The bavi arm is performing as expected but will not meet the assumptions tha it would beat the control arms to the extent expected. This I's due to control arm overachieving their expected results. Most likely due to there being new third line I/O drugs for control group to opt for after being told they are progressing
So what does active mean here? Aside from definition.
Will Bavi arm continue treatment?
ACTIVE, NOT RECRUITING
The clinical study is ongoing (that is, participants are receiving an intervention or being examined), but potential participants are not currently being recruited or enrolled. A type of Recruitment Status.
This may have been posted already
Peregrine Pharmaceuticals Inc (NASDAQ:PPHM) Will Recover
By Alex Carlson / in Biotech & Pharma, Stocks / on Monday, 29 Feb 2016 01:45 AM / 0 Comment / 984 views
Last week’s news from Peregrine Pharmaceuticals Inc (NASDAQ:PPHM) was bad, but not a death blow. Peregrine “announced that it is discontinuing the company’s Phase III SUNRISE trial of bavituximab in patients with previously treated locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC). The decision to stop the trial was based on the recommendation of the study’s Independent Data Monitoring Committee (IDMC) following a pre-specified interim analysis performed after 33% of targeted overall events (patient deaths) in the study were reached. 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. The interim analysis showed that the bavituximab combination group is performing as expected according to the original trial assumptions in terms of overall survival, while the docetaxel group is dramatically outperforming overall survival expectations based on the original trial assumptions and as compared to recently published studies.”
The key for investors to understand is that not all hope is lost. Peregrine now knows that it needs to regroup and develop a clear understanding of the SUNRISE study results. In the meantime, the company plans to put its other chemotherapy combination studies on hold. This is a smart move by management and will allow the company to save resources and plan its next course of action. Furthermore, Peregrine benefits from its Avid Biosciences division, which is not affected. As of February 1, 2016, Avid Bioservices had a revenue backlog in excess of $58 million under committed contracts from existing clients. In addition,Peregrine had $67.5 million in cash and equivalents as of January 31, 2016.
This is quite impressive for a company with a market cap of just $93 million after Friday’s selloff. Peregrine has a revenue generating business and over two-thirds of its market cap covered by cash. This does not take into account the potential of Bavituximab. For those not familiar with Peregrine, Bavituximab is an investigational chimeric monoclonal antibody that targets phosphatidylserine (PS). Signals from PS inhibit the ability of immune cells to recognize and fight tumors. Bavituximab is believed to override PS mediated immunosuppressive signaling by blocking the engagement of PS with its receptors as well as by sending an alternate immune activating signal. PS targeting antibodies have been shown to shift the functions of immune cells in tumors, resulting in multiple signs of immune activation and robust anti-tumor immune responses.
Now no doubt this news is a setback for the company. There is good news and bad news here. The bad news is that it lessens the value of Bavituximab on its own. The good news is that the best course of action is for Peregrine to be bought out by a big pharma player that can develop the right formula/combination for Bavituximab. The key here is that if Bavituximab can turn PD1 non responders into responders as it has shown in animals then Peregrine has accomplished a major breakthrough. AstraZeneca PLC (NYSE:AZN) will know this in the next several months with their combo trial with Bavituximab.
The one problem for Peregrine is that the ambulance chasing lawyers have already started circling the company. This is a distraction for the board and management as lawsuits always are. We don’t believe management in any way mislead shareholders and on the conference call they were as shocked as anyone that this happened.
Jeff It is tough sledding sometimes when you believe so much in your investment for all the right reasons and it goes awry.
I still fill the pain in my gut for and all of you and the patients. I have always felt that how you invest in something says a lot about a person. Your a stand up guy. Though I unloaded almost all of my shares I still have a lot of confidence in the science. Perhaps the I/O open label trials will produce results later toward the end of the year or when the first read out is possible. I will monitor this little Peregrine stock and if somethings develops I'll reinvest more shares. Meanwhile I'll keep 6K in.
The very best to you sir.
peregr Thanks for for candid feedback much appreciated
Question: This is uncharted territory for me as an investor. First speculative stock I have invested in always been with the big boy buy ins. I see the price settling around .40. Could somebody explain why we are not rolling down even more. Is it because the short crowd cannot trade now due to percentage drop? Secondly, with out too much detail what are the prospects of the dreaded RS in the up coming months ahead due to trading under a dollar. I am thinking I may recoup my losses and buyback in at these low prices. I only have 6K left of my initial investment of 275K in stock. Luckily I had a good PPS avg getting out to lower my loses.
Welcome anybody's point of view. Again I am so sorry this happened yesterday for so many investors here it was bad for our pocket books and sad for the patients in particular.
Gentleman/Ladies sorry the SUNRISE trial halted on this bad news. I for one have sold all of my shares and am completely out except 6K.
Good luck I hope somehow they resuscitate this for the remaining investors still in.
I know many of you were very optimistic about the possibilities and I feel for all of you because I was to. I have enjoyed my posting here. Speculative stocks have two components high risk reward or loss.
Was very hopeful this could work for the patients.
