UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): December 7, 2015
MEI Pharma, Inc.
(Exact name of registrant as specified in its charter)
| Delaware | 000-50484 | 51-0407811 | ||
| (State or other jurisdiction of incorporation or organization) |
(Commission File Number) | (I.R.S. Employer Identification No.) |
11975 El Camino Real, Suite 101, San Diego, California 92130
(Address of principal executive offices) (Zip Code)
Registrant’s telephone number, including area code: (858) 792-6300
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
| ¨ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
| Item 8.01. | Other Events |
On December 7, 2015, MEI Pharma, Inc. (the “Company”), presented the attached final results from an open-label Phase II clinical study of the Company’s lead investigational drug candidate Pracinostat in combination with azacitidine in elderly patients with newly diagnosed acute myeloid leukemia (“AML”) in an abstract entitled “Final Results from a Phase 2 Study of Pracinostat in Combination with Azacitidine in Elderly Patients with Acute Myeloid Leukemia (AML),” at the 57th American Society of Hematology (ASH) Annual Meeting and Exposition (the “ASH Conference”).
A copy of the above referenced abstract is filed as Exhibit 99.1 to this Current Report on Form 8-K and incorporated herein by reference.
The Company also presented the attached results from a randomized, double-blind, Phase II clinical study of the Company’s lead investigational drug candidate Pracinostat in combination with azacitidine in patients with previously untreated myelodysplastic syndrome (“MDS”) in an abstract entitled “A Randomized, Placebo-Controlled, Phase II Study of Pracinostat in Combination with Azacitidine (AZA) in Patients with Previously Untreated Myelodysplastic Syndrome (MDS),” at the ASH Conference.
A copy of the above referenced abstract is filed as Exhibit 99.2 to this Current Report on Form 8-K and incorporated herein by reference.
On December 7, 2015, the Company issued a press release reporting the final results from the aforementioned open-label Phase II clinical study of the Company’s lead investigational drug candidate Pracinostat in combination with azacitidine in elderly patients with newly diagnosed AML and announced its intent to initiate a Phase III registration study of Pracinostat and azacitidine in elderly patients with newly diagnosed AML in the second half of 2016.
A copy of the above referenced press release is filed as Exhibit 99.3 to this Current Report on Form 8-K and incorporated herein by reference.
| Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits.
| Exhibit No. |
Description | |
| 99.1 | Final Results from a Phase 2 Study of Pracinostat in Combination with Azacitidine in Elderly Patients with Acute Myeloid Leukemia (AML) | |
| 99.2 | A Randomized, Placebo-Controlled, Phase II Study of Pracinostat in Combination with Azacitidine (AZA) in Patients with Previously Untreated Myelodysplastic Syndrome (MDS) | |
| 99.3 | Press Release dated December 7, 2015 | |
Signatures
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| MEI PHARMA, INC. | ||
| By: | /s/ Daniel P. Gold | |
| Daniel P. Gold | ||
| Chief Executive Officer | ||
Dated: December 8, 2015
Index to Exhibits
| Exhibit No. |
Description | |
| 99.1 | Final Results from a Phase 2 Study of Pracinostat in Combination with Azacitidine in Elderly Patients with Acute Myeloid Leukemia (AML) | |
