Out in Left Field Again

The big news this week in the world of global health was the announcement by the Global Alliance for TB Drug Development that a combination of drugs (one completely novel drug candidate, a new TB drug candidate already approved to treat other infectious diseases, and one existing TB drug) was shown in a 14-day Phase II study to eliminate the infection in two weeks (TB Alliance brief).  Moreover, the Alliance noted the results indicate that the combination may be compatible with anti-retroviral treatment (TB is a major killer of HIV patients) and may be effective against the drug resistant forms of TB (Diacon 2012).   Also noted was that additional studies of this combination and another are underway and are needed to establish clinical utility, but clearly the results promise a better, faster, and more affordable drug therapy for TB.

As regular readers may remember I wrote about a different direction to TB therapy development last month and since I am just back from vacation, I am re-gifting that posting on two companies that are working on immuno-therapeutic approaches.

TB is one of the big three global infectious diseases (along with HIV/AIDS and malaria) and there are major international efforts, public and private, to development better drugs (see my post “TB DD Needy”) and vaccines (see the recently issued plan for vaccine development [Aeras Blueprint] and the announcement of a $220 million Gates grant to Aeras, the non-profit vaccine developer [Aeras Grant]).  Of less interest to the TB R and D community is a mash up of drug therapy and vaccines or “immunotherapy” which uses killed mycobacteria (a type of vaccine) to either rev up the immune system to eliminate a latent infection or to turn it down to increase the susceptibility of an active infection to drugs.  I’m no expert, but attribute the lack of interest among the mainstream researchers to slipperiness of immunotherapy data and that being unconventional is a risk to one’s career.

In any case, I wrote about clinical progress being made by a company taking the “rev up” route, Archivel Farma of Spain, about two years ago (“Una Sorpresa Prometedora” 6/24/10).  The company’s therapeutic is a heat-killed and “detoxified” M. tuberculosis prep (RUTI) which is co-administered with a standard TB drug over a one-month period and which apparently successfully completed a Phase II trial last June (Bio Cat News) (but apparently the data have not been published).  In December, the company raised more money and plans to go to Phase III at a cost of 10 million euros (Bio Cat News) in 2013 (January 2012 press release).  Unfortunately, my timing was off when I stopped in at the Archivel booth at the BIO 2012 conference I attended in late June, and I was not able to get an update.

The “turn down” approach seems counter-intuitive to me but is being taken by Immunitor/Immune Networks Ltd. of Vancouver, Canada, the source of the recent report of clinical progress.  According to a May 31 article in FierceVaccines (FV article) and press release (FV press release), in a Phase II trial more than 100 TB patients, including those being re-treated and with MDR-TB or with HIV co-infection, were treated daily with tablets containing heat-killed M. vaccae, a related strain, concurrently with either first- or second-line TB drugs.  After a month, 77.8% of the treated patients as opposed to 19% among placebo recipients had no M. tuberculosis in sputum smears (a standard measure of active infection).  Moreover, the same results were seen in the treatment-failed TB, MDR-TB, and HIV-TB groups.  The implication is that, due to a shorter treatment time, the “V7 vaccine” will reduce the chance of drug resistance and, due to oral dosing and low-cost, will be more available.  The press release also mentioned two studies, evidently done by other companies, Immodulon of the UK and Anhui Longcom Biologic Pharmacy Co., Ltd. of China, that showed efficacy with injectable forms of M. vaccae with drugs in treating MDR-TB, so V7 may work on these infections.

I tried to learn more about Immunitor and Immune Networks Ltd., but did not find much information.  Immune Networks has a cranky website with broken links (IN) and is apparently a publicly-owned company whose stock trades on the OTC/Vancouver Stock Exchange for pennies per share.  Immunitor has a functional website (Immunitor), developed the technology for making tablet forms of vaccines, and was apparently privately owned until IM bought 50% of it with stock in February 2011 (Globe Newswire).  Immunitor also says it has four products on the market and five in development (Products).  On the other hand, Immune Networks says it is delinquent in its regulatory filings due to financial constraints and is suing a contractor (IN Home).  But apparently, someone in the National Research Council of Canada likes them because the joint company received a unspecified grant under a cooperative research agreement in November 2011 (PR Web release).  More recently (this month, July), Immunitor’s principal investigator, Dmytro Butov, noted that a Phase III trial will start in the near future (Online PR).

While “out in left field” means to be nonsensical or absurd, “out of left field” means without warning, a surprise.  I am hoping that for the Archivel and Immunitor immunotherapies, the latter is more apropos.

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