Clinical Trials

* On January 8, 2014, Anaconda Pharma has announced that it has received  feedback on the publication of its phase IIa study results for its lead compound AP611074. Anaconda’s double-blind, placebo-controlled, phase IIa randomized clinical trial showed that AP611074 is safe and effective in removing or reducing ano-genital warts when applied as a topical gel over 6 weeks of treatment. The study demonstrated that AP611074 has an excellent safety profile resulting in high patient compliance, no patient drop-outs or treatment interruptions - in stark contrast to clinical trial data published for existing drug treatments. The “excellent safety profile” was lauded by leading clinicians in the field. “Condyloma is one of the world’s most frequent sexually transmitted diseases with millions of new cases each year. Condyloma is mostly perceived by affected individuals as a disfiguring and shameful condition, causing anxiety and severe social and psychological stress. Unfortunately there is so far no satisfactory treatment available. AP611074, which prevents the replication of the virus in infected cells, is the first compound in clinical development that has the potential to meet the substantial medical need of patients impacted by Condyloma” commented Prof. Silvio Tatti, M.D., Ph.D., President of IFCPC (International Federation of Cervical Pathology and Colposcopy), Immediate Past Chairman Advisory Group Cervical Cancer Initiative, UICC (Union for International Cancer Control), Director Screening Program Cervical Cancer Unit at Hospital de Clinicas, University of Buenos Aires, Argentina, and Principal Investigator of the Phase IIa clinical study. Anaconda plans further presentations of its data at a number of other important scientific conferences, including: 1st South-American HPV meeting HPV Chile 2014, March 31st- April 2nd 2014, in Santiago, Chile; AOGIN 2014, April 25th- 27th 2014 in Beijing, China; 15th World Congress IFCPC, May 26th- 30th 2014 in London, UK; and the 29th International Papillomavirus Conference August 21st - 25th 2014 in Seattle, USA.

* On October 31, 2013, Anaconda Pharma has announced the positive outcome of the Phase IIa trial of its novel, first-in-class therapeutic AP611074 against condyloma (ano-genital warts). Anaconda’s double-blind, placebo-controlled, phase IIa randomized clinical trial showed that AP611074 is safe and effective in removing or reducing ano-genital warts when applied as a topical gel over 6 weeks of treatment. The study demonstrated that AP611074 has an excellent safety profile resulting in high patient compliance, no patient drop-outs or treatment interruptions - in stark contrast to clinical trial data published for existing drug treatments. The detailed results of the trial will be presented at the upcoming conference of the European Research Organisation on Genital Infection and Neoplasia (EUROGIN) in Florence (Italy) from November 3 to 6 2013.

Marta Blumenfeld, Ph.D., President and Chief Executive Officer of Anaconda Pharma commented: “AP611074 is a scientific breakthrough as it is the first compound in clinical development that directly tackles HPV and prevents the replication of the virus in infected cells. Furthermore, AP611074 is a small molecule drug inhibiting a protein-protein interaction (PPI). Inhibiting PPI is a mode of action with large therapeutic potential which has been frustratingly difficult to address with small chemical molecules.”

AP611074 could also potentially be utilized to address Recurrent Respiratory Papillomatosis (RRP) – an orphan indication that affects between 1 and 7 persons in 100’000 (both infants and adults), with costs per patient of up to USD 470’000. AP611074 can also be formulated for oral delivery, e.g. to address RRP or to treat cases of widespread condyloma (e.g. for immunosuppressed persons). Furthermore, the company’s proprietary discovery knowhow could also be applied to search for inhibitors of other HPV subtypes, notably those causing skin warts or cervical cancer.