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Trex's new generics portfolio offers products tailored to patients with type II diabetes, including: TEXTOL (metformin), TEXTIEM (insulins), PLUS (metformin insulin). Trex's diabetes and asthma drug offering will also include: TEXTRON (insulins), PLUS EXCLUSIVE (insulin for asthmatics), and TEXTRON PLUS EXCLUSIVE (insulin for asthmatics). As described in our June 16, 2015 letter to investors, the following products will be in development if and when approved by the FDA.
Trex's new drugs currently under development include:
TEXTRON TEXTOL
Trex's TEXTRON, also known as glinide, is a rapidly acting high dose insulin that we developed on this product in late 2004. TEXTRON will be the most potent insulin in Trex's portfolio and is currently being used for patients with Type I diabetes low blood sugar and high pressure (previously known as Type III diabetes) who typically produce less insulin than Type I predialysis patients.
Trex expects to bring market TEXTRON within one year of the filing date for our new insulin product, and intends to begin commercially introducing it in the United States within two years of the filing date. Company recently received data from its clinical trial of TEXTRON, including data from patients being randomized to TEXTRON or Insulind in a Phase 1a study. The TEXTRON study concluded earlier this month with a result indicating statistically significant increase in the rate of insulin release after 30 minutes, which Trex plans to present at a later date.
Trex announced at an investor conference in late June that the FDA had approved TEXTRON for patients with insulin-dependent Type I diabetes the onset of symptoms or other signs heart disease. Further, after filing a new drug application with the FDA in July 2015, Trex announced that the FDA had approved TEXTRON for use in diabetes with onset of symptoms associated atherosclerosis. TEXTRON
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Trex's TEXTRON is in a four-week Phase 2a trial that evaluated the safety aspects of treatment to patients with Type II diabetes who are at high risk Ventolin 100mcg $145.26 - $24.21 Per pill for serious complications such as death or acute heart attack. TEXTRON is currently in its 12 month Phase 2b trial which is evaluating the best tolerable combination of insulin for diabetes with increased glucose in the blood compared to TEXTRON.
Trex has conducted a
generic drugstore job hiring Phase 2b oral TEXTRON-D study for patients with Type II diabetes an insulin-to-glucose ratio of 12 or greater. We expect to commence enrollment in the Phase 2b trial late 2017 and have approximately 240 patients included in the study at completion of this phase 3 study.
Trex announced at an investor conference in late June that, with the approval of current TETRON, we expect to begin enrolling in a Phase 3 trial of TEXTRON in the treatment adults and children with insulin resistance to determine the therapeutic benefit for both Type II diabetes and I diabetes. This phase 3 trial will evaluate the best tolerable combination of insulin for both Type I diabetes and III, or insulin-requiring, diabetes. If successful, the trial will enroll more than 850 patients and evaluate the clinical benefit associated with both Type I diabetes and II diabetes.
Trex's Phase 3 trials to date have been done in patients with Type III diabetes. TEXTRON entered one of these trials in patients who do not comply with the insulin protocol of their current medication regimen either due to inability tolerate or failure adhere to the insulin program. Trex expects to conduct a second phase 3 trial in patients who comply with the insulin program of their current medication regimen.
Trex has announced that it plans to initiate pre-clinical and clinical studies of drugs targeting type II diabetes with a view to establishing new drugs in these types of disease three or more major drug class therapeutic domains. These drugs are to be licensed another company for further development. Trex continues to plan the development of these specific drugs.
For additional information on Trex's portfolio of new and previously launched diabetes products including TEXTOL and TEXTRON, visit www.trexa.com/pharma. Interested investors can speak directly with a.
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