Kingsport, TN (June 12, 2013) – Intellectual Property Executives (IPE) announced today that it is now recruiting participants for the second phase of clinical trials for its new T3 drug to treat hypothyroidism, BCT303. BCT303 successfully completed Phase-1 in August 2012 at Georgetown University Hospital.
BCT303, classified as a 505(b)(2) drug, is a formulation improvement to the active ingredient Liothyronine Sodium, which is already approved by the Food and Drug Administration (FDA). BCT303 utilizes IPE’s patent-pending platform technology for sustained effects and improved stability.
IPE utilized the same platform technology to formulate its T4 drug candidate, BCT304, and its Reverse-T3 drug candidate, BCT305, both of which are ready for IND submission. It has also identified additional 505(b)(2) applications, including treatments for pain-relief and anti-inflammation.
The purpose of this Phase-2 study is to test the efficacy of BCT303, a new thyroid hormone preparation. The thyroid gland produces two thyroid hormones: mostly T4 and a smaller amount of T3. Thyroid hormone therapy for hypothyroidism or thyroid cancer is generally provided using levothyroxine, which is a synthetic form of T4. T4 is converted into the active hormone T3 in the circulation. Therefore, some researchers believe that T3 levels in T4-treated patients may be slightly lower than in individuals whose own thyroid gland is functioning normally. Symptoms of hypothyroidism have been suggested to occur because of this possible T3 deficiency, although this is controversial.
Studies of T3, added to or substituted for T4 in traditional levothyroxine regimens, have generally not shown any benefit of T3. However, it is still possible that no benefit is seen because of the short duration of action or “half-life” of T3. This short-life makes it necessary to dose T3 twice or three times daily. Despite multiple daily doses of T3, T3 levels during its therapy tend to be troubled by peaks and troughs. These peaks can be associated with symptoms of excessive thyroid hormone levels.
This study will look at TSH and thyroid hormone levels following a daily dose of a new preparation of T3 that may have longer duration of action than liothyronine. This preparation of T3 is called Thyromax® or BCT303. The investigators believe that steady levels of T3 will be seen after taking Thyromax®. The investigators believe that in patients with hypothyroidism use of Thyromax® in the correct dose will produce normal TSH levels, without producing symptoms of too much thyroid hormone. The goal of future studies is to test whether Thyromax® may be a potential treatment for hypothyroidism, by comparing it with traditional levothyroxine therapy.
Visit http://ipeamerica.com/bct303-clinical-trials to learn more about the Phase-2 clinical trial.
Intellectual Property Executives (IPE) is a pharmaceutical technology discovery and development corporation located in Kingsport, Tennessee, USA. For more info on IPE’s portfolio of patented technology and pipeline of drug candidates, go to http://www.ipeamerica.com.
IPE’s Drug Development Featured in the Johnson City Press on March 22, 2013:
“Local drug maker hopes to impact major diseases”
Levothyroxine has been considered the standard of care for treatment of hypothyroidism for many years. This treatment is easy to administer, efficacious, has a long serum half-life, and results in resolution of the sign and symptoms of hypothyroidism in the majority of patients. However, a proportion of patients being treated for hypothyroidism do not feel that they have been returned to optimum health by their therapy. The purpose of this meeting is to re-examine the evidence concerning alternatives therapies other than levothyroxine, to discuss gaps in our current knowledge of these therapies, and to determine whether new data provides reason to pursue these therapies.
Recent advances in our understanding of the thyroid physiology will be the focus of the basic science component of our program. Featured topics will include the sources and regulation of T3 within specific tissues, advances in measuring T3, and the regulation of TSH by T3 (see description of basic science program).
The clinical day of the conference will review the goals of levothyroxine therapy and examine sources of dissatisfaction with levothyroxine therapy. The latest data regarding combination therapy, T3 monotherapy, compounded thyroid hormones, nutraceuticals, and thyroid hormone analogs will be presented. Pharmacology and regulatory aspects of these therapies will be discussed. The potential for genetic variations to influence the ability to optimize thyroid hormone therapy will be explored. The challenges of titrating thyroid hormone therapy in specific groups such as the pediatric, pregnant, and elderly populations will be considered.
We hope that the 2013 Research Summit and Spring Symposium will help translate the latest basic and clinical research in thyroid hormone metabolism, transport, and action into recommendations for clinicians managing hypothyroid patients by exploring both the role of traditional thyroid hormone replacement therapy and alternatives to the use of levothyroxine alone.