Wednesday January 19, 9:02 am Eastern Time
Company Press Release
SOURCE: Afferon Corporation
WAYNE, Pa., Jan. 19 /PRNewswire/ -- Afferon Corporation today announced that it is beginning a U.S. Phase II clinical trial for its lead product, RTX(TM) (resiniferatoxin) Topical Solution, for the treatment of overactive bladder. This new trial is part of an international development program for RTX(TM) that Afferon is conducting along with its partner in Europe, Mundipharma (an associate of Purdue Pharma). Overactive bladder is a condition that affects over 17 million Americans, 85% of whom are women. Some patients experience incontinence (an involuntary loss of urine) while others may show a frequent urge to void and/or an increased voiding frequency.
The U.S. Phase II study follows positive results from a Phase I/II multi-center trial involving 36 patients with urge incontinence due to neurological diseases such as multiple sclerosis and spinal cord injury. The Phase I/II trial was a double blinded, placebo-controlled, dose escalation study in which patients received a single administration of RTX(TM). The multi-center Phase II study announced today will evaluate the safety and efficacy of RTX(TM), given in multiple cycles (1-4) to 45 patients with symptoms of frequency, urgency, and incontinent episodes due to neurological conditions. This trial will be double blind and placebo-controlled. The Company's intention is to determine the concentration of a single dose which relieves the symptoms of overactive bladder for up to three months.
``We are encouraged that RTX(TM) was used safely in our initial U.S. trial. It showed a positive trend to reduce incontinent episodes at higher concentrations,'' said Dr. H.P.K. Agersborg, Ph.D., Chairman of the Board of Directors and President of Afferon Corporation. ``With this new trial, we will advance our clinical program for RTX(TM) and identify the optimal regimen for the treatment of patients.''
Terry Winters, Ph.D., Chief Executive Officer of Afferon Corporation, stated, ``These studies, along with the trials in Europe, are designed to provide a large body of clinical data in support of RTX(TM) use in overactive bladder. Based on the preliminary results, we believe that RTX(TM) has the potential to provide relief to patients who suffer with overactive bladder symptoms without the unpleasant side effects associated with current therapies.''
Dr. Winters noted that Mundipharma is also conducting three Phase II clinical trials in Europe: one trial in non-neurogenic patients and two trials in neurogenic patients.
Overactive bladder with urge incontinence is an involuntary loss of urine associated with symptoms of frequency and a strong desire to void. RTX(TM) is a potent neuronal desensitizing agent, which acts by inhibiting the transmission of messages by peripheral sensory neurons to the central nervous system. RTX(TM) solution is delivered into the bladder by a routine catheter procedure performed in the urologist's office. The technology was originally developed at the National Institutes of Health, which holds several worldwide patents exclusively licensed to Afferon Corporation.
Afferon is a privately held pharmaceutical company building a specialty
pharmaceutical business focused on urology. For further information on
Afferon Corporation or RTX(TM), please visit the Company's web site at
SOURCE: Afferon Corporation