Replies to post #27014 on Innovation Pharmaceuticals Inc (IPIX)

[MinnieM]

No new question has been asked. The question raised about toxicity in humans will be answered by the phase I trial. We're all anxiously awaiting the outcome since we know there is no guarantee it will work as well in humans as it did in animals. Toxicity issues are the primary reason for the trial. This is a very basic issue we are awaiting answers for. It isn't a new question.

We are already in the 3rd cohort and the trial hasn't been halted due to the typically severe toxic events that come with chemotherapy. And, it hasn't been stopped due to reaching MTD. That is truly good news.

Here's FDA trial information with the primary outcome measures quoted.

http://clinicaltrials.gov/ct2/show/nct01664000?term=kevetrin+rank=1

Primary Outcome Measures: •Maximum Tolerated Dose (MTD) of Kevetrin [ Time Frame: up to 6 months ] [ Designated as safety issue: Yes ]

A dose will be declared the MTD if at least 1 patient out of 6 patients experience a dose limiting toxicity (DLT) at the highest dose level below the maximally administered dose. Once an MTD has been established, up to 12 additional patients may be enrolled at the MTD dose level for confirmation of safety.

The maximally administered dose is if 1 or more of 6 patients experience a DLT.


•Dose Limiting Toxicities (DLT) of Kevetrin. [ Time Frame: up to 4 weeks ] [ Designated as safety issue: Yes ]

The definition of dose limiting toxicity (DLT) is in accord with the NCI Common Terminology Criteria for Adverse Events v4.0 (CTCAE). Dose limiting toxicity will be defined as:
?Grade 3 or 4 neutropenia complicated by fever, or greater than 38.5°C documented infection, or Grade 4 neutropenia of greater than 7 days duration
?Grade 4 thrombocytopenia or grade 3 thrombocytopenia complicated by hemorrhage
?Any grade greater than 3 non-hematologic toxicity unless there is clear alternative evidence that the adverse event (AE) was not caused by Kevetrin
?Grade 3 diarrhea, nausea, or vomiting may be excluded from dose-limiting toxicities provided that the maximum time limit for supportive measures is 48 hours.

The secondary outcome is measuring efficacy. Anyone that doesn't realize this purchased shares for the wrong reasons since they haven't done any basic research.

I'm hoping the trial runs a long time before reaching maximum tolerated dose (MTD).

Diarrhea, nausea, and vomiting are considered toxic side effects. But, they usually aren't the type to limit dosing unless they go on with supportive measures for a couple of days after dosing. Most realize this isn't considered SEVERE toxic side effects.

I'm lactose intolerant and a delicious bowl of ice cream gives me diarrhea at times. If I'm willing to risk that for ice cream I sure won't hesitate to risk it for a cancer treatment.

Btw, I'm only in with what I can afford to lose. I'll get more once we know kevetrin and/or prurisol works in humans as it did in animals. Hedge funds will get in at that point too. Volume will rocket up at that time.

Good luck all...

[Pepsiman2001]

Reread his posts Eric. He hasn't said anything that isn't already common knowledge and the express reason for Clinical trials in the first place. The whole "not understanding MOA and which cancers to target or not? Thats why K is so special. They haven't been able to find cancers it hasn't worked against (so far). More about regurgitating common knowledge while trying to get as many big words in a post as possible. Manipulation at its finest.

Edited: is suppose to be isn't lol

[BonelessCat]

I don't see it that way at all. It wasn't the message, it was the method and style of delivery. It was also the refusal to acknowledge explanations and the constant spinning to be right.

As I said in a previous post, I was not aware that one of the drugs in the Nutlin family actually did have success, though the study took 3 years to complete. Also, once I found the correct clinical trial ID, not RG7112, I discovered that there are 4 new (7 total) follow-on trials after the first and second completed clinical trials. The first trial I found had stalled in Phase 1, as I stated, but a new trial started and there was a second version which has been successful (flies in the face of the statement about only getting one chance to prove a drug).

Exposure to facts is welcome, including those that shed light on possible problems. What's not appreciated is entrenchment and distortion to make one's case.

Perhaps part of the attack against him and his posts is a kind of a shoot the messenger thing going on? A kind of textbook exhibit of cognitive dissonance - where exposure to facts that challenge deeply entrenched beliefs and assumptions is so painful, that people will react irrationally in order to avoid exposure ( i.e., the earth is flat).

[P53dragon]

That was some funny logic, eric

If someone yells FIRE FIRE in a crowded theater, in a way I guess you can thank him for bringing up fire hazard awareness, that is to say, if you have survived the stampede.

Usually, on this forum, when posters mis-present or misrepresent something--for instance, pepsiman's most recent post has factual mistakes--I let it slide because some people may have some fuzzy thinking here and there like we all do.

But, there is a big difference between FACTS and STRONG BIAS AGAINST THE FACTS. What is sad is that some people actually KNOWINGLY mis-present and misrepresent!

[bunky]

I totally agree with your post...makes a ton of common sense'''

BOH...CharlieB