DYAX product looks like complement not competitor to Lomucin or the 2nd generation product GENR is developing for CF. GENR's products for CF are mucoregulators, while DYAX's product appears to be an anti-inflammatory....
Potential for orphan status for lomucin??? Perhaps this is incentive for continued talks with CF Foundation. One possible use of new funding is for phase II testing of Lomucin to gain this status....
Looking for another patent issued early 2004 to GENR for mucoregulating target based on Levit's WSJ November interview. GENR taking steps to protect IP in this area and intends to license this target to big pharma....
Dyax Corp. and Debiopharm S.A. Report Successful Results of Phase Iia Clinical Trial With DX-890 for Cystic Fibrosis
CAMBRIDGE, Mass. & LAUSANNE, Switzerland--(BW HealthWire)--July 15, 2002--Dyax Corp. (Nasdaq: DYAX) and Debiopharm S.A. today announced the results of the phase IIa study conducted by Debiopharm in adult patients with cystic fibrosis (CF) using DX-890 (also known as EPI-hNE4), a recombinant inhibitor of human neutrophil elastase discovered by Dyax. Human neutrophil elastase (hNE), an enzyme produced as part of the inflammatory response, is implicated in the loss of lung function in patients with CF and other clinical conditions.
The study, which was conducted by Debiopharm in France and Italy under its collaboration agreement with Dyax, was carried out in two stages, using two doses of DX-890 given by daily inhalation for 14 consecutive days. The study endpoints were safety as defined by general tolerability, and pulmonary function testing. The effect of the drug was measured by the ability of DX-890 to inhibit sputum neutrophil elastase.
In the first stage of the study, 7 CF patients were treated with 7.5 mg of DX-890 per treatment. DX-890 was well tolerated, with 6 of the 7 patients completing therapy. One patient in this study withdrew for personal reasons. The pulmonary function tests did not change between the start and end of treatment. Inhibition of elastase in sputum was observed and was complete in 2 of 6 subjects.
In the second stage of the study, 19 CF patients were treated with a dose of 30 mg of DX-890 per treatment. The drug was well tolerated, with 11 patients receiving a full course. Three patients were withdrawn due to drug related side effects (two had concurrent but unrelated chest infections, and the third had an adverse event during the first treatment). Five patients were withdrawn due to events unrelated to DX-890. The pulmonary function tests of the 11 patients that completed the higher dose portion of the study did not show any adverse changes compared to baseline. These patients had inhibition of sputum neutrophil elastase following the therapy, an effect that persisted from one inhalation treatment until the next. 7 of 11 of the patients had complete inhibition of elastase in sputum.
In summary, the results confirm the good tolerability and the expected pharmacological effect of DX-890 on inhibition of neutrophil elastase in the lungs of CF patients when given as a nebulised formulation. In light of these results, Debiopharm plans to initiate additional Phase II studies to confirm tolerability and detect potential clinical benefits of DX-890 in CF patients.
"We are pleased and encouraged by the results of the Phase IIa trial and look forward to learning more about DX-890 from further trials." said Henry E. Blair, Chairman and CEO of Dyax Corp.
Debiopharm, Debio R.P. and Debioclinic are an established and proven group of three synergistic and complementary companies, that has a successful track record in developing, registering and bringing to the market new chemical entities both in Europe and in the United States. Products successfully registered and launched include oxaliplatin for advanced colorectal cancer and triptorelin pamoate for prostate cancer, both market leaders in their therapeutic areas. Specialized in oncology, hormonal and niche products for serious medical conditions, Debiopharm is a partner of research institutions, pharmaceutical and biotechnology companies who seek to develop and register their drugs. Debio R.P., Debiopharm's sister company, is a leading world player in the research, development and manufacturing of polymer-based controlled release injectable formulations for peptides and proteins, including proprietary technologies suitable for other therapeutic modalities such as soluble polymer cytotoxic-drug conjugates for parenteral administration. Debio R.P. also carries out scale-up under current good manufacturing practice (cGMP) and has an FDA-inspected plant. Debioclinic, the third Debio company, is fully dedicated to clinical development.
