SOURCE: Zealand Pharma

September 06, 2007 05:36 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".

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).

Contact Information

  • 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 Email Contact
    www.zp.com