Biotech Orphans Seek Homes

 

Accentia and its majority-owned subsidiary Biovest International(BVTI.PK) (yes, another bulletin board stock) presented data on the first cancer vaccine purported to work in patients with non-Hodgkin's lymphoma.

BiovaxID is made from cells taken from a patient's own tumors. The vaccine works by training the body's immune system to recognize and attack a protein found only on cancerous B cells.

In a phase III study, patients with non-Hodgkin's lymphoma who were treated with BiovaxID experienced a median disease-free survival of 44.2 months compared to 30.6 months for patients treated with a control vaccone.

After almost five years of follow-up, the BiovaxID patients experienced a 38% lower risk of disease recurrence compared to patients receiving the control vaccine.

Two other now-defunct companies -- Genitope and Favrille -- failed with similar vaccines for non-Hodgkin's lymphoma.

Despite the imprimatur that an ASCO plenary session brings, there are reasons to be skeptical about these seemingly positive results.

Accentia and Biovest first announced the positive results from this study of BiovaxID in June of last year, but since then the stock prices of both companies have fallen even further below $1 a share. (Only Biovest's stock price has recently recovered.)

The results might also be a bit misleading as well because the study takes a funny accounting of patient responses, essentially not starting the clock until six months after patients are treated initially with a standard regime of drugs used to put the cancer into remission.

The disease-free survival benefit reported in this study was barely under the limit of statistical significance. If patient responses were counted in a more traditional way, i.e., as soon as the patients were admitted into the study, the results might not look so robust.

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