Maxygen Announces Positive Results of MAXY-G34 Phase IIa Study in Breast Cancer Patients
-MAXY-G34 was Effective in Reducing Chemotherapy-Induced Neutropenia (CIN) in this Study-
-Based on Recent FDA Feedback, Maxygen Foresees a Timely and Cost Effective Path to BLA Submission-
-Maxygen Continues Efforts to Out-License or Sell MAXY-G34 CIN Rights-
REDWOOD CITY, Calif.--(BUSINESS WIRE)--Jul 14, 2009 - Maxygen, Inc. (Nasdaq:MAXY) today announced the completion of a Phase IIa clinical study in breast cancer patients in which MAXY-G34 was safe and effective in reducing chemotherapy-induced neutropenia (CIN), a major side effect of myelosuppressive anti-cancer agents. “We are encouraged by these clinical data and FDA feedback on Maxygen's proposed development plan for MAXY-G34 in CIN,” said Russell Howard, Maxygen's Chief Executive Officer. “These events further confirm that, with the right partnership, a timely and cost effective development pathway to BLA filing can be achieved in 2013. MAXY-G34, with a product profile similar to Neulasta®, could be the 2nd entrant in the multi-billion dollar, long-acting G-CSF market.”
Phase IIa Clinical Study
The objectives of this recently completed Phase IIa study were to evaluate safety, tolerability, pharmacokinetics and efficacy of MAXY-G34 in breast cancer patients. The 35 patient trial included 27 patients receiving MAXY-G34 (doses of 10, 30, 45, 60 or 100 µg/kg) and 8 patients receiving Neulasta® (fixed dose of 6 mg). Both study medications were administered as a single, subcutaneous injection 24 hours post chemotherapy. A highly myelosuppressive TAC chemotherapy regimen was used in the trial (6 x 21-day cycles of docetaxel at 75 mg/m2, adriamycin at 50 mg/m2 and cyclophosphamide at 500 mg/m2). In the absence of G-CSF treatment, TAC chemotherapy is expected to induce 7-8 days of severe neutropenia [Nabholtz et al, Phase II Study of Docetaxel, Doxorubicin and Cyclophosphamide as First-line Chemotherapy for Metastatic Breast Cancer, Journal of Clinical Oncology (2001)]. The primary efficacy endpoint of the study was duration of severe neutropenia in chemotherapy cycle 1 (number of days with absolute neutrophil count < 0.5 x 109 per Liter).
In this clinical study, all doses of MAXY-G34 effectively reduced the duration of severe neutropenia (DSN) observed, compared to the above-referenced historical controls. Importantly, no MAXY-G34 patients required rescue therapy due to insufficient efficacy of MAXY-G34. The mean duration of severe neutropenia for MAXY-G34 dose groups in chemotherapy cycle 1 ranged from 0.8 to 2.2 days, versus 2.0 days in the Neulasta® control group. Data on the primary efficacy endpoint for the MAXY-G34 doses in the range proposed for further study and the Neulasta® control group are included below:
| Duration of Severe Neutropenia (DSN) in Cycle 1
|
MAXY-G34 | Neulasta® | ||||||||
| Dose | 30 µg/kg | 45 µg/kg | 60 µg/kg | 6 mg | ||||||
| Evaluable Patients (n) | 6 | 5 | 5 | 7 | ||||||
| Mean DSN (days) | 1.8 | 0.8 | 2.2 | 2.0 | ||||||
| Standard Deviation (days) | 1.8 | 1.1 | 0.4 | 1.7 | ||||||
“The safety and effectiveness of MAXY-G34 observed in this clinical study support future clinical development of a fixed dose in the range of 2 to 4 mg per chemotherapy cycle,” stated Elliot Goldstein, MD, Maxygen's Chief Medical Officer.
FDA Feedback
Maxygen submitted the Phase IIa data as part of a scientific advice briefing package to the United States Food & Drug Administration (FDA) to solicit feedback on key elements of the MAXY-G34 development plan, including:
Design of the Phase IIb trial;
Dose selection for the Phase IIb trial; and
Scope of clinical development required to support a broad indication label.
