Replies to post #223696 on Innovation Pharmaceuticals Inc (IPIX)

[PlentyParanoid]

Thanks. This helps. Learning every day.

[frrol]

Much more accurately: "Interesting BRI's efficacy is only in the higher cisplatin dose." If you're taking results at face value, the trial shows that B causes or exacerbates SOM at the lower dose (which is of course unlikely).

For the sub group results to be compelling, the company needs to try to explain why one arm performed and the other did not. So your hypothesizing was at least on the right track.

If the company doesn't acknowledge and explain, then we get the stink of "data mining" (aka cherry picking), and this management appear had enough credibility issues. Dumbed down: It's awesome B appears to work so well just for blondes, but why would that actually be? And why would non-blonde results be actually worse than (or same as) placebo?

We still have explaining to do. The company didn't handle it well.

[farrell90]

ASCO's current clinical guidelines for treatment of Oropharynegeal Squamous Cell Cancer, OPSCC, are consistent with the more recent article you posted.

Radiation and high dose Cis Platinum are the recommended treatments for advanced OPSCC and have a higher response rate than radiation and low dose cis platinum.

IPIX's prevention of OM in the high dose group is important and will correlate with the current recommended treatment of OPSCC. Lowering the morbidity of Oral Mucosidis in these extremely ill cancer patients will significantly lower weight loss, improve nutrition and lower the risk of other complications such as infection and sepsis. Points, Dr Sonis will be sure to make with the FDA when it considers IPIX for BTD.

Since no other treatment for Oral Mucositis is usually utilized and Brilacidin is a safe,oral medication, my handicapping suggests a 95% chance of approval for BTD.

Today was a very good day for IPIX.

JMO,Farrell

http://www.practicalradonc.org/article/S1879-8500(17)30045-0/fulltext

Radiation therapy for oropharyngeal squamous cell carcinoma: Executive summary of an ASTRO Evidence-Based Clinical Practice Guideline

KQ 1. When is it appropriate to add systemic therapy to definitive RT in the treatment of OPSCC?

1.In the scenario of stage IVA-B disease?

A.Concurrent high-dose intermittent cisplatin should be delivered to patients with stage IVA-B OPSCC receiving definitive RT. (Strong recommendation [Strong], high-quality evidence [HQE], percent consensus 100%) ...

Data from multiple randomized trials are consistent that concurrent chemotherapy improves locoregional control (LRC) and typically overall survival (OS) for patients with locally advanced OPSCC, regardless of fractionation approach.3 Although chemotherapy significantly increased acute toxicities, these trials did not confirm that physician-assessed late effects were worse than those after treatment with RT alone, recognizing that late complications may be challenging to study. The single randomized trial using cetuximab also confirmed LRC and OS advantages with concurrent systemic therapy.4 Because the majority of the patients in these trials presented with stage IV disease, concurrent systemic therapy should be delivered in this population of patients, with bolus cisplatin favored because of its long track record in successful large multi-institutional trials and well-known and predictable toxicity profile.

Although weekly cisplatin may be an acceptable alternative to high-dose administration, the evidence suggesting a survival benefit with its use is significantly weaker and based on extrapolation rather than high-level evidence.

KQ 2: When is it appropriate to deliver postoperative RT with and without systemic therapy following primary surgery of OPSCC?

1.In the scenario of positive margins and/or extracapsular nodal extension (ECE)?
A.Concurrent high-dose intermittent cisplatin should be delivered with postoperative RT to patients with positive surgical margins (PSMs) and/or extracapsular nodal extension; this high-risk population includes patients independent of HPV status or the extent of extranodal tumor.