Date: 2015-07-28
Type of information: Granting of the orphan status in the EU
Product name: SGX301
Compound: synthetic hypericin
Therapeutic area: Cancer - Oncology - Rare diseases
Action mechanism:
- photodynamic therapy. 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 improvement with topical hypericin treatment whereas the placebo was ineffective: 58.3% compared to 8.3%, respectively. SGX301 has received orphan drug and fast track designations from the FDA.
Company: Kinesys Consulting (UK) Soligenix (USA - NJ)
Disease: cutaneous T-cell lymphoma (CTCL)
Latest news:
- • On February 2, 2017, Soligenix announced that SGX301 (synthetic hypericin) has been granted Promising Innovative Medicine (PIM) designation in the UK by the Medicines and Healthcare Products Regulatory Agency (MHRA) for the treatment of cutaneous T-cell lymphoma.
The PIM designation is the first step towards inclusion in the Early Access to Medicines Scheme (EAMS). Launched in April 2014, EAMS offers severely ill patients with life-threatening and seriously debilitating conditions the lifeline of trying ground-breaking new medicines much earlier than they would normally be accessible.
- • On August 4, 2015, Soligenix announced that the European Commission has granted orphan drug designation to synthetic hypericin (the active pharmaceutical ingredient in SGX301) for the treatment of cutaneous T-cell lymphoma.
Soligenix is currently working with leading CTCL centers, as well as with the National Organization for Rare Disorders (NORD) and the Cutaneous Lymphoma Foundation (CLF) to begin a 120 subject pivotal Phase 3 clinical trial with SGX301 in the second half of 2015.
- • On 16-18 June, 2015, the Committee for Orphan Medicinal Products (COMP) has adopted a positive opinion recommending synthetic hypericin for designation as orphan medicinal product for treatment of cutaneous T-cell lymphoma.
Patents:
Submission of marketing authorization application USA :
Submission of marketing authorization application UE:
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
US authorization:
UE authorization:
Favourable opinion UE:
Favourable opinion USA:
Orphan status USA: 2000-02-07
Orphan status UE: 2015-07-28
Pediatric exclusivit _USA:
Pediatric exclusivity UE:
OTC status:
Other news:
Is general: Yes
