I’ll keep this brief, because there isn’t much to say. My ire with this company blossomed last month when it announced that it had filed a patent.
Yes, you heard me correctly.
They didn’t receive a notice of allowance on a patent. They didn’t expand their intellectual property (IP) into an international territory of commercial significance. They didn’t out-license their patent. They just… ahem… filed it. Not only did they file that whizz-bang patent, but they also told us that they are working on 5 potential other patents and roughly what their scope is. That’s kind of weird.
Let me tell you 7 things about Novogen that really bother me:
1) Intellectual Property
The academic pedigree of the company is not without merit, but the track record in capturing meaningful intellectual property is very poor, including from the academic founders in the university setting. Any public company that throws out a press release that a patent has been granted, should probably be avoided, let alone a company that announces that a patent has been filed. Seriously…
2) Benzopyrans are not interesting
I haven’t read Novgen’s newly filed IP because it isn’t in the public domain yet but Benzopyran-family compounds (a.k.a Chromenes) are not really all that exciting and are difficult to understand in terms of biological function. We have also known about them as a chemical class for a long time. When you look at the company’s positioning documents and you see statements that their intellectual property is “patentable” – be skeptical. Truly, nothing is patentable until a patent has been granted – and, in the case of pharmaceuticals, preferably defended. Don’t get me started on their anti-tropomyocin molecules – biologically very controversial.
3) Nobody cares about cell-based assays
Please please PLEASE don’t tell me that your compound is exciting because it kills cells in an in vitro assay (“petri dish” for all you punters out there). Please. Twice this month, Novogen has told has they have been able to kill certain types of cultured cells in laboratory experiments. It’s just not a real milestone and we don’t care.
4) Clinical claims lack inaccuracy
The company has asserted that it’s strategy to deliver drugs into the peritoneal (abdominal) cavity is unique. The CEO of the company has publicly asserted in relation to an FDA “guidance” announcement (more on this in a minute) that in relation to ovarian cancer “No standard of care exists currently for these conditions”. Utter rubbish. In the United States, intra-peritoneal chemotherapy for metastatic ovarian cancer is widely used and is indicated as a standard of care under specific (fairly common) conditions. Even in Australia, the Cancer Council informs of peritoneal chemotherapy. I just don’t understand this statement at all.
5) Spurious announcements about FDA guidance
The FDA has several different types of meetings with a potential sponsor of a clinical study. Generally, it is good practice to disclose whether it was a formal or an informal meeting, though usually not in a press release, and if a formal meeting – what type. In the case of the FDA guidance press release for Cantrixil late last year, the implication of this communication is that it was a non-binding, informal consultation with the FDA. At best, it could have been a Type C meeting but nothing in this announcement indicates it was a pre-IND (Type B) meeting. If that’s the case, then who cares?
6) Swim where the water flows
Chemo drugs are important, don’t get me wrong, and we will probably see a renaissance around the combination use of chemotherpeutic agents with new immunomodulatory drugs. But the money and development appetite isn’t in developing complex new small molecule agents anymore. So not only is the development risk inherently off-scale for Novogen, but getting partnership attention is going to be tough.
7) They will struggle to get patients recruited into later-stage trials
As alluded previously, not only is it incredibly tough to go head-to-head with existing chemotherapy drugs, but it’s getting harder all the time to recruit patients into oncology clinical studies – of all types. A woman with Stage III ovarian cancer doesn’t want to be the guinea pig for a new chemo agent, she wants to be on a cancer immunotherapy program. Alas, there are plenty of drugs at mid-stage clinical development for Stage III ovarian cancer that are already struggling to recruit patients, even drugs with promising data in humans (not animals… or cells). Cantrixil, quite frankly, will struggle to find patients beyond an initial pilot.