| 99.2 | A Randomized, Placebo-Controlled, Phase II Study of Pracinostat in Combination with Azacitidine (AZA) in Patients with Previously Untreated Myelodysplastic Syndrome (MDS) | |
| 99.3 | Press Release dated December 7, 2015 | |
G Garcia-Manero1, E Atallah2, B Medeiros3, M Arellano4, SK Khaled5, M Patnaik MD6, O Odenike7, SH Sayar8, MK Tummala9, P Patel10, L Maness-Harris11, R Stuart12, E Traer13, K Karamlou14 and A Yacoub15 1 University of Texas MD Anderson Cancer Center, Houston, TX; 2Medical College of Wisconsin, Milwaukee, WI; 3Stanford Cancer Center, Stanford University, Stanford, CA; 4Winship Cancer Institute, Emory University, Atlanta, GA; 5City of Hope Comprehensive Cancer Center, Duarte, CA; 6Mayo Clinic, Rochester, MN; 7University of Chicago, Chicago, IL; 8Simon Cancer Center, Indiana University, Indianapolis, IN; 9Mercy Medical Research Institute, Springfield, MO; 10UT Southwestern Medical Center, Dallas, TX; 11University of Nebraska Medical Center, Omaha, NE; 12Medical University of South Carolina, Charleston, SC; 13Oregon Health & Science University Center for Hematologic Malignancies, Portland OR; 14Bay Area Cancer Research Group, Pleasant Hill, CA; 15University of Kansas Cancer Center, Westwood, KS Abstract #453 Final Results from a Phase 2 Study of Pracinostat in Combination with Azacitidine in Elderly Patients with Acute Myeloid Leukemia (AML) Exhibit 99.1
Aza + Pracinostat in AML: Introduction Elderly AML patients, deemed unsuitable for intensive therapy, have limited treatment options Pracinostat is a potent hydroxamic acid based oral HDAC inhibitor selective for class I, II and IV isoforms The combination of azacitidine and pracinostat synergistic in vitro Pilot study of Aza + Pracinostat very high rate of complete and cytogenetic response Quintas-Cardama. ASH 2012; abstract #3821
Elderly (Age ≥ 65 years) Patients with Newly Diagnosed AML Aza + Pracinostat in AML: Study Design Pracinostat + Azacitidine 50 patients enrolled at 15 sites in the U.S. Last patient in on November 24, 2014 Primary endpoint: CR + CRi + MLFS* Secondary endpoints: ORR, CCyR, duration of response, EFS, OS, safety & tolerability Response assessments end of cycle 1 and 2, then every other cycle until CR is achieved or as clinically indicated * Morphologic leukemia-free state (i.e., marrow CR)
Key Inclusion Age ≥65 years Newly diagnosed de novo, secondary, or treatment-related AML Intermediate or unfavorable-risk cytogenetics (SWOG classification: Slovak et al, 2000) ≥ 20% bone marrow blasts Adequate renal, cardiac and liver function QTcF <450 ms for males or <470 ms for females Key Exclusion Acute promyelocytic leukemia (FAB M3); t(15;17), t(8;21), t(16;16), del(16q), or inv(16) karyotype Candidate for intensive chemotherapy within the next 4 months Active CNS disease Aza + Pracinostat in AML: Eligibility Criteria
Aza + Pracinostat in AML: Treatment Regimen Azacitidine 7 days (days 1-7) 75 mg/m2 IV/sq 28-day cycle Pracinostat 60 mg orally 3 days a week for 21 days on 28 day cycle Dose Modifications: Reductions Azacitidine for myelosuppresion Pracinostat: non-Heme toxicity Delays (between or within cycles) ≥Grade 3 hematologic toxicity in the absence of disease ≥Grade 3 non-hematologic toxicity following maximal medical treatment
