Soligenix Aims to Improve Quality of Life for Patients with Cutaneous Lymphoma

Cutaneous T-Cell Lymphoma (CTCL) is a rare NHL subtype which is manageable but not curable.

As one should expect in lymphomas, the term CTCL does not represent one disease but serves as a categorical name for several types of T-cell non-Hodgkin's lymphomas that affect the skin, including :

• Primary cutaneous large cell anaplastic lymphoma
• Angiocentric lymphoma
• Pleomorphic T-cell lymphoma
• Subcutaneous panniculitic-like T-cell lymphoma
• Epidermotropic CD8+ T-cell lymphoma
• Mycosis fungoides

The last one, mycosis fungoides, is by far the most frequently diagnosed CTCL subtype.

When diagnosed in early-stage and when there is so-called 'limited skin involvement' (this means that the patches or plaques that develop on the skin affect less than ten percent of the body surface) patients tend to live as long as people of the same age who do not have CTCL. However, as stage of diagnosis goes up; as it spreads to the likes of the lymph nodes and becomes a systemic problem and not simply a skin problem, survival goes down considerably, and may be as little as two years. When the disease progresses accordingly, it is known as Sezary Syndrome.

Fortunately most are diagnosed in early-stage. While this is good news on the survival front, it does mean that for the remainder of their lives these patients will be dealing with a disease that comes and goes. Each time the disease reemerges, it means itching, skin redness, skin patches or plaques, scaliness, and sometimes hair loss, among many other unpleasant effects.

And each time they undergo treatment to put the disease back into remission, they experience other unpleasant side effects that negatively impact their quality of life.

Radiation therapy, and the current standard of photochemotherapy known as PUVA, are both considered effective at controlling CTCL. However, as mentioned, these patients can often expect to live long, full lives, so being exposed to either radiation or the Ultraviolet A light in PUVA on a frequent basis boosts the risk these patients face of developing secondary cancers down the road, including melanoma.

A Safer Alternative

Soligenix, a biopharmaceutical company based in Princeton, is currently developing a CTCL treatment that would be a safer yet equally effective alternative to the likes of PUVA. Known right now as SGX301, this phototherapy treatment (which simply means it utilizes light) promises not only to eliminate the secondary cancer risk associated with multiple exposures to radiation or UV light, but to do it while requiring fewer clinic visits and to do it without causing as many of those unpleasant side effects.

According to Dr. Richard Straube, MD, MSc, Senior Vice President and Chief Medical Officer at Soligenix, SGX301 represents a distinct step forward in treating CTCL compared to PUVA.

"SGX301 uses hypericin, which is a naturally occurring, plant-derived and widely-studied substance that is not mutagenic [i.e. capable of mutating DNA]," says Straube. "It gets taken up by the malignant T-cells and we activate it with visible light—specifically, fluorescent light which, unlike ultra-violet light, is not carcinogenic [cancer-causing]."

The Patient Experience

Patient experience is crucial since they will very likely require several treatments over the course of their lifetimes in order to manage the disease.

"The vast majority of these patients live for many, many years—decades," adds Straube. "The disease will pop up sometimes a month later, sometimes not for three or four years."

Consequently, patients are facing multiple treatments. While PUVA is given as often as every day or once per week typically for between eight and 16 weeks, SGX301 is given twice a week for just six weeks.

"Our drug is an ointment applied by the patient," says Straube, explaining how it works. "It gets absorbed by the T-cells, a process that takes between 12 and 24 hours. At that time, the patient goes to the clinic and basically is exposed to a fluorescent light for about five to ten minutes. It's an extremely simple and very safe process."

Clinical Trial

Soligenix will soon begin recruiting CTCL patients for what they hope will be a pivotal phase III clinical trial for SGX301 ('pivotal' means that, assuming the results are positive, the trial data will be used as supporting documentation when the company seeks marketing approval from the FDA).

You can read more about this trial at ClinicalTrials.gov.

For more information on SGX301, visit the Soligenix website.

SOURCES INCLUDE:
The Cutaneous Lymphoma Foundation

Smoller BR1, Santucci M, Wood GS, Whittaker SJ. Histopathology and genetics of cutaneous T-cell lymphoma. Hematol Oncol Clin North Am. 2003 Dec;17(6):1277-311.

Demierre MF1, Kim YH, Zackheim HS. Prognosis, clinical outcomes and quality of life issues in cutaneous T-cell lymphoma. Hematol Oncol Clin North Am. 2003 Dec;17(6):1485-507.