Innovation Pharmaceuticals Inc (IPIX)

[Whoops]

Cabel, I am uncertain why the B-OM gets so much of the posts about partnering etc. I believe the trial will take a long time mainly due to difficulties in recruiting. The inclusion/exclusion listed on the trial site for this trial are very detailed. I believe the reason that MD Anderson was dropped as one of the trial sites is because there is already a trial running there for the last few years for OM with another drug. Someone please correct me if they heard different? IMO CTIX has a lot of catalysts coming up but B-OM is not likely in the picture for awhile. I am not even sure if there would be a interim safety review where would could gleam over some data early???

Below are some of the inclusions/exclusions listed that jumped out at me. I not sure what most of them mean but they are detailed requiring a patient to follow a particular path of treatment for the cancer. No previous treatments for OM etc and every head and neck cancer patient would have to fall through a few hoops to qualify for the trial. Also, as I stated earlier some cancer types that are "generally" considered head/neck cancers are also excluded.

Inclusions:

Have recently-diagnosed (within previous 3 months), pathologically-confirmed, non-metastatic squamous cell carcinoma of the oral cavity and/or oropharynx, that will be treated with CRT therapy as first line treatment; scans (CAT, PET, and/or MRI) obtained within 45 days prior to consenting (screening) can be used to determine the patient's eligibility

Have a plan to receive a continuous course of conventional external beam irradiation delivered by intensity-modulated radiotherapy (IMRT) as single daily fractions of 2.0 Gy to 2.2 Gy with a cumulative radiation dose =55 Gy and =72 Gy. Planned radiation treatment fields must include at least two oral sites (buccal mucosa, floor of mouth, ventral/lateral tongue, soft palate) with each site receiving = 55 Gy [Note: the independent RTQA consultant must confirm that the planned radiation treatment meets the protocol criteria]

Have a plan to receive a standard cisplatin chemotherapy regimen administered weekly (30-40 mg/m2) or approximately every 21 days (80-100 mg/m2)

Exclusions
Has tumor(s) of the lips, sinuses, salivary glands, nasopharynx, larynx, hypopharynx or unknown primary tumor

Has metastatic disease (M1) Stage IV C

Has had prior radiation to the head and neck

Plan to be treated with induction chemotherapy before initiation of RT

https://clinicaltrials.gov/ct2/show/NCT02324335?term=cellceutix&rank=3