Xerecept data in 40 subjects, if consistent with the previous 17 subjects (I am not sure if the previous 17 subjects are included in the total of 40 mentioned recently by Ceo in recent letter to stockholders), but 40 or 57 is a good number of patients to see a trend.
In the first pI trial 10 of 17 showed clinical improvement, independent of steroidal action. This is clearly proven in animal studies. NTI is judiciously stopping development of xerecept for lack of funding, but not lack of faith (should I say "fact")to control expenses and focus to get Memantine to market.
xerecept has potential for: 1. brain edema secondary to tumors, not only primitive brain tumors which is the subject of NTI research, but also secondary metastasis (breast, prostate, lungs) a much bigger market segment.
2. steroids are also big problem for adults: osteoporosis, gastric ulcers bleed, muscle wasting, hypertension, hypercalcemia, hyperglycemia, cardiac muscle hypertrophy, abnormal fat deposition in the face and back, especially in the chronic use as expected in brain tumors.
3. Combination with lower doses of steroids could prove to be ideal, CRF hypotension corrected with small doses of steroids, edema decrease from synergistic effects.
4. Brain trauma edema could be a huge market, but there is less evidence for effectiveness in this area. NTI try for a while to work on this area, lack of funding again stop them.
5. One big area is vasogenic edema, the allergic and non allergic types of Angioedema, common and with poor treatment availability. There is work on CRF and angioedema, but NTI not involved to my knowledge. Does NTI has the rights to all uses of CRF?
6. NTI try and failed years ago using crf for Rheumatoid arthritis, hindsight is clear, but there are other forms of Arthritis (part of the big umbrella angioedema) that could respond to crf, but much less chances.
7. Xerecept problem is that it is a difficult molecule (like all protein hormones)relatively expensive (compare to steroids is very expensive), and probably of complex manufacturing, and difficult delivery (injections, aerosols). But everything in biotech is expensive and complex.
It is very probable that different peptide versions of it could be developed to be more specific to the desired function, this imply more time and expense. A partner in development is obviously the route to go.
Memantine is the double digits, but xerecept could be the one to take NTI further ahead. Ok, I will not mentioned Dynorphin Again
Happy turkey.
|