Innovation Pharmaceuticals Inc (IPIX)

[DaubersUP]

Most recent ORAL MUCOSITIS deal:

Onxeo is entitled to an immediate $1.0m license fee and to future milestone payments that could reach up to $108m subject to the achievement of the agreed upon milestones, including $15.5m related to regulatory milestones, from phase III to registration. Escalating royalties on sales up to a 2-digit percentage are also part of the agreement.

https://globenewswire.com/news-release/2017/09/13/1120117/0/en/Onxeo-Grants-Exclusive-Worldwide-License-of-Validive-Developed-for-the-Treatment-of-Oral-Severe-Mucositis-to-Monopar-Therapeutics.html

NOW LOOK AT THE DATA:
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The completed Phase 2, multi-center, double-blind, randomized, placebo-controlled, three-arm study (NCT01385748) compared the efficacy and safety of Validive® 50 microgram (µg) and 100 µg mucoadhesive buccal tablets (MBT) to placebo in patients with head and neck cancer receiving chemoradiation therapy.

The full dataset from 183 patients (121 patients treated with Validive® and 62 patients given placebo) demonstrate that Validive® treatment reduces the incidence of SOM grade 3 or 4, with a good safety profile. While the findings were not statistically significant, all criteria – the observed differences in the incidence, in the dose of radiation before occurrence of severe mucositis and time to occurrence – were all going in the same direction, supporting the initiation of future confirmatory studies, leading the trial’s Advisory Board to approve further investigation in a Phase 3 trial.

The Phase 2 study found that SOM developed in fewer patients receiving Validive® than in patients receiving placebo, 45.3% and 60.0% respectively (p = 0.064). Furthermore, patients receiving Validive® who developed severe oral mucositis did so at a higher median radiation dose (60.0 Gy) compared to patients receiving placebo (48.0 Gy) (HR = 0.754; p = 0.211), indicating that Validive® prevents the onset of severe oral mucositis over a wider radiation dose range.

Safety profile of Validive® was very good, with occurrence of adverse events being similar between placebo (98.4%) and Validive® groups (90.8%). However patients treated with Validive® compared to placebo experienced less nausea (49.6% vs. 71%) and dysphagia (32.8% vs. 48.4%).
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https://www.onxeo.com/onxeo-announces-final-data-completed-phase-ii-trial-validive-prevention-severe-oral-mucositis-head-neck-cancer-patients-onxeo-offentliggor-endelige-data-fra-gennemfor/

https://meetinglibrary.asco.org/record/112356/abstract


Atleast this shows there is MONEY in this market. Only 1 Million upfront, and upto 108 Million in milestones, with DOUBLE DIGIT ROYALTIES. After looking at Onxeo and their quest to find a partner for this drug since 2015, I think they settled and just took what they could get because the actual data as stated above:

While the findings were not statistically significant

The delivery is also unusual for Validive and I have not had too much time to look into the adhesive patch placed inside your gum, but I think swish and spit would be much better.

So Validive trial was for prevention and it prevented SOM - 55%
While Placebo prevention rate was 40%

LET SEE - INTERIM Brilacidin:
B prevented OM in 78%
Placebo prevented OM in 30%


That is a big difference, and I am hoping our numbers go into the mid 80% with full topline data.


Have a great day.