Progenics Pharmaceuticals starts phase 1b trial of new HIV drug PRO 140

By Ted A. Knutson

Washington, Dec. 1 - Progenics Pharmaceuticals, Inc. said Thursday it is beginning a phase 1b clinical trial of new investigational HIV therapy PRO 140 - a humanized monoclonal antibody that specifically binds CCR5, a receptor that serves as a portal of entry for HIV into cells of the immune system.

PRO 140 is a humanized monoclonal antibody designed to bind CCR5 on immune-system cells and thereby shield the cells from HIV infection. CCR5 is a receptor for chemokines, which are members of a family of molecules that direct the migration of immune cells toward sites of inflammation in the body.

Progenics is seeking to develop PRO 140 as new HIV therapy that combines infrequent dosing and a more favorable side effect profile than existing therapies, the company said in an 8-K filing with the Securities and Exchange Commission.

Despite recent advances in the treatment of HIV infection, current therapies are not curative, and new drugs are urgently needed for this progressive, life-long condition, explained said Jeffrey M. Jacobson, M.D., assistant chief and program director, infectious diseases, Beth Israel Medical Center, and professor of medicine, Albert Einstein College of Medicine, New York City.

"Currently available therapies are limited by the emergence of multidrug-resistant virus, significant side effects, drug-drug interactions and the often-complex daily treatment regimens. PRO 140 has the potential to address each of these limitations and therefore may represent a new treatment paradigm for HIV patients," Jacobson said.

PRO 140 belongs to a new class of drugs, viral-entry inhibitors, which are designed to prevent HIV from entering and infecting healthy cells. The phase 1b trial is designed to evaluate the tolerability, pharmacology and antiviral activity of PRO 140 in patients infected with HIV, the virus that causes AIDS.

The phase 1b trial is designed to assess the tolerability, pharmacokinetics and preliminary antiviral activity of PRO 140 in about 40 HIV-positive patients. This multi-center, double-blind, placebo-controlled, dose-escalation study is being conducted in patients who have not taken any anti-retroviral therapy within the previous three months and who have HIV plasma concentrations greater than or equal to 5,000 copies/mL.

Patients will receive a single intravenous dose of study medication - either placebo or one of three increasingly higher doses of PRO 140. PRO 140 blood levels and CCR5 coating will be determined and compared with antiviral effects measured as changes in plasma HIV viral load following treatment.

Tarrytown, N.Y.-based Progenics' principal programs are directed toward symptom management and supportive care and the treatment of HIV infection and cancer.

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