By Lisa Seachrist
Swedish pharmaceutical giant Astra AB moved forward with two different biotechnology collaborations, one in pain and the other in ulcer treatment.
Rebounding from a January setback, CytoTherapeutics Inc. and corporate partner Astra have resumed patient enrollment in a European Phase IIb clinical trial of a cell-containing pain-control implant capsule in patients with cancer pain.
The implant broke open in three of 17 patients enrolled in a 10-week Phase IIa trial, forcing CytoTherapeutics to modify the surgical procedure in order to ensure the implant remained securely in the intrathecal space of the lumbar region. As a result, Sodertalje, Sweden-based Astra will increase support for CytoTherapeutics' pain program by 20 percent to $8.5 million for the year.
"When we announced the delay in January, we pointed out that the issue was related to the anchoring of the implant," said Elizabeth Razee, spokeswoman for Lincoln, R.I.-based CytoTherapeutics. "There was never any problem with the activity of the implant. Now we are back on the bandwagon."
The as-yet-unnamed implant, which previously was called CereCRIB and ACTID, contains live bovine adrenal cells that secrete naturally occurring analgesics such as catecholamines and opioid peptides, which disrupt the transmission of pain signals to the brain.
The capsule is implanted in the intrathecal space in the lumbar region via a minimally invasive surgical procedure Razee described as "similar to a spinal tap." The capsule, which is 7 centimeters long and 1 millimeter wide, must remain floating in the cerebrospinal fluid.
In the Phase IIa trial, some of the implants dislodged, migrated to surrounding muscle and broke open. The companies have added a small clip to the end of the tether to be sutured in place to ensure the implant stays put.
All 150 cancer patients in the Phase IIb trial will have the modified devices implanted. The double-blind, placebo-controlled trial will enroll patients who have pain from cancer that cannot be controlled by standard medications such as morphine and whose life expectancy is estimated at five months or less. Patients will receive either an active or placebo implant for 10 weeks. Following completion of the implantation, all patients will be offered an active implant.
Astra predicts enrollment will be completed by the end of the year, with the results to follow shortly thereafter. Once the data are in, the companies hope to perform a similar Phase IIb study in the U.S. starting in the first half of 1999.
CytoTherapeutics' stock (NASDAQ:CTII) closed at $1.812, up $0.125.
Genome Therapeutics H. Pylori Deal Extended
Astra Research Center Boston (ARCB), a drug discovery company established in Cambridge, Mass., by Astra, extended its alliance with Genome Therapeutics Corp. to identify and develop anti-infectives and vaccines to combat Helicobacter pylori infections.
The alliance, originally established in 1995 and expected to generate $22 million for Genome Therapeutics, was extended last August for one year. ARCB has now extended the collaboration until August 1999. The extension will increase the dollar amount of the entire collaboration, but the companies aren't disclosing by how much.
"We are very excited about our work with Astra," said Fenel Eloi, chief financial officer of the Waltham, Mass.-based biotechnology company. "It is one of our most advanced programs. We are on our way to developing small molecules to treat Helicobacter pylori infections."
H. pylori bacteria are a cause of peptic ulcers, gastritis and stomach cancer. In 1994 Genome Therapeutics sequenced the H. pylori genome, and in September 1995 entered into an agreement with Astra to provide the targets for high-throughput screening for drugs and vaccines. Eloi told BioWorld Today Genome Therapeutics has met all preclinical milestones and the program has moved to high-throughput screening of molecules at Astra.
"Hopefully, we will see a few hits," Eloi said.
Genome Therapeutics will receive royalties from any products Astra markets based on the collaboration.
Genome Therapeutics' stock (NASDAQ:GENE) closed at $5.688, down $0.188.
Astra's stock (NYSE:A) closed at $19.812, down $0.438. *