RXi Pharmaceuticals
Corporation RXII, a biotechnology company focused on discovering,
developing and commercializing innovative therapies addressing major unmet
medical needs using RNA-targeted technologies, today announced that it has
entered into an assignment and exclusive global license agreement with Hapten
Pharmaceuticals, LLC 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 2a trial to evaluate the efficacy and safety of
Samcyprone™ for the treatment of viral warts has been completed and Phase 2a
trials for the treatment of cutaneous metastases of various cancers including
melanoma and for the treatment of alopecia areata are underway.
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"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, Lifetime Professor of Dermatology at Rockefeller
University. He further added, "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."
Under the terms of the Agreement, 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.
"Following the release reporting the Company's good progress in our Phase 2a
program with RXI-109, our sd-rxRNA® compound for treatment of hypertrophic
scars and keloids, I am very pleased to also announce the acquisition by RXi
Pharmaceuticals of Samcyprone™, a Phase 2a product. Samcyprone™ is a
proprietary formulation of DPCP, a new chemical entity (NCE), being evaluated
in clinical trials in the USA for treatment of alopecia areata, warts, and
cutaneous metastases of malignant melanoma," said Dr. Geert Cauwenbergh,
President and CEO of RXi Pharmaceuticals. He added that, "Samcyprone™,
currently in clinical development by Hapten Pharmaceuticals, provides RXi with
a second Phase 2 asset for its development pipeline. The published therapeutic
benefits of DPCP in the targeted diseases dramatically increase the likelihood
of a successful development pathway for Samcyprone™ which should result in
favorable safety and efficacy as well as providing for adequate exclusivity
once the product is marketed."
At closing, the assignment and exclusive license of Samcyprone™ to RXi will
immediately add a second clinical development candidate that comes with some
unique features:
1. Many world class academic dermatology centers use DPCP topically as an
unregulated experimental tool in alopecia areata, warts and cutaneous
metastases of malignant melanoma. This experience supports the efficacy of
DPCP as the active ingredient and should significantly increase the
likelihood of successful clinical development of Samcyprone^™ as a drug
product;
2. DPCP is a new chemical entity under a U.S. IND. Samcyprone^™, the
proprietary formulation of DPCP, should provide a favorable safety profile
while providing a consistent cGMP formulation. It is expected to achieve
market exclusivity post approval; and
3. Multiple synergies exist between RXi's sd-rxRNA® platform and Samcyprone™.
The mechanism of action of Samcyprone™ is linked to DPCP's ability to
alter the expression of multiple genes and miRNAs involved in the immune
response. These gene targets may be modulated by an RNAi approach,
utilizing sd-rxRNAs, to further enhance Samcyprone's™ efficacy and
response rates. Additionally, this approach may result in the discovery
and development of sd-rxRNA or other drugs that are more potent and
selective for treatment of alopecia areata, warts or cutaneous metastases
of malignant melanoma.
In addition, the Company announced that it has entered into a new purchase
agreement with Lincoln Park Capital Fund, LLC, 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.
Additional information is available within a shareholder Q&A document that may
be found on the "Investors" section of the Company's website,
www.rxipharma.com.
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