Will check in from time to time.
Good day in the market
CP Distinctive marketing advantage. Approval first then were off and running.
Therefore emphasizing to be a COMBO-PLAYER, certainly in this stage of the product, is a plus too. Bavituximab is MADE to be combined. Opdivo, Keytruda, Yervoy, etc CAN be combined but where not initially intended to. They were alternatives for the SOC. Now that they perform insufficiently well they'll end up in combo's.
That is a clear distinction.
APRIEM ADVISORS 12/31/2015
4 shares New
ADVOCACY WEALTH MANAGEMENT SERVICES, LLC 12/31/20151
1 share New
Guess they will purchase more later?
Read more: http://www.nasdaq.com/symbol/pphm/institutional-holdings?page=2#ixzz411fW8Sh0
Excellent read EOM
CJ So sorry to hear about his passing. Prayers go out to his family.
Archiek. Agreed. I am in this camp of thought. It is another source of information complied by many in one focal point to review and consider for investment purposes or just to become more informed of the potential development of the MOA of Bavi in the fight against cancer among the many new immunological treatments arising.
Thanks edcpf for for all commentary on Wiki.
CNET jytdog's profile
jytdog
MEMBER SINCE: September 7, 2011
From Course Hero
some commentary....
who named themselves “123lazyg” or “Jytdog” and also other editors who do not even bother to set up a Wikipedia account. Hence, the lack of qualified expertise on Wikipedia poses a risk of generating less valid knowledge from peers. Moreover, Wikipedia’s unreliability is further accentuated by the restricted framework of its own reliability policy. Under the policy, Wikipedia does not demand its editors to possess any background knowledge of the subject or even fully understand what they are talking about as long as they can provide verifiable information from a reliable source. However, Edwin Black (2010) argues that over-dependency on variability is unhealthy because “what passes for a reliable source can span the spectrum, as any patchwork of policies and weighing measures can discredit the best sources and highlight the worst, depending upon the moment and motive”. Hence, it is extremely difficult for readers to arrive at a comprehensive judgement of an article’s overall accuracy when they have to examine every individual source that was referenced to, instead of being able to simply evaluate the article contributors as their primary source of information. More ironically, Wikipedia discourages dedicated researchers from sharing their own findings because it violates the no original research principle while amateurs can freely edit the article. When comparing the stem cell article on Wikipedia (2014) and Britannica Encyclopedia, the latter source provides a much better insight on the subject because readers can clearly identify Jonathan M.W. Slack (2014), a director of Stem Cell Institute at the University of Minnesota, as the article’s primary contributor who has credentials in the subject area, as opposed to a prolonged list of anonymous users on Wikipedia. Therefore, Wikipedia’s reliability policy can also be regarded as suppressing expert opinion, which is easily the most reliable source of information, and hence substantially decreases its reliability. Furthermore, in the highly unlikely scenario where all the content on Wikipedia articles are provided by specialists, it does not ensure that all information is accurate because information on Wikipedia is often exaggerated and deviates from the truth. In particular, people with ingenuous intensions such as paid advocates can anonymously exploit Wikipedia for selfish purposes. In relation to the article on stem cells, Wikipedia (2014) only listed the disadvantages of stem cell
FEB.19TH,2016 Financial Market News
A hedge fund recently raised its stake in Peregrine Pharmaceuticals stock. Millennium Management LLC raised its stake in shares of Peregrine Pharmaceuticals (NASDAQ:PPHM) by 17.3% during the fourth quarter, according to its most recent disclosure with the Securities and Exchange Commission. The institutional investor owned 1,088,730 shares of the biopharmaceutical company’s stock after buying an additional 160,670 shares during the period. Millennium Management LLC owned 0.47% of Peregrine Pharmaceuticals worth $1,274,000 as of its most recent SEC filing.
Nice to see this one being set up. Thanks
MD Excited for possible opportunity here. I adjusted my Bio portfolio. Sold some more PFE. Own 275K shares of PPHM now.
Recap
Designation Year enacted What it means Qualifications When to apply
Accelerated approval 1992 FDA approves the drug using a surrogate endpoint prior to Phase 3 results showing clinical benefit. (Phase 3 trials still must bear out the drug’s efficacy and safety after approval.) Drug must treat a “serious condition,” provide a “meaningful advantage over available therapy,” and have a measurable effect predictive of clinical benefit that can be measured earlier than final endpoints. During drug development, well before submitting a new drug application
Priority review 1992 The FDA reviews the new drug application within 6 months, rather than within 10 months. Drug must treat a “serious condition” and provide a “significant improvement in safety or effectiveness.” (Alternatively, companies can provide a priority review voucher, which allows a company to choose any drug to receive priority review. The FDA awarded vouchers to certain companies for developing drugs for tropical diseases and rare pediatric diseases. Companies have subsequently sold the vouchers to each other for as much as $350 million.) Submit with new drug application
Fast track 1997 Additional opportunities for interaction with the FDA; rolling review (drug company can submit parts of new drug application before whole application is complete) Drug must treat a “serious condition” and there must be some preclinical or clinical evidence that it has “the potential to address unmet medical need.” Submit with investigational new drug (IND) application at earliest
Breakthrough therapy 2012 FDA will provide “intensive guidance on efficient drug development” and will involve senior management to “expedite the development and review” of the therapy. The designation also comes with rolling review. Drug must treat a “serious condition” and clinical evidence must “demonstrate substantial improvement on a clinically significant endpoint(s) over available therapies.” Sometime between the investigational new drug (IND) application and the end of Phase 2 trials
NH Very promising science bavi has the goods. I would put a high premium on SUNRISE approval. Which I have.
