Tuesday, June 26, 2012

Coronado Biosciences is not exactly kosher

Crohn's disease is an autoimmune bowel disease (or maybe just an immune deficiency) which has symptoms ranging from abdominal pain to diarrhoea and other unpleasantness. It is a disease that I associate with Orthodox Jews of European - particularly German origin and I always thought of as an inherited genetic disease prevalent most strongly amongst Orthodox Jews.* Wikipedia says that it is more common amongst Ashkenazi Jews but they also suggest wider incidence (which somewhat upsets my story). Perhaps my preconception that it is a disease more prevalent among Orthodox Jews in New York probably has as much to do with the original description (at Mt Sinai Hospital).

Coronado Biosciences - now listed on the Nasdaq - is researching a treatment for Crohn's (and possibly a few other autoimmune diseases including the big-daddy of them MS). The technology is all licensed. To quote the original prospectus:
All of our product candidates were in-licensed from third parties. Under the terms of our license agreements, the licensors generally have the right to terminate such agreement in the event of a material breach by us. Our licenses require us to make annual and milestone payments prior to commercialization of any product and our ability to make these payments depends on our ability to generate cash in the future. These agreements generally require us to use diligent and reasonable efforts to develop and commercialize the product candidate. In the case of CNDO-201, the company from which we sublicense CNDO-201, OvaMed, licenses CNDO-201 from a third party, UIRF, in exchange for annual and milestone payments, patent cost reimbursement, royalties based on sales and diligence obligations. Our rights to CNDO-201 are, therefore, also subject to OvaMed’s performance of its obligations to UIRF, certain of which are outside of our control. For example, upon our acquisition of this license from Asphelia, we paid certain overdue patent cost reimbursement obligations to UIRF.   
So the stock holders (those that participated in the recent capital raise) get to fund the development of someone else's drug and have to make milestone payments based on the success of that development.

I will leave it to readers to work out the nuances of that disclosure.

I am more interested in the treatment. Here is how it is described in their latest prospectus:

TSO, or CNDO-201, is a biologic comprising Trichuris suis ova, the microscopic eggs of the porcine whipworm, for the treatment of autoimmune diseases, such as Crohn’s disease, or Crohn’s, ulcerative colitis, or UC, and multiple sclerosis, or MS.

The treatment comes from porcine whipworm - that is a worm that lives in pig intestines.

That is an obscure ingredient. You would think they breed pigs for it - but no a subcontractor of OvaMed breeds the pigs and CNDO pays OvaMed for that. This is the same OvaMed they are licensing the drug from. Here is the disclosure:

We have contracted with OvaMed to produce and supply us with all of our requirements of TSO. OvaMed’s contractor inoculates young pathogen-free pigs with T. suis from a master ova bank and harvests the ova which are incubated to maturity and are processed to remove any viruses and other pathogens. Ova then are processed and extensively tested to assure uniformity. They are then used to repopulate the master ova bank and are processed further by OvaMed into a final formulation of the drug product that is a clear, tasteless and odorless liquid. OvaMed manufacturing is conducted at one facility in Germany.
This disclosure leaves out the really funny detail. Here it is:

Mature T. suis produce ova that exit the porcine host with the stool, however, ova are not infective until incubating in the soil for several weeks, thereby preventing direct host-to-host transmission.

So get this - Coronado Biosciences is a company testing a drug to treat a disease prevalent amongst New York Orthodox Jews where the drug is extracted from pig stools.

And you get the messy relationship with OvaMed thrown in for free.


It is not exactly Kosher.


Either this does not work or the Old Testament God does not exist or, if the Old Testament God does exist he has a wicked sense of humour.




John


*There are other inherited autoimmune disorders linked to people with other origins. Coeliac disease is of Anglo-Celtic origin. Beh├žet's disease is sometimes called Silk Road disease and has higher incidence in people of Turkish and Middle Eastern origin.

14 comments:

John Hempton said...

Via email I have received admittedly fairly liberal Rabbinical opinion that there is no problem with taking medicine that is extracted from pig stools.

I just thought I should note this.


John

Ben said...

I'm guessing there is a lot more wrong with the company than just what you posted but I don't think the fact that the researched treatment is not kosher would be an issue. I know several people who have UC and Crohn's, none of whom are Jewish. Also David Garrad an African American NFL quarterback has Crohn's. I think there is a large non Jewish population that is affected by the diseases the treatment targets.

