Navigation Links
Maxygen Initiates Phase IIa Clinical Trial of MAXY-G34 in Breast Cancer Patients

Maxygen, Inc. today announced that it has initiated a phase IIa trial to evaluate the efficacy, safety and tolerability of MAXY-G34 in the treatment of chemotherapy-induced neutropenia . MAXY-G34 is a novel pegylated granulocyte colony stimulating factor (PEG-GCSF) shown in preclinical and Phase I studies to have novel and potentially superior properties compared to the current PEG- GCSF therapy.

"Patients and physicians have limited options for treatment of neutropenia," said Russell Howard, chief executive officer of Maxygen. "With MAXY-G34, we hope to expand those options and improve the outcome for many chemotherapy patients. During this first Phase II trial we will begin to learn more about how our drug might play a role in the large, undifferentiated GCSF market."

The Phase IIa trial, which will be conducted at multiple centers in Eastern Europe, is the first trial of MAXY-G34 in patients. Approximately 30 patients with Stage I-III breast cancer will undergo TAC (docetaxel, adriamycin and cyclophosphamide) chemotherapy followed by next-day administration of either MAXY-G34 or Neulasta (control population). The trial is designed as a multiple ascending dose study, with planned doses at 10, 30, 60, or 100 micrograms per kilogram of MAXY-G34 compared to 6mg of Neulasta. Both MAXY-G34 and Neulasta will be administered as a single subcutaneous injection once per chemotherapy cycle.

The primary objective of the Phase IIa trial is to identify one or more doses of MAXY-G34 that effectively treat chemotherapy-induced neutropenia. Patient tolerability, safety, and immunogenicity will be monitored and assessed. Data will also be collected on the pharmacokinetic properties of MAXY-G34 and the mobilization of CD34+ stem cells.

Phase I Results

A Phase I trial was previously conducted to assess the safety and tolerability of MAXY-G34 in 40 healthy volunteers. This study showed MAXY-G34 to be a potent , long-lasting stimulator of neutrophils and an efficient mobilizer of CD34+ stem cells. The drug exhibited a median half-life approximately 2.3 times that of Neulasta. No serious adverse events were reported, and there were no dose-limiting toxicities. No binding or neutralizing antibodies were found at any dose level, with dose levels ranging from 10 - 150 micrograms per kilogram.


'"/>




Related medicine news :

1. Bird Flu: Orissa Initiates Protective Measures
2. Biota Initiates Drug Testing War against Common Cold
3. Russia Initiates Mass Vaccination Of Poultry To Restrict Bird Flu
4. Government Initiates A Program To Curb HIV
5. Alteon Initiates Phase 2 Trial of ALT-2074 in Diabetes and Haptoglobin 2-2
6. Peregrine Pharmaceuticals Initiates Patient Enrollment In New Cotara(R) Brain Cancer Trial
7. SARS-Free Taiwan to Mark End Phase of Global Fight
8. Spray on contraceptive clears Phase I trial
9. Phase 3 trials of two multi-kinase inhibitors against cancer
10. Antigenics Pharmaceuticals plans for Phase III trial of its Melanoma vaccine
11. Phase II trails of new HIV vaccine to be held in South Africa
Post Your Comments:
*Name:
*Comment:
*Email:


(Date:2/8/2016)... ... February 08, 2016 , ... Remember the old saying “rub some ... to Perry A~, author of “Calcium Bentonite Clay” the health benefits of integrating clay ... and detoxifying the body. , A former motivational speaker, Perry A~ has since dedicated ...
(Date:2/8/2016)... ... 2016 , ... Discover the Rocky Mountain region’s longest running and impressive garden ... Attendees also get to see the most incredible gardens and home improvement experts that ... the Colorado Convention Center - 700 14th St. Denver CO, is an exciting event ...
(Date:2/8/2016)... ... February 08, 2016 , ... TopConsumerReviews.com recently awarded their highest five-star rating ... Moles are derived from a cluster of melanin when exposed to sunlight. Although most ... create a lifetime of embarrassment. Historically, mole removal has involved a painful, ...
(Date:2/8/2016)... CA (PRWEB) , ... February 08, 2016 , ... The ... held annually in this country. The AutismOne 2016 Conference, which is being held May ... they often won’t hear elsewhere about helpful interventions and causes of chronic illness in ...
(Date:2/7/2016)... Orion, Clarkston, Metamora, Michigan (PRWEB) , ... February 07, 2016 , ... ... Friday in recognition of National Wear Red Day. National Wear Red Day is ... and stroke in women. Heart disease and stroke cause 1 in 3 deaths among ...
Breaking Medicine News(10 mins):
(Date:2/8/2016)... , Feb. 8, 2016  Avista Pharma Solutions ... Eric Setzer as Chief Financial Officer (CFO). Mr. Setzer ... years of experience in various roles within growing technology ... he served as the Executive Director of Finance at ... Raleigh, NC . Previously, Mr. Setzer ...
(Date:2/8/2016)... DUBLIN , Feb. 8, 2016 /PRNewswire/ ... announced the addition of the "Label-Free ... Global Forecasts to 2020" report to ... has announced the addition of the ... - Global Forecasts to 2020" report ...
(Date:2/8/2016)... , Feb. 8, 2016  Unilife Corporation ("Unilife" or "Company") ... of injectable drug delivery systems, today announced that it will ... ended December 31, 2015 after market close on February 9, ... conference call to discuss these financial results.    ... --> About Unilife Corporation ...
Breaking Medicine Technology: