Soligenix Earns Orphan Status in Europe

Late-stage biopharmaceutical company Soligenix has announced that the European Commission, acting on a positive recommendation from the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP), has granted orphan drug designation to synthetic hypericin (which is the active pharmaceutical ingredient in the company's SGX301 product) for the treatment of cutaneous T-cell lymphoma (CTCL).

Soligenix is currently working on a large, phase III clinical trial for SGX301, a novel, first-in-class, photodynamic therapy that uses safe, visible light instead of DMA-damaging ultraviolet light or radiation. Synthetic hypericin, a photosensitizer, is applied to skin lesions and activated by visible fluorescent light.

A phase II trial has confirmed the safety of SGX301 and patients had good responses to the treatment; 58 percent of patients in the phase II trial had responses compared to just over eight percent with placebo.

"We are extremely pleased to have received European orphan drug designation for the SGX301 program," stated Christopher J. Schaber, PhD, President & Chief Executive Officer of Soligenix, Inc. "This EU orphan designation, combined with our US orphan and fast track designations, positions SGX301 for an accelerated global regulatory product development pathway to address the significant unmet need that exists for this important indication. We look forward to aggressively advancing our pivotal Phase 3 study of SGX301 in CTCL."

Source: PR Newswire

More Articles

More Articles

Amazon.com is pleased to have the Lymphoma Information Network in the family of Amazon.com associates. We've agreed to ship items...

The question ought to be what are myelodysplastic syndromes (MDS), since this is a group of similar blood and bone marrow diseases that...

Merkel Cell Carcinoma (MCC) is a very rare and aggressive skin cancer that usually develops when a person is in his or her 70s. It is...

Radiation Therapy Topics

...

At some point, the Seattle biotech company Cell Therapeutics Inc (CTI) should earn an entry in the Guinness Book of World Records for utter and...

Site Beginnings

This site was started as Lymphoma Resource Page(s) in 1994. The site was designed to collect lymphoma...

Three papers appearing in the journal Blood and pointing towards a regulator-suppressor pill could offer hope to blood cancer...

The US Food and Drug Administration (FDA) has granted a third so-called Breakthrough Therapy Designation for the investigational oral...

The US Food and Drug Administration today has approved an expanded use of Imbruvica (ibrutinib) in patients with...

The U.S. Food and Drug Administration has announced that it has granted "Breakthrough Therapy Designation" for the investigational agent...

According to a new study published in the Proceedings of the National Academy of Sciences, a team from the University of California, San...

Pharmacyclics has announced that the company has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for...

New research suggests that frontline radioimmunotherapy...

Gilead Sciences has announced results of the company's Phase II study of its investigational compound idelalisib, an oral inhibitor of...

Sitemap