Phase III, Dignan?

A board to discuss future MS therapies in early stage (Phase I or II) trials.

Phase III, Dignan?

Postby leeeeeway » Sun Jun 24, 2007 12:22 pm

Hi Dignan et al,
I haven't posted or read for a long time...pls excuse any data that may need repeated here but could you off the top of your head update when the drugs currently in phase III might be available? You did did this for me last September and the info has been invaluable.

Lee
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Postby Frank » Sun Jun 24, 2007 1:43 pm

Hello Lee,

when everything goes on fine, the soonest I would expect some new MS drugs is late 2009 or early 2010.

It takes month to recruit participants, then Phase-III trials in MS usually have a treatment period of two years, followed by an analysis period and the approvement process.

The next dugs I would expect on the market are FTY720, MBP8298 (SPMS) and Cladribine (oral).

--Frank
Treatment: Gilenya since 01/2011, CCSVI both IJV ballooned 09/2010, Tysabri stopped after 24 Infusions and positive JCV antibody test, after LDN, ABX Wheldon Regime for 1 year.
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Postby dignan » Sun Jun 24, 2007 7:10 pm

What Frank said...I'll add that Mylinax and MBP8298 both completed phase 3 enrollment in January 2007, so those 2 are clearly in the lead over the rest. To my knowledge, none of the others have yet completed phase 3 enrollment. Based on that, either of those drugs could be available in the second half of 2009, but I imagine that could easily slip to 2010. The other drugs I mentioned last time you asked are all on about the same schedule. I suppose the one I'm most surprised about is teriflunomide, as I thought it would be about even with mylinax, but it's falling behind now.
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Postby leeeeeway » Tue Jun 26, 2007 2:59 pm

Thanks Dignan and Frank...
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How about rituxuan?

Postby Smilingface » Thu Jul 12, 2007 2:01 pm

The OLYMPUS trial should end by November. I heard some talk about another
Phase 3 with Rituxuan with a different measure of disability, but haven't been able to confirm that. Any thoughts out there???
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Postby dignan » Thu Jul 12, 2007 3:14 pm

I don't know much about the rituxan trial. You (smilingface) know more than I do. I notice that they expect to report the results of the trial in the first half of 2008, which makes sense based on what you say about the trial ending in November of this year. Your question about another trial brings up another question that I have: do you have to conduct at least 2 phase 3 trials to get approval? I have a feeling you do and that's why we see a lot of phase 3s where there is one trial vs placebo and another trial vs one of the CRABs.
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Postby Lyon » Thu Jul 12, 2007 5:26 pm

Hi dignan,
This topic has come up before and I've never been able to find anything documenting the need for more than one phase III http://www.fda.gov/cder/about/smallbiz/faq.htm
Phases of an Investigation

An IND may be submitted for one or more phases of an investigation. The clinical investigation of a previously untested drug is generally divided into three phases. Although in general the phases are conducted sequentially, they may overlap. The three phases of an investigation are as follows:

Phase 1 includes the initial introduction of an investigational new drug into humans. These studies are usually conducted in healthy volunteer subjects. These studies are designed to determine the metabolic and pharmacological actions of the drug in humans, the side effects associated with increasing doses, and, if possible, to gain early evidence on effectiveness. Phase 1 studies also evaluate drug metabolism, structure-activity relationships, and the mechanism of action in humans. The total number of subjects included in Phase 1 studies is generally in the range of twenty to eighty.

Phase 2 includes the early controlled clinical studies conducted to obtain some preliminary data on the effectiveness of the drug for a particular indication or indications in patients with the disease or condition. This phase of testing also helps determine the common short-term side effects and risks associated with the drug. Phase 2 studies usually involve several hundred people.

Phase 3 studies are intended to gather the additional information about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of the drug. Phase 3 studies also provide an adequate basis for extrapolating the results to the general population and transmitting that information in the physician labeling. Phase 3 studies usually include several hundred to several thousand people.
If drug companies aren't required to hold more than one phase III, why would they voluntarily endure the time and, what to us laymen seems the huge cost of another phase III?

The clinical trial process has become more than just a requirement to prove safety and efficacy to the FDA. The drug companies have huge amounts invested to get their product to that point and the clinical trial process is also the only way they can prove to themselves whether or not the results justify the upcoming costs of production, advertising and distribution. What we see as the huge cost of another phase III is small change compared to accepting those costs without confidence that their new drug will pull a sizable market share from the current drugs. Maybe that's why the obvious phase III against one of the crabs has become so obvious?

I don't think you're going to see a second phase III in a hands down winner against the crabs.

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Postby leeeeeway » Sun Jul 15, 2007 3:45 pm

So envision this: Your company has spent $10 Million on developing the next MS drug. A guy you routinely talk to at the FDA has told you "off the record" that while the latest results on that drug are fascinating at the end of the day what he uses to convince his boss is data and you know this drug only has one Ph 3 behind it and Tysabri-like retrenchments impact drug sales for years. Do you spend an additional million on another Ph 3?

This is just one possible example...

(BTW, I was surprised to see this thread running. Had not seen the phase discriptors before. Thanks!)

Lee
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Phase III again?

Postby Smilingface » Sun Jul 15, 2007 6:35 pm

Sometimes Drug Companies will conduct more than one trial if the results the first time have shown the drug works but the results may not be black and white. For example, a cancer drug may be successful in only a certain subset of patients and the FDA might want to see it work in a broader context before granting approval. As far as rituxuan goes, the rumor I heard through the grapevine is that another parameter of success may need to be measured other than time between relapses and number of lesions to determine efficacy in progressive MS patients. Makes sense to me.
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Postby dignan » Sun Jul 15, 2007 8:09 pm

I couldn't remember where I had seen it, but I had a nagging feeling there was something out there about multiple phase 3 trials. It turns out it is Wikipedia that says something about multiple phase 3s in their "clinical trials" section, so I'm not 100% sure if it's correct:


"While not required in all studies, it is typically expected that there be at least two successful phase III trials, proving a drug's safety and efficacy, for approval from the standard regulatory agencies (FDA, TGA, EMEA, etc.). Though the current trend in recent months seems to be a move toward adaptive (live, changing) studies to expedite the process, there are no formal regulations for these trials in the pharmaceutical industry as of yet."

http://en.wikipedia.org/wiki/Clinical_trial
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