Soligenix Announces Collaboration with the National Organization for Rare Disorders and the Cutaneous Lymphoma Foundation in Advancing its Phase 3 Study of SGX301 for the Treatment of Cutaneous T-Cell Lymphoma

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Jun 23, 2015, 07:15 ET

PRINCETON, N.J., June 23, 2015 /PRNewswire/ -- Soligenix, Inc. (OTCQB: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company developing products that address unmet medical needs in the areas of inflammation, oncology and biodefense, announced today that it will be working with the National Organization for Rare Disorders (NORD) and the Cutaneous Lymphoma Foundation (CLF) to educate and recruit patients for its pivotal Phase 3 clinical study of SGX301 (synthetic hypericin) in the treatment of cutaneous T-cell lymphoma (CTCL). SGX301 has previously been granted both orphan drug and fast track designations from the US Food and Drug Administration (FDA) for the first-line treatment of CTCL, a rare disease and a class of non-Hodgkin's lymphoma, a type of cancer of the white blood cells that are an integral part of the immune system.

NORD, the leading, independent nonprofit organization committed to the identification, treatment and cures of rare diseases, and CLF, an independent, nonprofit patient advocacy organization whose mission is to support patients with cutaneous lymphoma, will assist the Company in educating patients and raising awareness of the Phase 3 clinical trial among patients who are eligible for participation.

SGX301 is a novel, first-in-class, photodynamic therapy utilizing safe visible light for activation. The active ingredient, synthetic hypericin, is a potent photosensitizer which is topically applied to skin lesions and activated by visible fluorescent light. This treatment approach avoids the risk of secondary malignancies (including melanoma) inherent with the frequently employed DNA-damaging chemotherapeutic drugs and other photodynamic therapies that are dependent on ultraviolet A (UVA) exposure. Topical hypericin has demonstrated safety in a Phase 1 clinical study in healthy volunteers. In a Phase 2, double-blind, placebo-controlled clinical study in CTCL patients, the drug was safe and well tolerated, with 58.3% of the CTCL patients responding to SGX301 treatment compared to only 8.3% receiving placebo (p ≤ 0.04).

"We enthusiastically support Soligenix in its efforts to improve outcomes for patients with CTCL, which affects over 20,000 patients in the US," stated Peter L. Saltonstall, President and Chief Executive Officer of NORD. "We are working with Soligenix to advance our shared commitment to the identification of treatments for neglected, orphan diseases."

"CLF is committed to supporting efforts to identify therapies to treat cutaneous lymphomas. We are pleased that the Soligenix team is advancing this product into a Phase 3 clinical study as an option for our patients," stated Susan Thornton, Chief Executive Officer of CLF. "We are always eager to learn about potential new therapies such as SGX301 that may be a major step forward in the treatment of cutaneous lymphoma by providing a safe and effective therapy over the course of the patient's disease."

Based on the positive results demonstrated in the Phase 2 study of SGX301, the upcoming Phase 3 protocol will be a highly powered, double-blind, randomized, placebo-controlled, multicenter trial and will seek to enroll approximately 120 subjects. The trial will consist of three treatment cycles, each of 8 weeks duration. Treatments will be administered twice weekly for the first 6 weeks and treatment response will be determined at the end of Week 8. In the first treatment cycle, approximately 80 subjects will receive SGX301 and 40 will receive placebo treatment of their index lesions. In the second cycle, all subjects will receive SGX301 treatment of their index lesions and in the third cycle all subjects will receive SGX301 treatment of all their lesions. Subjects will be followed for an additional 6 months after the completion of treatment. The primary clinical efficacy endpoint is treatment response assessed using the CAILS (Composite Assessment of Index Lesion Severity) score evaluating the three index lesions at the end of Cycle 1 (Week 8). The trial is anticipated to begin in the second half of 2015 with primary data available in the second half of 2016.

"We look forward to working with NORD and CLF as we aggressively advance our pivotal Phase 3 study of SGX301 in CTCL," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "Both NORD and CLF are committed to increasing awareness of both treatment options and medical advances in combating this disease. We are excited to move forward with this pivotal trial in an effort to address the significant unmet medical need in this orphan disease."

About Cutaneous T-Cell Lymphoma

Cutaneous T-cell lymphoma (CTCL) is a class of non-Hodgkin's lymphoma (NHL), a type of cancer of the white blood cells that are an integral part of the immune system. Unlike most NHLs which generally involve B-cell lymphocytes (involved in producing antibodies), CTCL is caused by an expansion of malignant T-cell lymphocytes (involved in cell-mediated immunity) normally programmed to migrate to the skin. These skin-trafficking malignant T-cells migrate to the skin, causing various lesions to appear that may change shape as the disease progresses, typically beginning as a rash and eventually forming plaques and tumors. Mortality is related to the stage of CTCL, with median survival generally ranging from about 12 years in the early stages to only 2.5 years when the disease has advanced. There is currently no cure for CTCL.

CTCL constitutes a rare group of NHLs, occurring in about 4% of the approximate 500,000 individuals living with the disease. It is estimated, based upon review of historic published studies and reports and an interpolation of data on the incidence of CTCL that it affects over 20,000 individuals in the US, with approximately 2,800 new cases seen annually.