Dyax Corp. is a biopharmaceutical company focused on the discovery, development and commercialization of therapeutic products. The company uses its patented phage display technology to identify a broad range of protein, peptide, and antibody compounds with potential to treat a variety of inflammatory diseases and cancers. Dyax has two recombinant proteins in exploratory clinical trials. One, DX-88, is being studied in two indications (hereditary angioedema and cardiopulmonary bypass) and the other, DX-890 is being studied for cystic fibrosis. Dyax leverages its technology broadly through licenses and collaborations in therapeutics and in non-core areas of affinity separations, diagnostics and imaging, and research reagents. Through its subsidiary, Biotage, Inc., Dyax develops, manufactures and sells chromatography separations systems and products worldwide for drug discovery and purification.
Dyax Disclaimer
This press release contains forward-looking statements, including statements regarding our research and development program and collaboration with Debiopharm and the prospects for further clinical trials and commercialization of the DX-890 compound. Statements that are not historical facts are based on our current expectations, beliefs, assumptions, estimates, forecasts and projections about the industry and markets in which Dyax competes. The statements contained in this release are not guarantees of future performance and involve certain risks, uncertainties and assumptions, which are difficult to predict. Therefore, actual outcomes and results may differ materially from what is
Today’s guidance is essentially unchanged from DYAX’s 12/15/03 PR announcing U.S. orphan-drug status for DX-890 in CF. It looks like DYAX has a good chance to be the first to market in this orphan indication, which would confer seven years of marketing exclusivity. DX-890 also has CF orphan status in Europe. Despite a big rise in the past year, DYAX remains a pretty cheap stock; I don’t have any position at this time.
>> In collaboration with Debiopharm S.A., we will be announcing results from the Phase IIa study of DX-890 in children with CF in the very near term. Debiopharm is also planning to initiate a larger Phase II trial of DX-890 in CF in the second half of 2004. <<
[This phase-2a trial in children supplements the phase-2a trial in adults reported in 2002 (#msg-1946072). Not much data here on efficacy, but the parties intend to proceed to a phase-2b trial, according to the PR.]
>> Dyax Corp. and Debiopharm S.A. Report Positive Results from Phase IIa Clinical Trial with DX-890 'EPI-hNE4' in Children with Cystic Fibrosis
CAMBRIDGE, Mass. and LAUSANNE, Switzerland--(BUSINESS WIRE)--Feb. 24, 2004--Dyax Corp. (Nasdaq: DYAX) and Debiopharm S.A. today announced the preliminary results of a phase IIa dose escalating multicenter study conducted by Debiopharm in 34 pediatric patients with cystic fibrosis (CF) using DX-890 (also known as EPI-hNE4), a recombinant inhibitor of human neutrophil elastase discovered by Dyax. Human neutrophil elastase (hNE), an enzyme produced as part of the inflammatory response, is implicated in the loss of lung function in patients with CF and other clinical conditions.
The study, which was conducted by Debiopharm in Europe under its collaboration agreement with Dyax, evaluated the daily administration of DX-890 when given as a nebulized formulation at four concentrations (1 mg/ml in week 1, 2.5 mg/ml in week 2, 5 mg/ml in week 3, and 10 mg/ml in week 4), administered during a 10 minute nebulization session. This open label study measured the inhibitory effects of DX-890 on sputum hNE.
The preliminary results confirm the good tolerability and the expected pharmacological effect, inhibition of neutrophil elastase, in the sputum of pediatric CF patients when given as a nebulized formulation. A total of 34 children were recruited, of which 27 completed the protocol and were assessable. Of these, 20 responded to treatment as demonstrated by decreases in hNE activity in sputum. There was a pronounced dose effect. DX-890 was well tolerated, with only four of the 34 recruited patients experiencing minor treatment related side effects, mainly coughs.
In light of these results, Debiopharm S.A., in cooperation with Dyax Corp., is planning a larger multicenter phase IIb study later this year to detect potential clinical benefit and to confirm tolerability of DX-890 in CF patients.
"We are pleased and encouraged by the results of this phase IIa trial with DX-890, a Dyax discovered small protein with high affinity and specificity for human neutrophil elastase. I look forward to learning more about DX-890 from subsequent clinical efficacy trials," said Henry E. Blair, Chairman and CEO of Dyax Corp.
"In this trial we have demonstrated the safety and pharmacological effect of DX-890 in pediatric patients when administered by inhalation after nebulization," said Rolland-Yves Mauvernay, President and CEO of Debiopharm. "Cystic fibrosis is a debilitating illness which dramatically reduces life expectancy. With positive results from this trial it is essential that we now progress to conducting the phase IIb trial to demonstrate clinical benefit and define DX-890 dosing for a phase III subsequent trial." <<
Market Data 
Markets 
AI
