Summary of CTIX's Research and Upcoming Catalysts (8/19/15)
CTIX has 3 drugs in 4 clinical trials for 4 different applications.
1) Brilacidin: flagship of the first new class of antibiotics since 1987. First clinical trial has shown that one intravenous dose is as effective on horrible possibly fatal skin infections (ABSSSI) as the current standard of care antibiotic, which takes 7 infusions and is usually done in a hospital. This means that they can give patients one dose of the new antibiotic and send them home -- saves a hospital stay. (Unless they are so sick that they need other supportive care.) This is just the first infection it's being tested on -- there will be others down the road. They have QIDP designation from the FDA* (see footnote)
2) Brilacidin-OM: That same antibiotic seems to have powerful anti-inflammatory properties too. A clinical trial in several hospitals is for cancer patients who develop terrible debilitating mouth ulcers (oral mucositis) from chemotherapy or radiation. These often are so bad that patients have to discontinue chemo or they are hospitalized with feeding tubes. The current standard of care is ice chips. The animal studies, done on hamsters which are very similar to humans in the way they react to radiation, showed a tremendous reduction in the number of animals who developed oral mucositis, and the severity of any lesions was greatly reduced. It's easy to administer, in humans as an oral rinse. Virtually every chemo or radiation patient would be a candidate to use this. It's being tested initially in head and neck cancer patients, who almost always develop these lesions.
3) Kevetrin: A novel cancer drug which seemingly activates the p53 gene, the "guardian angel" gene that kills cancer cells. In many cancers, the tumors manage to turn off this gene. In Phase 1 safety trials with terminally ill Stage 4 cancer patients, we know anecdotally that one ovarian cancer patient had a metastatic spleen lesion "disappear" with some scar tissue as the only trace of the tumor. We know that a man with the rare cancer of the thymus, thymoma, is still alive after 11 months of dosage, with shrinkage of his tumor. This is from the Phase 1 SAFETY trial, where the dosage and timing has not been optimized. He's been getting only 1 dose a week -- probably several doses a week would be optimal -- and yet has had these results. We know that the company is focusing on ovarian cancer and lung cancer, and maybe now with this info, perhaps thymoma, for their Phase 2 trials. However, they are still in Phase 1 trials (at Dana-Farber) because even though they are now giving doses that are 75 times the initial dose, there has been no dose-limiting toxicity. They hinted in a press release that they think that "further increases in dosage" won't have MORE effect than what they've given already (meaning they've seen efficacy). They also stated in a press release that they "presented evidence of efficacy to the FDA." They have Orphan Drug designation for the ovarian cancer use.
4) Prurisol: had remarkable effect treating or perhaps curing psoriasis in rats. Human trials have recently started. This seems to be the drug no one pays much attention to, as it is least far in human trials.
*QIDP = Qualified Infectious Disease Product -- FDA grants an expedited review and 5 additional years of patent protection for QIDP designated drugs.
LIST OF CATALYSTS prepared by Sox0407
Q4 Milestones / Upcoming Catalysts
- Start of B-ABSSSI (Phase 3)
- Start of K + cytarabine (Phase 2)
- Completion of K (Phase 1)
- 10-K (mid-September)
- NASDAQ uplisting
Past Milestones
- QIDP designation for B-ABSSSI
- K orphan drug designation for ovarian cancer
- Start of B-OM (Phase 2)
- Start of P (Phase 2)
- B-ABSSSI positive Phase 2b top-line & bottom line data
- Completion of cohort 10 (450 mg/m2)
- P (Phase 1) primary endpoint met
- Stable formulation of B at room temperature
- Signed agreement for testing B in implanted devices (after FDA approval)
Clinical Trials
1. P (Phase 2, recruiting): https://clinicaltrials.gov/ct2/show/NCT024944...amp;rank=1
2. P (Phase 1, completed): https://clinicaltrials.gov/ct2/show/NCT021012...amp;rank=2
3. B-OM (Phase 2, recruiting): https://clinicaltrials.gov/ct2/show/NCT023243...amp;rank=3
4. K (Phase 1, recruiting): https://clinicaltrials.gov/ct2/show/NCT016640...amp;rank=4
5. B-ABSSSI (Phase 2, completed): https://clinicaltrials.gov/ct2/show/NCT020523...amp;rank=5
Abbreviations
K – Kevetrin
B – Brilacidin
P – Prurisol
OM – oral mucositis
ABSSSI – acute bacterial skin and skin structure infections
QIDP – qualified infectious disease product
CTIX has 3 drugs in 4 clinical trials for 4 different applications.
