I sure hope Leo can partner with someone before 2016 , if we don't get some credibility around here soon with a big pharmaceutical company this company is going nowhere as people don't want anymore excuses from Leo
look up the past and current NCT trials for tis problem. i read about 6 or 7 of them and all of them took a long time recruiting. one reason comes to mind and that is would i want to be on a placebo which guarantees a tortuous life while getting chemo and maybe a feeding tube besides? answer "no".
maybe if these people had the clout of HIV sufferers they could push for an earlier declaration of success (Gleevac).
prurisol drugs that test in europe are based in germany and the scandinavian countries because the sunshine states have the most patients. therefore i am glad to see florida and alabama on the list of sites.
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
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