Pracinostat + Azacitidine n=50 % Age, Years Median 76 Min-max 67-84 ≥75 50 Male gender 58 AML classification (by WHO) Not otherwise specified 44 With myelodysplasia-related changes 40 With therapy-related myeloid neoplasms 10 With recurrent genetic abnormalities* 6 Prior MDS Yes 24 Secondary 10 No 66 Aza + Pracinostat in AML: Patient Characteristics * Excluding the provisional entities of AML with NPM1 and AML with CEBPA mutation (molecular data not available)
Pracinostat + Azacitidine (n=50) % BM blasts Median 40 Min-max 20 – 89 ECOG PS 0 - 1 84 2 16 Cytogenetic risk group Intermediate 54 Intermediate, cytogenetically normal 42 Poor* 42 *The poor risk category for MEI-004 was defined using Southwest Oncology Group (SWOG) and Medical Research Council Cytogenetic Risk Definitions. The following cytogenetic abnormalities were included in this definition for this study: Del(5q)/-5, -7/del(7q), abnormal 3q, 9q, 20q, 17p, t(6;9), t(9;22) and complex karyotypes (≥ 3 unrelated abnormalities) Aza + Pracinostat in AML: Patient Characteristics
Pracinostat + Azacitidine (n=50) WBC (x 109/L) Median 2.6 Min-max 0.8 – 29.6 Hemoglobin (g/dL) Median 9.2 Min-max 6.5 – 14.9 Platelets (x 109/L) Median 47 Min-max 11-643 Peripheral Blasts (x 109/L) Median 0.2 Min-max 0 – 8.5 Serum Creatinine (mg/dL) Median 0.6 Min-max 0.2 – 1.5 Total Bilirubin (mg/dL) Median 0.9 Min-max 0.5 – 1.7 Aza + Pracinostat in AML: Patient Characteristics
n=50 (%) Number of Patients Alive Number of Patients Active Median Observation Time: 14.3 months 28 (56) 11 (22) Number of Patients Discontinued Reasons for discontinuation: Progressive Disease Adverse Event Other* 39 (50) 15 (30) 11 (22) 13 (26) Aza+Pracinostat in AML: Patient Disposition 50 patients have been enrolled at 15 centers FPI: December 24, 2013 LPI: November 24, 2014 * Includes patient and/or physician decision
Aza+ Pracinostat in AML: TEAE’s in ≥25% of Patients (all causality) All Grades (%), n=50 Grades 3-4 (%), n=50 Hematologic Febrile Neutropenia 24 (48.0) 20 (40.0) Thrombocytopenia 22 (44.0) 22 (44.0) Anemia 18 (36.0) 15 (30.0) Neutropenia 17 (34.0) 17 (34.0) Non-Hematologic Nausea 38 (76.0) 3 (6.0) Constipation 35 (70.0) 0 Fatigue 30 (60.0) 15 (30.0) Decreased Appetite 26 (52.0) 4 (8.0) Diarrhea 23 (46.0) 2 (4.0) Vomiting 18 (36.0) 2 (4.0) Cough 17 (34.0) 0 Dyspnea 17 (34.0) 1 (2.0) Dizziness 16 (32.0) 0 Hypokalemia 16 (32.0) 0 Edema Peripheral 15 (30.0) 0 Pyrexia 14 (28.0) 0 Back Pain 14 (28.0) 3 (6.0) Insomnia 13 (26.0) 0 TEAE = treatment-emergent adverse events
Treatment Emergent Adverse Events Leading to Drug Discontinuation (n=11) AE Term Grade Discontinuation (Cycle/Day) Outcome Intermittent Fatigue 1 4/28 Resolved Acute Kidney Injury 1 3/7 Not Resolved Peripheral Motor Neuropathy 3 3/15 Resolved Intermittent Fatigue 3 4/28 Not Resolved Parainfluenza 3 3/15 Resolved w Sequelae Diverticulitis 3 7/15 Not Resolved Prolonged QTc/AF 3 2/4 Resolved Supraglotic Ulcer 3 7/15 Resolved w Sequelae Sepsis 5 1/22 Fatal Sepsis 5 1/22 Fatal Sepsis 5 2/15 Fatal AE, adverse event; AF, atrial fibrillation; QTc, Corrected QT interval
Aza + Pracinostat in AML: Response Response Assessment Cytogenetic Risk* All n=50(%) Intermediate n=27(%) High n=21(%) CR/CRi/MLFS (Primary endpoint) 28 (56) 17 (81) 11 (52) CR 21 (42) 15 (56) 6 (29) CRi 2 (4) 0 (0) 2 (10) MLFS 5 (10) 2 (7) 3 (14) *2 not evaluable for cytogenetic risk assessment CR, complete response; Cri, complete response with incomplete blood count recovery; MLFS, morphologic leukemia free state;
Aza + Pracinostat in AML: Overall Survival
Aza+ Pracinostat in AML OS by Cytogenetic Risk
Aza + Pracinostat in AML: Association of Survival with CR
