A human blood substitute technology licensed from Texas Tech University Health Sciences Center and being developed in partnership with Dallas firm HemoBioTech is expected to enter clinical trials in India and the US by next year, and could represent Texas Tech’s first “homerun” tech-transfer deal, HemoBioTech and Texas Tech official said this week.
If it clears regulatory hurdles, the product, called HemoTech, would be the first viable substitute for human blood transfusion, and would look to play in transfusion markets worth up to $2 billion and $4 billion in India and the US, respectively.
A marketed product could also pay off big for Texas Tech, which has a 6-percent equity stake in HemoBioTech, according to a university official.
Scientists at TTUHSC began developing the underlying technology for the blood substitute in the late 1980s. According to David Miller, managing director of the office of technology transfer and intellectual property at Texas Tech University, its development was initially slowed by the same toxicity concerns that have shelved several other human blood substitutes in recent years.
Specifically, most scientists attempting to develop blood substitutes have attempted to incorporate modified forms of hemoglobin, the iron-containing protein responsible for binding and carrying oxygen throughout the body.
According to HemoBioTech, these technologies have been hampered by side effects such as kidney toxicity, vasoconstriction, and inflammation, and in some cases have failed because the modified hemoglobin lacked the appropriate co-factors needed to release and deliver oxygen to cells.
For these reasons, Miller said, Texas Tech found it “much more difficult to not only move through the funding cycle, but also [regulatory] approval. Investors have been wary of another blood substitute tech, because they’ve lost money on others, so it makes it more difficult for them to come back and say definitively that this is the answer.”
However, Texas Tech researchers were able to develop alternatives to steer around these concerns, including using bovine blood, which does not need the same co-factors to release its oxygen; as well as modifying the blood substitute with the chemicals GSH, ATP, and adenosine to address the toxicity issues.
In 2001, HemoBioTech was founded to commercialize the technology, and the company has continued to develop HemoTech over the last several years to ready it for clinical trials.
HemoBioTech CEO Arthur Bollon this week told BTW that the adenosine modification has thus far been the key to distinguishing the product from past failures.
“Companies have tried for about 35 years to come up with a substitute for red blood cells,” Bollon said. “There is an intrinsic toxicity to the hemoglobin. What makes this product unique is that our scientists from Texas Tech used adenosine to polymerize the hemoglobin. It turns out this overcomes this intrinsic toxicity. Instead of being vasoconstrictive, [HemoTech] is vasodilatory. It’s also anti-inflammatory.”
Furthermore, Bollon said, HemoTech induces erythropoiesis and has produced promising data in both pre-clinical and foreign clinical trials to date.
“There is a tremendous market potential, and need, for a substitute for red blood cells in India. As a potential market, it is $1 billion to $2 billion in India alone, and we consider it a potential stand-alone market.”
When HemoBioTech was founded, Texas Tech took an equity stake in the company in exchange for a license to the patents surrounding HemoTech. That equity stake today stands at about 6 percent, Miller told BTW.
HemoBioTech has also sponsored ongoing research at TTUHSC to further develop the product, including the use of animal facilities at the health sciences center to produce HemoTech and further prepare it for regulatory submission.
HemoBioTech and Texas Tech have cultivated what officials from both entities termed a “close-knit” and “excellent” relationship with the shared goal of bringing HemoTech to market.
Miller estimated that the university has pumped in between $6 million and $10 million in research funds to help develop the technology. These funds include research investments made by the university prior to the founding of HemoBioTech, as well as an unspecified amount from an undisclosed private foundation.
So far, Texas Tech’s equity stake in HemoBioTech has provided little return: HemoBioTech has lost a cumulative $8.1 million between 2001 and the end of 2006, the last year for which the company released full financial data.
However, both HemoBioTech and Texas Tech are betting that their investment will pay off if the HemoTech product can tap into a global blood market that HemoBioTech has estimated is worth more than $25 billion.
In the near term, HemoBioTech is in particular eyeing the Indian and US blood transfusion markets, Bollon said, and hoping to alleviate a common problem in transfusions: contaminated blood.
Bollon said that market research conducted by the company showed that the frequency of HIV-infected blood in the entire donated blood market in India is 1 in 9,000 units, while in the US it is 1 in 1.8 million.
“There is a tremendous market potential and need for a substitute for red blood cells in India,” Bollon said. “As a potential market, it is $1 billion to $2 billion in India alone, and we consider it a potential stand-alone market.”
Bollon added that the US market is estimated to be between $3 billion and $4 billion, but that the path to commercialization in India “could be quicker, and the cost would be probably a third less expensive.”
With the help of California-based contract research organization Paragon, HemoBioTech is in the process of submitting its pre-clinical and foreign clinical data to regulatory authorities in India.
The company has also presented its data to the US Food and Drug Administration, which in April 2006 provided several pre-Investigational New Drug recommendations that Bollon said HemoBioTech and Texas Tech are currently addressing.
Bollon said that the company’s goal is to initiate clinical studies in India this year and to receive approval to start clinical trials in the US by the end of the year, which would put the firm on target to begin US clinical trials next year.
Patents covering the technology have been issued in 21 countries, Bollon said, so HemoBioTech expects to pursue commercialization in some of those countries should HemoTech be approved in India and/or the US. “We’re interested in other markets also, but India and the US are the main focus right now, and they’re going in parallel,” he said.
Texas Tech’s Miller suggested that the school hopes HemoTech can become its first real “homerun” tech-transfer deal. The school does not have updated tech-transfer metrics available, but Miller said that to this point it has had “some base hits and doubles, but never one that put us on the map in terms of commercialization.”
Miller added that even aside from the promise of an economic return on HemoTech, Texas Tech’s near-term focus is helping HemoBioTech get the product on the market as soon as possible to start saving lives.
“Our particular focus is on soldiers — they’re all over the world, and you look at the blood supply they have available, it’s a big issue,” Miller said. “Even if we were narrowly focused on that, this would be a worthy endeavor.”