September 17, 2014 6:03 AM ET

Biotechnology

Company Overview of Manhattan Pharmaceuticals, Inc.

Company Overview

As of December 29, 2011, Manhattan Pharmaceuticals Inc. was acquired by TG Therapeutics, Inc., in a reverse merger transaction. Manhattan Pharmaceuticals, Inc., a specialty healthcare product company, focuses on developing and commercializing treatments for underserved patient populations. Its portfolio of product candidates includes AST-726, a nasally delivered form of hydroxocobalamin for the treatment of vitamin B12 deficiency; AST-915, an oral treatment for essential tremor; Hedrin, a non-insecticide treatment for pediculosis (head lice); and a topical GEL for the treatment of mild psoriasis. The company has a joint venture agreement with Nordic Biotech Advisors ApS to develop and commer...

48 Wall Street

Suite 1100

New York, NY 10005

United States

Founded in 2001

2 Employees

Phone:

212-582-3950

Fax:

212-582-3957

Key Executives for Manhattan Pharmaceuticals, Inc.

Manhattan Pharmaceuticals, Inc. does not have any Key Executives recorded.

Manhattan Pharmaceuticals, Inc. Key Developments

Manhattan Pharmaceuticals, Inc. Amends Phase I/II Trial of TG-1101 in Patients with Rituximab Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma

Manhattan Pharmaceuticals, Inc. announced that it has amended its Phase I/II study of single agent ublituximab to initiate its first expansion cohort following early signs of clinical activity. The protocol has been expanded to enroll up to 25 additional patients at the 900 mg dose level in the Phase I/II trial evaluating the safety, tolerability and efficacy of ublituximab, the Company's novel third-generation anti-CD20 monoclonal antibody, for patients with rituximab (Rituxan(R)) relapsed or refractory B-cell non-Hodgkin's lymphoma (NHL). Dose escalation will continue as planned to the 1,200 mg dose cohort. Following successful completion of the dose escalation component of the study, an additional expansion cohort may be added at the highest dose of 1,200 mg. The trial, entitled "An Open Label Phase I/II Trial of the Efficacy and Safety of Ublituximab in Patients with B-cell Non-Hodgkin Lymphoma who have Relapsed or are Refractory After CD20 Directed Antibody Therapy," (NCT01647971) has completed enrollment in 3 cohorts (450, 600 and 900mg) in the Phase I dose escalation component. All patients continue to be stratified by subtype of B-cell Lymphoma and all enrolled patients will be relapsed or refractory to Rituxan(R) or a Rituxan(R) containing regimen, and in most cases multiple other lines of therapy. In addition to the cohort expansion, the study was amended to now allow enrollment of patients with Chronic Lymphocytic Leukemia (CLL), Small Lymphocytic Lymphoma (SLL) as well as Primary Central Nervous System Lymphoma (PCNSL). Phase I data from a trial conducted in France with ublituximab administered as a single agent at a dose of 450 mg to relapsed and refractory CLL patients reported an objective response rate of 45%, with a manageable safety profile.

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