Innogenetics (BE) - LyphoDerm(TM) final results in hard-to-heal ul ...

Gent (Belgium), May 13, 2004 - XCELLentis, a wholly owned subsidiary of Innogenetics, today announced the final results of its open-label phase 2 clinical trial with LyphoDerm(TM) for the treatment of hard-to-heal venous leg ulcers. In addition to confirming the previous topline results announced in early March 2004, further analyses provide new evidence of potential treatment effectiveness in this difficult-to-treat condition.

 

 

In September 2002, XCELLentis initiated a randomized, open-label, parallel-group phase 2 clinical trial involving 193 patients with hard-to-heal venous leg ulcers, treated at 24 centers in Europe. Patients treated with LyphoDerm(TM) (a human keratinocyte lysate in a proprietary topical formulation) (n=95) were compared to controls receiving standard of care alone (n=45) or standard with the proprietary topical formulation (n=53).

 

The primary endpoint to measure effectiveness was the incidence of complete wound closure within 24 weeks. Final results reconfirm those communicated in the press release of March 2, 2004, namely a difference of 11% between LyphoDerm(TM) and the combined controls. The number of patients achieving 100% wound closure with LyphoDerm(TM) amounted to 38% (36/95), whereas in the control group this remained 27% (26/98).

 

 

Further analyses were then carried out in order to better understand which patients might be more likely to benefit from LyphoDerm(TM) treatment and which might not.  A particularly striking and clinically relevant finding was identified for the predefined subgroup of 75 patients (out of the 193) whose venous ulcers were actually enlarging in size before they began treatment. The number of patients achieving 100% wound closure with LyphoDerm(TM) after 24 weeks (primary efficacy endpoint) in this patient subpopulation with enlarging ulcers amounted to 31% (13/42), whereas in the control group this was only 9% (3/33). The difference of 22% between LyphoDerm(TM) and the combined controls was statistically significant (p=0.0048).

 

Peter De Waele, Chief Operating Officer of XCELLentis, commented: "The subgroup analysis in the 75 patients with enlarging venous ulcers not only supports, but further strengthens the  positive trend in the topline results found for the entire 193 patient population. Identifying responders for LyphoDerm(TM) also creates opportunities in better defining health economics and correct labeling.  We also want to re-iterate that LyphoDerm(TM) was very well tolerated and has shown its effectiveness after only 8 applications." 

 

Furthermore, Patrice Froidure, Chief Executive Officer of XCELLentis, added: "While all the patients in the trial had hard-to-heal venous leg ulcers, the most difficult patient subgroup to treat were those with ulcers that were enlarging.  Exceeding the 20% mark in such patients was our objective. The significant difference compared to controls makes LyphoDerm(TM) the unique candidate treatment of choice for over 1 million patients."

 

 

 

 

XCELLentis' focus of activities is on chronic wounds, the largest part of the wound care market.  The size of this market exceeds the €1 billion mark and is growing at a high single digit rate.

The incidence (number of patients developing a condition each year) of venous leg ulcers is estimated to be no less than 1% of the population in Europe and the USA. Currently, the gold standard for the treatment of venous leg ulcers consists of the application of a dressing under compression. On average, 60% of the wounds heal after 12 weeks.  However, the other 40% fail to heal and are thereby considered as being hard-to-heal wounds. Consequently, the gold standard is widely regarded as unsatisfactory both in terms of clinical efficacy and economic outcome. For hard-to-heal ulcers, there is clearly an unmet medical need.

 

 

 

XCELLentis' lead development product, LyphoDerm(TM), consists of freeze-dried cultured human keratinocytes.  The wound repair stimulating effect of keratinocyte cultures can be partially attributed to the presence of growth factors.  Keratinocytes are cells located in the outer part of the skin that synthesize unique elements relevant to wound healing in addition to a variety of growth factors. 

 

LyphoDerm(TM) combines these latest advances in wound healing with attractive pharmaceutical properties that include ease-of-storage, product availability, long shelf life, and ease-of-application.  Global patent protection has been obtained in Europe, the USA, and Japan for this proprietary process and product.

 

LyphoDerm(TM) is categorized by the American and European agencies as a medicinal product.

 

 

 

Incorporated in February 2001, XCELLentis is the result of the spin-off of Innogenetics' wound care activities. Its therapeutic programs are directed towards discovery and development of advanced approaches for the improvement of the wound healing process, especially hard-to-heal wounds.  XCELLentis, a wholly owned subsidiary of Innogenetics, has its corporate headquarters in Gent, Belgium, and currently employs 14 staff.

 

 

 

Innogenetics is a Belgian-based international biopharmaceutical company building parallel businesses in the areas of specialty diagnostics and therapeutic vaccines. In its Diagnostics Division, Innogenetics develops a large number of specialty products covering three areas: infectious diseases (hepatitis C, hepatitis B, and HIV), genetic testing (HLA tissue typing and cystic fibrosis), and neurodegeneration (Alzheimer's disease).  In 2003, total revenues increased by 16% to €73 million, and total revenues reached €62 million. The Company's candidate therapeutic vaccine for the treatment of hepatitis C - a global unmet medical need - is currently considered to be ahead of the competition. With a strong commercially oriented management team and distinctive dual business model, Innogenetics provides a low-risk biotech investment with potentially high returns.  Founded in 1985, Innogenetics is listed on Euronext Brussels. Innogenetics' headquarters are in Gent, Belgium, with sales affiliates in the United States, Germany, France, Spain, and Italy.  Innogenetics employs 590 people worldwide and has a market capitalization of approximately €350 million.

 

 

 

 

 

 

 

Dear Madame,

Dear Sir,

 

XCELLentis, a wholly owned subsidiary of Innogenetics, today released the LyphoDerm (TM) final results in hard-to-heal ulcers.

 

We would like to invite you at the conference call in presence of Patrice Froidure, Chief Executive Officer XCELLentis, Peter De Waele, Chief Operating Officer XCELLentis, and Philippe Archinard, Chief Executive Officer Innogenetics.  This conference call will be held today, March 13, 2004 at 6:30 p.m. CET.

 

To attend the conference call, please dial + 44 (0) 20 7162 0184 (Europe) or
+ 1 334 420 4951 (USA).

 

To access the instant replay service for the period March 13, 2004 until March 20, 2004, please dial:

 

• UK replay number:
  + 44 (0) 20 8288 4459 or freephone number 0500 637 880 (UK only)

Access code: 788122

 

• US replay number:

+ 1 334 323 6222 or freephone number +1 866 484 2564

Access code: 788122

 

We are looking forward to welcoming you at this event.

 

Thank you very much for your consideration.

 

Best regards,

 

 

 

Technologiepark 6
9052 Gent, Belgium

Tel.: 09/329 17 01

Fax: 09/329 1765

 

 

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