RXi Pharmaceuticals, a Marlborough, Mass.,-based biotechnology company focused on discovering, developing and commercializing innovative therapies addressing major unmet medical needs using RNA-targeted technologies, has entered into an assignment and exclusive global license agreement with Hapten Pharmaceuticals, an early stage dermatology product development company based in New York, for the therapeutic use of Samcyprone.
Samcyprone is a proprietary gel formulation of diphenylcyclopropenone (DPCP), an immunomodulating agent that works by initiating a T-cell response. Although DPCP is not a registered drug, it is used successfully by dermatologists as a topical immunomodulator to treat dermatological diseases. Samcyprone is expected to demonstrate an improved safety and use profile over DPCP as currently applied. A phase IIa trial to evaluate the efficacy and safety of Samcyprone for the treatment of viral warts has been completed and phase IIa trials for the treatment of cutaneous metastases of various cancers including melanoma and for the treatment of alopecia areata are underway.
"Because of its proprietary gel formulation, Samcyprone is expected to demonstrate an improved safety and usage profile over DPCP as currently used," said Dr. William Levis, professor of dermatology at Rockefeller University. "Published reports on clinical results with the use of DPCP as an experimental tool for treatment of these three difficult to treat skin conditions support the efficacy of the compound, substantially reducing the clinical risk of the ongoing product development effort."
Hapten will sell and assign to RXi certain patent rights and related assets and rights to Samcyprone. The agreement will become effective at a closing that is scheduled to occur in early 2015 and which is subject to the satisfaction of certain closing conditions. Once the agreement is effective, Hapten will receive an upfront payment payable in cash and common stock, will be entitled to receive future milestone payments tied to the achievement of certain clinical and commercial objectives and will receive royalties based on product sales.
In addition, the company has entered into a new purchase agreement with Lincoln Park Capital (LPC) Fund, a Chicago-based institutional investor, whereby LPC is committed to purchase an aggregate of up to $10.8 million in shares of RXi common stock over a 28-month term. Prior to entering this new agreement, the company and LPC mutually agreed to terminate the prior purchase agreement that was in place, with respect to the $18 million unsold balance. The company plans to use the proceeds from this new agreement with LPC to support the development of Samcyprone, as well as the advancement of the company's ophthalmology and dermatology franchises and for other general corporate purposes.