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Regeneus Ltd: DEEP DIVE

Regeneus close to finalising first clinical partnership for its lead cell therapy in Japan

The Australian regenerative medicine company is developing a portfolio of innovative cellular therapies targeting significant unmet medical needs with a licence-driven strategy.
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Progenza’s share price has increased about 46% since the start of 2018

Regeneus Ltd (ASX:RGS) has made significant progress towards finalising the terms and conditions in securing the first clinical partner for Progenza in Japan.

Progenza is the company’s lead cell therapy technology being developed for the treatment of osteoarthritis and other musculoskeletal disorders.

It also has the potential to be used for other inflammatory conditions.

Regeneus anticipates the partnership to be secured and details of the collaboration to be revealed this quarter.

Poised for clinical and marketing partnerships in Japan

This clinical collaboration is expected to be an inflexion point for Regeneus, complementing its existing manufacturing relationship and commercial venture with AGC Inc (TYO:5201).

It is worth noting that Regeneus’ share price has increased about 46% since the start of 2018, with the potential for further growth on more positive news.

READ: Regeneus receives intention notice for Progenza patent in Europe

The US and European patent offices have confirmed that patents would be granted for Progenza, providing commercial rights to Regeneus in the US and across 38 European member states until 2032.

These patents will join corresponding patents already granted in Australia, New Zealand and Japan and provides strong protection around the world for Regeneus’ intellectual property.

READ: Regeneus welcomes positive step forward for Progenza’s US patent

In September 2017, Regeneus released positive results from its preclinical study of Sygenus and its effects on postoperative pain.

The study showed the topical application of Sygenus delivered pain relief which was longer lasting than morphine.

READ: Regeneus finds impressive pain relief properties in Sygenus

This was an exciting preclinical trial result and the company continues to conduct additional preclinical studies of Sygenus and Progenza, in the treatment of pain.

Additionally, the topical application of Sygenus gel delivered some exciting results when topically applied in the treatment of acne and age spots.

READ: Regeneus shares rise as results show Sygenus gel successfully fights acne

The gel was found to reduce the appearance and severity of acne in acne patients and reduce the size of 95% of age spots and reduce the size and lighten 63% of age spots for age spot sufferers.

Regeneus has been granted a broad Australian Patent for the topical application of Sygenus in the treatment of both aging skin and age spots, and a Chinese patent for the use of Sygenus to treat acne, with commercial rights protected to 2032.

Patent portfolio

The company also completed the phase I safety study of its RGSH4K cancer vaccine immunotherapy treatment across a wide range of tumours in humans.

The trial met its primary endpoint of safety and tolerability and showed encouraging signs of immune stimulation in patients and anti-tumour activity.

Regeneus anticipates the publication of the study results this year.


Regeneus remains poised to deliver on a number of important commercial, clinical and R&D milestones in FY19 and into FY20, including:

• Securing its first clinical development and marketing partner for Progenza in Japan;

• Progressing the clinical development of Progenza for osteoarthritis and other indications in Japan;

• Commencing manufacturing of cGMP Progenza in Japan under the company’s existing strategic collaboration and licensing agreement with AGC;

• Securing additional licensing opportunities for Progenza in additional key territories, including the US, China and the European Union;

• Progressing the development of Progenza for specific pain indication;

• Progressing the development of Sygenus for specific pain and dermatological indications;

• Advancing licensing discussions for RGSH4K following positive ACTIVATE trial results; and

• Reporting on CryoShot canine pre-pivotal trial and advancing licensing discussions.

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