About SGX301

SGX301 is a novel first-in-class photodynamic therapy utilizing safe visible light for activation. The active ingredient in SGX301 is synthetic hypericin, a potent photosensitizer which is topically applied to skin lesions and then activated by fluorescent light 16 to 24 hours later. Combined with photoactivation, hypericin has demonstrated significant anti-proliferative effects on activated normal human lymphoid cells and inhibited growth of malignant T-cells isolated from CTCL patients. In a published Phase 2 clinical study in CTCL, patients experienced a statistically significant (p ≤ 0.04) improvement with topical hypericin treatment whereas the placebo was ineffective: 58.3% compared to 8.3%, respectively. SGX301 has received orphan drug designation from the FDA.

About National Organization for Rare Disorders

The National Organization for Rare Disorders (NORD), established in 1983, is the leading, independent nonprofit organization representing all patients and families affected by rare diseases in the US. NORD is committed to the identification, treatment and cure of all 7,000 rare diseases, 95 percent of which have no treatment, and affect 30 million Americans, or 1 in every 10 people. NORD provides programs of advocacy, education, research and patient/family services to improve the lives of all people living with rare diseases. NORD represents more than 230 disease-specific member organizations and partners with many other organizations in specific causes of importance to the rare disease patient community. Join NORD at www.rarediseases.org/ and on Twitter at @RareDiseases.

About Cutaneous Lymphoma Foundation

The Cutaneous Lymphoma Foundation (CLF) is an independent, nonprofit patient advocacy organization whose mission is to support every person with cutaneous lymphoma by promoting awareness and education, advancing patient care, and facilitating research. CLF was founded in 1998 and it is the only organization worldwide that offers comprehensive programs and services that provide information, resources and support to people affected by cutaneous lymphoma. CLF currently serves people from 67 countries who access the organization for assistance and support. For more information, please visit www.clfoundation.org or contact the Foundation at (248) 644-9014 or [email protected].

About Soligenix, Inc.

Soligenix is a late-stage biopharmaceutical company developing products that address unmet medical needs in the areas of inflammation, oncology and biodefense. Our BioTherapeutics business segment is developing SGX301 as a first-in-class photo-dynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma, proprietary formulations of oral beclomethasone 17,21-dipropionate (BDP) for the prevention/treatment of gastrointestinal (GI) disorders characterized by severe inflammation including pediatric Crohn's disease (SGX203) and acute radiation enteritis (SGX201), and our novel innate defense regulator technology (SGX942) for the treatment of oral mucositis.

Our Vaccines/BioDefense business segment includes active development programs for RiVax™, our ricin toxin vaccine candidate, VeloThrax™, our anthrax vaccine candidate, OrbeShield™, our GI acute radiation syndrome therapeutic candidate and SGX101 and SGX943, our melioidosis therapeutic candidates. The development of our vaccine programs incorporates the use of our proprietary heat stabilization platform technology, known as ThermoVax™. Currently, this business segment is supported with up to $57 million in government grant and contract funding from the National Institute of Allergy and Infectious Diseases (NIAID) and the Biomedical Advanced Research and Development Authority (BARDA). Additionally, Soligenix has an exclusive worldwide collaboration with Intrexon Corporation (NYSE: XON) focused on the joint development of SGX101 for the treatment for melioidosis.

For further information regarding Soligenix, Inc., please visit the Company's website at www.soligenix.com.

This press release may contain forward-looking statements that reflect Soligenix, Inc.'s current expectations about its future results, performance, prospects and opportunities, including but not limited to, potential market sizes, patient populations and clinical trial enrollment. Statements that are not historical facts, such as "anticipates," "estimates," "believes," "intends," "potential," or similar expressions, are forward-looking statements. These statements are subject to a number of risks, uncertainties and other factors that could cause actual events or results in future periods to differ materially from what is expressed in, or implied by, these statements. Soligenix cannot assure you that it will be able to successfully develop, achieve regulatory approval for or commercialize products based on its technologies, particularly in light of the significant uncertainty inherent in developing vaccines against bioterror threats conducting preclinical and clinical trials of vaccines, obtaining regulatory approvals and manufacturing vaccines, that product development and commercialization efforts will not be reduced or discontinued due to difficulties or delays in clinical trials or due to lack of progress or positive results from research and development efforts, that it will be able to successfully obtain any further funding to support product development and commercialization efforts, including grants and awards, maintain its existing grants which are subject to performance requirements, enter into any biodefense procurement contracts with the US Government or other countries, that it will be able to compete with larger and better financed competitors in the biotechnology industry, that changes in health care practice, third party reimbursement limitations and Federal and/or state health care reform initiatives will not negatively affect its business, or that the US Congress may not pass any legislation that would provide additional funding for the Project BioShield program. These and other risk factors are described from time to time in filings with the Securities and Exchange Commission, including, but not limited to, Soligenix's reports on Forms 10-Q and 10-K. Unless required by law, Soligenix assumes no obligation to update or revise any forward-looking statements as a result of new information or future events.

SOURCE Soligenix, Inc.