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Not from scratch. If they do find an extended release formulation that can pass into circulation unharmed (big IFs for anybody) they now know that it should do something with tumors. Of course we do not know if that something is good enough.
Notice, I am not saying that K trials were perfectly designed, timed and executed. Nope, but they were not total waste of time and money.
I absolutely agree. Kevetrin should be put on ice (even oral formulation) until Brilacidin and prurisol situations are resolved.
RD, you are not that s.... They needed to see if Kevetrin works in human.
IF every drug candidate that worked in animal models would have worked in actual subjects we would all be cancer free. Furthermore, everything that walks, runs, crawls, flies or swims would also be cancer free.
Predictable and anticipated result for Kevetrin trial.
Quote from filing at clinicaltrials.gov
Incidence of Treatment-Emergent Adverse Events [ Time Frame: 6 Weeks ]
Reporting of Adverse Events, and severity of adverse events
Evaluate changes in biomarkers between pre-treatment sample and post-treatment sample [ Time Frame: 3 Weeks ]
Changes in RNA and/or protein level of pre-specified biomarkers associated with the p53 signalling pathway and apoptosis will be compared between pre-treatment sample (tumor biopsy, ascites fluid, and peripheral blood) and post-treatment sample (tumor biopsy, ascites fluid, and peripheral blood)
This is an open label, dose-escalation trial to study the safety, biomarker changes (including modulation of p53), objective tumor response changes, and pharmacokinetics following administration of two different treatment regimens of Kevetrin over a 3-week period to subjects with platinum-resistant/refractory ovarian cancer. Following the 3 weeks of Kevetrin dosing, subjects are to be followed up for 3 weeks after completion of Kevetrin treatment. Standard of care treatment, as medically appropriate and per local guidelines, outside of this study protocol can commence after the collection of the post-Kevetrin treatment biomarker samples (collected on Day 21±1 day).
“What we and potential partners are extremely interested in is learning via tumor biopsies if Kevetrin is reaching its target and modulating pathways within the tumor that can deliver a clinically meaningful benefit; this would be a significant development in the p53/oncology dynamic,” said Arthur P. Bertolino, MD, PhD, MBA, President and Chief Medical Officer at Innovation Pharmaceuticals. “If that is indeed the case in any number of patients, we will have compelling evidence to move forward expeditiously. A next step would be to complete development of an oral formulation of Kevetrin, which is the preferred delivery method of patients and facilitates the potential for multiple daily doses.
Highly encouraging preliminary positive data from the first patients treated showed direct evidence of molecular pathways modulation in tumors. Modulation of the p53 protein was observed in response to administration of Kevetrin; pathways analyses also pointed to concomitant cell cycle modulation at the level of gene expression. The Company believes that further pathways detail and clinical tumor responses would best be observable with more frequent and potentially higher drug exposure. Thus, the Company has decided to discontinue further enrollment into the current clinical trial and consider a similar trial when ongoing efforts result in the development of an oral formulation of Kevetrin for treating cancer.
The Company previously engaged KARD to conduct specified pre-clinical studies. The Company did not have an exclusive arrangement with KARD. All work performed by KARD needed prior approval by the executive officers of the Company, and the Company retained all intellectual property resulting from the services by KARD. The Company now has its own research study capabilities and no longer uses KARD.
Agreed. I also think March/April time frame is doable, if on early side.
Rd,
Have you ever worked for big pharma? If so, can you tell me what was the longest time you had to wait to get all the decision makers onboard?
Remember that there are money magic letters associated with Juno: CAR T. Everybody wants in.
Okay. Let's put my guess this way. Probable day of Leo's 2 weeks notice: First full week of March.
IPIX trading weather forecast for the month of February:
Until the announcement all sorts of freakouts are possible. After the announcement increased probability for mostly localized breakouts of intense freakishness. And that is how is usually goes until a firm result front arrives.
Probable range: March 5th to March 16th, weight towards the end. My guess-estimate. Does not invalidate Infinity's prediction, thou. There might be a communal anxiety attack before that.
Nicely done!
