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MONMOUTH JUNCTION, N.J.–(BUSINESS WIRE)–MicroDose Therapeutx, Inc., announced today the completion of its third and final Phase 1 clinical study for MDT-637 with its novel inhaled antiviral fusion inhibitor, MDT-637, for the treatment of RSV infection. MicroDose will present the data from all three clinical studies at the 8th Annual International Respiratory Syncytial Virus Symposium taking place from Sept. 27-30 in Santa Fe, NM. Successful completion of the previous two Phase 1 studies (Study MDT-637-CP-101 and MDT-637-CP-102) was announced on April 24, 2012.

MicroDose Therapeutx and Moerae Matrix Announce Collaboration to Develop Novel Inhaled Treatment for Idiopathic Pulmonary Fibrosis (IPF)

Monmouth Junction, NJ, USA, June 19, 2012 – MicroDose Therapeutx, Inc. and Moerae Matrix, Inc. announced today that they have signed a collaboration agreement to develop a dry powder inhalation product of Moerae’s novel MK2 inhibitor, MMI-0100, for the treatment of idiopathic pulmonary fibrosis (IPF), a serious and fatal lung disease for which there are no approved treatments in the U.S. The collaboration will involve the development and supply of a pulmonary drug delivery system for Moerae and/or its partners utilizing MicroDose’s proprietary inhaler technology in support of chronic administration.

Monmouth Junction, NJ, USA, April 24, 2012 – MicroDose Therapeutx, Inc. announced today that it has concluded the second of two Phase I studies with its novel inhaled antiviral fusion inhibitor, MDT-637, for the treatment of RSV infection.

MicroDose has completed two double-blind, randomized, placebo-controlled dose-ranging studies in healthy volunteers assessing the pharmacokinetics, safety and tolerability of MDT-637 after single (Study MDT-637-CP-101) and multiple ascending doses (Study MDT-637-CP-102) of inhaled MDT-637 from MicroDose’s novel dry powder nebulizer technology.

MicroDose Therapeutx Begins Phase 1 Trial Of MDT-637 For Treatment of Respiratory Syncytial Virus

Monmouth Junction, NJ, September 27, 2011 — MicroDose Therapeutx, Inc. today announced that the first human subject has been dosed in a Phase 1 clinical trial of MDT-637, MicroDose’s inhalable small molecule antiviral fusion inhibitor for the treatment of respiratory syncytial virus (RSV).  This Phase 1 trial follows the reactivation of the United States IND for MDT-637 as re-formulated for delivery using MicroDose’s proprietary dry powder nebulizer.

The Phase 1 clinical trial is a U.S.-based, single ascending dose, randomized, placebo controlled trial studying the safety, tolerability and pharmacokinetics of MDT-637 in 48 healthy adult subjects.

MicroDose Therapeutx Announces Achievement of Development Milestone Triggering a Payment Under Respiratory Collaboration

MONMOUTH JUNCTION, N.J., (BUSINESS WIRE) May 2, 2011 – MicroDose Therapeutx, Inc. (MicroDose) today announced that a development  milestone in its collaboration with Novartis  has been achieved, triggering a payment under the multi-product development and licensing agreement for the MicroDose proprietary dry powder inhaler (DPI). This milestone signals the successful incorporation of MicroDose’s DPI technology into a Novartis platform pulmonary device.

As previously announced, under the terms of the agreement Novartis is funding development and commercialization of products that employ MicroDose’s DPI technology for the administration of Novartis’ proprietary respiratory compounds. In addition to the upfront payment received, MicroDose is eligible for additional milestone payments and royalties on product sales.

For Immediate Release

GILEAD AND MICRODOSE THERAPEUTX ANNOUNCE LICENSE AND COLLABORATION AGREEMENT TO DEVELOP MDT-637 FOR TREATMENT OF RESPIRATORY SYNCYTIAL VIRUS

Foster City, CA and Monmouth Junction, NJ, April 20, 2011 — Gilead Sciences, Inc.
(Nasdaq: GILD) and MicroDose Therapeutx, Inc. today announced that the companies have entered into an exclusive worldwide license and collaboration agreement for the development and commercialization of MDT-637, MicroDose’s inhalable small molecule antiviral fusion inhibitor for the treatment of respiratory syncytial virus (RSV).

MicroDose Therapeutx Awarded Four Therapeutic Discovery Grants Totaling approximately $1 million

Non-dilutive grants support development programs in RSV disease, COPD and IBS-C

MONMOUTH JUNCTION, N.J. USA—November 4, 2010—MicroDose Therapeutx Inc. today announced that it was awarded Therapeutic Discovery Project grants, totaling $977,917, by the U.S. Internal Revenue Service (IRS) in support of four major programs the company is currently progressing.

The grants, which target therapeutic discovery projects that show a reasonable potential to result in new therapies to treat areas of unmet medical need or prevent or treat chronic or acute diseases, among other criteria, were awarded to MicroDose to support four internal projects, two of which are highlighted below:

MicroDose Therapeutx to Present at the 30th Annual Cowen Healthcare Conference on Tuesday, March 9th

MONMOUTH JUNCTION, N.J. USA – March 3, 2010 — MicroDose Therapeutx Inc. today announced that it has been invited to give a corporate presentation at Cowen & Company, LLC’s 30th Annual Healthcare Conference being held at the Boston Marriot Copley Place, Boston, MA from Monday March 8th through Thursday, March 11th, 2010.

Anand V. Gumaste, PhD, MicroDose’s President and Chief Executive Officer, will provide an overview of the company on Tuesday, March 9th at 10:00a.m. Eastern Standard Time.

About MicroDose Therapeutx

MicroDose Therapeutx Acquires Epix Pharmaceuticals Portfolio of Compounds for Treatment of Chronic Constipation and Irritable Bowel Syndrome with Constipation (IBS-C)

Acquisition expands MicroDose’s portfolio in its PolyCap® oral delivery platform

MONMOUTH JUNCTION, N.J. USA – December 1, 2009 — MicroDose Therapeutx Inc. today announced that it has acquired a portfolio of compounds for the potential treatment of chronic constipation, irritable bowel syndrome with constipation (IBS-C) and other diseases, from Epix Pharmaceuticals, Inc. (EPIX) (Lexington, MA). The lead compound in the portfolio, formerly known as EPX-16006, is a novel, highly selective, oral, small molecule, now called MDT-006. The compound is extremely potent, possibly allowing for once-a-day dosing, and has demonstrated efficacy and safety in preclinical studies. Because of MDT-006’s unique mechanism of action, it may also have application in non-gastrointestinal diseases. MicroDose intends to develop MDT-006 initially in an oral format using its PolyCap® delivery platform.

MicroDose Therapeutx Acquires ViroPharma Portfolio of Investigational Compounds for Treatment of Respiratory Syncytial Virus (RSV)

Acquisition expands MicroDose’s portfolio of proprietary products.

MONMOUTH JUNCTION, N.J. USA—November 9, 2009—MicroDose Therapeutx Inc. (formerly MicroDose Technologies) today announced that it has acquired a portfolio of compounds for the potential treatment of respiratory syncytial virus (RSV) from ViroPharma Incorporated (Exton, PA).  The lead investigational compound in the portfolio is an inhalable small molecule fusion inhibitor, now called MDT-637.  This highly potent compound has demonstrated antiviral activity in preclinical studies in both prophylaxis and treatment, and was generally well tolerated in multiple adult volunteer Phase I studies.  MicroDose plans to develop the newly acquired compound in dry powder format for inhalation via MicroDose’s novel dry powder inhaler (DPI).