Press Release: Helix BioPharma announces positive phase II clinical results with its Topical Interferon Alpha-2b
Helix BioPharma announces positive phase II clinical results with its Topical Interferon Alpha-2b AURORA, ON, March 30 - Helix BioPharma Corp. Helix today announced positive results from its phase II clinical study of its Topical Interferon Alpha-2b in women with human papilloma virus (HPV) induced low-grade cervical lesions. The study showed a clinically efficacious response to treatment in nearly half of the treated patients. In addition, the product demonstrated an excellent safety profile, with no significant local intolerance or drug-related serious adverse event observations. "Treated patients responded well, both in terms of efficacy and safety to this new investigational therapeutic," said Prof. Dr. med. Achim Schneider M.P.H., a world expert in the field of cervical cancer and Director of the Department of Gynaecology at the Charite University Hospital in Berlin. "Helix's product shows real promise as a practical and effective pharmaceutical means of preventing cervical cancer development in women presenting with HPV-induced cervical lesions", continued Prof. Schneider. About the Clinical Study A total of 41 women with cytologically confirmed, HPV-induced low-grade squamous intraepithelial lesions (LSIL) of the cervix were studied across four sites in Germany. Twenty women received Topical Interferon Alpha-2b, self-administered intravaginally three times per week for a period of 6 weeks with a follow-up evaluation at 12 weeks, compared with 21 separately studied women who received no treatment whatsoever over the same study period. The primary endpoint and main outcome for both groups was the Pap-response rate defined as the proportion of patients with resolution of their abnormal Pap smear LSIL cytology to normal during the 12 week study duration. Pap smear normalization was considered to occur if the patient's Pap smear improved to group II or better from any of Pap smear groups IIW through IIID as per the common European standard, "Munich Classification System" of LSIL cytology. Pap smear testing is a leading method to diagnose potentially precancerous cervical disease caused by HPV in women today. Nearly half (46.7%) of the women in the treated per-protocol population had their abnormal Pap smears revert to normal during the 12 week period, compared with only 15.8% of the untreated women (i.e., nearly a three-fold improvement). Of these women, one treated patient's LSIL cytology returned following the end of treatment, which suggests that a longer dosing regimen may be advisable in future studies. Furthermore, upon stratification of the patients according to the North American definition of LSIL cytology (i.e., "The Bethesda Classification System"), the relative difference in the Pap-response rate between the treated and untreated patient groups increased substantially. Using this approach, only those women who entered the study belonging to the Pap smear group IIID classification (i.e., the more advanced/serious Pap smear diagnosis described above) were evaluated. Of the women in the stratified per-protocol treatment population, 41.7% experienced normalization of their Pap IIID smear, whereas none (0.0%) of the untreated Pap IIID women experienced improvement. Beyond the Pap-response rate efficacy parameter, all other efficacy parameters evaluated showed the same tendency in favour of treatment. For example, 60% of the treated women experienced resolution of their associated abnormal cervical findings upon colposcopic diagnosis versus only 9.5% of the untreated women. "We are very pleased to have achieved this milestone in the continuing development of our Topical Interferon Alpha-2b product candidate," said John Docherty, Helix's Vice President of Corporate Development. "Helix is committed to further advancing its clinical development program for this extremely prevalent condition, in order to bring this product to market as expeditiously as possible." About HPV and Cervical Cancer Cervical cancer is a condition that develops in women caused by today's most common sexually transmitted infection, HPV. HPV infections have grown to epidemic proportions around the world, with over 6 million new cases arising in the USA alone each year. The development of cervical cancer is generally preceded by a series of progressively worsening disease conditions of the cervix detectable upon gynaecological exam and Pap smear testing. Each year, millions of women worldwide present with potentially precancerous, abnormal cervical Pap smears associated with HPV infection. For women today, there are no available pharmaceutical treatments for potentially precancerous cervical lesions. Instead, surgical or other ablative techniques are practiced in an effort to destroy infected tissue and prevent further disease progression, but, due to unwanted side effects, these practices are generally restricted to only the more advanced patients. Alternatively, new vaccines are becoming available to ideally prevent infection with HPV from occurring in the first place, but, despite this, millions of women are expected to continue to contract HPV and develop potentially precancerous cervical lesions, and millions of additional women are already infected in the world today. About Topical Interferon Alpha-2b Interferon alpha-2b is an immune system modulator that is active against a variety of HPV-induced lesions. Interferon alpha-2b is thought to function by triggering an antiviral response within infected cells, by activating certain intracellular enzymes which cause degradation of viral RNA, and by mobilizing the body's natural immune system to destroy the infected cells. Interferon alpha-2b has been widely used commercially as a treatment for certain HPV induced lesions, but is not generally favoured due to the fact that conventional administration requires painful intradermal injection by a medical professional. Furthermore, intradermal injection is restricted to visible lesion administration, while HPV infection is often characterized by both visible and non-visible (i.e., sub-clinical) lesions. Helix's Topical Interferon Alpha-2b is expected to offer a safe, discreet, self-administered, pain-free therapy that can be broadly applied across a wide treatment surface area. Helix anticipates that this will prove highly advantageous not only from a patient compliance perspective, but also from an efficacy standpoint, by offering a new means of targeting both visible and sub-clinical lesions and treating cervical infection that was previously impractical to treat via injection. About Helix BioPharma Corp. 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's product development initiatives include its Topical Interferon Alpha-2b and its novel L-DOS47 new drug candidate. Helix is listed on the TSX under the symbol "HBP". This News Release contains certain forward-looking statements and information regarding the Company's Topical Interferon Alpha-2b and the Company's research and development initiatives, which statements and information can be identified by the use of forward-looking terminology such as "promise", "expected", "anticipates", "committed to", "further advancing", "possible", or that events "will" occur, or comparable terminology referring to future events or results. Forward-looking statements and information are statements and information about the future and are inherently uncertain, and Helix's actual results could differ materially from those anticipated in these forward-looking statements as a result of numerous factors, including without limitation, uncertainty whether Topical Interferon Alpha-2b study will be successfully developed and commercialized at all; the need for additional studies and clinical trials, the occurrence and success of which cannot be assured; the risk that many new drugs fail in later studies and clinical trials; the risk of unexpected side effects; product liability and insurance risks; research & development risks; the risk of technical obsolescence; the need for further regulatory approvals, which may not be obtained in a timely manner or at all; intellectual property risks; marketing/manufacturing and partnership/strategic alliance risks; the effect of competition; uncertainty of the size and existence of a market opportunity for Helix's products; Helix's need for additional future capital, which may not be available in a timely manner or at all; as well as a description of other risks and uncertainties affecting Helix and its business, as contained in the Company's Annual Information Form and other filings with the Canadian Securities Regulatory Authorities, any of which could cause actual results to vary materially from current results or Helix's anticipated future results. Forward-looking statements and information are based on the beliefs, opinions and expectations of Helix's management at the time they are made, and Helix does not assume any obligation to update any forward-looking statement or information should those beliefs, opinions or expectations, or other circumstances change.