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http://www.renovo.com/content.asp?c_id=9
Renovo has safety data on more than 1,500 human subjects. Juvista has no current safety or tolerability issues for its application in the prevention or reduction of scarring in the skin. In addition, the design of the clinical trials involved the excision of the scar at 6 or 12 months which, as well as providing efficacy information, further supported Juvista’s safety profile.
On analysis, Juvista-treated wounds showed a statistically significant improvement in scar appearance as evaluated by the surgeons and the lay panel and a response rate of over 70% was observed. Histological analysis of excised scars also supported this efficacy.
In summary, it appears that acute dosing of Juvista around the time of surgery to approximated wound margins causes a prevention and reduction of scarring such that good scars like those that would normally result from plastic surgery or dermatology procedures are further improved (and difficult to detect) and poor scars such as those that might result from trauma or major excisions are improved – both at the same optimal dose. Importantly Renovo has also established the long-term benefit of Juvista, indicating a permanent regeneration of more normal skin which is consistent with the drug’s mechanism of action.. -
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Mi informerò di più su questo prodotto che sembra, se le aspettative saranno confermate, dare speranze a tutti coloro che si ritrovano con una brutta scar. . -
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Purtroppo le notizie non sono buone:
UPDATE: Renovo Shares Fall Following Flawed Juvista Trial12-13-07 7:46 AM EST
LONDON -(Dow Jones)- Shares in U.K. biotech Renovo Group PLC (RNVO.L) fell Thursday after its lead drug candidate, scar prevention treatment Juvista, failed a trial.
The Manchester, England-based wound care specialist, which also reported a wider full year pretax loss, said Juvista flunked a study to determine if it reduced scarring following the removal of moles.
Renovo said it failed because the trial was flawed.
Shares fell 7% or 12 pence at 1145 GMT to 158 pence, in a lower London market. They remain 15% up on the year but beneath a June high of 227 pence.
Chief Executive Mark Ferguson said in a conference call that the failure is unlikely to derail Juvista's progress.
Renovo expects to enter Juvista into phase III trials, typically the final stage before marketing approval for a new drug can be sought, by the second half of 2008.
Ferguson said the trial cost about GBP100,000, and even if the U.S. Food and Drug Administration excludes mole removal as an area where Juvista can be used it represents just 2% of a $4 billion potential market in surgery. He stressed that he didn't think it would.
In June, Renovo signed an exclusive licensing deal worth $825 million plus royalties on sales with the U.K.'s third largest drugmaker, Shire PLC (SHP.L), to develop and commercialize Juvista worldwide. Shire took a 7% stake in the biotech.
Renovo held on to the European marketing rights for the drug.
Ferguson said Renovo has more than GBP100 million in the bank, which will fund its programs through to 2011.
It has a second product, Zesteem, in phase III trials that is likely to get approved before Juvista, he said, and Renovo is seeking a partnering agreement similar to its deal with Shire.
It estimates Zesteem's market potential at about GBP300 million to GBP500 million.
Other drug candidates, also focused on wound care, include Prevascar and Juvidex, in early and mid-stage trials.
Nomura Code analyst Samir Devani said in a note prospects for Juvista remain positive despite the mole trial failure. He rates the stock buy, with a fair value range of 230 pence to 240 pence.
Renovo Thursday reported a full year pretax loss of GBP23 million compared to a loss of GBP12 million in 2006, which it blamed on a GBP9 million hike in research spending.
It booked revenues of GBP491,000 for the year, versus revenues of nil in 2006.
Company Web site: http://www.renovo.com
-By Jason Douglas, Dow Jones Newswires; 44-20-7842-9272; jason.douglas@ dowjones.com
(END) Dow Jones Newswires
12-13-070746ET
Copyright (c) 2007 Dow Jones & Company, Inc.
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-Ronald-.
User deleted
ma in soldoni che prodotto sarebbe? e di acell non si sa + nulla? .
JUVISTA TRIALPer tutti quelli con una brutta scar |
