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Bio-Path Leukemia Combo Study Shows Positive Early Data

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Bio-Path Holdings, Inc. announced positive interim data from phase II study (BP1001-201) on its lead pipeline candidate — prexigebersen — in combination with low-dose cytarabine (“LDAC”) for the treatment of patients with acute myeloid leukemia (“AML”) who cannot or choose not to be treated with more intensive chemotherapy.

The primary objective of the study is to determine whether the combination of prexigebersen and LDAC provides greater efficacy compared with LDAC alone. Shares of the company rose by almost 25% following the news.

The combination therapy demonstrated early anti-leukemic activity in nearly 50% of evaluable AML patients. Out of the 17 evaluable patients, four patients achieved complete remission and four experienced stable disease to date in this study. In total, 47% of patients achieved some form of response from the combo treatment.

The combination was also well tolerated in the study.

Shares of the company have underperformed the industry in a year’s time. The stock has declined 71.9%, against the industry’s increase of 5%.



The average age of patients in the study was 73.5 year. These results are encouraging as the complete response rate in elderly AML patients greater than 65 years of age on LDAC alone have been estimated to be only 10%.

The company also stated that it is amending the protocol of the study to change the dosing schedule to that used in the phase Ib study in which a higher dose of prexigerbesen was administered. The company expects that the planned protocol amendments will provide better results for the patients suffering from AML and if successful will lead to potential approvals in the United States and Europe.

The company also released results for the year ended Dec 31, 2017. The company reported a loss of 80 cents per share compared with a loss of 73 cents in 2016. The company did not generate any revenues.

Bio-Path does not carry a Zacks Rank.


Stocks That Warrant a Look

A few stocks from the same space worth looking at are Regeneron Pharmaceuticals(REGN - Free Report) , Enanta Pharma (ENTA - Free Report) and Ligand Pharmaceuticals (LGND - Free Report) . While Regeneron and Enanta Pharma sport a Zacks Rank #1 (Strong Buy), Ligand carries a Zacks Rank#2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Regeneron’s earnings per share estimates have moved up from $18.67 to $18.68 for 2018 in the last 30 days. The company pulled off a positive earnings surprise in three of the last four quarters, with an average beat of 9.15%.

Enanta Pharma delivered a positive earnings surprise in three of the last four quarters, with an average beat of 373.1%. The company’s shares have surged 164.4% over a year.

Ligand’s earnings per share estimates have moved up $3.78 to $4.20 from $4.75 to $5.32 for 2018 and 2019, respectively, over the last 60 days. The company delivered a positive earnings surprise in three of the trailing four quarters, with an average beat of 24.88%. The company’s shares have rallied 50% over a year.

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