Navigation Links
Pharmion and MethylGene Initiate Phase One Combination Clinical Trial with MGCD0103 and Taxotere(R) in Patients with Solid Tumors
Date:10/10/2007

BOULDER, Colo. and MONTREAL, Oct. 10 /PRNewswire-FirstCall/ -- Pharmion Corporation (Nasdaq: PHRM) and MethylGene Inc. (TSX: MYG) today announced the initiation of a Phase One clinical trial evaluating MGCD0103, the Companies' isotype-selective histone deacetylase inhibitor (HDACi) product candidate, in combination with Taxotere(R) (docetaxel; Sanofi Aventis) in patients with solid tumors. Taxotere is an approved chemotherapy agent marketed for use in breast, lung, prostate, gastric and head and neck cancer.

In the first portion of the trial, MGCD0103 will be given orally, three times per week for three weeks in combination with Taxotere, which will be administered on Day 1 of each three-week cycle to patients with cancer where treatment with Taxotere is approved or considered standard of care, or patients who have no available standard of care therapeutic options. Key objectives for this portion of the study will be threefold: to evaluate the safety of administering these two agents together; determine the maximum tolerated dose of MGCD0103 when combined with the two fixed doses of Taxotere; and to define optimal dosing for the second portion of the trial. In the second portion of the trial, objectives include further assessment of the safety of the drug combination, quantification of tumor responses and measurement of the pharmacodynamic and pharmacokinetic characteristics. The trial may enroll up to 50 patients at cancer centers in North America. The trial is expected to take 12 to 18 months to complete.

"This is an important step forward in the clinical development of MGCD0103," said Andrew Allen, executive vice president and chief medical officer of Pharmion Corporation. "Cytotoxic chemotherapies such as Taxotere remain the primary therapy for the treatment of most solid tumors, and we know from preclinical models that MGCD0103 is synergistic with Taxotere and could potentially sensitize and re-sensitize patients to microtubule-targeted therapy. Because MGCD0103 is an isotype-selective HDACi, rather than a broad spectrum HDACi, it targets specific isotypes likely relevant to cancer, with potential reduction in off-target toxicity. This may be particularly important as we combine MGCD0103 with cytotoxic chemotherapy."

"We are delighted to be participating in this trial of docetaxel plus MGCD0103," commented Dr. Keith Flaherty, Associate Professor of Medicine, Abramson Cancer Center of the University of Pennsylvania Health System and a principal investigator for this trial. "MGCD0103 has shown significant activity in preclinical models, as well as objective responses in ongoing clinical trials. This clinical study will help build an understanding of the role of HDAC inhibitors in the treatment of solid tumors for which docetaxel remains an important standard treatment, an area of great interest to the research and clinical community."

About MGCD0103

MGCD0103 is an orally-administered, isotype-selective HDAC inhibitor. Preclinical data suggest that the Class I HDAC isotypes targeted by MGCD0103 are important in cancer biology and, consequently, such selective HDAC inhibitors may have increased efficacy and reduced toxicity compared to non- selective inhibitors. MGCD0103 is being investigated as a single agent and in combination with other anticancer therapies in the treatment of a variety of hematological malignancies and solid tumors. MGCD0103 is currently being studied in clinical trials including Hodgkin's lymphoma, non-Hodgkin's lymphoma (NHL), myelodysplastic syndromes (MDS), acute myelogenous leukemia (AML), and pancreatic cancer as either a single agent or in combination with anticancer therapies.

MGCD0103 has received orphan drug designation from the U.S. Food and Drug Administration (FDA) and has been designated an orphan medicinal product by the European Medicines Agency (EMEA) for the treatment of Hodgkin's lymphoma.

About Pharmion

Pharmion is a leading global oncology company focused on acquiring, developing and commercializing innovative products for the treatment of hematology and oncology patients in the U.S., Europe and additional international markets. Pharmion has a number of products on the market including the world's first approved epigenetic drug, Vidaza(R), a DNA demethylating agent. For additional information about Pharmion, please visit the company's website at http://www.pharmion.com.

About MethylGene

MethylGene Inc. (TSX: MYG) is a publicly-traded biopharmaceutical company focused on the discovery, development and commercialization of novel therapeutics for cancer. The Company's lead product, MGCD0103, is an oral isotype-selective HDAC inhibitor presently in multiple clinical trials for solid tumors and hematological malignancies, including Phase II monotherapy and Phase I/II combination trials with Vidaza(R), Gemzar(R) and Taxotere(R). MGCD265 is an oral kinase inhibitor targeting the c-Met, Tie-2, Ron and VEGF receptor tyrosine kinases. In addition, MethylGene has several preclinical programs: MGCD290 an HDAC inhibitor in combination with azoles for fungal infections; an HDAC program for Huntington's disease; a sirtuins program for cancer; and a beta-lactamase program to overcome antibiotic resistance. MethylGene's development and commercialization partners include Pharmion Corporation, Taiho Pharmaceutical and EnVivo Pharmaceuticals. Please visit our website at http://www.methylgene.com.

Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995: This release contains forward-looking statements relating to the planned development program for MGCD0103, which express the current beliefs and expectations of management. Such statements are based on current expectations and involve a number of known and unknown risks and uncertainties that could cause Pharmion's future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include, but are not limited to, the potential failure of MGCD0103, to demonstrate safety and efficacy in clinical and non-clinical testing; the ability to complete regulatory submissions and gain regulatory approvals in a timely manner; the ability to initiate and complete trials at the referenced times; the impact of competition from other products under development by Pharmion's competitors; the uncertainty of the regulatory environment and changes in the health policies of various countries; acceptance and demand for new pharmaceutical products and new therapies; uncertainties regarding market acceptance of products newly launched, currently being sold or in development; failure of third-party manufacturers to produce the product volumes required on a timely basis and fluctuations in currency exchange rates. Additional risks and uncertainties relating to Pharmion and its business can be found in the "Risk Factors" section of Pharmion's Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2007, its Annual Report on Form 10-K for the year ended December 31, 2006 and in our other filings with the U.S. Securities and Exchange Commission. Forward-looking statements speak only as of the date on which they are made, and Pharmion undertakes no obligation to update publicly or revise any forward-looking statement, whether as a result of new information, future developments or otherwise.


'/>"/>
SOURCE Pharmion Corporation
Copyright©2007 PR Newswire.
All rights reserved

Related medicine technology :

1. Pharmions Amrubicin Shows Encouraging Results Compared to Standard of Care in Second Line Treatment of Small Cell Lung Cancer
2. Pharmion to Present Clinical Data on Commercial and Pipeline Products at 2007 American Society of Clinical Oncology (ASCO) Meeting
3. Malvern initiates European user group meetings for chemical imaging
4. Protalix BioTherapeutics, Inc. Receives Approval from the FDA to Initiate a Phase III Clinical Trial of prGCD
5. Data Available From Erbitux Phase III Study in First-Line Treatment of Advanced Lung Cancer
6. Phase 3 Results for Dabigatran Etexilate, an Investigational Oral Anticoagulant, Presented Today at the XXIst Congress of the International Society on Thrombosis and Haemostasis
7. YM BioSciences Announces Secondary Efficacy and Safety Findings in Randomized Phase IIB Aerolef Trial
8. Portola Pharmaceuticals Announces Positive Data from a Phase II Study of its Factor Xa Inhibitor at the XXI Congress of the International Society on Thrombosis and Haemostasis
9. Manhattan Pharmaceuticals Announces Results of Phase 2a Studies for Oral Oleoyl-estrone
10. Actemra (tocilizumab) Third Phase III Study Results Show Significant Improvement in Symptoms of Patients with Rheumatoid Arthritis
11. AVI BioPharma Partner Cook Medical Announces Completion of Patient Enrollment for APPRAISAL Phase II Clinical Trial for Treatment of Cardiovascular Disease
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/23/2017)... , Feb 23, 2017 ... Research and Markets has announced the addition ... Forecast to 2025" report to their offering. The ... around 1.8% over the next decade to reach approximately $12.8 billion by ... and forecasts for all the given segments on global as well as ...
(Date:2/23/2017)... YORK , February 23, 2017 ... its report on the global market for intraoperative ... be presently valued at US$ 513.9 million. According ... will keep surging on the grounds of increasing ... in the field of diagnostic imaging for neurosurgeries. ...
(Date:2/23/2017)... -- LG Innotek today announced that the company has developed the ... performance is 1.5 times higher than the competitor,s 45mW module. ... range of 200 -- 280nm, allowing it to be used for sterilization ... LG Innotek,s product emits UV in the range of 280nm. ... Until now, UV-C LED ...
Breaking Medicine Technology:
(Date:2/23/2017)... ... February 23, 2017 , ... ... leadership , media relations, content marketing, social media management, corporate communications, SEO and ... in the state and in nearby New Hampshire, Massachusetts and Canada, Rosica will ...
(Date:2/23/2017)... Angeles, California (PRWEB) , ... February 23, 2017 ... ... Global Sports Development will host a diverse symposium on “Doping in ... of Law and Sheppard Mullin Richter & Hampton LLP. The symposium will be ...
(Date:2/23/2017)... Colorado (PRWEB) , ... February 23, 2017 , ... ... Magazine, an exciting, new, interactive publication where generations converge and explore the world ... expand their worldview, Dialog Magazine enables readers to gain understanding, increase empathy, and ...
(Date:2/23/2017)... , ... February 23, 2017 , ... ... announced today that it will soon begin franchising throughout the U.S. starting this ... to help bring the practice of meditation mainstream. Current Meditation will be the ...
(Date:2/23/2017)... ... February 23, 2017 , ... The Center for Autism ... Consortium for Autism Research and Treatment (RI-CART) and Cinemaworld to present Sensory Friendly ... (ASD) to see films in an environment that accommodates their unique needs. , ...
Breaking Medicine News(10 mins):