Blog Coverage MEI Pharma and Helsinn Group Announced Data from Phase II Clinical Study of Pracinostat in Acute Myeloid Leukemia

Upcoming AWS Coverage on Depomed Post-Earnings Results

LONDON, UK / ACCESSWIRE / November 4, 2016 / Active Wall St. blog coverage looks at the headline from MEI Pharma, Inc. (NASDAQ: MEIP) and Swiss pharmaceutical group, Helsinn Group, announced that on November 03rd, 2016, that long-term survival and response data from a Phase II clinical study of Pracinostat and azacitidine in older patients with acute myeloid leukemia have been selected for oral presentation at the upcoming American Society of Hematology (ASH) Annual Meeting in San Diego on December 3-6, 2016. Register with us now for your free membership and blog access at: http://www.activewallst.com/register/.

One of MEI Pharma’s competitors within the Drug Manufacturers – Other space, Depomed, Inc. (NASDAQ: DEPO), will release its Q3 fiscal year 2016 financial results on Monday, November 7, 2016, after the closing bell. The Company will host a conference call at 4:30 p.m. ET to discuss its results. AWS will be initiating a research report on Depomed in the coming days.

Today, AWS is promoting its blog coverage on MEIP; touching on DEPO. Get all of our free blog coverage and more by clicking on the link below:

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Abstract of the presentation

As per the abstract posted on ASH website, for the Phase II study between December 2013 and December 2014, 50 patients were enrolled at 15 U.S. sites. With median age 75 years (range 66-84 years); 33 de novo and 17 secondary with 27 patients having intermediate-risk and 21 high-risk cytogenetics while for 2 person it was not known. The treatment consisted of Pracinostat 60 mg orally, 3 days per week, on alternate days for 3 weeks, and AZA 75 mg/m2 subcutaneously or intravenously daily for 7 days, with cycles repeated every 28 days until disease progression, lack of response, or poor tolerability.

The primary endpoint was a composite complete response rate (cCR) of CR + CRi+ MLFS by IWG criteria. Secondary endpoints included overall response rate (cCR + PR), duration of response and overall survival (OS). A CR was achieved in 21 patients (42%), CRi in 2 (4%), and MLFS in 3 (6%) for a cCR rate of 52%. Median time to BM blasts <5% was 57 days (range 25-243 days) and exceeded 168 days (6 cycles) in 3 patients (12%). Median duration of cCR was 13.2 months (95% CI 10.9-21.5 months), with 6 of 26 patients (23%) continuing on therapy for a periods ranging from 20.5 to 29.5 months. With a median follow-up of 21 months, the median OS is now 19.1 months (95% CI, 10.0-not reached). One-year and 2-year OS are 62% and 45%. Non-protocol therapies (NPT) were administered in 23 patients (46%). There was no effect on OS after censoring survival duration at the start of NPT.

The trials concluded that Pracinostat + AZA led to a high rate of responses in elderly patients with AML. Responses were durable and observed irrespective of age, cytogenetics risk, ECOG performance status, and de novo or secondary AML. Marrow remission was typically achieved early, but prolonged exposure was required in some patients to maximize response. The results compared favourably with historical single-agent AZA data in a similar AML population. A phase 3 study of AZA +/- pracinostat in untreated patients with AML unfit for standard induction chemotherapy will be launched soon.

Pracinostat

Pracinostat is an oral histone deacetylase (HDAC) inhibitor. The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for Pracinostat in combination with azacitidine for the treatment of patients with newly diagnosed AML who are ≥75 years of age or unfit for intensive chemotherapy. In August 2016, Helsinn and MEI Pharma entered into an exclusive licensing, development and commercialization agreement for Pracinostat in AML and other potential indications. The deal provides the complementary resources from both organizations to rapidly advance Pracinostat into Phase III clinical development and expand into additional indications, including high-risk myelodysplastic syndrome (MDS).

About AML

Acute myeloid leukemia (AML) is one of 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 have remained virtually unchanged for nearly 40 years.

Stock Performance

At the close of yesterday’s trading session, MEI Pharma’s stock price declined 3.33% to end the day at $1.45. A total volume of 266.5 thousand shares were exchanged during the session. The company’s shares have advanced 8.21% in the past six months. The stock currently has a market cap of $54.98 million.

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