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Daiichi Sankyo Cancer Enterprise

On January 1, 2018 Daiichi Sankyo presents "Daiichi Sankyo Cancer Enterprise" presentation (Presentation, Daiichi Sankyo, JAN 1, 2018, View Source [SID1234525225]).

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Corporate Presentation

On January 1, 2018 Juno presented Corporate Presentation (Presentation, Juno, JAN 1, 2018, View Source [SID1234523901]).

10-Q – Quarterly report [Sections 13 or 15(d)]

Rich Pharmaceuticals has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Rich Pharmaceuticals, 2017, DEC 29, 2017, View Source [SID1234522790]).

Progenics Pharmaceuticals Announces FDA Acceptance of New Drug Application for AZEDRA® (iobenguane I 131) in Pheochromocytoma and Paraganglioma

On December 29, 2017 Progenics Pharmaceuticals, Inc. (NASDAQ:PGNX), an oncology company developing innovative medicines and imaging analytical tools for targeting and treating cancer, reported that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for AZEDRA in patients with malignant, recurrent and/or unresectable pheochromocytoma and paraganglioma, which are rare neuroendocrine tumors (Press release, Progenics Pharmaceuticals, DEC 29, 2017, View Source [SID1234522856]). The FDA granted Progenics’ request for Priority Review and has set an action date of April 30, 2018 under the Prescription Drug User Fee Act (PDUFA).

"With no FDA-approved therapies for these rare tumors, AZEDRA has the potential to address the high unmet need of patients with malignant pheochromocytoma and paraganglioma," said Mark Baker, Chief Executive Officer of Progenics. "We are pleased that the FDA has accepted our NDA with Priority Review, and look forward to working with the Agency during the review process. At the same time, we will continue to lay the groundwork for our commercial plan and prepare to launch quickly following a potential approval."

The NDA is supported by data from a pivotal phase 2b open-label, multi-center trial that was conducted under a Special Protocol Assessment (SPA) with the FDA. The trial met the primary endpoint evaluating the proportion of pheochromocytoma and paraganglioma patients who achieved a 50% or greater reduction of all antihypertensive medication for at least six months, and showed favorable results from a key secondary endpoint evaluating the proportion of patients with overall tumor response as measured by Response Evaluation Criteria In Solid Tumors (RECIST). AZEDRA was also shown to be safe and generally well tolerated.

About AZEDRA

AZEDRA (iobenguane I 131) is a high-specific-activity radiotherapeutic product candidate in development as a treatment for malignant, recurrent, or unresectable pheochromocytoma and paraganglioma, which are rare neuroendocrine tumors of neural crest origin. AZEDRA is a substrate for norepinephrine reuptake transporter which is highly expressed on the cell surface of neuroendocrine tumors. AZEDRA has been granted Orphan Drug designation, Fast Track status, and Breakthrough Therapy designation in the U.S. Under a SPA agreement with the FDA, a phase 2b pivotal study has been completed in patients with malignant, recurrent, or unresectable pheochromocytoma and paraganglioma. There are currently no FDA-approved therapies for the treatment of this ultra-rare disease.

About Pheochromocytoma and Paraganglioma

Pheochromocytoma and paraganglioma are rare neuroendocrine tumors that arise from cells of the autonomic nervous system. Pheochromocytoma forms in the adrenal medulla, whereas paragangliomas form outside the adrenal gland. Standard treatment options for these tumors include surgery, palliative therapy and symptom management. Pheochromocytoma and paraganglioma tumors frequently secrete high levels of hormones that can lead to life-threatening hypertension, heart failure, and stroke in these patients. Malignant and recurrent pheochromocytoma and paraganglioma may result in unresectable disease with a poor prognosis, representing a significant management challenge with very limited treatment options and no approved anti-tumor therapies.

Bio-Path Holdings Provides Clinical Update and 2018 Business Outlook

On December 29, 2017 Bio-Path Holdings, Inc., (NASDAQ: BPTH), a biotechnology company leveraging its proprietary DNAbilize antisense RNAi nanoparticle technology to develop a portfolio of targeted nucleic acid cancer drugs, reported an update from several clinical programs and provided a 2018 business overview (Press release, Bio-Path Holdings, 29 29, 2017, View Source [SID1234522814]).

"We are very excited about the potential for Bio-Path as we enter 2018. The year ahead is expected to be highlighted by a variety of value-creating milestones across a number of important clinical development programs aimed at further validating our DNAbilize platform as a potential treatment for a variety of oncology indications," stated Peter H. Nielsen, chief executive officer of Bio-Path Holdings. "We continue to advance our unique platform technology to address a number of cancers that remain unresponsive to current treatment paradigms."

"We are very encouraged about the potential for our DNAbilize technology, which is supported by compelling earlier data that show prexigebersen to be safe and efficacious against a wide range of cancer indications and are hopeful that these positive data will be replicated in our ongoing late-stage clinical trials," continued Mr. Nielsen.

Phase 2 Study of Prexigebersen in De Novo AML Patients

Bio-Path is conducting a Phase 2 clinical trial of its lead drug candidate, prexigebersen, in combination with frontline therapy low dose cytarabine (LDAC) in de novo acute myeloid leukemia (AML) patients who are ineligible or unwilling to undergo intensive induction therapy. The single arm trial is designed for up to 54 evaluable patients with an interim analysis performed after 19 patients.

To-date in this study, over 50 potential patients have been pre-screened, 26 patients have been screened, 23 patients have been enrolled and 17 patients have been deemed evaluable with 6 additional patients currently undergoing treatment. Bio-Path expects the 19 patient pre-specified analysis to be completed in early 2018, at which time the assessment of these patients will be addressed by Bio-Path.

Plans for a pivotal trial will be discussed with the FDA if these results exceed expectations for current standard of care therapy.

Phase 2a Study of Prexigebersen in Accelerated and Blast Phase CML Patients

Bio-Path today announces the initiation of its Phase 2a clinical study of prexigebersen for the treatment of chronic myeloid leukemia (CML) in accelerated and blast phase patients. The trial is being conducted at The University of Texas MD Anderson Cancer Center as a potential salvage therapy for accelerated and blast phase CML patients.

Two cohorts of three evaluable patients each will be enrolled to evaluate two doses (60 mg/m2 and 90 mg/m2) of prexigebersen in combination with the front-line treatment dasatinib.

Phase 1 Study of BP1002 in Refractory or Relapsed Lymphoma Patients

In 2018, Bio-Path intends to initiate a Phase 1 clinical trial of BP1002, an antisense RNAi nanoparticle targeting the Bcl-2 protein, in refractory or relapsed lymphoma patients. The clinical trial would evaluate the safety of BP1002 in several dose escalating cohorts to determine a maximum tolerated dose and/or optimal biologically active dose.