Press Release: Mimosa Project

Rome, 26 January 2007 Florida, US, June 19, 2007 Bologna, June 26th 2007
 
 

The MIMOSA blooms even in summer. Until the 21st of June 100 women have already enrolled in the study of the vaccine for the treatment of ovarian cancer

logo_mimosa

Bologna, June 26th 2007
The MIMOSA clinical trial, which is being conducted in 120 of the best clinics worldwide, tests the efficacy of the abagovomab vaccine for the treatment of ovarian cancer. Abagovomab is a biotechnical vaccine which induces the female immune system to selectively kill tumour cells in order to prevent tumor relapse. Many patients with cancer of the ovary in fact, around 50-80%, suffer a relapse even after a successful treatment with surgery and chemotherapy.

“Summer could not have started in a better way”, said Prof. Franco Pannuti, founder and president of the non-profit organization Fondazione ANT Italia Onlus, “Every year in Italy about 5,000 women contract a malignant tumour of the ovaries. Foundazione ANT started to cooperate with MIMOSA project during last spring and made a toll-free phone number available to all women affected by this disease, (800 929203), with oncologists and psychologists at their disposal on Mondays and Thursdays from 3pm to 5pm. And we will go on with it even in August as ANT never goes on holiday!”.

“ANT, through the MIMOSA project, was able to combine the aim of assisting patients with that of supporting the development of an innovative therapy”, said Geraldina Fiechter Domenici, journalist and wife of the Mayor of Florence, besides being a promoter of the MIMOSA project through ANT.

“I am proud that I could contribute to make people more aware of the importance of supporting innovative research and this project in particular, which could save many women’s lives” added Stefania Prestigiacomo, former Minister for Equal Opportunities and promoter as well of the MIMOSA “campaign”.

For almost 30 years Fondazione ANT Italia Onlus has been providing free home assistance to about 3 thousand cancer patients every day and night throughout Italy. Its project called EUBIOSIA – “the good life and the dignified life” – allows cancer patients during the various stages of the disease not only to have the best assistance but also to enjoy the best possible quality of life.

 
 

Goodwin Biotechnology
and Menarini Announce
the Successful Completion of

their Strategic
US-Italian Cooperation to Fight Ovarian Cancer

 

Florence, Italy and Plantation, Florida, US, June 19, 2007
Goodwin Biotechnology, Inc. (GBI), of Plantation, Florida and Menarini Group, of Florence, Italy, have just announced the successful completion of a strategic co-operation for the manufacturing of the monoclonal antibody Abagovomab. This antibody is the active principle of the Menarini Group’s groundbreaking ovarian cancer vaccine, now in phase II/III clinical studies around the world.
The monoclonal antibody, produced by GBI to standards fully compliant with both US and European requirements, will be used to kick off the initial phase of a multicenter clinical trial, known around the world as MIMOSA (Monoclonal antibody Immunotherapy for Malignancies of the Ovary by Subcutaneous Abagovomab).
In this internationally important clinical trial, Abagovomab will be administered as a maintenance therapy, after surgery and first line platinum + taxane chemotherapy with the aim to prevent the reappearance of tumor and prolong survival. Around nine hundred women will be enrolled in the MIMOSA study throughout the world (USA, Germany, Italy, Poland, Czech Republic, Spain, Hungary and Belgium). They will be treated in more than 120 selected highly specialist clinical sites.
The important milestone of the production of the antibody for MIMOSA clinical lots supply represents, according to Stephanie Finnegan, CEO, Goodwin Biotechnology Inc., a significant milestone for GBI and Menarini. “We are extremely pleased to have manufactured this product”. She also commented, “It is always gratifying when our clients’ products are successful in the clinic, and we are especially proud that Menarini, from among the many partnering options they had, chose GBI to manufacture this important product for Phase II/III registrative trials.”
GBI, currently undergoing expansion to double its manufacturing capacity, is a subsidiary of one of India’s leading drug manufacturers, Wallace Pharmaceuticals India Pvt. Ltd. GBI’s expertise in biopharmaceutical process development and manufacturing has been extensively leveraged by clients in North America and Europe. GBI recently commissioned new laboratories in India, offering its global client base the ability to leverage the advantages that Asia offers towards their product development strategy.
Andrew Slade, Menarini Biotech Managing Director, also was delighted with the results obtained: “As Menarini Biotech (the Menarini Group’s biotech Company) we oversaw the production of the active principle. The two companies have worked hand in hand to achieve this outstanding result. We now hope Abagovomab will help the over 200 thousand women attacked by Ovarian cancer every year in the world.”

