On May 11, 2017 Bio-Path Holdings, Inc. (NASDAQ: BPTH), a biotechnology company leveraging its proprietary DNAbilize liposomal delivery and antisense technology to develop a portfolio of targeted nucleic acid cancer drugs, reported its financial results for the first quarter ended March 31, 2017 and provided an update on recent corporate developments (Filing, Q1, Bio-Path Holdings, 2017, MAY 11, 2017, View Source [SID1234519008]).

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"Our ongoing Phase 2 trial of prexigebersen for the treatment of acute myeloid leukemia (AML) is advancing according to plan and we remain on track to complete our 19 patient interim analysis by the end of this year," said Peter Nielsen, President and CEO of Bio-Path Holdings. "Additionally, we were honored to welcome Dr. William Hahne to our team as Vice President of Clinical Research. His extensive experience directing clinical research programs, curating product pipelines, and liaising with regulatory agencies will be critical as we see our next candidate, BP1002, into the clinic for the treatment of lymphoma."

Recent Corporate Highlights

· Presented Pre-Clinical Results Showing Potential of BP1002 as Treatment for Aggressive Non-Hodgkin’s Lymphoma at AACR (Free AACR Whitepaper) Annual Meeting. In an in vitro study, lymphoma cell lines were incubated with BP1002. It was determined that BP1002 induced greater than 50% inhibition in 11 of the 15 cell lines tested. In two in vivo mice studies, BP1002 enhanced survival of mice over untreated and control arms. Bio-Path is preparing to submit an investigational new drug (IND) application for evaluating BP1002 in lymphoma.

· Appointed Dr. William Hahne as Vice President of Clinical Research. In April, the Company announced the appointment of Dr. William Hahne as Vice President of Clinical Research. Before joining Bio-Path, Dr. Hahne was a medical consultant for a number of organizations including Medimmune, Lion Biotechnologies, Seattle Genetics, Aminex Therapeutics, Therakos, and Celgene Cellular Therapeutics. He held executive positions in clinical research and medical affairs at Celator Pharmaceuticals (now a subsidiary of Jazz Pharmaceuticals), Celsion Corp, and CurGen Corp, during which he was integrally involved in the design and management of oncology clinical trials, development of key opinion leaders, and growth of clinical departments to meet needs of advancing pipelines. Earlier, he worked in various clinical and medical positions at Glaxo Inc., Marion Merrell Dow, Hoechst Marion Rousel, and Eisai, Inc. Dr. Hahne earned his BA in chemistry from Grinnell College and his MD from Cornell University. He conducted his residency in general surgery at Emory University Affiliated Hospitals in Atlanta, Georgia.




Financial Results for the First Quarter Ended March 31, 2017

The Company reported a net loss of $0.4 million, or $0.01 per share, for the three months ended March 31, 2017, compared to a net loss of $1.9 million, or $0.02 per share, for the same period in 2016. The decrease was primarily due to a non-cash change in the fair value of the Company’s warranty liability during the period of $1.6 million.

Research and development expenses for both the three months ended March 31, 2017 and March 31, 2016, were $1.0 million.

General and administrative expenses for the three months ended March 31, 2017 increased to $1.0 million, compared to $0.8 million for the three months ended March 31, 2016 primarily due to increased stock-based compensation expense during the period.

Change in fair value of the Company’s warrant liability for the three months ended March 31, 2017 resulted in non-cash income of $1.6 million. The company did not have the warrant liability in the comparable period for 2016.

As of March 31, 2017, the Company had cash of $7.1 million, compared to $9.4 million at December 31, 2016. Net cash used in operating activities for the three months ended March 31, 2017 was $1.8 million compared to $2.4 million for the comparable period in 2016. Net cash used in investing activities for the three months ended March 31, 2017 was $0.4 million.

On May 11, 2017 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that the results of the Japanese phase III study (J-ALEX) of Alecensa, in patients with ALK fusion gene positive non-small cell lung cancer (NSCLC), were published in the electronic version of "The Lancet" on May 11, 2017 (Press release, Chugai, MAY 10, 2017, View Source [SID1234519004]).

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(http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(17)30565-2/fulltext)

The initial results of the J-ALEX study were presented at a session of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) meeting held in Chicago, on June 6, 2016.

"The publication of the J-ALEX study results in ‘The Lancet’ assures the firm position of Alecensa in the first line therapy of patient with ALK fusion gene positive NSCLC," said Dr. Yasushi Ito, Senior Vice President, Head of Project & Lifecycle Management Unit. "We believe that Alecensa will also contribute to improving the outcomes for patients in first line therapy, as well as second line therapy in the future."

The J-ALEX study was an open-label, randomized phase III study that compares the efficacy and safety between Alecensa and crizotinib. The J-ALEX study enrolled 207 ALK-inhibitor naïve patients with ALK fusion gene positive advanced or recurrent NSCLC, who either had not undergone chemotherapy or had undergone one chemotherapy regimen. The primary endpoint of the J-ALEX study was progression free survival (PFS) as assessed by an independent review board. The secondary endpoints included overall survival, objective response rate, safety, and other endpoints.

The PFS hazard ratio of the Alecensa arm to the crizotinib arm was 0.34 (99.7% CI: 0.17-0.71, stratified log-rank p<0.0001) and Alecensa demonstrated significantly prolonged PFS. Median PFS was not reached (95% CI: 20.3-Not Estimated) in the Alecensa arm while it was 10.2 months (95%CI: 8.2-12.0) in the crizotinib arm. In the Alecensa arm, constipation (35%) was an adverse event (AE) with >30% frequency, while in the crizotinib arm nausea (74%), diarrhea (73%), vomiting (58%), visual disturbance (55%), dysgeusia (52%), constipation (44%), ALT elevation (32%), and AST elevation (31%) were each seen in >30% patients. Grade 3-4 AEs occurred in 26% of the Alecensa arm and in 52% of the crizotinib arm, there were no treatment-related deaths in either arm.

In February 2016, Chugai carried out a prospectively-defined interim analysis and had an independent data monitoring committee examine the results. Since the results showed that the Alecensa arm significantly prolonged the PFS, the committee decided to recommend an early discontinuation of the J-ALEX study.

Based on the results of the J-ALEX study, Alecensa was granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration in September 2016 for first line therapy of patients with ALK-positive non-small cell lung cancer.