• Polynovo to get first orders of NovoSorb BTM in India
  • Clinuvel Pharma reports positive results from Phase 2 study

 

Polynovo approved for Indian government e-portal site

Polynovo (ASX:PNV) announced that the Indian government has approved NovoSorb BTM to be included in the Government-e-Marketplace (GeM) portal.

GeM is a centralised procurement platform for government hospitals that can now buy NovoSorb BTM throughout India.

This approval provides access to supply BTM across all the Defence hospitals, railways hospitals, ESIC (Employees State Insurance Corporation) hospitals, and the various AIIMS (All India Institute of Medical Sciences) hospitals.

Polynovo expects the first order within a month.

The company’s NovoSorb BTM is a dermal scaffold for the regeneration of the dermis when lost through extensive surgery, trauma or burn. It’s made from a novel range of bio-resorbable polymers that can be produced in many formats including film, fibre, foam, and coatings.

“Our India team is optimistic we can win a number of other tenders that will open the doors of public hospitals for BTM,” said Polynovo chairman, David Williams.

 

Clinuvel reports positive results from Phase 2 trial

Meanwwhile, Clinuvel Pharma (ASX:CUV) announced positive results from its first Phase 2 study evaluating SCENESSE (afamelanotide 16mg), as a treatment for variegate porphyria (VP) patients.

Analyses from the CUV040 study showed that SCENESSE provides systemic photoprotection to VP patients, reducing disease severity and clinical symptoms, and improving patients’ quality of life.

VP is a metabolic disorder which leads to the accumulation and storage of excessive porphyrin intermediates in the skin and liver. For people living with this condition, sun and light exposure can cause severe dermatological symptoms such as dermal lesions, ulcers, and blistering.

The six-month CUV040 study had evaluated whether the drug could offer systemic photoprotection to VP patients and reduce the impact of dermatological symptoms.

Six adult VP patients with active dermal symptoms were enrolled and commenced treatment in the spring and summer months, receiving six SCENESSE doses and completing all study visits.

All six patients experienced a positive change – improvement up to three times baseline scores – in disease severity after treatment.

The average CGIC (Clinical Global Impression of Change) change – which was the primary endpoint of the study – was rated as “much improved”, with first changes observed as early as four weeks after the first treatment.

All patients also experienced decreased fragility of sun exposed skin following treatment.

“These results give us the momentum to continue the development program for VP,” said Clinuvel’s head of Clinical Operations, Dr Pilar Bilbao.

“It will establish a larger clinical trial program and subsequently preparing and filing a marketing authorisation application.”

 

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