The FDA's written response provides a clear development path for MAXY-G34 to achieve a broad label indication for chemotherapy-induced neutropenia. FDA provided feedback on Maxygen's Phase IIb study proposal, Phase III plan and overall scope of development anticipated to support a Biologic License Application (BLA). This feedback leads Maxygen to conclude that a potential timely and cost effective path to BLA filing for MAXY-G34 in CIN can be achieved.
Other Recent Events
In May 2009, Maxygen announced a licensing arrangement with Cangene Corporation for MAXY-G34 for acute radiation syndrome (ARS), while retaining rights to MAXY-G34 for all other indications. Maxygen continues partnering discussions regarding the out-license or sale of MAXY-G34 for chemotherapy-induced neutropenia.
About MAXY-G34
MAXY-G34 is a novel, pegylated granulocyte-colony stimulating factor (G-CSF) that has been developed to treat chemotherapy-induced neutropenia. G-CSF is a natural protein that stimulates the body's bone marrow to produce neutrophils, a specific type of white blood cell that plays an important role in the defense against bacterial infections. For more information, please visit our website at www.maxygen.com.
About Chemotherapy-Induced Neutropenia
Neutropenia is a severe decrease in neutrophil cell counts in the blood. Chemotherapy-induced neutropenia (CIN) is a common side effect of myelosuppressive chemotherapeutic treatments for many forms of cancer, including breast cancer, lung cancer, lymphomas and leukemias. Neutropenic patients are at increased risk of contracting bacterial infections, some of which can be life threatening. Further, neutropenic patients may require reduced or delayed chemotherapy treatment, which can result in cancer progression. For more information, please visit our website at www.maxygen.com.
About Maxygen
Maxygen is a biopharmaceutical company focused on developing improved versions of protein drugs through both internal development and external collaborations and other arrangements. Maxygen uses its proprietary DNA shuffling technology and extensive protein modification expertise to pursue the creation of biosuperior proteins. For more information, please visit our website at www.maxygen.com.
Cautionary Statement Regarding Maxygen Forward-Looking Statements
This document contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. These statements are based on the current expectations and beliefs of Maxygen's management and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The forward-looking statements contained in this document include statements about the potential future clinical development of MAXY-G34 for chemotherapy-induced neutropenia. These statements are not guarantees of future performance, involve certain risks, uncertainties and assumptions that are difficult to predict, and are based upon assumptions as to future events that may not prove accurate. Therefore, actual outcomes and results may differ materially from what is expressed herein. For example, if Maxygen is unable to enter into a licensing or other arrangement for the further development of MAXY-G34 for chemotherapy-induced neutropenia or is unable to otherwise sell its rights to such product, MAXY-G34 may not be further developed for this indication, and may never be commercialized. In any forward-looking statement in which Maxygen expresses an expectation or belief as to future results, such expectation or belief is expressed in good faith and believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will result or be achieved or accomplished. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: our failure to out-license or sell our rights to the MAXY-G34 program or the ability or plans of any future third party to continue the clinical development of MAXY-G34, and the status and timing of any potential out-licensing or other arrangement, sale or future clinical development of MAXY-G34; whether MAXY-G34 will demonstrate any benefit in treating chemotherapy-induced neutropenia as compared to currently marketed drugs; whether this product can be further developed in a timely or cost effective manner; whether this product, if commercialized, will be competitive in its relevant markets; the delay or suspension of predicted development and commercial timelines for this product; the failure to protect intellectual property portfolio and rights related to this product; and the risk that MAXY-G34 may have adverse side effects or inadequate therapeutic efficacy; and other economic, business, competitive, and/or regulatory factors affecting Maxygen's business and the market it serves generally, including those set forth in Maxygen's most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q, especially in the “Risk Factors” and “Management's Discussion and Analysis of Financial Condition and Results of Operations” sections, and its Current Reports on Form 8-K and other SEC filings. Maxygen is under no obligation to (and expressly disclaims any such obligation to) update or alter its forward-looking statements whether as a result of new information, future events, or otherwise.
Neulasta® is a registered trademark of Amgen Inc.
Contact: Maxygen
Investors:
Linda Chrisman, +1-650-298-5351
linda.chrisman@maxygen.com
Partners:
Grant Yonehiro, +1-650-298-5486
Chief Business Officer
businessdevelopment@maxygen.com
