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Example research essay topic: Risk Of Developing Clinical Trials - 1,126 words

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Obesity drug Famoxin gives Genset shot in the arm By Noah Barkin PARIS, Feb 6 (Reuters) Investors scrambled to buy shares in French biotechnology firm Genset GENX. LN on Tuesday after the company announced pre-clinical tests showed its anti-obesity drug Famoxin was effective in treating laboratory mice. Genset said its star drug, for which it now plans to begin human clinical trials at the end of the year, had caused obese laboratory mice to lose weight without a change in their diet. The findings were published in the on-line edition of respected industry journal Proceedings of the National Academy of Sciences. If Famoxin passes human clinical trials, where many drugs fail, it would complete the groups dramatic transformation from genomics boutique to successful drug developer.

We will know if it works on humans at the beginning of 2002, said Francois Human, analyst at CIC EIFB in Paris. I give them a good chance of proving it works and developing a drug which is likely to be limited to obese diabetes patients. Shares in Genset, which surged last month on hopes that Famoxin could pave the way for a partnership with a large drugs group, were suspended from trading in Paris for much of Tuesday as a flood of buy orders pushed the stock to its upper-limit. When the shares finally began trading at 1445 GMT, they showed a rise of 17. 53 percent to 59 euros. A SMALL REVOLUTION? Famoxin is a protein that Genset says helps burn fat in much the same way insulin converts sugar into forms of energy the body can use.

Bernard Bihain, who heads the firms obesity research and is the driving force behind Famoxin, warned against over-optimism but said mice that were given the protein had lost roughly eight percent of their weight in just two weeks. It is certainly not a miracle, but it could eventually be a small revolution, Bihain told Europe 1 radio. He said he hoped the first tests would take place on humans at the end of this year, although the drug was unlikely to be on the market for five or six years. Bihain also made clear the medication would be destined for sick people who had tried classic ways of losing weight and who were at risk of developing diabetes or cardiovascular illnesses. The eight percent reduction in body weight in obese mice is about as good as you could hope for, said Ian Smith, biotech analyst at Lehman Brothers. That would be a very good result if the product turns out to be similarly effective in humans.

While it will take years of research before the product is ready to be filed for regulatory approval, Genset could benefit much sooner from milestone payments paid by a licensing partner. The company, which has generated losses for years, would need backing to finance development of the drug. Last month, Genset Chief Executive Andre Pernet said he was talking with a number of major pharmaceutical firms about Famoxin. DEAL TO WAIT UNTIL AFTER HUMAN TRIALS But he told Reuters on Tuesday that the company planned to wait until the human trials had demonstrated the drugs effectiveness before signing a deal. We can get a lot of money if we have a medication that works for humans, Pernet said in an interview. He said the company could expect an initial advance payment of 25 million euros and a total sum of 100 million euros excluding royalties.

A partnership with an industry heavyweight would permit the group to turn a profit by next year, or three years sooner than otherwise possible. The pre-clinical success of Famoxin is a crucial step in the companys effort to develop drugs on its own. In the past it has relied on partnerships with big drug companies for its revenues. Genset have a very, very interesting story in Famoxin which could help transform the group into a drug development operation, but it is still at an extremely early stage, said a London-based fund manager.

A French biotechnology firm, Genset, has produced what may be a drug that could reduce weight, up to 8 %, without changing your diet. This drug is called Famoxin. They have just finished research with lab mice. In the study, the lab mice on Famoxin lost about 8 % of their body weight within two weeks.

Biotechnology analysts say that 8 % is the best you could expect from it, if it even works at all in humans. They say that they will know if it works on humans by the beginning of 2002. Even if it does work on humans and everything goes according to how it is planned, it will probably only be available to at risk patients. These are people who are obese and have tried other means of weight loss and just cannot do it, and are at risk of developing diabetes or cardiovascular illnesses.

This means, not just anyone who thinks they are fat can take it. The drug still has many stages of research and regulations to pass, where most drugs fail, before it hits the market. Shareholders are already jumping the gun and are ready to support the next few stages of development. This is a big turnaround for Genset, who in the last few years has experienced great losses.

I think this is definitely a good drug to be developed. However, it could easily be miss-used by many teenage girls. For people who are at risk of developing diabetes or cardiovascular illnesses, this drug could possibly save their lives. Where at the same time, teenage girls who look in the mirror and see a fat person could potentially endanger their lives. If the drug actually proves that it does cause weight loss without change in diet, and passes the rigorous tests and regulations set by the government, I will be surprised. Many drugs have come to the public attention, claiming that they do some miraculous task, but after extensive research, they reveal that they actually dont do a thing that was earlier claimed, and could actually do more harm than good.

If it does become available to the public, I have faith that strict government protection will keep it out of the hands of common teenage girls obsessed about their weight, in fear of not finding the perfect dress for the perfect boy. Everyone knows that people with no business using the drug will get their hands on it, but through regulation, that number could be limited. It could become a prescription drug, where a doctors written approval would be needed to receive it. This will help prevent miss-use. Overall, it could be a good thing, but I have my doubts that it will pass the scrutinizing of the government.


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Research essay sample on Risk Of Developing Clinical Trials

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