History of PAR.
I looked atPARsubsidiariesXosomaand 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 ANDONLY25% PAUL RENE.
Xosomatechnology was never used.
PHS was established in 2010 with funding from seed investors who paid for the wages! PG was initially chief scientist in PARin 2015but then disappeared. 2010 was when PG first patented “bone marrow oedema” treatment by PPS.
PARboard andmanagement wasinitially widelypopulated by executives from Mesoblast, where PG worked. With the exception ofPR and Dr DonnaSkerret(DS),all havequietlydeparted.Others have come and gone, with one notablyquickly.
Initially osteoarthritis(OA)was the target (of first prospectus)butsuprisinglyinitiallyPARdid not exploit theOAindication 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 toextensiveprior 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 companyRecmedand Mount Sinai Hospital. Gene therapyof thisraregenetic diseaseis having some effect, and PPS is mildly effective on clinical signs insome ofthis complex of different syndromes.
Then PAR pivoted to OA bone marrow oedema(BME),an x-raymagnetic resonance imaging (MRI)finding in numerous conditions including osteoporosis. BMEoften resolves spontaneously. BME occurs inmanydifferent diseases with different pathology and causes.BMEdoes not cause OA and is often symptomless.
Threepoor decisionswerethenmade:
Firstly,PAR didnot carry out a well organisedand compliantprotocol for dose responsefor PPS inOAwhich was the responsibility ofDS,whoisthehighly paidregulatory affairs“expert”atPAR. The FDA haspublishedextensive detailed recommendations on how to carry out these studies which PAR hasapparentlyignoredor misunderstood. Slow FDA responses may be slow as the refusal toapproveprogressto Phase 3 clinicalrequiresdetailedlegalargumentandcarefulexplanationof serious procedural deficiencies.The FDA lettercoming soonshould 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). Thisdecisionappeared to be guided by PR,whothenmarketedPPS as a solution for the US “opioidcrisis” to the FDA, a hurdle they do not seem to have achieved.
Thirdly PAR focussed on “Disease modification” at great expenseand distraction. Itmay betoo difficult forregulatory authorities to approveclaimsfromearly investigationswith inadequate numbers,reproducibility,and validated criteria.
Conclusion of my privatehomeoffice is TheLeakyShip is sinking. I welcome any comments andrequestsfor clarification.
NOT ADVICE-DYOR
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