Techniclone Stock Drops on News of Drug Delay

Techniclone shares lost a quarter of their value Monday after the Tustin company said development of an experimental treatment for non-Hodgkin’s lymphoma is likely to be delayed six to eight months.

The company’s stock fell $2 a share to $6.06 on the Nasdaq market.

John Bonfiglio, Techniclone’s interim president, said in an interview late Friday that a decision by development partner Schering AG to test its drug in a so-called Phase I/II study will delay its clinical development, though the change will eventually make the treatment a better product.

“Delays in products delay profitability and delay revenues,” said Jim McCamant, a biotech hedge fund manager and editor of the Medical Technology Stock Letter.

The change means it will take Schering and Techniclone longer than expected to guide the product, known as Oncolym, through the drug development process.

The companies had previously said they were getting ready to enter a Phase II trial, the second of three stages of testing generally required for U.S. approval. Last week, they said the next trial will be a combination Phase I/II trial that will look at issues including drug safety and the maximum dose that a patient can tolerate.

McCamant said that though the change delays the product’s development schedule, it boosts the chances that the treatment will eventually win U.S. approval.

The companies changed the trial because they’ve decided to test it using one dose instead of the three doses that were given in previous trials, Techniclone’s Bonfiglio said in a statement.

Analysis of clinical data from previously conducted trials showed that 80% of patients “responded well” to the first dose, he said.

McCamant said the decline in Techniclone shares may have been exacerbated by a broader slump in biotechnology shares. The Nasdaq Biotechnology Index fell 12%.

Techniclone is lagging behind two other biotechnology companies, Idec Pharmaceuticals Corp. and Coulter Pharmaceutical Inc., which are in a race to win approval for a new type of injected treatments for non-Hodgkin’s lymphoma that directs radiation to tumor cells.

All three experimental treatments are antibodies designed to seek out tumor cells in patients with non-Hodgkin’s lymphoma, then dose the tumors with radiation from a radioactive isotope attached to the antibody.

Drug testing and approval take years and cost tens of millions of dollars. The FDA says about one-fifth of the drug candidates that enter human trials make it to market.