  About Menarini Biotech Menarini Biotech is a wholly owned subsidiary of the Menarini Group. We manage the development and cGMP manufacture of in-house biologic products, assist in the in-licensing of novel biologics with a focus on oncology, cardiovascular and other niche indications or markets and undertake strategic third party contracts.
Menarini Group is the biggest Italian pharmaceutical company in the world with a 3 billions euro turnover and 13 thousands employees all over the world. Research-oriented company, in the last 25 years, it has developed a major skill in cardiovascular, asthma, and general inflammations diseases. But it is on cancer, both in chemiotherapies and vaccines field, that Menarini has developed the highest and most valuable specialization over the years.
 

About Goodwin Biotechnology Inc.

GBI is one of the earliest biologics contract manufacturing organizations (CMO), specializing in process development and cGMP compliant mammalian cell culture of bio-therapeutics for pre-clinical through Phase II/III clinical trials. The company and its predecessor, The Goodwin Institute for Cancer Research, have been operating in the biologics CMO sector since the early 1980s. GBI's clients include small to midsized biotech companies, renowned cancer research institutes and various branches of the U.S. government.

 
 

Project MIMOSA against ovarian cancer
The Fondazione ANT Italia and the Menarini Group together
on 8 March for the Day of the fight against ovarian cancer

 

Rome, 26 January 2007
As of February, the non-profit organisation Fondazione ANT Italia, for many years deeply involved in free home care for cancer patients at advanced and very advanced stages of the disease, and the pharmaceutical company Menarini will carry out a joint project known by the acronym MIMOSA for the fight against and the prevention of ovarian cancer.

The project is inspired by a clinical trial also known by the acronym MIMOSA, which is just starting worldwide in order to study the efficacy of Abagovomab, a biotechnical vaccine for the treatment of ovarian cancer. The goal of the initiative is to provide women with helpful information and assistance. To this end, as of 8 March ANT makes its toll-free number available Mondays and Thursdays from 3 to 5 p.m. in order to provide information about all issues surrounding ovarian cancer, and in particular about this new type of treatment (800 92 92 03).

This coming 8 March, re-christened Mimosa Day for the occasion, ANT, with a contribution from Menarini, will offer mimosas for sale, the proceeds of which will go entirely to the EUBIOSIA project (“the good life”, “dignified life”) for free home care for cancer patients assisted by ANT (circa 3,000 every day and every night) as well as to other ANT projects for the fight against cancer.
“At the current state of knowledge, the MIMOSA project is certainly innovative and risk-free,” affirms Prof. Franco Pannuti, President of the Fondazione ANT Italia.
“Its possible importance,” continues Professor Pannuti, “also lies in the fact that unfortunately to date there is no recognised method for an early diagnosis of ovarian tumours. For this reason, the MIMOSA project becomes fundmental, and the funds collected by ANT on the 8th of March will also go towards financing projects whose goal is the early diagnosis of this tumour.”

Angela Capriati, Clinical Research Director at Menarini, adds “The collaboration between ANT and Menarini provides great additional value to the MIMOSA project: in fact, while the clinical development of our vaccine will go ahead during the next 4 years, the cooperation with ANT will allow us to have an immediate impact on the fight against ovarian cancer with a 360-degree approach that starts with the research and development of innovative experimental treatments but does not neglect the care that guarantees patients a dignified quality of life during all stages of the disease. This is Menarini’s commitment in support of ANT.
If the results of the pilot study are confirmed during the international megatrial MIMOSA, Menarini will be able to offer the first vaccine able to fight the recurrence of ovarian cancer, a battle from which we expect the most important of victories: a longer life without having to sacrifice quality of life.