Biotech excited about hair-growth results

A subject in the early-stage clinical trial of hair regrowth therapy ReGenica before treatment (left) and after 12 weeks (right).


If your forehead is more like a fivehead, or you've started to see a lot more scalp at the crown of your head, the tiny San Diego biotechnology company Histogen has some promising news.

The company today is unveiling preliminary results from an early-stage clinical trial that showed its experimental hair regrowth therapy, ReGenica, increased new hair growth and the thickness of existing hair in men after 12 weeks.

“These results appear to be phenomenal, although this trial is still in the very early stages,” said Los Angeles-based hair transplant specialist Dr. Craig Ziering.

“Wimpy hairs became thicker, which is pretty significant to the patient because even if you cannot increase the numbers of hairs, if you increase the diameter, you increase the volume. And preliminary hair counts show there was an increase in new hair of 15 to 20 percent in some patients,” said Ziering, a paid member of the company's scientific advisory board.

ReGenica is made of a cocktail of proteins that are present in the early-stage embryo and help direct stem cells to become either hair, bone or blood, said Histogen Chief Executive Gail Naughton.

Although scientists have known about the role these proteins play, Histogen's aha moment was figuring out how to create them in a lab, said Naughton, who is also dean of San Diego State University's School of Business Administration.

Fibroblasts, early-stage stem cells that form connective tissue, are grown in the simulated low-oxygen and free-floating, low-gravity conditions of the embryo, Naughton said. The important Wnt proteins and growth factors then build up in that environment, she said.

The 18-person company, which opened in 2007, conducted research showing ReGenica stimulated hair growth in animals. It started its Phase 1 human trial to show the therapy was safe; no dangerous side effects were experienced, Ziering said.

Histogen was also hoping the trial would show ReGenica's effectiveness, which might give the company the buzz it needs to raise funding, build a manufacturing facility and then begin Phase 2 trials, Naughton said.

The Phase 1 trial involves 25 men ages 18 to 45 who have varying stages of male-pattern baldness.

Each of the balding spots was mapped into quadrants. Each quadrant received an injection of either the drug or a placebo. Some of the quadrants were also treated with microdermabrasion or lasers as well as the drug, to test previous medical theory that a wound helps to stimulate stem cells in the skin to regenerate hair follicles.

At 12 weeks, penny-size pieces of scalp were biopsied to observe the changes. Histogen staff even counted the follicles and hairs sprouting out of them. Once the trial is completed, an independent data-monitoring board will review the results after five months and make an assessment.

More than 50 million men in the United States alone suffer from hair loss, and about 35 million women are dealing with the problem, said Ziering, who has been treating patients for hair loss for 18 years.

“There's a tremendous need for something that can help people with their hair loss because there are many ramifications on people's lives,” Ziering said.

Histogen's product shows promise to do multiple things, including slowing the progressive nature of hair loss, increasing the thickness of the follicles and actually getting new follicles to grow, the physician said.

Histogen also sees ReGenica as a means toward lifesaving therapies that trigger stem cells to generate new tissue in damaged heart muscle and new neurons in damaged spinal cords, Naughton said.

“We wanted to go after a market where there is really an unmet need and a large patient population, which could help us generate the cash flow to fund longer-term projects that would be more of a regulatory and reimbursement hurdle,” she said.

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Biotech rice may be in the market by 2010

BIOTECH rice—the insect resistant variety and Golden Rice—will lead the new genetically modified crops for commercial use in the second wave (2006 to 2015) of market availability, according to the International Service for the Acquisition of Agribiotech Applications (ISAAA).

Dr. Randy Hautea, ISAAA global coordinator and its SEAsiaCenter director, told reporters that Bacillus thuringiensis (Bt)-resistant rice from China “may be available within 24 months,” or between now and 2010, and Golden Rice by 2012.

Hautea made the disclosure last week at the press conference on the global launching of the 2008 Global Status of Commercialized Biotech/GM (Genetically Modified) Crops report authored by Dr. Clive James, founder and chairman of ISAAA board of directors.

Bt rice is “extensively field tested in China and awaiting approval by the Chinese regulatory authorities” for commercialization, the report said.

Golden Rice—or genetically biofortified rice with beta carotene that produces vitamin A—is being field-tested at the International Rice Research Institute in Los Baños, Laguna. Its adoption for the Philippines is being done by the Philippine Rice Research Institute with two other traits incorporated in the rice—tungro virus and bacterial blight resistance.