MEI-004 AZA-0011 Pracinostat + Azacitidine (n=50) Azacitidine (n=241) Age, Years Median 76 75 Min-max 67-84 64-91 ≥75 50 57 Male gender 58 57.7 AML classification (by WHO) Not otherwise specified 44 63.5 With myelodysplasia-related changes 40 31. With therapy-related myeloid neoplasms 10 3.3 With recurrent genetic abnormalities* 6 2.1 Prior MDS Yes 24 20.3 Secondary 10 1.2 No 66 79.7 MEI-004 vs. AZA-001: Baseline Characteristics * Excluding the provisional entities of AML with NPM1 and AML with CEBPA mutation (molecular data not available) 1Dombret et al. Blood. 2015 Jul 16;126(3):291-9
MEI-004 AZA-0011 Pracinostat + Azacitidine (n=50) Azacitidine (n=241) BM blasts Median 40 70 Min-max 20 – 89 2 - 100 ECOG PS 0 - 1 84 77.2 2 16 22.8 Cytogenetic risk group Intermediate 54 64.3 Intermediate, cytogenetically normal 42 46.9 Poor 42 35.3 1Dombret et al. Blood. 2015 Jul 16;126(3):291-9 MEI-004 vs. AZA-001: Baseline Characteristics
AZA-001 MEI-004 Conventional Care Regimens Azacitidine Pracinostat + Azacitidine High-Risk Population1 n=85 n=85 n=21 1-year survival estimate 14 30.9 57 Median overall survival 3.2 months 6.4 months 13.3 months Overall Population2 n=247 n=241 n=50 CR rate 21.9 19.5 42 60-day mortality rate 18.2 16.2 10 1-year survival rate 34.2 46.5 62 Event-free survival 4.8 months (3.8-6.0) 6.7 months (5.0-8.8) 7.7 months (0.9 – 21.2+) Duration of response 12.3 months (9.0-17.0) 10.4 months (7.2-15.2) 11.2 months (2.1-19.7+) Median overall survival 6.5 months (95%CI: 5.0-8.6) 10.4 months (95%CI: 8.0-12.7) >14 months (95%CI: 10.7-NR) MEI-004 vs. International Phase III Study of Azacitidine in Newly Diagnosed AML (AZA-001) 1 Döhner et al. ASH 2014. Abstract 621 2Dombret et al. Blood. 2015 Jul 16;126(3):291-9
Aza+ Pracinostat in AML: Conclusions Combination of Aza+ Pracinostat is safe in elderly AML High response rate compared to single agent Azacitidine Potential for prolongation of survival Apparent correlation of CR and survival in this low intensity therapy Future plans: Additional analysis genomic annotation Confirmation in planned phase III trial
Acknowledgements This work was supported by MEI Pharma, Inc.
Guillermo Garcia-Manero, MD1, Jesus G. Berdeja, MD2, Rami S. Komrokji, MD3, James Essell, MD4, Roger M. Lyons, MD5, Michael Maris, MD6, Amy E. DeZern, MD, MHS7, Mikkael A. Sekeres, MD, MS8 and Gail J Roboz, MD9 1Department of Leukemia, The University of Texas M.D. Anderson Cancer Center, Houston, TX, Houston, TX; 2Sarah Cannon Research Institute, Nashville, TN; 3H. Lee Moffitt Cancer Center, Tampa, FL; 4Oncology/Hematology Care, Cincinnati, OH; 5Cancer Care Center of South Texas, San Antonio, TX; 6Colorado Blood Cancer Institute, Denver, CO; 7Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore, MD; 8Leukemia Program, Cleveland Clinic, Cleveland, OH; 9Joan and Sanford I. Weill Department of Medicine, Weill Cornell Medical College, New York, NY Abstract #911 A Randomized, Placebo-Controlled, Phase II Study of Pracinostat in Combination with Azacitidine (AZA) in Patients with Previously Untreated Myelodysplastic Syndrome (MDS) Exhibit 99.2
Aza + Pracinostat in MDS: Introduction Combination studies with HDAC inhibitors plus HMA has the potential to improve outcomes in MDS Pracinostat is a potent hydroxamic acid based oral HDAC inhibitor selective for class I, II and IV isoforms A pilot study of Pracinostat in combination with azacitidine (AZA) in higher risk MDS showed a CR/CRi rate of 89%1 This study was designed to assess clinical activity of this combination in multi-center environment 1 Quintás-Cardama et al. ASH 2012: Abstract 3821