I don't contest your example of the abuse of preferred shares. Surely true. But you seem to be saying that the same is an imminent risk with IPIX. I beg to differ. IPIX has some less dilutive means of financing left like Aspire 30 M common class A share purchase agreement:
Assuming that IPIX's short term activity stays at year 2017 level (around 15 M a year) IPIX has about 2 years left before desperation times come. I have assumed for solvent time: IPIX does not wind down (as they seem to be doing) their trial activities for the duration of partnership negotiations and the end of all partnership negotiations will be no deal whatsoever. Then, if IPIX is still without a partnership or funds from a patent sale, might be time to worry about preferred stocks.
Considering current convertible loan situation this can be found the latest 10-K by IPIX:
4,078,232 shares of Class A common stock into which a convertible loan in the amount of $2,022,264 and accrued interest $16,852 may be converted at $0.50 per share
Ah, you are referring to the famous ab culus analysis. I suspect the same, but let's give S. a chance.
Dear Suvorov, handicapping is usually based on some number of observations. Could you kindly enlighten us about your observations in addition to the number of registered but not issued preferred stock. It would be helpful if the forthcoming observations of yours would pertain to IPIX.
Okay. I see you point. I assumed and you assumed that I knew. Fault is mine, not yours.
Good question. To which I don't have a good answer. But if guessing is allowed:
In an effort to attract investors/partners. The selection of daptomycin over vancomycin as a comparator smells a little like an attempt to grab some attention.
I was familiar with Dryships and it's CEO's way of maintaining control of the company.The other candidate would be some company in OTC mining industry, which, as I guess you already know, does not always smell like financial Irish Spring.
As to apologizing. I don't think there has even been an insult, unless you consider being flabbergasted with somebody's preoccupation with the dangers of registered but unissued preferred stock somehow offensive.
Tsat, tsat die Bunny. Leo can't be Der Leo if he administers mushroom treatments. Das Leo at most.
Recommended reading about probable trial size for ABSSSI.
Brilacidin trial for ABSSSI would require a trial comparable to antibiotic trials. That means a larger and costlier trial than a typical cancer trial. To make things worse FDA has been a wind vane about the sort of trial it wants to see, requiring tightening non-inferiority criteria and, hence, even larger trial one day, then, surprise, saying: "well, maybe not". That flip flopping has pissed industry off and has made them abandon some promising antibiotics.
I recommend enlightening excerpt here.
Damn, this is a great board. I am getting educated every day. Thanks, loanranger, very much.
loanranger. Yes S. has. One word: Dryships - A bulk shipping company with the most manipulative CEO. At least S has been posting about the company. And some of the preferred shares story is here.
I really don't know how fair it is to equate a shipping company in the middle of decade long shipping slump to clinical stage micro cap pharma co., but one can always try :)
looking at daily OBV, aren't you? Well, OBV has memory. For the last month Fidelity's hourly OVB is positive while daily is negative. What OBV shows depends of period(s) used. One might say that daily OBV vs hourly OBV shows signs of price manipulation.
Thanks for schooling, loanranger. Was a revelation: this sword has two edges and can cut both ways: against and for.
Thanks for clarifying. About Common Class B. IPIX has those:
"Krishna Menon and Leo Ehrlich, our President and Chief Executive Officer, respectively, each have vested options that they can each exercise and convert into 18,000,000 shares of Class B common stock."
Each IPIX Class B share comes with 10 votes. That is potential 360,000,000 votes. No much point launching a hostile takeover bid.
I suspect S. does not expose himself to banking stock either. Number of them keep issuing preferred shares because big retirement funds tend to like them.
For those wondering what this particular fuzz is about - these are the usual characteristics of preferred stock:
- no voting right
- prefixed dividend payable before common dividend
- in liquidation situation redeemed before common stock
- may be callable i.e. corporation can pay them back at predetermined price.
-may be convertible to common stock at set ratio
I guess S. is worried over the non-set conversion ratio of non-issued preferred stock.
No disagreement, BTM.
BioH,
if there will be a licensing deal for B I am leaning towards
about 20 million upfront, 300 to 400 million tied with regulatory and commercialization milestones and 15 to 20 % royalty. As you said, it is their first deal plus I suspect that IPIX is looking to take at least one of their drugs thru regulatory approval by themselves. They will go for faster payments.