The ISAAA report recognized biotech rice as “the most important of the new biotech crops that are now ready for adoption.”

This development is of great significance because rice is the most important food crop in the world, especially for the poor, aside from answering the current food security problem, James said.

“[More than] 90 percent of rice is grown and consumed in Asia by some of the poorest people in the world—the 250-million Asian households whose resource-poor rice farmers cultivate on average a meager half a hectare of rice,” the ISAAA report said.

Bt eggplant may be available as the first biotech-food crop in India within the next 12 months, the ISAAA report said. India is the fourth-largest producer of biotech crops with GM cotton planted in 7.6 million hectares.

Other crops that are expected to be available in the market before 2015 are potatoes with pest and/or disease resistance and modified quality for industrial use; sugar cane with quality and agronomic traits; and disease-resistant bananas.

Biotech vegetable crops—such as tomato, broccoli, cabbage and okra—that would require reduced amount of insecticides are being developed, along with propoor biotech cassava, sweet potato, pulses and ground nut, the report said.

Hautea noted the significance of 2015 as the end of the second decade when new biotech crops are available, because it is the target year under the Millennium Development Goals when a secure supply of affordable food is ensured and poverty and hunger have been reduced by 50 percent.

James said in the report that 2 billion acres or 800 million hectares were planted to biotech crops from 1996 to 2008, and that 13.3-million farmers in 25 countries planted biotech crops in 125 million hectares last year.

Among the notable developments, the report said, was the adoption of biotech crops in the African countries of Egypt (700 hectares of Bt corn) and Burkina Faso (8,500 hectares of Bt cotton), joining South Africa in biotech farming which, since 1998, has planted biotech cotton, corn and soybean.

“...Africa is considered the ‘final frontier’ for biotech crops as it has perhaps the greatest need and most to gain,” ISAAA said.

In the Philippines, 200,000 small farmers planted about 350,000 hectares of Bt corn farms in 2008.

A socioeconomic impact study cited by ISAAA said that small farmers in the Philippines earn an additional income of P7,482 a hectare in the dry season and P7,080 in the wet season from Bt corn in crop year 2003-2004.

Multiawarded biotech corn farmer Lydia Lapastora of Isabela province said in the same media briefing she netted P11,021 a hectare from planting GM corn compared with the traditional varieties.

Bt corn is the only transgenic crop commercially planted in the Philippines. However, 46 other products with GM traits, such as soya and canola, are allowed to be imported into the country, said Dr. Emil Javier, president of the National Academy of Science and Technology, in the same briefing.

Javier said in a speech that in order for the Philippines to hasten the development of biotech crops, it should “sharpen [its] focus” on transgenic traits already commercialized by other countries and apply them in local crops so that it could “reap the full benefits of plant biotechnology with the resources and opportunities at hand.”

He cited as example the development of Bt eggplant, and ring-spot virus-resistant papaya and delayed-ripening papaya in the country.

“We must put in more resources and speed up and scale up their testing and commercialization,” he urged.

He also raised the need for more lawyers and technical people with “business savvy” that would sort out the legal and financial applications of biotech technologies that could be applied in the country.

He said almost all of the country’s agribiotech research and development experts are in public hands but they do not have this kind of expertise in house.

“We must explore new ways of sourcing these expertise from the private sector to free our scientists from these roles they have no aptitude for, in the first place. We need lawyers and ‘techies’ to negotiate with foreign technology owners as well as with domestic private investors who will put up the capital and manage the enterprise,” Javier said.

Besides the 25 countries growing biotech crops, Hautea said, 30 countries are not growing but importing such products, and three to four countries “unofficially” (not legally sanctioned by their governments) grow GM crops.