Thank you
We need a glowing bright morning STAR
I expect this to grow by next couple QTS
103 Institutional Holders
36,489,018 Total Shares Held
eb0783 I think my mind was drifting towards the beta bodies because of the virus ability to move and spread so fast as a more efficient
MOA.
Setting up websites to sell Bavi for in vitro lab work is interesting. Adds to legitimacy. But for influenza as related disease?
Progression-free survival (PFS) is a measure of the activity of a treatment on a disease. It is the time that passes from a certain date (generally the first day of treatment, or the day in which a patient is enrolled in a clinical trial) and the date on which disease "progresses" or the date on which the patient dies, from any cause. PFS can only be measured in patients in which a tumor is present[dubious – discuss] (a similar term that applies to patients that have been successfully operated, and are therefore free from disease, is Disease-Free Survival).
Time to progression (TTP) does not count patients who die from other causes but is otherwise a close equivalent to PFS (unless there are a large number of such events).[1] The FDA gives separate definitions and prefers PFS.[2]
PFS is widely used in oncology.[3] Since (as already said) it only applies to patients with inoperable disease[dubious – discuss] that are generally treated with drugs (chemotherapy, target therapies, etc.) it will mostly be considered in relation to drug treatment of cancer.
A very important aspect is the definition of "progression" since this generally involves imaging techniques (plain radiograms, CT scans, MRI, PET scans, ultrasounds) or other aspects: biochemical progression may be defined on the basis of an increase in a tumor marker (such as CA125 for epithelial ovarian cancer or PSA for prostate cancer). At present any change in the radiological aspect of a lesion is defined according to RECIST criteria. But progression may also be due to the appearance of a new lesion originating from the same tumor or to the appearance of new cancer in the same organ or in a different organ.
Progression-free survival is often used as an alternative to overall survival (OS): this is the most reliable endpoint in clinical studies, but it will only be available after a longer time than PFS. For this reason, especially when new drugs are tested, there is a pressure (that in some cases may be absolutely acceptable while in other cases may hide economical interests) to approve new drugs on the basis of PFS data rather than waiting for OS data.
PFS is considered as a "surrogate" of OS: in some cancers the two elements are strictly related, but in others they are not. Several agents that may prolong PFS do not prolong OS.
CP Patents are often extended when a drug is approved beyond their original expiration date.
But as far as I know the way to make the Bavituximab molecule has not been disclosed (other then in the patent) in sufficient extend for others to be able to make it. (this statement could use some confirmation from other nut I think there is a 15 years period in which PPHM can keep that secret !!!!).
CP Your are correct SK sated in one of the CC'S in referencing AZN they were not in the first pole position as in race car.
That statement had a lot packed into it for the discerning ear.
CP who do you think is in the first pole positioned as commented by SK on a previous CC regarding AZN not being?
eb0783 AF is like a sack of sh*t rolling down the hill @ 20 MPH you can smell him comming 10 miles away. The air is fresh, crisp and clear right now.
Has anyone contacted any of these retail outlets and inquired about there operation etc?
CJ this is why confidence is very high. EOM
Approval means net effect of a wealth transfer.
BIO These numbers are very attainable upon approval from the starting block. I agree.
It's best to be prepared for what conditions on approval with Bavituximab. Maybe if just approved for 2nd line NSCLC the initial spike to $20 ...but we must start to consider off label use and the more off label conditions, could bring us to $40+ for that initial spike.
The poison pill EOM
cheynew I am comfortable with this possibility
CONCLUSION
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PPHM knows the above and in MORE detail because they have one invaluable source that we do not have and which allows this puzzle to be laid-out.
They have the EXACT enrolment dates for each patient (without ID double blinded trial) and the eventing totals (without patient ID). If you have that a lot of the guessing work disappears. That is why they are already busy with Avid III and seem not to hesitate to start other Doce+Bavi trials. They now they'll capture the SOC for NSCLC and Breast behind what IO can put down today on the same large foot-prints. AIMO.
EXcuseme4 Bingo! Very real possible scenario.
It is precisely because the market is performing bearishly that PPHM would garner extra attention and extra PPS. People are looking for bright spots or some ray of hope in a gloomy market. PPHM could very well be that ray of hope with a simple PR proclaiming their recent successes.
Spent several hours today reviewing all the videos and poster presentations on Bavi and it's MOA. Remarkable science. Yes we have a winner.