Interferon alpha-2b cream to treat HPV cervical cancer, genital warts is on trials: Helix

Non-injectable interferon alpha-2b in self-applicable topical form to treat cervical lesions has been found effective in safety trials, Helix BioPharma Corp announced.

Topical interferon alpha-2b, which incorporates Helix’s Biphasix drug delivery technology, is a topical preparation that is intended to be easily self-applied to HPV-infected tissues, in order to deliver interferon alpha-2b into the skin and mucosal tissues.

Interferon-alpha therapy is often prescribed to patients by way of injection to augment their innate defense system capabilities by complementing the effect of interferon alpha-2b naturally produced by the body.

Helix’s Topical Interferon Alpha-2b is intended to offer a superior means of delivering interferon-alpha therapeutically into diseased skin or mucosal tissues by eliminating the need to inject interferon-alpha by syringe.

Interferon alpha-2b cream is intended for liberal application to the surface of the skin or mucosa, due to its anticipated relatively non-irritating properties.

The cream is believed to achieve drug delivery across a broad tissue surface area in order to target the HPV infection widely and efficiently. Because of its anticipated effectiveness against both visibly-apparent and sub-clinical HPV infection.

The topical interferon alpha-2b study enrolled the first ten patientsin its phase-II pharmacokinetic trial in patients with low-grade cervical lesions have completed the pharmacokinetic primary endpoint analyses with positive findings.

All ten of these patients, at all sampling time points, were found to have systemic interferon alpha-2b levels below the lower limit of detection of the validated bioassay used in the study.

Topical interferon alpha-2b causes no significant systemic interferon alpha-2b exposure in patients following cervical application, the study found.

Of the ten patients reported above who have completed the fourteen dose pharmacokinetic portion of the study, five have also completed the full thirty five dose safety and efficacy evaluations.

Three of these five showed resolution of their cervical intraepithelial neoplasia (CIN) upon colposcopic biopsy/histology at the conclusion of the study.

Three also showed improvement of their Pap IIID squamous intraepithelial lesions upon cytological assessment at the conclusion of the study.

None of the patients enrolled in the study have shown any significant local intolerance or have experienced any serious adverse events, Helix said in a press release.

Helix expects that the study will over-enrol several patients beyond the minimum of twelve required for the primary study endpoint, and that it will take until the middle of its fourth quarter of fiscal 2010 for all enrolled patients to complete the study.

Helix plans to file its planned US phase-II/III IND for this indication around the end of its fourth quarter of fiscal 2010 and its planned European phase-III CTA filing thereafter.

Helix is developing Topical Interferon Alpha-2b for the treatment of low-grade cervical lesions and ano-genital warts caused by HPV infections.

What are cervical lesions?

Infection with Human Papilloma Virus (HPV) is now regarded as the definitive cause of cervical cancer in women.

Once infected, women may experience progressively deteriorating disease states of the cervix unless the viral action is successfully combated by the human immune system or today’s interventional medical treatments. In the United States, for instance, there are almost 2 million women diagnosed each year with potentially precancerous squamous intraepithelial lesions of the cervix3, for which there is no pharmaceutical treatment available today.

HPV infection is known to cause hyperplasia of the intermediate viable epithelial layers of the skin. Unless resolved by the effects of the natural host immune system or otherwise by medical intervention, this rapid and unmediated cellular proliferation may proceed to cause any one of a range of cancerous conditions of the ano-genital tissues.

Another disease state induced by ano-genital HPV infection is a condition referred to as condylomata accuminata, or ano-genital warts. Ano-genital warts result from HPV infection of the external genitalia, and can manifest as outwardly visible growths of varying sizes and shapes in both men and women.

At present, treatment is limited to invasive destructive procedures such as surgery and laser therapy, which, due to associated pain and potentially serious side effects, are not usually prescribed unless the cervical disease is determined to be in the more advanced dysplastic stages.

Helix BioPharma Corp is a biopharmaceutical company specializing in the field of cancer therapy. The Company is actively developing innovative products for the prevention and treatment of cancer based on its proprietary technologies.

Helix has entered into an agreement with Schering-Plough which grants Schering-Plough the option to obtain an exclusive worldwide license to use Helix’s Biphasix technology in pharmaceutical products containing interferon alpha-2b.

Schering-Plough’s option may be exercised at any time up to a specific period following the successful completion of Phase III clinical trials. Included in the option agreement are terms for the grant of a license to Schering-Plough that provides for milestone payments and royalties on product sales.