Biscayne Pharmaceuticals, said today it has merged with Insero Health, a developer of new treatments for epilepsy, pain, and other CNS disorders, for an undisclosed price.

The deal adds a clinical-stage new epilepsy development program and other CNS programs to Biscayne’s pipeline of drug candidates for cancer and other conditions based on growth hormone-releasing hormone (GHRH) analogs.

Biscayne is developing GHRH antagonists that inhibit tumor growth by blocking the activity of tumoral GHRH. The treatments are based on work by scientific co-founder, Nobel laureate Andrew Schally, Ph.D., who discovered that cancer cells also have GHRH receptors and produce GHRH on their own.  In xenograft studies, the GHRH antagonists showed excellent safety and promising antitumor activity in a range of cancers, the company said, adding that it believes they may have therapeutic potential in multiple types of difficult-to-treat tumors.

Biscayne is also developing GHRH agonists as a potential treatment for cardiac damage resulting from heart attacks and other cardiovascular disorders. Biscayne’s GHRH agonists act on GHRH receptors that are present on heart muscle cells to enhance the activity of GHRH, with the goal of helping to produce healthy new heart tissue.

Insero's lead compound, BIS-001, is an acetylcholinesterase inhibitor (AChE) that is a synthetic form of a single agent traditional Chinese medicine. According to Biscayne, BIS-001 has demonstrated striking efficacy in highly predictive models of difficult-to-treat epilepsies, such as Dravet syndrome and refractory complex partial (focal) seizures.

An Insero Phase I study in adults with drug-resistant complex partial epilepsy showed BIS-001 to be safe and well-tolerated, and blood levels necessary for development of an extended release form of the drug were established, Biscayne added.

“With a Phase Ib/IIa proof-of-concept epilepsy trial planned for 2016, our lead cancer compound entering initial IND-enabling studies and an expanded, highly experienced management team in place, we believe we are well-positioned to launch the series B financing that will enable us to advance these high potential programs,” Samuel Reich, a co-founder of both Biscayne and Insero health, said in a statement.

Reich will retain the position of executive chairman of the combined companies as a result of the merger while Insero’s former CEO Stephen Collins, M.D., Ph.D., has become president and CEO of Biscayne.








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