RXi Pharmaceuticals Expands its Clinical Pipeline with an Exclusive Global License for a Second Phase 2 Clinical Compound

Dec 19, 2014, 07:05 ET from RXi Pharmaceuticals Corporation

MARLBOROUGH, Mass., Dec. 19, 2014 /PRNewswire/ -- RXi Pharmaceuticals Corporation (NASDAQ: 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.

About RXI-109

RXI-109 is an sd-rxRNA® that targets the mRNA of connective tissue growth factor (CTGF), a gene known to modulate fibrosis and scar formation. RXI-109 is initially being developed to reduce or inhibit scar formation in the skin following surgery.  The first clinical trials with RXI‑109 (RXI‑109‑1201 and RXI‑109‑1202) showed excellent safety and tolerability with ascending single and multiple doses, as well as dose-dependent effects on the CTGF protein and on the mRNA that controls production of this protein.

Three Phase 2a clinical trials are currently underway to evaluate the effectiveness and safety of RXI‑109 on the outcome of scar revision surgeries performed on hypertrophic scars resulting from lower abdominal surgeries (RXI‑109‑1301), to evaluate the effectiveness and safety of RXI‑109 in healthy subjects who undergo an elective surgical excision of two similarly sized and placed keloids (RXI‑109‑1401) and the outcome of scar revision surgeries performed on hypertrophic scars (RXI-109-1402).

About Samcyprone™

Samcyprone™ is a proprietary immunomodulating topical gel, containing the active agent DPCP, currently in Phase 2a clinical trials for the treatment of alopecia areata, warts and cutaneous metastases of malignant melanoma.  The proprietary gel, developed by Hapten Pharmaceuticals, LLC, should demonstrate an improvement in the overall safety and tolerability profile compared to treatment with DPCP as currently used.  Typically, patients treated with DPCP are initially sensitized with a single high concentration of drug and subsequently treated with low non-irritant concentrations.  Use of high concentrations of DPCP during the sensitization dose results in hyper-sensitizing the patient to subsequent challenge doses. In contrast, Samcyprone™ uses much lower concentrations of DPCP for the sensitization dose, avoiding hyper-sensitization to challenge doses which should result in an improved safety and tolerability profile while maintaining the known efficacy of DPCP.

Additional information on Samcyprone™ is available on the Company's website and may be found on the "Technology" section of the Company's website, www.rxipharma.com.

About Hapten Pharmaceuticals, LLC

Hapten Pharmaceuticals, LLC is an early stage dermatology product development company based in New York, NY. Hapten's Samcyprone™, is a topical immunomodulator that incorporates diphenylcyclopropenone (DPCP) in a proprietary gel formulation.

About RXi Pharmaceuticals Corporation

RXi Pharmaceuticals Corporation (NASDAQ: RXII) is a biotechnology company focused on discovering, developing and commercializing innovative therapies based on its proprietary, self-delivering RNAi (sd-rxRNA®) platform. Therapeutics that use RNA interference, or "RNAi," have great promise because of their ability to down-regulate the expression of specific genes that may be over-expressed in disease conditions. Building on the pioneering work of scientific founder and Nobel Laureate Dr. Craig Mello, a member of the RXi Scientific Advisory Board, RXi's first RNAi product candidate, RXI‑109, a self-delivering RNAi compound (sd-rxRNA), entered into human clinical trials in June 2012 and is currently being evaluated in Phase 2 clinical trials to reduce the formation of dermal fibrosis (e.g., hypertrophic scars and keloids).  RXI-109 is designed to reduce the expression of connective tissue growth factor (CTGF), a critical regulator of biological pathways involved in fibrosis, including scar formation in the skin.  RXi's sd‑rxRNA oligonucleotides are designed for therapeutic use and have drug-like properties, such as high potency, target specificity, serum stability, reduced immune response activation, and efficient cellular uptake. These hybrid oligonucleotide molecules combine the beneficial properties of conventional RNAi and antisense technologies.  This allows sd‑rxRNAs to achieve efficient cellular uptake and potent, long-lasting intracellular activity. For more information, please visit www.rxipharma.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about future expectations, planned and future development of RXi Pharmaceuticals Corporation's products, technologies and partnerships. Forward-looking statements about expectations and development plans of RXi's products and partnerships involve significant risks and uncertainties such as:  the risk that we may not be able to successfully develop our candidates, or that development of RNAi-based therapeutics may be delayed or not proceed as planned, or that we may not develop any RNAi-based products; risks that the development process for our product candidates may be delayed, risks related to the development and commercialization of products by our competitors, the risk related to our ability to control the timing and terms of collaborations with third parties, the possibility that other companies or organizations may assert patent rights preventing us from developing our products, and risks related to the actual usage or realization of anticipated benefits of the sales of our common stock pursuant to the purchase agreement with Lincoln Park Capital Fund, LLC. Actual results may differ from those contemplated by these forward-looking statements. RXi does not undertake to update forward-looking statements to reflect a change in its views, events or circumstances that occur after the date of this release.

Contact
RXi Pharmaceuticals Corporation
Tamara McGrillen
508-929-3646
tmcgrillen@rxipharma.com

SOURCE RXi Pharmaceuticals Corporation



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