The countries planting biotech crops are (according to hectarage): United States covering 62.5 million hectares with soybean, corn, cotton, canola, squash, papaya, alfalfa and sugar beet; Argentina, 21 million (soybean, corn and cotton); Brazil, 15.8 million (soybean, corn and cotton); India, 7.6 million (cotton); Canada, 7.6 million (canola, corn, soybean and sugar beet); China, 3.8 million (cotton, tomato, poplar, petunia, papaya and sweet pepper); Paraguay, 2.7 million (soybean); South Africa, 1.8 million (corn, soybean and cotton); Uruguay, 700,000 (soybean and corn); Bolivia, 600,000 (soybean); Philippines, 400,000 (corn); Australia, 200,000 (cotton, canola and carnation); Mexico, 100,000 (cotton, soybean); Spain, 100,000 (corn);

Those planting biotech crops in less than 100,000 hectares are Chile with corn, soybean and canola; Colombia (cotton and carnation); Honduras (corn); Burkina Faso (cotton); and Czech Republic, Romania, Portugal, Germany, Poland, Slovakia and Egypt with GM corn.

By 2015, the ISAAA projection is that from the current 25 countries 40 more will plant biotech crops with 20 million or more farmers involved in about 200 million hectares.

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Biotechnology's potential barely exploited

The promising potential of biotechnology remains largely unused, especially in such crucial areas as healthcare and production of environmentally friendly fuels, scientists said.

The experts gathered here at an annual conference of the American Association for the Advancement of Science predicted that biotechnology was likely to experience a boom in coming years.

"What you have seen over the last 35 years of biotech are tremendous applications, immediate applications of biotech starting with recombinant therapeutics all the way through," said Drew Endy, assistant professor of bioengineering at Stanford University.

He said the phenomenon can be explained by the fact that no one thus far has even "scratched the surface" of the promising science.

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But Endy argued that science was moving forward fast. In only six years, he said, the gene sequencing project went from reading a bacteria genome to reading a human genome.

Last year, researchers at the Venter Institute built a bacteria genome from scratch, he noted.

"I bet we will be able to construct a human chromosome, and the yeast genome," Endy said, offering a six-year forecast.

"It sounds a little bit crazy because it's an exponential improvement in the tools."

He said there were lots of opportunities to take those tools forward.

"We are advocating now a national initiative in synthetic biology that would include in part a route map for getting better in building genetic material, constructing DNA from scratch and assembling it into genes and genomes," the scientist pointed out.

Jay Keasling, professor of biochemical engineering at the University of California at Berkeley, said his project was using a microbe in order to produce a drug while significantly reducing its cost.

"We anticipate in one or two years that the optimization process will be completed and that production of the drug will commence and have it in the hands of people in Africa shortly thereafter," Keasling said.

Meanwhile, Christina Smolke, assistant professor of bioengineering at Stanford University spoke about her efforts to design molecules that go into the cell and analyse the cellular state before delivering a therapeutic effect.

"Our goal is to make more effective therapies by taking advantage of the natural capabilities of our immune system and introducing slight modifications in cases where it is not doing what we would like it to do," she said.

Smolke said she hoped to translate her technologies into intelligent cellular therapeutics for glioma cancer patients in the next five years.

"That's a very optimistic view... but so far things are moving quickly," she pointed out.

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Despite slow economy, biotech industry is booming

Despite our economic slowdown, biotech is booming led by Silicon Valley companies giving a big boost to both their patients and their investors.

At the end of 2008, MAP Pharmaceuticals was struggling with a stock price around 2 dollars a share.

Then, lightning struck...twice.

First, MAP made progress on a new way to treat migraine headaches. Then, it signed a billion dollar deal with Pharma giant Astra-Zeneca to co-develop a drug to fight childhood asthma.

Now, the Silicon Valley biotech company is a genuine up and comer, money in the bank, stock price up about 500 percent.

And it's hiring.

"We're taking medicines that are well-established, and trying to make them better," said MAP Pharma CEO Tim Nelson.

Nelson's company is poised for growth, but it's far from alone.

His Silicon Valley biotech neighbors like Varian Systems, which makes this device to fight cancerous tumors and Gilead Sciences, battling aids have rewarded both patients and investors lately bucking the recession, and growing by the day.

"The aging of the population, the need for medical care, and a lot of real good science by a lot of smart people can hopefully provide for better outcomes for all of us," said Nelson.

For MAP, the recent stream of success means more attention, better recruiting, and a way to shake things up for millions of potential patients.

"Asthma and migraine are significant underserved medical needs. So it's a focus of trying to find an underserved medical need, and seeing if we can provide better medicine," Nelson said.

Fighting through the recession with companies like MAP showing the way.

Since the therapies are still in development, it's too early to even guess when they'll be on the market.

