Pharmos (PARS) is currently engaged in the development of a marijuana-based treatment for head trauma known as Dexanabinol. The drug, HU211, is in Phase II clinical trials on human patients. If everything goes as planned, Pharmos expects to submit the drug to the US Food and Drug Administration for approval in three to four years.
Last week, the "Washington Post" reported on its front page that the National Institute of Health had made a scientific "breakthrough" in the use of marijuana to treat head trauma and stroke in rat brain cells in petrie dishes. Despite the massive press coverage given the results, Pharmos managing director Michael Schickler says, "they are five years behind Dexanabinol".
Marijuana-based pharmaceutical development is currently very fashionable and receives massive press coverage. Schickler says that such fashions are passing things, usually in much less time than it takes to develop a drug through FDA approval and marketing stages. "Pharmos will continue the serious work of pharmaceutical development even if it goes out of fashion in six months.
"A few years ago, when we started working on HU211, you couldn’t mention the fact that it is based on THC, the active ingredient in cannabis. It was immediately associated with hallucinogens."
Professor Rafi Meshulam was one of the first pioneers in the field and the first to isolate the active ingredient in hash in a laboratory environment at the beginning of the 1960’s. By the end of the 1980’s, he had isolated the therapeutic component from the hallucinogenic component using a chemical process. According to Schickler, Pharmos today holds an international license for that process and is continuing Meshulam’s work.
Schickler says it is nearly impossible to estimate the market potential of Dexanabinol as there is currently no approved medication for head trauma. A patient admitted to an emergency room today is likely to be given a cocktail of 20-30 different medications, each of which deal with different indications of head trauma. None of these deal with the brain and nerve damage resulting from the injury.
In head trauma particularly, but also in stroke patients, there is a process of spreading nerve damage from the original injury. This is caused by many factors. Although Schickler says a number of companies are currently developing medications for similar indications, only one, which is far behind Pharmos, protects against more than one of these factors. Pharmos’ drug handles three of them.
Schickler says conservative estimates of the potential market for this drug are around $500 million annually, although some estimates mention $1 billion, depending on the methodology used to estimate the number of potentially treatable patients.
Pharmos is processing the results of Phase II clinical trials on Dexanabinol, in which a small number of patients are recruited and various dosages are examined to find the best technical parameters in such matters as safety and certain hints of efficiency. This sets up the best conditions for Phase III clinical trials, in which a few hundred to a few thousand patients are recruited for testing the drug.
Pharmos carefully maintains a good relationship with its investors, Schickler says. The company is not interested in day traders, but makes a concerted effort to open channels to bigger investors who will stay with the company. "I believe that those who stay with us for the long term will find we fulfill our promises. We have fulfilled or beaten all our milestones until now and I expect us to continue to do so. For instance, we projected revenues in Q3, but will be able to post them already in Q2."
Pharmos nurtures investor relations, disseminating all possible information through the Internet or direct telephone conversations. "Pharmos makes sure they receive newspaper articles about us by fax or mail. The "Financial Times" recently gave us a very favorable write up."
If all this is true, why are NIH lab rats getting national coverage in the US, while Pharmos remains a virtual unknown? "Why can’t we make this a bigger story? I have no idea. I have no answer for why we don’t get serious coverage," says Schickler.
Schickler says the "Washington Post" article doesn’t do the reporter any credit. "The NIH didn’t invent anything. There are folklore accounts of the use of marijuana and hash as painkillers going back to the Chinese 4000 years ago. Based on these folklore accounts, a great deal of modern scientific work has been done. There is even an extremely limited product sold in the US by a company called Unimed as a pain killer for cancer patients based on the active ingredient in hash."
"I don’t know why this happened to the NIH and not to us. I come from the science side of the industry, where you quote people who have done similar work before you. Maybe if we had a $1 million PR guy, this would happen to us too."
Pharmos recently hired Gwynn Crosson to handle its public relations. Crosson says one of her primary goals is to increase media and investor awareness of Pharmos and Dexanabinol.
Crosson stated that Pharmos was happy to see press coverage of the NIH trials, which use a similar, cannabis-based, compound for the same indications. "This story, the story of cannabis compounds in treating head trauma, is the story we want to get out. True, the "Washington Post" didn’t specifically tell the Pharmos story, but this coverage helps us too."
Crosson also pointed out, that the NIH is using the compound as a single mechanism in treatment of head trauma and stroke, an anti-oxidant, while Pharmos’s Dexanabinol uses the compound as three simultaneous mechanisms.
Published by Israel's Business Arena July 14, 1998