Alize Pharma, a group of companies developing drugs for the treatment of metabolic diseases and cancer, announces today that it has completed a funding round of EUR 3.3 million. The funds will allow to take AZP-531, its UAG (UnAcylated Ghrelin) analog, into Phase I clinical trials.

Alize Pharma will carry out the first (Phase I) clinical trial of AZP-531 in healthy volunteers in 2013, which will be followed by Phase Ib and Phase II trials in patients with type II diabetes as well as in patients suffering from the Prader Willi syndrome. Preclinical and clinical data suggest that UAG and its analogs have therapeutic potential in the targeted indications, by reducing acylated ghrelin blood levels, improving glycemic control and insulin sensitivity, and improving additional cardiovascular risk factors.

The company's main shareholders participated in the funding round, namely Sham, OCTALFA, CEMA Inc. and Thierry Abribat. Since its creation, the company has raised a total of EUR 8.3 million, has created value by reaching significant R&D milestones and has entered into its first strategic partnerships.

"We are grateful to our shareholders for their renewed confidence and support and are very enthusiastic to initiate the clinical development of our UAG analog," said Thierry Abribat, president & CEO of Alize Pharma. "This development program is extremely important, since it will address significant unmet clinical needs in type II diabetes and the Prader Willi syndrome. In line with our business model, the results obtained from the first clinical trials will help us select a pharmaceutical partner capable of developing and commercializing the product under a licensing agreement."

"As a historic shareholder in Alize Pharma, we are very pleased to support its development strategy," said Gilles Alberici, president of Octalfa. "The quality of the team and the research programs are outstanding and we strongly believe in the company's business model, as demonstrated by the success of the ASPAREC(R) program."

The UAG program was launched in 2007 and resulted in the discovery of AZP-531, the first unacylated ghrelin analog. This 8-amino acid peptide is stable and its pharmacokinetic properties make it suitable for pharmaceutical development. AZP-531 will be the first unacylated ghrelin analog to enter regulatory development.

"The mechanism of action of AZP-531 may lead to improved glycemia control in type II diabetes and also to positive effects on other cardiovascular risk factors, such as obesity, dyslipidemia and vascular complications," explained Professor AJ van der Lely, head of the clinical endocrinology department at the Erasmus Medical Center in Rotterdam (Netherlands) and scientific advisor at Alize Pharma. "In addition, it could be used to target clinical conditions where acylated ghrelin levels are abnormally high, such as the Prader Willi syndrome, thus opening up a new treatment option for these patients."

Alize Pharma owns a portfolio of five families of patents comprising a total of 34 patents and patent applications for the protection of UAG, its analogs, including AZP-531, and their applications. Professor AJ van der Lely and his team will present new clinical data on the effects of unacylated ghrelin in diabetic patients at the upcoming annual meeting of the Endocrine Society (ENDO 2012) that will be held in Houston from June 23 to 26, 2012.

About type II diabetes
Type II diabetes is a disease characterized by hyperglycemia, which is to say an excessively high level of glucose (sugar) in the blood. This disease generally occurs in adults of an advanced age and tends to affect obese or overweight people. The number of patients suffering from type II diabetes is constantly rising as a result of the spread of obesity and the aging of the population. The International Diabetes Federation expects the number of diabetic patients to rise worldwide from 285 million in 2010 to 438 million in 2030. Treating diabetes and its cardiovascular complications is a major public health challenge. At present, there is no treatment that can properly cure diabetes and its complications. In this context, there is a major medical need for developing innovative drugs that are based on new mechanisms of action and target several cardiovascular risk factors.

About Prader Willi syndrome
The Prader Willi syndrome is a rare genetic condition with an incidence estimated at 8 in 100,000. At birth, the child exhibits a diminution of muscle tone (hypotonia) causing in particular sucking problems. After the age of two, the hypotonia diminishes and a severe hyperphagia is observed, correlated with abnormally high levels of circulating acylated ghrelin. The needs in calories intake decline which, together with the hyperphagia, results in obesity which may lead to life-threatening complications (diabetes, cardiovascular complications). The child also exhibits endocrine disturbances (short stature and hypogonadism), learning difficulties and behavioral problems.

There is currently no specific treatment for this syndrome, and no effective treatment for eating disorders. Patients' quality of life can be improved by early multidisciplinary care (growth hormone, adequate diet, orthophony, etc.).

About UAG (UnAcylated Ghrelin)
The UAG program aims at developing an analog of unacylated ghrelin, a first product of a new therapeutic class for the treatment of metabolic disorders. Alize Pharma launched the program five years ago in close collaboration with the Erasmus Medical Center in Rotterdam and the University of Turin, and under a research collaboration with the Indianapolis-based pharmaceutical company Eli Lilly, which is now completed. Preclinical and clinical data suggest that unacylated ghrelin and its analogs have the therapeutic potential to address unmet medical needs in the treatment of type II diabetes and the Prader Willi syndrome through a novel mechanism of action that includes: marked decrease in circulating levels of acylated ghrelin, an orexigenic and diabetogenic hormone, improved glycemic control, improved insulin sensitivity, trophic effect on beta cells, reduction in fat deposition and a positive effect on vascular remodeling and on recovery following ischemia.

About Alize Pharma
Alize Pharma is a group of companies specialized in the development of innovative biopharmaceutical drugs, proteins and peptides, for the treatment of metabolic diseases and cancer. Its management is made up of a team of drug development experts and a board of directors offering wide international experience. Its business strategy is to advance programs based on medical innovation at the clinical stage and establish partnerships with the pharmaceutical industry in order to secure both near-term and longterm revenue streams. Since its inception in 2007, the group has raised EUR 8.3 million (USD 10.8 million) with private and institutional investors. The first of the two entities of the group, Alize Pharma SAS, is dedicated to a peptide (AZP-531) derived from unacylated ghrelin, currently at the preclinical stage of development for the treatment of the Prader Willi Syndrome and Type II diabetes. The second entity, Alize Pharma II SAS, is focused on the development of ASPAREC(R), a new PEGylated recombinant L-asparaginase for the treatment of acute lymphoblastic leukemia, partnered with EUSA Pharma and currently in Phase I clinical development.