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Study Reports Significant Malignant Melanoma Survival Results With Natural Human Alpha Interferon

PLANTATION, FL -- June 20, 2006 -- Viragen, Inc. and its majority-owned subsidiary, Viragen International, Inc., today announced that Acta Oncologica, a leading European journal in clinical oncology, has published an article profiling the use of Multiferon (natural human alpha interferon) for the adjuvant treatment of high-risk (Stages IIb-III) malignant melanoma patients (Volume 45, Number 4, June 2006, pp.389-399).

The article, entitled "Long-term survival benefit after adjuvant treatment of cutaneous melanoma with dacarbazine and low dose natural interferon alpha (Multiferon): A controlled, randomized multi-center trial," reports positive results for a category of melanoma patients for whom prognosis is generally poor.

The article concludes that the dacarbazine/Multiferon regimen "was found to be well tolerated and to give beneficial effects on survival that were particularly significant in patients with deep and/or metastasizing stages of melanoma, but still free from distant metastases."

The article's publication follows the February approval of Multiferon for sale in Sweden for the first-line adjuvant treatment of high-risk malignant melanoma following dacarbazine (DTIC) after surgical removal of tumors.

Viragen's President and CEO, Charles A. Rice, said that the Company was "very optimistic" about its current ongoing negotiations for a European Union licensee, while cautioning that there can be no guarantee of securing any agreement.

"Our partnering discussions continue at an accelerated pace, and we are encouraged at the level of interest, particularly with respect to the melanoma indication," Mr. Rice said. "Additionally, at the 6th Annual International Conference on the Adjuvant Therapy of Malignant Melanoma last week in Stockholm, we met with a cadre of international melanoma experts who will participate in our next semi-global clinical trial with Multiferon. Their comments and suggestions will be included in our final trial design criteria, and we will move forward with this post-marketing study as quickly as possible."

Acta Oncologica Article Abstract:
In a prospective, controlled, randomised, multicentre study 252 patients with totally resected cutaneous melanoma (248 in stage II-III and 4 in stage IV) were either treated with two doses of dacarbazine (DTIC) followed by a 6- month treatment with 3 MU thrice weekly of highly purified natural interferon- alpha (n=128; arm A) or received no adjuvant treatment (n=124; arm B).

Treatment was well tolerated. After a median follow-up of 8.5 years ITT analysis showed that the difference in survival was statistically significant with respect to melanoma-related deaths (HR=0.65, CI=0.46-0.97, P =.022) and close to significance with respect to overall survival (HR 0.71, CI 0.49-1.00, P =.052). The risk reduction of melanoma-associated death, calculated by Cox proportional hazards modeling, after adjusting for identified predictive variables, was almost 50% (P =.002). The overall efficacy of the treatment appeared to be mainly attributable to effects observed in patients with deep and/or metastasizing tumours (HR 0.60, CI 0.40-0.90, P =.013).

"We received a tremendous amount of interest regarding these results at the Stockholm conference," stated Orjan Norberg, Managing Director of ViraNative AB, the Viragen International subsidiary that manufactures Multiferon in Umea, Sweden.

"Based on meetings with prominent, leading melanoma physicians, there is continuing dissatisfaction with the use of recombinant alpha interferon for the adjuvant treatment of melanoma. This is not surprising since recombinant, single subtype alpha interferon is often poorly tolerated, while demonstrating no improvement in overall survival. It is our mission to demonstrate that all alpha interferons are not alike, and that our impressive results in melanoma treatment are directly attributable to the unique attributes of Multiferon."

Mr. Norberg explained, "Multiferon is comprised of six alpha interferon subtypes, which we believe influence antiproliferative and immunological effects that are quantitatively and qualitatively different from recombinant interferon products. Most importantly, we are convinced that our Multiferon regimen offers a safe and effective treatment option with a significant reduction in total treatment time and cost."


SOURCE: Viragen, Inc.

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