Wednesday, September 11, 2013 10:57:57 PM
A Biotech newsletter writer who really follows the science behind cancer has added CTIX to his list. He had actually put it on his watchlist when speculation about major pharma interest showed up in an SA piece a few months ago (and because of the p53 connection).
Any way it might interest you that put a buy recommendation on CTIX with a price target of $4.
Here is something in the letter that concluded what I was thinking of posting earlier today as I went through Polymedix stuff on Bralicidin. Polymedix, before it went under, was going to focus the continuation of clinical studies on the infection of the oral mucosa following radiation treatment for head and neck cancer. I wondered if this was a reason for CTIX' interest. He seems to think so. I copy the relevant info from Polymedix here as well as the link for any who is interested.
Best regards to all.
http://files.shareholder.com/downloads/ABEA-4ITCYZ/2675371836x0x556268/4772089E-3CE5-4BCD-A950-AF3FC7098211/Corporate_Presentation.pdf
Brilacidin--Opportunity for Use in Human Oral Mucositis
31
• High efficacy in preventing ulceration in widely used, established
model of oral mucositis
• Robust and highly reproducible activity – clearly outperforms
other compounds tested in model
• Easy to use topical delivery (mouthwash)
• User friendly; easy complement to normal hygiene regimen
• More direct translation from animal model to human setting
• Favorable Pre-IND FDA communication
• Outlines clinical & regulatory path
• Planned clinical study in patients in 2013
• Significant commercial opportunity and favorable competitive
landscape
Phase 2 Oral Mucositis – Planned Protocol
Phase 2, Multi-center, Randomized, Double-blind, Placebo-controlled
Control and prevent oral mucositis in patients with Head and Neck Cancer
receiving chemotherapy and radiation therapy
“Swish and spit” brilacidin 3x/daily for 7 weeks – 15 ml oral mouthwash
60 patients – 30 each of drug or placebo
Primary endpoint: proportion of patients with clinically observed severe
ulcerative mucositis (WHO grade > 2) at a cumulative radiation dose of 55 Gy
Secondary endpoints: health resource use/pharmacoeconomics; mouth soreness
Additional dose regimen possible
Brilacidin for Oral Mucositis - Summary and Perspective
Oral mucositis caused by cancer therapy is:
• Painful and debilitating, costly, and an unmet medical need
• An attractive commercial opportunity based on incidence and pricing opportunity
An oral rinse of brilacidin for ulcerative oral mucositis:
• Brilacidin displays robust and reproducible efficacy in relevant animal model
• Topical formulation may translate more predictably to human setting
• Easy-to-use mouthwash
Clinical path for oral mucositis:
• Pre-IND FDA communication suggests that clinical trial can be initiated in patients
• Possible accelerated program with one phase 3 study
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