Intermediate Risk-2 or High Risk MDS Patients Previously Untreated w/ HMA Pracinostat + Azacitidine Placebo + Azacitidine Aza + Pracinostat in MDS: Study Design 102 evaluable patients: one-to-one randomization Primary analysis population defined as all randomized and treated patients Randomization stratified by IPSS risk group with a planned sample size of 100 24 sites in the U.S. activated, 19 sites enrolled patients FPI: June 17, 2013; LPI: Aug 29, 2014
Aza + Pracinostat in MDS: Study Design Primary endpoint: Confirmed CR within 6 cycles, based on IWG criteria (Cheson 2006) CR rates calculated for each group with 95% CI’s and compared using Chi-square testing BMBx and aspirate as well as a CBC with differential were required at the end of Cycles 2 and 6 CBC with differential was required for confirmation of CR or PR Cycle Day 1, 8 weeks following the initial report of response Secondary endpoints: ORR, HI, clinical benefit rate, duration of response, PFS, rate of leukemic transformation, OS, safety & tolerability Time-to-event secondary endpoints (PFS, EFS, OS) analyzed by Kaplan-Meier and hazard ratios calculated
Aza + Pracinostat in MDS: Inclusion Criteria Age ≥18 years Morphological diagnosis of MDS (any FAB subtype that is classified as intermediate 2 (1.5 to 2.0 points) or high risk (≥2.5 points) according to IPSS Previously untreated with hypomethylating agents Peripheral WBC count of <20,000 /μL ECOG Performance status ≤2 Adequate organ function
Aza + Pracinostat in MDS: Exclusion Criteria Received the following prior to administration of study treatment Investigational agent within 14 days or 5 half-lives Hydroxyurea within 48 hours prior to first study treatment Hematopoietic growth factors at least 7 days prior Treatment with the HDAC inhibitors Cardiopulmonary function abnormalities Current unstable arrhythmia requiring treatment History of symptomatic congestive heart failure History of myocardial infarction within 6 months of enrollment Current unstable angina Evidence of central nervous system involvement GI tract disease, causing the inability to take oral medication Active infection with human immunodeficiency virus or hep B or C Presence of a malignant disease within the last 12 months
Aza + Pracinostat in MDS: Treatment Regimen Azacitidine: 75 mg/m2 7 days I.V./sq every 28 days Pracinostat or placebo P.O., 60 mg 3 days/week for 3 weeks Cycles repeated every 28 days until disease progression, lack of benefit, or intolerance
Study Status Number of Sites 19 Number of Patients Enrolled 102 FPI 17-Jun-2013 LPI 29-Aug-2014 Last Patient Completed 11-May-2015 Aza + Pracinostat in MDS: Study Status
Azacitidine + Pracinostat n=(51) Azacitidine + Placebo (n=51) Age 70 (26-90) 69 (43-83) Gender (male/female) 32/19 38/13 ECOG 0 16 18 1 31 28 IPSS @ baseline Int-2 34 34 High Risk 17 17 FAB RAEB (-1/-2) 36 (12/21) 36(8/28) RAEB-T 6 2 CMML 3 5 Aza + Pracinostat in MDS: Patient Characteristics
Pracinostat + Azacitidine (n=51) Pracinostat + Placebo (n=51) WBC (x 109/L) Median 2.3 2.5 Min-max 1 – 15 1 – 47 Hemoglobin (g/dL) Median 9.2 9.2 Min-max 7 – 13 7 – 13 Platelets (x 109/L) Median 39.0 53.5 Min-max 2 – 1370 15 – 701 Peripheral Blasts (%) Median 0.0 0.0 Min-max 0 – 12 0 – 33 Serum Creatinine (mg/dL) Median 1.0 0.9 Min-max 0 – 2 1 – 2 Total Bilirubin (mg/dL) Median 0.7 0.7 Min-max 0 – 2 0 – 1 Aza + Pracinostat in MDS: Patient Characteristics
