CLINUVEL says it will decide in the next few weeks whether to launch a Phase 3 trial of photoprotective drug afamelanotide (formerly CUV1647) as an adjunct to some cancer treatments, after posting positive results of a small Phase 2 trial yesterday.

Clinuvel drug delivery system

Clinuvel launched the trial in September last year, to test whether afamelanotide can protect against the light sensitivity that is a major side effect of photodynamic therapy.

PDT is a cancer treatment that uses a laser combined with a light-sensitive drug (called photosensitising agent) to destroy cancer cells in some gastro-intestinal cancers.

One of the limiting factors and key side effects of PDT therapy, according to Clinuvel, is debilitating photosensitivity of skin and eyes to light (sunlight as well as artificial light). The company believes the use of afamelanotide may protect against these side effects and possibly extend the use of the therapy in cancer patients.

Clinuvel says the trial yielded clinically significant results despite recruiting only 16 patients (up to 30 were originally planned).

The objective of the pilot Phase 2 trial was to determine the effect of a single 16mg dose of afamelanotide on the quality of life and phototoxicity in patients undergoing PDT.

Clinuvel says seven of the nine patients who received its implant “revealed a positive trend to tolerate ambient light at standardised exposure” at the seven and 12-day mark, and the trial group also noted a statistically significant improvement on quality of life scores on a standardised test 60 days after implantation (p=0.002).

Quality of life was measured using the SF-36 scale, and other measurements were based on daily exposure time to ambient light and recorded symptoms.

No significant drug-related adverse events were reported, according to Clinuvel.

The company says clinical observations from all physicians and reports from patients “supported and encouraged further use of afamelanotide in PDT cancer trials”.

Clinuvel chief scientific officer Dr Hank Agersborg described the results of the trial as “meaningful” and said the data might also assist the company in registering the drug as a treatment for another condition stemming from light sensitivity, erythropoietic protoporphyria.

“In the next few weeks we will decide on a further Phase 3 trial in PDT,” he said.

“The particular choice for afamelanotide as an adjuvant photoprotective drug in gastro-intestinal cancer stems from the common biochemical pathways seen in both PDT and erythropoietic protoporphyria [EPP], a disease in which we are using afamelanotide in parallel advanced Phase 3 trials.

“Today’s results are of particular relevance because we have learned from regulatory agencies that data from PDT studies may be used as supporting evidence when we file for EPP registration.

“Therefore, the confirmation of safety and the improvement in quality of life in these light-intolerant patients provides a substantial step toward the registration of afamelanotide for EPP.”

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