Angiotech Pharmaceuticals Inc. reported that its Phase II trial of a reformulation of paclitaxel for multiple sclerosis did not meet its primary endpoint.
The company said the study in 174 patients did not meet its primary endpoint of the difference in new lesion activity as measured by magnetic resonance imaging after treatment with Paxceed or placebo. Paxceed is Angiotech’s systemic formulation of micellar paclitaxel.
“There was some data that was encouraging, but the primary data was not there,” Chairman and CEO William Hunter told BioWorld Today, noting that Angiotech had thought, based on the data it had seen, that it was a worthwhile risk to pursue the Phase II study.
Hunter said Vancouver, British Columbia-based Angiotech told its shareholders that it would complete a “decent-sized Phase II” before spending three years and $40 million on a Phase III trial. After the disappointing results, Hunter said the company decided it was “not prudent” to move the product into a Phase III MS program.
Angiotech’s stock (NASDAQ:ANPI) fell $10.66 Monday, or 19.8 percent, to close at $43.23.
“Even under the best of circumstances, it’s not something we could have launched before 2006,” he said.
There was never any plan, he said, to build an MS franchise. The money that would have been invested in a Phase III trial instead will be directed to its drug-coated medical device programs.
“The primary focus [of this company] is drug-coated medical devices,” Hunter said, noting that 99 percent of Angiotech’s value comes from that portion of the business.
For example, two of its paclitaxel-coated stents are scheduled to launch in Europe next quarter, he said.
However, when the company raised $93.6 million in a public offering in December 2000, part of the reason was to advance its clinical programs for the reformulated paclitaxel, including for multiple sclerosis, which was its most advanced component of the program using a systemic formulation of paclitaxel. (See BioWorld Today, March 20, 2000.)
The trial for multiple sclerosis was begun in early 2000 and completed enrollment in February 2001. The company has a small Phase II trial for topical paclitaxel in psoriasis continuing, and has completed a Phase I study in rheumatoid arthritis.
The main problem with the Phase II MS trial was in the study design, said Rui Avelar, vice president of investor relations at Angiotech. When the Phase II trial was designed, it was based on Angiotech’s Phase I data, which was in relapsing/remitting MS. The Phase II trial was for secondary progressive MS.
“The main flaw was it was too short,” Avelar said. “Six months is just too short to realistically come up with data.”
The trial was a double-blind, randomized, placebo-controlled study conducted at nine centers in Canada.
Angiotech is “taking the stance that [it is] ending the program” for MS, while the programs in psoriasis and rheumatoid arthritis will continue, Avelar said.
Angiotech said that paclitaxel is an antimicrotubule agent initially isolated from the yew tree, and it is the active component in Taxol, a successful chemotherapeutic agent.
Angiotech said it had demonstrated in preclinical studies that in addition to its anticancer uses, it blocks the AP-1 cellular pathway and inhibits several biological processes, including abnormal white blood cell activation, cell migration, angiogenesis and the production of enzymes responsable for tissue destruction.