Skin cancer melanoma vaccine Allovectin-7 data promising, says Vical

Allovectin-7, an experimental vaccine to treat advanced melanoma, has shown encouraging results in late phase human studies, Vical inc, the developer of Allovectin-7 reported.

Allovectin-7 is a plasmid/lipid complex containing the DNA sequences encoding HLA-B7 and beta-2 microglobulin, which together form a Class I Major Histocompatibility Complex, or MHC-I antigen.

Injection of Allovectin-7 directly into tumors is designed to stimulate an immune response against both local and distant metastatic tumors.

Vical conducted a large Phase 2 trial evaluating Allovectin-7 immunotherapeutic as a single agent for patients with Stage III or IV metastatic melanoma.

Allovectin-7 has been granted orphan drug designation for the treatment of invasive and metastatic melanoma by US FDA. Orphan drug designation provides U.S. marketing exclusivity for seven years if marketing approval is received from the FDA, in addition to certain tax benefits for qualifying expenses.

A Phase 3  trial of Allovectin-7 in patients with metastatic melanoma has completed its third scheduled safety analysis and recommended that the trial continue per the protocol.

The Allovectin-7 trial is expected to complete enrollment of the planned 375 subjects in the next few weeks.

Vical is conducting the AIMM (Allovectin-7 Immunotherapeutic for Metastatic Melanoma) trial, a Phase 3 pivotal trial to study the cancer immunotherapeutic as first-line therapy in approximately 375 chemotherapy-naive patients with Stage III or IV metastatic melanoma in accordance with a Special Protocol Assessment (SPA) agreement completed with the U.S. Food and Drug Administration.

The AIMM trial is currently enrolling patients at clinical sites in key centers worldwide.

AnGes MG, Inc., is funding the AIMM trial through a series of cash payments and equity investments.

Vical has received the full $22.6 million committed by AnGes, under an agreement signed previously.

In exchange for funding the trial, AnGes received exclusive marketing rights in Japan and other key Asian countries.

Vical will also pay AnGes tiered royalties based on defined sales levels in the United States, and fixed royalties on rest-of-world sales.

While, AnGes will pay Vical royalties on product sales in the specified Asian countries, plus certain sales-based milestone payments if defined sales levels are achieved.

Each company will be responsible for obtaining regulatory approvals in any countries where it plans to market Allovectin-7.

What is melonoma?

Melanoma is a type of skin cancer. It begins in cells in the skin called melanocytes. To understand melanoma, it is helpful to know about the skin and about melanocytes — what they do, how they grow, and what happens when they become cancerous.

Often, the first sign of melanoma is a change in the size, shape, color, or feel of an existing mole. Most melanomas have a black or blue-black area. Melanoma also may appear as a new mole. It may be black, abnormal, or “ugly looking.”

People with Stage 0 melanoma may have minor surgery to remove the tumor and some of the surrounding tissue.

People with Stage I melanoma may have surgery to remove the tumor. The surgeon may also remove as much as 2 centimeters (3/4 inch) of tissue around the tumor. To cover the wound, the patient may have skin grafting.

People with Stage II or Stage III melanoma may have surgery to remove the tumor. The surgeon may also remove as much as 3 centimeters (1 1/4 inches) of nearby tissue. Skin grafting may be done to cover the wound. Sometimes the surgeon removes nearby lymph nodes.

People with Stage IV melanoma often receive palliative care.

More than 68,700 new diagnoses of, and approximately 8,650 deaths from, melanoma would occur in 2009 in the United States, according to the American Cancer Society estimates.

Currently, there are no consistently effective therapies for advanced cases of metastatic melanoma where the cancer has spread to other parts of the body.

The toxicity associated with FDA-approved treatments such as dacarbazine or interleukin-2 is often significant, resulting in serious or life-threatening side effects in many of the patients treated.

Patients with metastatic melanoma often are treated off-label with drugs such as temozolomide, which has been approved by the FDA for the treatment of certain types of brain cancer but not for the treatment of metastatic melanoma. Temozolomide is an orally-delivered pro-drug that converts in the body into the same active compound as dacarbazine.

Vical researches and develops biopharmaceutical products based on its patented DNA delivery technologies for the prevention and treatment of serious or life-threatening diseases. Potential applications of the company’s DNA delivery technology include DNA vaccines for infectious diseases or cancer, in which the expressed protein is an immunogen; cancer immunotherapeutics, in which the expressed protein is an immune system stimulant; and cardiovascular therapies, in which the expressed protein is an angiogenic growth factor.
Vical is also developing certain infectious disease vaccines and cancer therapeutics internally.

In addition, Vical collaborates with major pharmaceutical companies and biotechnology companies that give it access to complementary technologies or greater resources.