Freelance
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Bioscience gets tot he Heart of the Matter
By William Cracraft
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Surgical trauma control and protein synthesis intervention are two ways Bay Area biotech companies are trying to help people. Heartport and Ribogene are typical in how they were formed and have evolved, but each has a unique product in place or on its way down the long pipeline to FDA approval.
The path followed by Heartport is fairly common to biotech companies. Someone in the field, medical, pharmaceutical, or other biological area, joins hands with a businessman to get financing and a professional administrator.
In 1991, Dr. John H Stevens had an idea and Dr. Wesley D Sterman helped get it on the road to fruition. It was venture-financed from the get-go. Wes was president and CEO and raised the first financing. Stevens was completing fellowship training at Stanford, said Frank Fischer who took over as president and CEO for Heartport in May of this year.
Both founders are still involved with the firm. Wes is chairman of the board and John continues to work with us from a technology assessment vantage point and in helping with the adoption of the procedure in the field, said Fischer.
Stevens had seen the trauma associated with that portion of the surgery, began to think about how it might be lessened and conceptualized this kind of activity to accomplish that, said Fischer. The greatest advantage to the procedure is the greatly reduced damage to the patient’s chest during surgery. Instead of making a foot-long incision in the skin, sawing through the breastbone and spreading the ribs up and out with a mechanical device, the Heartport system bypasses the heart with a series of tubes and pumps inserted in the neck and groin.
The new procedure accesses the chest area through catheters (which are then) moved through the system to appropriate places at or near the heart. By virtue of that activit,y the patient is put on bypass without opening the chest. Operations are then performed through small incisions between the ribs, Fischer explained.
Cardiac surgery is relatively safe. Given what the body is put through, the mortality statistics are already pretty low, Fischer said. Heartport's solution deliver's comparable outcomes with less trauma to the patient. The recovery of the (Heartport) patient is generally much faster than recovery from open-chest procedures, Fischer said.
No business can afford to stand still and Heartport is improving and expanding its products constantly. Since the original approval which took place at the end of 1996 they have made a score of improvements
" We still have a significant challenge ahead of us. It is difficult for a physician to learn the technique because it is a new technique and different from the way they have typically trained. The easier and faster we can make the procedure the lower those obstacles will be to future adoption," said Fischer.
RiboGene, like many biotechnology companies is still working towards a commercial product. The company was started in 1990 to synthesize proteins in vitro, that is, in a machine instead of through natural protein synthesis.
"That’s difficult to do and no one has done it yet," said Tim Morris, vice president of finance and administration, and CFO for RiboGene. RiboGene turned a corner in 1993 and began focusing on therapeutics. They had learned a lot about protein synthesis. Every living organism needs proteins to survive, that’s why its a nice target for drug discovery especially in the infectious disease area.
"If you‘re able to stop protein synthesis, you should be able to kill what ever is making the protein," said Morris. The challenge is to kill proteins for the bad organisms but allow the necessary human proteins to form. Bleach is a great killer of all proteins, but it also kills humans.
"You want to find something that will kill proteins that are specific to the pathogen or bacteria you want to kill. We are an infectious disease drug discovery company. We have some novel technology that allows us to identify new potential anti-infectives," Morris added.
The company aims to develop treatment for systemic fungal and bacterial infections. Yeast infections, athletes foot and toenail infections for the most part are all topicals." Those are not where our market is, (but) if those infections ever get into the blood, then it becomes systemic. It happens to a lot of people, AIDS patients, people who are organ transplants recipients, people in chemotherapy, anyone whose immune system is knocked down a bit," said Morris.
To implement its shift in strategy, the company changed its research team and brought in a new CEO, Charles J. Casamento, who drew on his successful track record to raise money from venture capitalists.
Five years later the company has progressed towards a marketable product enough to sell stock to the public. "We are still early-stage, we are still in research. Our analysts predict we will have a product on the market in 2004." said Morris.
The medical need is clearly there with drug-resistant pathogens showing up every other day. "More than likely will be something coming from our anti-bacterial or anti-fungal areas. We haven’t started human testing and the analyst predicts we will start human testing somewhere around the year 2000," Morris said.
The next step for the 38-person company is pre-clinical work, which comes before testing on humans. "Among other steps, this involves some work on the chemistry side, to see if you can make it, make it oral active and make it cheaply," he added.
The company started in Hayward and is still headquartered there. "We moved to a new facility here a year or so ago and made the decision to stay here for a couple of reasons. For one thing the cost of land here is just probably half of what it is on the Peninsula, and we are also at the foot of the San Mateo Bridge and that allows employees live all over the Bay Area. Being in the Bay Area alone is of great help.
"The ability to draw talent from this area, both at the consulting level and the employee level, is very important. Access to Stanford Cal and UCSF is also critical. In addition, the infrastructure is here: attorneys, venture capitalists, people we buy equipment from, its all here. We’d be hard pressed to put this in Omaha," said Morris.