Stock jumps 40% on U.S. fast-track status for LC Vaccine

[Hebbie]

Biomira stock jumps 40% on U.S. fast-track status for lung cancer vaccine

Canadian Press

Wednesday, September 29, 2004

EDMONTON (CP) - Shares in Biomira Inc. shot up 40 per cent in early trading Wednesday after the firm said one of its cancer vaccines has won fast-track investigation status from the U.S. Food & Drug Administration.

FDA fast-track programs are designed to speed the review of drugs intended to treat serious or life-threatening conditions, Edmonton-based Biomira said in a release.

On the Toronto stock market, Biomira shares (TSX:BRA) jumped 61 cents to $2.11.

Fast-track status was granted for investigation of BLP25 liposome vaccine (L-BLP25) for proposed use in the treatment of non-small cell lung cancer.

The fast-track designation "is an important step in the development of this product candidate and may help us bring this potentially promising drug to patients more quickly," said Alex McPherson, CEO of Biomira.

"This is a significant milestone for the company, highlighting the importance of product candidates such as L-BLP25 to one day address a sizable unmet need in this patient population."

Biomira's partner in the project is Merck KGaA of Darmstadt, Germany

[Elaine]

Anyone here had this treatment? Does fast track mean it can be gotten under compassionate use?

Having trouble finding anything but financial stuff on this...

[tnmynatt]

Hebbie & Elaine,

Here's what I was able to find on the Biomira.com website:

Enrolment has been completed in our BLP25 Phase IIb study for individuals who have either Stage IIIb or Stage IV non-small cell lung cancer. This trial was conducted at various cancer treatment centres in Canada and the United Kingdom. A total of 171 people were enrolled into the study. The trial design is a prospective, randomized, controlled study. Patients with advanced non-small cell lung cancer who have either stable disease or a clinical response following first-line chemotherapy were randomized to receive either the BLP25 together with their doctor's best supportive care or patients will be randomized to receive their doctor's best supportive care alone. Clinical data is expected in the second half of 2003.

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BLP25 Liposome Vaccine for Lung Cancer

Lung cancer continues to be the leading cause of cancer-related death among both men and women in North America. Non-small cell lung cancer is the most common type of lung cancer, accounting for about 80 per cent of all cases.

Biomira's investigational BLP25 offers an innovative approach to treating the disease and potentially prolonging life. It is designed to induce a T-cell immune response to the cancer. Similar to Biomira's other cancer vaccines, BLP25 does not appear to have any significant side effects.

BLP25 is a synthetic 25-amino acid sequence of the cancer-associated marker MUC-1 encapsulated in a specially designed liposomal delivery system. Liposomes, which are fat droplets smaller than red blood cells, are believed to enhance immune recognition of cancer cells.

In September 2004, the FDA granted fast track status to the investigation of L-BLP25 for its proposed used in the treatment of NSCLC.

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FDA GRANTS FAST TRACK STATUS FOR BLP25 LIPOSOME VACCINE

EDMONTON, ALBERTA, CANADA: September 29, 2004

Biomira Inc. (Nasdaq: BIOM) (TSX: BRA) and Merck KGaA of Darmstadt, Germany today announced that the U.S. Food & Drug Administration (FDA) has granted Fast Track status to the investigation of BLP25 Liposome Vaccine (L-BLP25) for its proposed use in the treatment of non-small cell lung cancer (NSCLC).

The FDA’s Fast Track programs are designed to facilitate the development and expedite review of drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. With Fast Track designation, there may be more frequent interactions with the FDA during the development of a product and eventually a company may be eligible to file a U.S. biologics license application (BLA) on a rolling basis as data becomes available. This permits the FDA to review a filing as it is received, rather than waiting for the entire document prior to commencing the review process. Due to the nature of these types of products, BLAs filed with Fast Track status are generally eligible for priority review, which could decrease the typical review period.

Biomira submitted a Fast Track application to the FDA, which included encouraging results from a controlled, randomized Phase IIb study in Stage IIIB and IV NSCLC patients. Results from the Phase IIb study will be presented at the European Society of Medical Oncology meeting (ESMO) to be held in Vienna, Austria, on November 1.

A recent letter received from the FDA stated, “We have reviewed your request and concluded that it meets the criteria for the Fast Track designation. Therefore, we are designating as a Fast Track Drug Product development program the investigation of Liposomal Vaccine in the extension of survival among patients with unresectable stage 3a and locoregional stage 3b non-small cell lung cancer following first line chemotherapy. We look forward to working with you to expedite the development and review of this promising proposed use of the product.”

“Fast Track designation for L-BLP25 for the treatment of these patients is an important step in the development of this product candidate and may help us bring this potentially promising drug to patients more quickly,” said Alex McPherson, MD, PhD, President and CEO of Biomira. “This is a significant milestone for the Company, highlighting the importance of product candidates such as L-BLP25 to one day address a sizeable unmet need in this patient population. We believe our vaccine will be able to provide a new treatment option for men and women with NSCLC that has the potential to both extend and improve the quality of their lives.”

L-BLP25 is a synthetic MUC1 peptide vaccine, designed to induce an immune response to cancer cells. L-BLP25 incorporates a 25-amino acid sequence of the MUC1 cancer mucin, encapsulated in a liposomal delivery system. The liposome enhances recognition of the cancer antigen by the immune system and facilitates better delivery.

Biomira and Merck KGaA continue to explore opportunities for early registration for this product candidate with other regulatory agencies. Plans are also underway for a confirmatory Phase III study.

[Elaine]

I also found that the Phase II is closed. Additionally, all sites are in Canada, but they may open some sites in US for Phase III.

elaine