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Latest News Ion Channel Innovations, LLC submits a grant entitled to the National Institutes of Health "A phase 2 multicenter study evaluating the safety and activity of two escalating doses of hMaxi-K gene transfer in men with erectile dysfunction of 6 months duration: a double blind, placebo controlled design within 2 sequential active treatments." If funded the trial will be managed by CE3, Inc., 491 Main Street, Branford, CT. The IRB and IBC will be Biomedical Research Alliance of New York, 1981 Marcus Avenue, Suite 210, Lake Success NY 11042. The submission is under the Title: Recovery Act limited competition: Biomedical Research, Development, and Growth to Spur the Acceleration of New Technologies (BRDG-SPAN) Pilot Program (RC3), RFA-OD-008.
Manuscript entitled, "Gene transfer for Erectile Dysfunction," authored by Drs. Melman and Christ accepted for publication in the journal, Current Issues in Urology.
Canadian Patent No. 2,280,770 Gene Therapy for Alleviating Erectile Dysfunction issued. Dr. Arnold Melman invited to present, "Gene Therapy for the Treatment of Erectile Dysfunction," at the 12th Biennial Meeting of the Asia Pacific Society for Sexual Medicine in Singapore December 14th. A podium presentation at the American Urology Association Chicago, IL was made by Dr. Arnold Melman entitled, "Short and long-term safety of six escalating doses of hMaxi-k as potential therapy for moderate to severe erectile dysfunction of diverse etiology." Final participant enters phase 1b ED trial at highest dose. Study closed to new entries. Final participant enters phase 1 OAB trial, Study closed to new entries. Ion Channel Poster entitled, "Restoration of erectile function and sexual behavior in atherosclerotic monkeys following Maxi-K gene transfer with a smooth muscle-specific promoter" wins first prize at the annual, American Urological Association meeting. The poster first authored by Dr. George Christ described the effectiveness of Ion Channel's new gene product that successfully corrects erectile dysfunction in a third species, a primate model, for another major cause of ED, hardening of the arteries.
First OAB trial cohort complete Small Business Technology Transfer (STTR) grant submitted to NIH under sponsorship of Ion Channel Innovations. The grant entitled, "Design of a device incorporating bioelectric reporter cell technology," will be conducted by Drs. Kelvin Davies and Marom Bikson.
Review paper for Urologists on the subject of Gene Transfer by Arnold Melman published in the Urologic Clinics of North America. SMSNA Lecture: Dr. George Christ presented "Human Gene Therapy in ED - an update." Master Lecture at the 10th Congress of the European Society for Sexual Medicine in Lisbon, Portugal on Nov. 27th, 2007. Official Webcast Point-Counterpoint Debate
Dr. Melman presented an official webcast point-counterpoint debate at the American Urological Association meeting entitled "Gene vs Surgical Therapy for Erectile Dysfunction" before 5000 AUA members. The debate can be viewed online at: Trial for treating urinary urgency, frequency and incontinence (OAB) begins at seven sites in the United States. hMaxi-K Gene Transfer in Males with Erectile Dysfunction: EDITORIAL: The Tale of Two Trials EDITORIAL: Commentary: Improving Quality of Life Is a Morally Important Goal for Gene Therapy HUMAN GENE THERAPY 18:1165-1176 (December 2006) More Articles On June 21, the Recombinant DNA Advisory Committee (RAC) of the National Institutes of Health unanimously approved Ion Channel Innovation's human gene transfer protocol #0604-774 entitled, "A phase I Multicenter Study Evalutating the Safety and Potential Activity of Three Escalating Doses of hMaxi-K Gene Transfer in Female Participants with Overactive Bladder Syndrome and Detrusor Overactivity: Double-blind, Imbalanced Placebo-controlled Design with Three Sequential Active Treatment Groups." Korean Application No. 10-2001-7002140 Gene Therapy For Regulating Smooth Muscle Tone has now been allowed. Dr. Arnold Melman presented the results of the Phase I erectile dysfunction trial at the American Urological Association annual meeting in Atlanta Georgia on Monday, May 22. The podium presentation was highlighted as newsworthy and presented to the press on the following day. As a result, three items have either webcast or published concerning the results of Ion Channel Innovations:
Invited Lecture: Dr. George Christ, "Novel Mechanisms: K+ Channel Gene Transfer for the Treatment of Post Radical Prostatectomy ED", Society for Basic Urologic Research, 2006 Annual Spring Meeting, May 20, 2006, Atlanta, GA. A poster entitled "Results of a phase I hMaxi-K gene transfer trial for erectile dysfunction," authors A. Melman, N. Bar-Chama, A. McCullough, K. Davies, and G. Christ was presented at the European Urology Association Annual Meeting in Paris, France on April 6, 2006. The poster was considered the best in session and highlighted by the EUA. An abstract entitled "Results of the first human trial for gene transfer therapy for the treatment of erectile dysfunction, authors A. Melman, N. Bar-Chama, A. McCullough, K. Davies, and G. Christ" has been accepted for podium presentation at the American Urology Association Annual Meeting in Atlanta, Georgia on May 22, 2006. After interviewing six CRO organizations, ICI management has chosen CE3 president Holly Coulter, based in Branford, CT, to manage the new Overactive Bladder trial now being submitted to FDA. The previously applied for patent application entitled "Medicament for gene therapy Invited Lecture: Dr. George Christ, "K+ Channel Gene Transfer for ED: From Concept to Clinic", 2005 SMSNA Winter Meeting, November 16-18, 2005, New York, NY. The manuscript entilted "The First Human Trial for Gene Transfer Therapy for the Treatment of Erectile Dysfunction: Preliminary Results" was accepted for publication in European Urology. It is the first full publication describing the outcome of the the human trial. Invited Lecture: Dr. George Christ, "Converging Technologies", 14th Annual North Carolina Biotechnology Conference, May 25th, 2005, Research Triangle Park, NC. The Department of Urology at the Long Island Jewish Medical Center and Columbia University have been added as investigational sites. Article published online in the Medscape Medical News - The Department of Urology at the New York University Medical Center led by Director and Associate Professor Andrew R. McCullough M.D. is added as a second investigational site. On January 3, 2004, Ion Channel Innovations receives approval from the Biomedical Alliance of New York (BRANY) to begin phase 1 trial at the Mt. Sinai School of Medicine. |