All Grades ≥ Grade 3 Pracinostat Placebo Pracinostat Placebo Hematologic 77% 63% 77% 59% Anemia 31% 39% 20% 33% Febrile Neutropenia 33% 18% 33% 18% Neutropenia 45% 33% 45% 33% Thrombocytopenia 49% 29% 47% 26% Non-Hematologic Nausea 69% 57% 4% 2% Fatigue 55% 51% 24% 0% Constipation 53% 53% 2% 2% Vomiting 47% 33% 4% 2% Dyspnoea 43% 29% 8% 0% Diarrhoea 39% 33% 4% 2% Peripheral Oedema 43% 24% 4% 0% Dizziness 37% 29% 4% 2% Pyrexia 26% 28% 4% 0% Cough 22% 31% 0% 0% Decreased Appetite 33% 22% 0% 0% Myalgia 20% 14% 2% 2% Dehydration 24% 12% 8% 0% Pneumonia 18% 14% 16% 10% Headache 20% 18%z 0% 0% QTc Prolongation 2% 2% 0% 0% Aza + Pracinostat in MDS: Adverse Events (>10%)
PRACINOSTAT / PLACEBO AZACITIDINE Pracinostat Placebo Pracinostat Placebo Drug Withdrawn 18% 8% 2% 2% Dose Reduced 10% 6% 18% 6% Dose Interrupted 63% 69% 69% 69% Aza + Pracinostat in MDS: Summary of Dose Modifications by Treatment Arm
Pracinostat Placebo CR, within 180 days 18% 33% Best Response Complete Remission 20% 33% Partial Remission 0% 0% Marrow CR 28% 22% Stable Disease 26% 29% Progressive Disease 6% 6% Not evaluable 22% 10% Aza + Pracinostat in MDS: Summary of Response Azacitidine
RESPONSE Pracinostat Placebo Hematological improvement 35% 55% Erythroid response (HI – E) 28% 45% Platelet response (HI – P) 31% 53% Neutrophil response (HI – N) 26% 39% Clinical benefit rate (CR + PR + HI + mCR) 53% 63% Cytogenetic response 42% 55% Cytogenetic CR 24% 29% Cytogenetic PR 18% 26% Aza + Pracinostat in MDS: Summary of Response
Aza + Pracinostat in MDS: Overall Survival Median Follow Up = 15.4 months One Year Survival: Pracinostat = 57.1% Placebo = 57.4% HR =1.21
Aza + Pracinostat in MDS: Progression Free Survival HR = 0.93
Aza + Pracinostat in MDS: Duration of Response HR = 0.64
Sensitivity analyses suggest that patients that tolerate treatment with Pracinostat plus azacitidine for > 4 cycles appear to derive benefit compared to azacitidine alone Aza + Pracinostat in MDS: Exploratory Sensitivity Analyses
Aza+ Pracinostat in MDS: OS For Patients On Study For 4 or More Cycles HR = 0.59
Aza+Pracinostat in MDS: DR For Patients On Study For 4 or More Cycles HR = 0.59 HR = 0.48
SWOG S1117 Azacitidine (n=92) Vorinostat + Azacitidine (n=91) CR rate 24% 15% Off Tx due to adverse events 9% 24% On Tx > 6 months (median) Relapse-free survival: 7 months Relapse-free survival: 13 months (P = .11) MEI-003 vs. North American Intergroup Randomized Phase 2 MDS Study (SWOG S1117)1 1 Sekeres et al. ASH 2014: LBA - 5 MEI-003 Azacitidine (n=51) Pracinostat + Azacitidine (n=51) CR rate 33% 20% Off Tx due to adverse events 10% 26% On Tx > 4 cycles (n=54) HRs: OS=0.59, DR=0.48, PFS=0.37
Aza + Pracinostat in MDS: Conclusions Pracinostat failed to improve the clinical effectiveness of AZA in this population of higher risk MDS Pracinostat resulted in more toxicity when added to AZA Grade 3 Fatigue, 24% vs. 0% Febrile Neutropenia, 33% vs.18% Thrombocytopenia, 47% vs. 26% This toxicity led to more, and earlier, drug discontinuation in the Pracinostat group Drug discontinuations for adverse events, 26% vs 10% Not evaluable for response, 22% vs 10% Exploratory analyses suggest that patients able to tolerate Pracinostat for at least 4 cycles may derive benefit Need consider alternative doses/schedules
Acknowledgements We would like to acknowledge the assistance of the MDS Consortium This work was supported by MEI Pharma, Inc.