Over 60 %. I try to follow a simple rule for getting in: are the chances of success, in my mind, over 60 %? If they are I am in.
After IN / OUT decision I try my damndest not put more accurate number on the changes in order to avoid the delusions of glory (called also confirmation bias - one tries selectively justify position taken) which happens easily to me if I have money in. However, I do repeat my decision process every time when new data emerges. And I am still in.
George, I will be happy with anything over 25 % for PASI 75. If prurisol efficacy is capped at 100 mg BID then the range would still be there, 25 to 35, and prurisol would still be approvable. Anything above that is gravy.
Okay. Let's say 150 mg BID should land somewhere above 40 %. Your's prediction PASI 75 better than 80 % is, I am afraid, in the realm of IV biological immunosuppressants. If prurisol hits that IPIX can start printing money.
George, this may interest you. In a trial with moderate (defined as sPGA/IGA = 3) psoriasis subjects about 30 % of patients treated with Otezla scored at least 2 point drop to sPGA 0/1. We know that least 33 % of subjects with moderate psoriasis (sPGA/IGA = 3) and treated with prurisol 100 mg BID experienced similar 2 point drop.
What might these observations mean to moderate to severe psoriasis trial with prurisol dosed at 150 or 200 mg BID?
Yup! My guess range is from the last week of February to mid-March. Before that I would be surprised. After that I will get gradually nervous reaching agitated state by April 15 and bouncing off the walls by May 1st. Seriously.
I have heard the same numbers, also. And I don't expect to hear anything from IPIX before day 60.
Patience, please. Prurisol trial had 199 subjects. The last follow-up visit was reported on Dec 21, 2017, effectively less than 30 days ago.
I have been told repeatedly that the first-pass analysis of a trial of this size will take anywhere from 30 to 90 days depending on the complexity of the analysis and the resources available.
I promise to get nervous if we haven't heard anything by March 15th.
brodalumab is approved in US in second line for moderate to severe psoriasis. Valeant got approval from FDA Feb 17 2017.
In three trials with subjects having moderate to severe psoriasis about 85 % of brodalumab subject scored PASI 75 response. BUT
1. Brodalumab is administered by injection
2. Brodalumab is immunosuppressant (and seriously so)
3. Brodalumab has a FDA black box warning about induced suicidal tendencies
That 3rd point is a real baddie marketing wise.
Thanks. I forgot that one. To me CSR is a part of due diligences i.e. after CDA.
ffrol,
I don't doubt that IPIX will be as nimble as it can, but they can't help if the buyer is meticulous. I am, also, waiting the Prurisol results with baited breath and some patches of psoriasis I would love to introduce to Prurisol.
Regardless, I probably would still whine about some sort of discomfort and pain. It's in my character.
Possible, of course. But don't count on big-pharma moving fast. They don't need to. But, if Leo had CDA at hand before releasing B-OM results then I would agree that it is possible to hear something on the deal front during this quarter.
Yikes! Times I quoted were what I remembered as standard infusion times for doxorubicin and ifosfamide. I guess they gave you something else.
After writing the stuff above I went and checked and, yes, there are (off-label) infusion schedules even for ifosfamide where one is in the tubes for 24 hours straight. Must be hell.
I am afraid that people are expecting Leo to deliver lightning speed negotiations. The quote below is from "Getting Ready for a BioPharma Partnering Deal" by Linda Pullan. She was the head of oncology and hematology licensing for Amgen and before that worked in licensing at ICI/Zeneca (now AstraZeneca).
Unfortunately, getting a deal done can take a long time. After initial talks, getting a CDA can take a month or more. It might take another month for the other side to assemble appropriate team members and schedule team meetings.
It can then easily take another month for them to evaluate all the information and to decide that they will indeed go forward with the formal due diligence process. From the point when the other party has decided to go forward with term sheet negotiations, it can take another six to twelve months to get to a signature on a full agreement.
Patience. And comfort yourself with another quote from Dr. Pulla:
"the faster a deal progresses the more likely it is to come to a successful conclusion."
DaubersUP, I am guessing that 180 min infusion time is on the long side. I have seen times like 30 - 60 min, but those are for chemo. No idea at all what it might be for biologicals. I hope somebody knows better.