1) Brilacidin: flagship of the first new class of antibiotics since 1987. First clinical trial has shown that one intravenous dose is as effective on horrible possibly fatal skin infections (ABSSSI) as the current standard of care antibiotic, which takes 7 infusions and is usually done in a hospital. This means that they can give patients one dose of the new antibiotic and send them home -- saves a hospital stay. (Unless they are so sick that they need other supportive care.) This is just the first infection it's being tested on -- there will be others down the road. They have QIDP designation from the FDA* (see footnote)
2) Brilacidin-OM: That same antibiotic seems to have powerful anti-inflammatory properties too. A clinical trial in several hospitals is for cancer patients who develop terrible debilitating mouth ulcers (oral mucositis) from chemotherapy or radiation. These often are so bad that patients have to discontinue chemo or they are hospitalized with feeding tubes. The current standard of care is ice chips. The animal studies, done on hamsters which are very similar to humans in the way they react to radiation, showed a tremendous reduction in the number of animals who developed oral mucositis, and the severity of any lesions was greatly reduced. It's easy to administer, in humans as an oral rinse. Virtually every chemo or radiation patient would be a candidate to use this. It's being tested initially in head and neck cancer patients, who almost always develop these lesions.
3) Kevetrin: A novel cancer drug which seemingly activates the p53 gene, the "guardian angel" gene that kills cancer cells. In many cancers, the tumors manage to turn off this gene. In Phase 1 safety trials with terminally ill Stage 4 cancer patients, we know anecdotally that one ovarian cancer patient had a metastatic spleen lesion "disappear" with some scar tissue as the only trace of the tumor. We know that a man with the rare cancer of the thymus, thymoma, is still alive after 11 months of dosage, with shrinkage of his tumor. This is from the Phase 1 SAFETY trial, where the dosage and timing has not been optimized. He's been getting only 1 dose a week -- probably several doses a week would be optimal -- and yet has had these results. We know that the company is focusing on ovarian cancer and lung cancer, and maybe now with this info, perhaps thymoma, for their Phase 2 trials. However, they are still in Phase 1 trials (at Dana-Farber) because even though they are now giving doses that are 75 times the initial dose, there has been no dose-limiting toxicity. They hinted in a press release that they think that "further increases in dosage" won't have MORE effect than what they've given already (meaning they've seen efficacy). They also stated in a press release that they "presented evidence of efficacy to the FDA." They have Orphan Drug designation for the ovarian cancer use.
4) Prurisol: had remarkable effect treating or perhaps curing psoriasis in rats. Human trials have recently started. This seems to be the drug no one pays much attention to, as it is least far in human trials.
*QIDP = Qualified Infectious Disease Product -- FDA grants an expedited review and 5 additional years of patent protection for QIDP designated drugs.
LIST OF CATALYSTS prepared by Sox0407
Q4 Milestones / Upcoming Catalysts
- Start of B-ABSSSI (Phase 3)
- Start of K + cytarabine (Phase 2)
- Completion of K (Phase 1)
- 10-K (mid-September)
- NASDAQ uplisting
Past Milestones
- QIDP designation for B-ABSSSI
- K orphan drug designation for ovarian cancer
- Start of B-OM (Phase 2)
- Start of P (Phase 2)
- B-ABSSSI positive Phase 2b top-line & bottom line data
- Completion of cohort 10 (450 mg/m2)
- P (Phase 1) primary endpoint met
- Stable formulation of B at room temperature
- Signed agreement for testing B in implanted devices (after FDA approval)
Clinical Trials
1. P (Phase 2, recruiting): https://clinicaltrials.gov/ct2/show/NCT024944...amp;rank=1
2. P (Phase 1, completed): https://clinicaltrials.gov/ct2/show/NCT021012...amp;rank=2
3. B-OM (Phase 2, recruiting): https://clinicaltrials.gov/ct2/show/NCT023243...amp;rank=3
4. K (Phase 1, recruiting): https://clinicaltrials.gov/ct2/show/NCT016640...amp;rank=4
5. B-ABSSSI (Phase 2, completed): https://clinicaltrials.gov/ct2/show/NCT020523...amp;rank=5
Abbreviations
K – Kevetrin
B – Brilacidin
P – Prurisol
OM – oral mucositis
ABSSSI – acute bacterial skin and skin structure infections
QIDP – qualified infectious disease product
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