History of PAR. I looked at PAR subsidiaries Xosoma and Paradigm...

History of PAR.

I looked at PAR subsidiaries Xosoma and Paradigm Health Sciences (PHS). To my surprise PHS was owned by 25% Peter Ghosh (PG), 25% Peter Ghosh’s wife, 25% Peter Ghosh’s son AND ONLY 25% PAUL RENE.

Xosoma technology was never used.

PHS was established in 2010 with funding from seed investors who paid for the wages! PG was initially chief scientist in PAR in 2015 but then disappeared. 2010 was when PG first patented “bone marrow oedema” treatment by PPS.

PAR board and management was initially widely populated by executives from Mesoblast, where PG worked. With the exception of PR and Dr Donna Skerret (DS), all have quietly departed. Others have come and gone, with one notably quickly.

Initially osteoarthritis (OA) was the target (of first prospectus) but suprisingly initially PAR did not exploit the OA indication but a licence for rhinitis (blocked nose). Clinical trials failed. The reason appears to be lack of confidence in the “bone marrow oedema” patent due to extensive prior art of PPS and treatment of OA.

The next studies were viral brain infections which showed some efficacy but was discontinued. Early on they started the mucopolysaccharidosis (MPS)studies with Japanese company Recmed and Mount Sinai Hospital. Gene therapy of this rare genetic disease is having some effect, and PPS is mildly effective on clinical signs in some of this complex of different syndromes.

Then PAR pivoted to OA bone marrow oedema(BME), an x-ray magnetic resonance imaging (MRI) finding in numerous conditions including osteoporosis. BME often resolves spontaneously. BME occurs in many different diseases with different pathology and causes. BME does not cause OA and is often symptomless.

Three poor decisions were then made:

Firstly, PAR did not carry out a well organised and compliant protocol for dose response for PPS in OA which was the responsibility of DS, who is thehighly paid regulatory affairs “expert” at PAR. The FDA has published extensive detailed recommendations on how to carry out these studies which PAR has apparently ignored or misunderstood. Slow FDA responses may be slow as the refusal to approve progress to Phase 3 clinical requires detailed legal argument and careful explanation of serious procedural deficiencies. The FDA letter coming soon should be published in full.

Secondly the inclusion of severe OA cases against the evidence from early studies that PAR concluded and announced that severe OA should not be included (contra-indicated). This decision appeared to be guided by PR, who then marketedPPS as a solution for the US “opioid crisis” to the FDA, a hurdle they do not seem to have achieved.

Thirdly PAR focussed on “Disease modification” at great expense and distraction. It may be too difficult for regulatory authorities to approve claims from early investigations with inadequate numbers, reproducibility, and validated criteria.

Conclusion of my private home office is The Leaky Ship is sinking. I welcome any comments and requests for clarification.

NOT ADVICE- DYOR