Anonymous said...

John,

Halacha (jewish law) provides for a hierarchy of obligations.

Life takes priority over all else, and health (being required for life) takes priority over almost all else.

Thus (technically speaking), if eating non-kosher meat (ie. pork) is a necessary medical treatment, it would be OK under Jewish law.

By the way, the major issue here would not be that the worms come from pigs, but that worms are not Kosher in an of themselves - no crawly things (like insects) are.

SB

Anonymous said...

To support the previous anonymous:
"Every law of Kashruth, according to all Jewish Rabbinic authorities of the ages in a rare agreement, makes the assertion that the laws can be broken when any life is at stake. "

Tim Worstall said...

Doesn't have to be all that liberal an opinion either. Kosher or not also depends upon the number of removes, the distance from whatever it is that was not kosher.

As an example, cochineal, derived from insects and the red in red Smarties for many years, is not kosher. But I seriously doubt that a wheat crop that had been fertilised with some amount of pig slurry would be regarded as non-kosher.

Perhaps even that would: but there is still a limit to the number of removes that count.

Anonymous said...

I don't see why people see the pig connection as a "kosher" problem. The first commecial insulin was derived from pigs (and both Jews and muslims had no problem with that). Heart valves were also initially taken from pigs, again, no issue. ACTH (see Questcor Pharmaceuticals) is extracted from pig pituitary glands, again no issues. Ultimately, the pig has been a source of pharmaceutical preparations for a long time. And for those that are worried about "creepy crawlers", have you seen the recent commercials for activia. That contains live bacterial culture, and people don't seem to mind. And on that topic, bacteria for cheesemaking is derived from cow stomachs, yet cheese consumption in the US continues to grow steadily (caveat: I am not sure if there is any live culture or even milk products in American cheese, but that's a separate discussion).

Anonymous said...

Noticed that a director bought 200,000 shares today!

Anonymous said...

A small correction - An Orthodox Jew may well be Ashkenazi (European), Sephardic (Iberian/North African), or Mizrahi (generally Middle Eastern). An Orthodox Jew can be a member of any of the three main regional backgrounds, much as a member of the Conservative or Reform Movement can be. I believe that Crohn's is indeed found in greater numbers among the Ashkenazi population, regardless of which movement they follow.

Anonymous said...

Same goes for Heparin

John Hempton said...

I am not sure I see the pig problem in terms of Kosher any more. See the Rabbinical opinion up front.

--

It is amusing though.

And the small correction re origin versus orthodoxy of the Jews in question is fair comment and my mistake...

John

Bob Schriver said...

Crohn's is certainly not exclusive to Ashkenazi.

I have a cousin with it who's pretty pure red haired Irish - I think there are other populations to test this in.

Bob

Anonymous said...

If the treatment worked, no one would care if it was OK with the rabbi or not.

But your are right that god does have a wicked sense of humor.

Anonymous said...

Although I know absolutely nothing about Coronado Biosciences and although I am always highly skeptical of anything coming from a publicly traded biotech firm, there may be some basis for their statements:

http://en.wikipedia.org/wiki/Helminthic_therapy

And believe it or not, research indicates whipworm infection may harbor value as a treatment for Crohn's disease as well as for ulcerative colitis:

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1856386/?tool=pmcentrez

And as for Ovamed GmbH, although it all sounds strange, they are indeed the primary source for the trichura suis ova done in most related research:

http://opensourcehelminththerapy.org/mediawiki2/images/b/ba/Trichuris_suis_ova_therapy_for_allergic_rhinitis.pdf

Again, I'm not vouching for Coronado or any of its claims but Crohn's disease is an incurable, difficult to treat disease that has sufficient prevalence that someone with an effective therapy would likely make a lot of money:

http://en.wikipedia.org/wiki/Crohn's_disease

Erin said...

Anonymous, re. yoghurt and cheese: a bacterium isn't the same as a parasite. Some bacteria are actually symbiotic with humans--they are "good" in that we benefit from having them, and may feel terrible if we don't. Parasites are just parasites.

Is it just me or does medicine seem to be getting more and more disgusting as our proficiency with technology increases?

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