TRXE-002-1 (Cantrixil) Toxicology, page-15

What is TRX-E-002-1 (Cantrixil)?

A good starting point is the Novogen website: http://www.novogen.com/pdf/cantrixil.pdf

Cantrixil is the first of the 3^rd generation of super-benzopropan (SBP) drugs developed by Novogen to be submitted for formal toxicology testing prior to planned first in human trials later this year.

Yale University has been co-developing Cantrixil with Novogen and they have established CanTx as the company which owns Cantrixil but not the other SBP drugs under development by Novogen. Yale has a 15% stake in the venture and Novogen has the other 85%.

Cantrixil has been shown to be highly active against ovarian cancer cells and, more importantly, is also highly active against ovarian cancer stem cells (OCSCs).

After initial treatment with regular chemotherapy the cancer cells are killed but the OCSCs remain which develop resistance to the regular chemotherapy and pass that  resistance on to the next generation of cancer cells – this results in recurrence of the cancer which is now resistant to the drug that was previously used to treat it.

Cantrixil is highly active against the OCSCs and has been shown in an invivo model of resistant cancer to prevent growth of  chemo-resistant ovarian cancer: http://www.asx.com.au/asxpdf/20150421/pdf/42y09tbzqfwr78.pdf

In the same invivo model of resistant cancer Cantrixil in combination with Cisplatin has been shown to significantly improve survival (p<0.001) compared to Cisplatin alone. http://www.asx.com.au/asxpdf/20151021/pdf/43286fz4yf5kyw.pdf

The successful use of Cantrixil in combination with cisplatin for the treatment of Primary Ovarian Cancer has recently been reported in full. It was first reported last year that “Intraperitoneal administration of Cantrixil at a dose of 100 mg/kg as a first-line therapy in combination with standard of care (cisplatinum or paclitaxel), improved survival compared with the respective monotherapy  controls (p<0.001)” http://www.asx.com.au/asxpdf/20151019/pdf/4325fr405t3q58.pdf This was published in full recently, http://mct.aacrjournals.org/content/early/2016/04/08/1535-7163.MCT-16-0005.abstract

Cantrixil has been granted Orphan Drug Designation by the FDA on the basis of these outstanding pre-clinical results and is now, having completed formal toxicology studies, almost ready to enter the clinic for first in human trials. Ethics committee approval and granting of IND status by the FDA cannot be far away and given the results of the toxicology study must be a mere formality at this stage.