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DFH Pharma Obtains Exclusive Rights to Second-Generation HIV Maturation Inhibitor Program
Date:11/1/2011

GAITHERSBURG, Md., Nov. 1, 2011 /PRNewswire-iReach/ -- DFH Pharma, Inc., (DFH) a privately held specialty pharmaceutical company focused exclusively in the HIV-1 therapeutic space, announced today an agreement that grants DFH an exclusive research license with an option to worldwide commercial rights to a second-generation HIV maturation inhibitor program.  Maturation inhibitors are a novel class of antiretroviral drug candidates that inhibit HIV-1 replication by interfering with the maturation of the HIV-1 virus.

The clinical proof-of-concept for maturation inhibitors was established in a monotherapy study in HIV-infected patients with the first-in-class inhibitor bevirimat (1,2).  While this first generation drug candidate was shown to be safe and well-tolerated with potent antiviral activity in some patients, only limited activity was observed in other patients.  The focus of the second generation program is to identify drug candidates with potent activity against all HIV-1 strains, including those that exhibit reduced sensitivity to first-generation compounds.

"We are extremely pleased to have obtained rights to this second-generation HIV maturation inhibitor program," said Carl Wild, PhD, President and Chief Executive Officer. "We are excited by the pre-clinical profile of a number of the second-generation maturation inhibitor drug candidates that in addition to enhanced antiviral activity against the first generation-resistant HIV strains, show evidence of a favorable metabolic profile and exhibit significantly reduced protein binding compared to first-generation compounds," Dr. Wild continued, "DFH Pharma plans to leverage its background and experience in the maturation inhibitor space to rapidly identify a set of lead drug development candidates with the goal of returning an HIV maturation inhibitor drug candidate to the clinic in the near future".

While there are 32 approved antiretroviral drugs and combination products there are only five validated targets in the viral lifecycle. Research has shown that multiple drugs acting against the same viral target can result in resistance development, the main cause of HIV treatment failure. Additionally, cross-resistance to drugs within the same class is an increasingly important consideration in the long-term treatment of HIV infection. Because maturation inhibitors represent a new class of antiretroviral agents, they are expected to retain activity against drug-resistant virus, and their successful development would offer additional treatment options to patients no longer responding to the currently available therapies. "I believe that maturation inhibitor drugs for the treatment of HIV infection can and should be developed", said Dr. Mark Wainberg, Professor at McGill University, Director of the McGill AIDS Centre and a leader in the field of HIV drug resistance, "Second generation maturation inhibitors that overcome the resistance related problems of the first generation candidates could provide the basis for the further clinical development of this novel class of HIV drugs".

About Maturation Inhibitors

Maturation inhibitors are a novel class of antiretroviral drug candidates that inhibit HIV-1 replication by interfering with the maturation of the HIV-1 virus. Specifically, drugs in this class interfere with the last step in the processing of the HIV-1 Gag protein. This interference leads to the formation of noninfectious, immature virus particles, thus preventing subsequent rounds of HIV infection. As expected for a novel mechanism of action, these drugs retain inhibitory activity against HIV-1 isolates resistant to all classes of currently approved drugs commonly used by HIV infected patients. DFH plans to develop maturation inhibitors for application in both first-line and salvage therapy.

About DFH Pharma, Inc.

DFH founders are Dr. Wild and David E Martin, PharmD.  Dr. Wild was a co-founder of Panacos Pharmaceuticals and served as the Chief Scientific Officer.  He will serve on the Board of Directors in addition to serving as the company's President and Chief Executive Officer.  While at Duke University, Dr. Wild discovered the Fusion Inhibitor class of HIV drugs and invented the first approved member of that drug class, Fuzeon® (Enfuvirtide).  Dr. Martin was Senior Vice President, Drug Development and Regulatory Affairs at Panacos.  He will serve as the Chief Development Officer and on the Board of Directors.  While at Panacos, Drs. Wild and Martin played critical roles in the development of bevirimat (1-4).  In addition, Dr. T.J. Nitz was appointed Chief Scientific Officer.  Dr. Nitz was Senior Director of Chemistry at Panacos and headed up the medicinal chemistry program that resulted in the discovery of the second-generation maturation inhibitors. Together the DFH Pharma team has more than 60 years of experience in antiviral drug discovery and development.

Contact:
Carl Wild, PhD
cwild@dfhpharma.com
Telephone: (301) 461-4231
or
David E. Martin, PharmD
dmartin@dfhpharma.com
Telephone: (301) 538-1878

References

  1. Beatty G, Lalezari J, Eron J, Pollard R, Saag M, Doto J, Salzwedel K, Wild C, Allaway G,Jacobson J, Martin DE.  Safety and Antiviral Activity of PA-457, the first-in-class Maturation Inhibitor, in a 10-day monotherapy study in HIV-1 infected patients.  Presented as a late-breaker to 45th Annual ICAAC Meeting, Washington, DC. December 16-19, 2005.  Abstract H-416d.
  2. Smith P, Forrest A, Jacobson J, Beatty G, Lalezari J, Eron J, Pollard R, Saag M, Doto J, Salzwedel K, Wild C, Allaway G, Martin DE.  Pharmacokinetic/Pharmacodynamic Effects of a novel maturation inhibitor (PA-457) in HIV-infected patients following multiple oral doses.  Presented at the 13th Conference on Retroviruses and Opportunistic Infections.  Denver, CO, February 2006.
  3. Li F, Zoumplis D, Matallana C, Kilgore NR, Reddick M, Adamson CS, Salzwedel K, Martin DE, Allaway GP, Freed EO, and Wild CT.  Determinants of Activity of the HIV-1 Maturation Inhibitor PA-457.  Virology. 2006;356(1-2):217-24.
  4. Li F, Goila-Gaur R, Salzwedel K, Kilgore NR, Reddick M, Matallana C, Castillo A, Zoumplis D, Martin DE, Orenstein JM, Allaway GP, Freed EO, and Wild CT.  PA-457:  A potent HIV inhibitor that disrupts core condensation by targeting a late step in Gag processing.  Proc. Natl. Acad. Sci. USA2003;100:13555-13560.

Media Contact: David Martin, DFH Pharma, Inc., 301-538-1878, dmartin@dfhpharma.com

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