SOURCE: Zealand Pharma

September 06, 2007 05:00 ET

FDA has approved Zealand Pharma's Investigative New Drug application (IND) for ZP1846 to be administered in humans. ZP1846 is developed for the prevention and treatment of severe diarrhoea induced by chemotherapy.

GLOSTRUP, DENMARK--(Marketwire - September 6, 2007) -



Summary:

Zealand Pharma advances ZP1846 into Phase I clinical trials. ZP1846, a peptide which incorporates Zealand's proprietary SIP technology, is developed as a therapy for the prevention and treatment of chemotherapy-induced diarrhoea, a debilitating adverse reaction affecting patients undergoing treatment with many anti-cancer therapies.

The Phase I study will be a double-blind, placebo controlled, randomized, escalating intravenous single dose safety and tolerability study in healthy volunteers and takes place in the United States.

Zealand's pre-clinical studies have demonstrated that ZP1846 inhibits chemotherapy-induced injury in the small intestine, and consequently, it also reduces the incidence of chemotherapy-induced diarrhoea. It is anticipated that the use of ZP1846 in patients undergoing chemotherapy may ameliorate the destructive effects of the chemotherapy on the small intestine and reduce the severity of diarrhoea.

Today, serious gastrointestinal side effects are observed in up to 50% of patients undergoing certain forms of chemotherapy, which in turn may require dose modification or cessation of cancer chemotherapy

Eva Steiness , Chief Executive Officer, commented: "Advancing ZP1846 into clinical trials further strengthens our development pipeline. Zealand Pharma has applied its knowledge of peptide optimization and its proprietary SIP technology to develop a series of novel peptides that specifically enhance the growth and function of the lining of the small intestine.

Chemotherapy-induced diarrhoea can be a serious debilitating adverse reaction affecting patients undergoing treatment with anti-cancer therapies and the gastrointestinal injury may lead to serious complications such as uptake of intestinal bacteria into the blood stream (sepsis), dehydration and kidney insufficiency. There is a strong need for drugs that are able to prevent or treat the mucosal damage and eliminate the diarrhoea induced by chemotherapy, and we believe that ZP1846 is a promising drug candidate for the treatment of chemotherapy-induced diarrhoea".

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Further information

Mogens Vang Rasmussen, Chief Financial Officer, IT & Communications

Zealand Pharma A/S, Smedeland 26 B, DK-2600 Glostrup, Denmark
T +45 4328 1200   F +45 4328 1212   E info@zp.dk  www.zp.com

About Zealand Pharma

Zealand Pharma is a biopharmaceutical company dedicated to the discovery and development of innovative peptide-based drugs. Zealand is one of the leaders within the peptide area, a growing market with significant drug development activities including treatment of metabolic and cardio-vascular diseases. All of Zealand's products target diseases and symptoms of significant unmet clinical need and commercial potential.

Since 1999, Zealand's scientists have built a pipeline that includes seven compounds in clinical development, three of which have been out licensed to major pharmaceutical companies (Wyeth and Sanofi-Aventis). All Zealand's compounds emerge from Zealand's own drug discovery.

* ZP10 (AVE0010), a pharmaceutical agent for the treatment of type 2
  diabetes, has been out-licensed to Sanofi-
   Aventis (www.sanofi-aventis.com) and is currently in Phase II
clinical development.

* ZP120 is a first-in class peptide with diuretic, vasodilatory and
  neuromodulatory properties. Zealand has all the
    rights to the drug. Zealand has recently terminated a Phase II
dose finding study in patients with acute
    decompensated heart failure.

* Rotigaptide (GAP486/ZP123) is a first-in-class peptide that acts on
  cell-to-cell communication channels called gap
    junctions. In April 2003, Zealand entered a development and
license agreement with Wyeth on rotigaptide for
    treatment of arrhythmias and other cardiovascular disorders.
Wyeth has finalized a global multi-centre Phase IIa
    safety and tolerability trial in patients with large myocardial
infarcts.

* ZP1846 is targeted for the prevention and treatment of
  chemotherapy-induced diarrhoea, a debilitating adverse
    reaction affecting patients undergoing treatment with many
anti-cancer therapies.  The compound has entered into
    phase I clinical development.

* GAP-134/ZP1609 has shown remarkable pharmacological effects in
  experimental models of both ventricular and
    atrial arrhythmias, and with its oral bioavailability, this
molecule represents a breakthrough for the clinical testing of
    this novel paradigm in chronic pharmacological prevention of
cardiac arrhythmias.  The compound is in the pre-
    clinical development phase.

* ZP2435 is targeted for the subcutaneous treatment of obesity with
  the aim to control metabolic parameters. In vivo
    studies in mice with diet-induced obesity have demonstrated that
the compound produces an effective and
    sustained suppression of food intake. The compound is in the
pre-clinical development phase.

* ZP1848 is targeted for the treatment of inflammatory bowel diseases
  and expected to improve and maintain
    remission of gastrointestinal episodes. The compound is in the
pre-clinical development phase.

Zealand also has a portfolio of pre-clinical projects targeting a number of other disease areas.

Zealand Pharma is based in Copenhagen and has approximately 65 employees.

The Company's investors include BankInvest, LD Pensions, Dansk Erhvervsinvestering and Vaekstfonden as well as the leading international biotech investors CDC Entreprises Innovation and AGF Private Equity (both in Paris) and Life Sciences Partners (Amsterdam).





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