Exhibit 99.3
| Contact: | ||||
|
Pete De Spain Vice President, Investor Relations & Corporate Communications (858) 792-3729 pdespain@meipharma.com |
MEI Pharma Announces Positive Results from Phase II Study of Pracinostat in
Acute Myeloid Leukemia, Plans to Initiate Phase III Registration Study
San Diego – December 7, 2015 – MEI Pharma, Inc. (Nasdaq: MEIP), an oncology company focused on the clinical development of novel therapies for cancer, today announced positive results from a Phase II study of its investigational drug candidate Pracinostat in combination with azacitidine (marketed as Vidaza®) in elderly patients with newly diagnosed acute myeloid leukemia (AML). The results were presented earlier today at the American Society of Hematology (ASH) Annual Meeting in Orlando. A copy of the presentation is now available at www.meipharma.com.
According to the oral presentation by principal investigator Dr. Guillermo Garcia-Manero, MD Anderson Cancer Center, 28 of the 50 patients in the study (56%) achieved the primary endpoint of complete response (CR) plus complete response with incomplete blood count recovery (CRi) plus morphologic leukemia-free state (MLFS), including 21 patients (42%) who achieved a CR. Notably, 19 of the 21 patients who achieved a CR are still alive with a 100% one-year survival rate among all CR patients, indicating a correlation between CR and survival with this low intensity therapy.
Median overall survival for all 50 patients in the study has not been reached, with 28 patients still living and a median observation time of 14.3 months. These data compare favorably to a recent international Phase III study of azacitidine (AZA-001)1, which showed a median overall survival of 10.4 months with azacitidine alone and a CR rate of 19.5% in a similar patient population. Median survival among patients with high-risk cytogenetics in this study (n=21) was 13.3 months, more than double the median survival of the high-risk population in the AZA-001 study (6.4 months).
“These are impressive results by virtually any measure for a group of patients in dire need of effective new treatment options,” said Dr. Garcia-Manero. “Not only did we observe a high rate of responses, but many occurred rapidly and continued to improve with ongoing therapy. Most importantly, we are seeing an encouraging trend in overall survival, particularly among patients who achieved a complete response. These data clearly support further development of Pracinostat in combination with azacitidine for the treatment of elderly patients with AML.”
The open-label study enrolled a total of 50 patients at 15 centers across the U.S. Median age in the study was 76 years. Patients received 60 mg of Pracinostat orally three times a week for three weeks followed by one week of rest and 75 mg/m2 of azacitidine via subcutaneous
| 1 | Dombret H et al. International phase 3 study of azacitidine vs conventional care regimens in older patients with newly diagnosed AML with >30% blasts. Blood. 2015 May 18. |
injection or intravenous infusion for the first seven days of each 28-day cycle. The combination of Pracinostat and azacitidine was generally well tolerated in the study, with no unexpected toxicities. The most common grade 3/4 treatment-emergent adverse events reported in >10% of all patients included febrile neutropenia, thrombocytopenia, anemia and fatigue.