Fresh from the farm, a biotech 'milestone'

A Framingham biotech company yesterday became the first to win federal approval to manufacture a drug by using genetically modified animals, an approach that could eventually be used to produce many drugs using farm animals.

The US Food and Drug Administration yesterday approved GTC Biotherapeutics Inc.'s ATryn, an anticlotting drug made using genetically modified goats that live on a farm in Charlton. GTC engineered the herd to secrete a special therapeutic protein in their milk.

"It's really a milestone event," said Eric Overstrom, chairman of biology and biotechnology at Worcester Polytechnic Institute, who collaborated with GTC on some of its early research using goats. "This adds to the toolbox for the pharmaceutical industry."

Though ATryn is likely to have limited marketing potential because it would serve a relatively small pool of patients, the drug's approval could clear the way to produce many more drugs with genetically modified animals, an approach nicknamed "pharming."

European regulators approved the drug - and the novel production technique - in 2006.

In addition to goats, Overstrom said, drug companies could potentially use other animals, such as cows or rabbits, to produce drugs in their milk, blood, or even urine. Overstrom said animals could be particularly helpful in cultivating enzymes and other large molecules that are more difficult to produce using bacteria or individual cells.

Still, some activists are wary about the use of genetically engineered animals. The Center for Food Safety, a nonprofit group, complained that the animals could pose unforeseen health and environmental risks.

"The creation of GE animals is a very slippery slope," Jaydee Hanson, the center's policy analyst on cloning and genetics, said in a statement. "All it takes is one mating between an escaped specimen and a natural animal to set off a chain of events that could lead to contamination or extinction."

Some investors are also uncertain how much GTC will benefit from its achievement. The company's stock closed at 70 cents yesterday, down 12 cents, far from its peak of more than $44 per share in early 2000.

Thomas Newberry, GTC's vice president of corporate communications, acknowledged the drug's revenue potential is modest. And like many small biotech companies, Newberry said the firm only has a limited amount of cash, which could cause some investors to worry about its future.

But he said GTC's technology could eventually produce billions of dollars in revenue.

"It's still tough times for development-stage companies," Newberry said. "But the upper bounds for the company are virtually limitless."

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Next Biotech Opportunity Could Be in Hospital Acquired Infections

Hospital acquired infections (HAI) are exacting a significant toll on human life, ranking among the top ten leading causes of death in the United States. With an estimated 5%-10% hospital patients acquiring an infection, about two million cases each year and about 90,000 deaths, there is a huge associated financial burden which a new report from Kalorama Information, "Nosocomial Infections: Market Assessment for Diagnostics and Therapeutics," estimates at between $4.5 billion and $5.78 billion annually.

Though some progress has been made in combating HAIs, more and more infections are proving resistant to antibiotics that are currently on the market. Another threat is beginning to appear in the form of global bugs that are hitching a ride on the backs of travelers. Bugs such as hepatitis C, the West Nile Virus, multi-drug resistant TB and yellow fever could be the next pandemic with the ability to severely cripple our healthcare system.

Just as infections can enter the hospital environment from abroad, so they can leave the hospital and enter our communities, often after swapping gene components with other bacteria and becoming even more drug resistant. For example, MRSA is increasingly present in schools and sports teams.

One thing is clear -- there is a strong need for new treatments to combat HAIs. But where will they come from? In 2007, the FDA approved 74 new drugs, of which only two were antibiotics. Also, of over 2,700 compounds currently in development, only about 50 are being developed as bacterial antibiotics.

"HAIs, especially the foreign bugs, are a considerable problem and the healthcare community needs help," said Bruce Carlson, publisher of Kalorama Information. "Unfortunately, the pharmaceutical industry has practically abandoned developing treatments. It will fall to the biotechnology community, and biotech companies have a market opportunity here that could provide them a major revenue stream."

Kalorama Information's new report "Nosocomial Infections: Market Assessment for Diagnostics and Therapeutics," focuses primarily on the more common bacterial infections, with some mention of viral infections. The report discusses the diagnostic and therapeutic technologies that are currently available and projects trends in these product areas. For further information visit: www.kaloramainformation.com/redirect.asp?progid=66469&productid=2065254

About Kalorama Information

Kalorama Information supplies the latest in independent market research in the life sciences, as well as a full range of custom research services. We routinely assist the media with healthcare topics.