LONDON, July 24 (Reuter) - News that the people who cloned Dolly the sheep had also cloned Polly the lamb means that genetically engineered products from clones are now one step closer.
Analysts say PPL Therapeutics (PTH.L), the Scotland-based company that keeps astonishing the world with its cloning advances, has a wide open field in the genetic engineering market.
PPL announced on Thursday it had cloned five lambs -- all near-identical sisters from the same cell line -- that carried human genes.
This marriage of cloning technology with genetic engineering is the point of PPL's existence and its close link with the Roslin Institute, a government-funded research laboratory right next door.
The idea is to create herds of animals that all pump out human products for the medical market.
PPL is currently testing alpha-1-antitrypsin (AAT), a protein used for treating cystic fibrosis and emphysema, in human volunteers.
It also has sheep that can produce human factor VII, factor IX and fibrinogen, all blood-clotting products, as well as activated protein C, which prevents blood clots.
Cows in PPL's Blacksburg, Virginia herd produce human milk protein, and its rabbits make human calcitonin, which helps the body replace bone and thus helps osteoporosis victims.
Ron James, managing director of the company, has said commercial products are at least five years down the road.
PPL must get through strict clinical tests first and faces flak from environmental groups and some government officials who regard cloning and genetic engineering technology with suspicion.
``Transgenic'' plants and animals are not uncommon: products already on the market include Calgene Inc's (CGNE.O) Flavr Savr tomato and Monsanto Co's (MTC.N) Round Up ready soybean.
Dutch biopharmaceuticals firm Pharming, which produced one of the world's first transgenic farm animals with Herman the bull in 1988, plans to sell human lactoferrin produced by its herd of transgenic cows. Lactoferrin can help boost the immune system.
What is difficult is getting the animals to consistently produce the products. Sometimes the gene ``takes'' when inserted into an embryo, but often it doesn't, and months have been wasted.
If a successfully engineered trangenic animal can be cloned, and then bred successfully, it would be possible to create herds of the creatures, all pumping out commercial product of identical quality.
Analysts say PPL faces little competition.
The U.S.-based Genzyme Transgenics said on Thursday it was starting Phase II clinical tests on its genetically engineered human antithrombin III product, which prevents blood clots.
Genzyme Transgenics, partly owned by Genzyme Corp (GENZ.O), is also working on cows that produce human serum albumin and glutamic acid decarboxylase (GAD), a protein that could be used to treat the effects of diabetes.
Raymond Rodriguez, a genetics professor at the University of California at Davis and founder of the genetic engineering company Applied Phytologics, said he has grown rice that produces human AAT.
Currently, human proteins are produced using bacteria in a laboratory. This yields only small amounts at an often exorbitant cost -- up to $1,000 a dose.
``There's only a few groups worldwide which have the capability of doing this kind of transgenic work,'' said Erling Refsum, a biotech analyst at Yamaichi. ``(PPL) are certainly ahead of (the) field in this particular area.''
Nick Woolf, an analyst at Robertson Stephens and Co, said there was little competition among the companies, which often made deals to avoid patent battles.
``They have various cross-sharing licenses,'' he said. ``None of them will actually be taking each other to court.''
Both analysts thought the technology was sound and that PPL could quickly get a product to market now.
But Refsum warned: ``We've still got to find out whether this stuff is actually effective and useful in cystic fibrosis patients.''
12:28 07-24-97
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