“We are very excited about our growing body of AML data, which continues to exceed expectations and guide us forward with the development of this program,” said Daniel P. Gold, Ph.D., President and Chief Executive Officer of MEI Pharma. “Over the past several months we have learned that our randomized study of Pracinostat and azacitidine in myelodysplastic syndrome (MDS) was hindered by a high rate of discontinuations due to adverse events, but appeared to show a benefit for patients who were able to tolerate treatment for at least four cycles compared to azacitidine alone. The results from our AML study demonstrate that many patients are achieving responses within the first two cycles, with fewer discontinuations overall due to adverse events compared to our MDS study, suggesting a prudent development path forward for the combination.
“Based on these findings,” continued Dr. Gold, “we will now begin to prepare for a Phase III registration study of Pracinostat and azacitidine in elderly patients with newly diagnosed AML, which we plan to initiate in the second half of 2016. We look forward to sharing more information regarding the design of this study in the months ahead.”
About Pracinostat
Pracinostat is a potent oral inhibitor of a group of enzymes called histone deacetylases, or HDACs. HDACs belong to a larger set of proteins collectively known as epigenetic regulators that can alter gene expression by chemically modifying DNA or its associated chromosomal proteins. Abnormal activity of these regulators is believed to play an important role in cancer and other diseases. Pracinostat has been tested in multiple Phase I and Phase II clinical studies in advanced hematologic diseases and solid tumor indications. The results of these studies suggest that Pracinostat has potential best-in-class pharmacokinetic properties when compared to other oral HDAC inhibitors, with side effects often associated with drugs of this class, including fatigue and myelofibrosis. Pracinostat has not been approved for commercial distribution in the U.S.
MEI Pharma owns exclusive worldwide rights to Pracinostat.
About AML
Acute myeloid leukemia (also known as acute myelogenous leukemia) is the most common acute leukemia affecting adults, and its incidence is expected to continue to increase as the population ages. The American Cancer Society estimates about 20,830 new cases of AML per year in the U.S., with an average age of about 67 years. Treatment options for AML remain virtually unchanged over the past 30 years. Front line treatment consists primarily of chemotherapy, while the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology recommend azacitidine or decitabine (marketed as Dacogen®) as low intensity treatment options for AML patients over the age of 60 who are unsuitable for induction chemotherapy.
About MEI Pharma
MEI Pharma, Inc. (Nasdaq: MEIP) is a San Diego-based oncology company focused on the clinical development of novel therapies for cancer. The Company’s portfolio of drug candidates includes Pracinostat, a potential best-in-class, oral HDAC inhibitor that is expected to enter a Phase III registration study in combination with azacitidine for the treatment of elderly patients with newly diagnosed AML in the second half of 2016. The Company is also developing ME-344, a novel mitochondrial inhibitor that has shown evidence of clinical activity in refractory solid tumors, and ME-401 (formerly PWT143), a highly selective, oral PI3K delta inhibitor that is expected to enter a Phase Ib study for the treatment of B-cell malignancies in the first half of 2016. For more information, please visit www.meipharma.com.
Under U.S. law, a new drug cannot be marketed until it has been investigated in clinical trials and approved by the FDA as being safe and effective for the intended use. Statements included in this press release that are not historical in nature are “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. You should be aware that our actual results could differ materially from those contained in the forward-looking statements, which are based on management’s current expectations and are subject to a number of risks and uncertainties, including, but not limited to, our failure to successfully commercialize our product candidates; costs and delays in the development and/or FDA approval, or the failure to obtain such approval, of our product candidates; uncertainties or differences in interpretation in clinical trial results; our inability to maintain or enter into, and the risks resulting from our dependence upon, collaboration or contractual arrangements necessary for the development, manufacture, commercialization, marketing, sales and distribution of any products; competitive factors; our inability to protect our patents or proprietary rights and obtain necessary rights to third party patents and intellectual property to operate our business; our inability to operate our business without infringing the patents and proprietary rights of others; general economic conditions; the failure of any products to gain market acceptance; our inability to obtain any additional required financing; technological changes; government regulation; changes in industry practice; and one-time events. We do not intend to update any of these factors or to publicly announce the results of any revisions to these forward-looking statements.