Advanced Cell Technology

ACT streamlines, cuts costs

Maureen Martino — Tue, 09 Sep 2008 11:09:59 -0400

Advanced Cell Technologies is restructuring. The company has been on the rocks since it saw stock prices nosedive in July on news that the company didn't have enough funding to continue operations. Now the Worcester, MA-based stem cell company is looking to save $5 million to $6 million a year in operating costs by streamlining and focusing on its most advanced clinical program. As part of the process, ACT has not renewed its Alameda, California sublease and has vacated its Charlestown, Massachusetts facility. ACT will be looking for a partner on its preclinical programs in retinal disease and the manufacturing of red blood cells. It is also on the hunt for funding for a Phase II Trial for its Myoblast program.

"We believe in this challenging capital market environment that it is prudent to focus on our most advanced clinical programs," stated William M. Caldwell IV, Chairman and CEO of ACT. "These cost reduction activities and successfully implementing our partnering/licensing strategy should afford the Company the ability to allocate funding to further develop its later-stage clinical programs while significantly reducing its cash utilization for developmental activities. Near term funding continues to be our major challenge."

- see ACT's release

ALSO: The Defense Advanced Research Projects Agency--a key player in biomedical research--has begun a blood pharming project that will explore just how feasible it would be to produce an unlimited supply of blood. The work has been pioneered by Advanced Cell Technology. Report

ACT says it has found key to limitless blood supply

John Carroll — Wed, 20 Aug 2008 10:21:29 -0400

Advanced Cell Technology may be running out of cash, but the biotech still knows how to garner headlines around the world. The company is reporting that it has been able to gin quantities of red blood cells from human embryonic stem cells. And that could create a virtually limitless supply of blood--as well as a possible pathway to the company's survival.

While others have made red blood cells from ESCs, ACT and researchers at the University of Illinois at Chicago and Mayo Clinic have created a way to make billions of red blood cells. A six-well plate of ESCs spawned 10 billion to 100 billion red blood cells. And that could eventually make routine blood shortages a thing of the past. Dr. George Daly from the Harvard Stem Cell Institute told the Boston Globe that this new work constituted a "very nice proof-of-principle." But he cautioned that there's a deeply entrenched system in place for gaining blood supplies.

About 16 people still work for the cash-strapped ACT, which raised $250,000 this month from a tech licensing deal with BioTime.

--read the article in the Boston Globe

High-flying Advanced Cell Technology crashes

John Carroll — Thu, 17 Jul 2008 10:59:39 -0400

One of the highest profile stem cell developers in the U.S. may be close to shutting down. The Boston Globe is reporting that in new SEC documents Advanced Cell Technology has said that it can't continue to operate past July 31 without new funding or a restructuring to reduce expenses. ACT has $17 million in liabilities and $1 million in cash. And its stock, worth $8 a share three years ago, is now trading at 2.5 cents a share.

The Globe notes that ACT was repeatedly singled out by analysts as well as experts in the field for touting its work in stem cell therapies and cloning. They achieved some big headlines along the way, but their high-wire act also scared away investors that flock around promising young biotech companies.

"They may have had some useful technologies, but people in the biotech community have learned not to make wild claims," Una Ryan, former chairwoman of the Massachusetts Biotechnology Council, told the Globe. "People want to know you are not just full of fluff and that you are going to deliver."

- reaad the story in the Boston Globe

ALSO: William Rauch, the mayor of Beaufort, S.C., has agreed to pay $44,000 to settle SEC charges of insider trading of ACT stock. Story

FDA's delay of Geron ESC trial raises concerns

Thu, 15 May 2008 06:59:57 -0400

Getting an embryonic stem cell therapy through clinical trials in the U.S. is looking like an increasingly tough challenge after Geron announced that the FDA is delaying a study of its experimental therapy for spinal cord injuries. Geron, which has been racing to become the first biotech with a hESC therapy in clinical trials, says it was given verbal notice that regulators are putting a hold on the planned trial. The company's shares plunged 20 percent on the news.

No details were offered on the reasons for the delay, though Geron's Dr. Thomas Okarma noted that "we are disappointed with this action given the interactions we had with the FDA." Analysts also note that FDA delays can be routine and of short duration.

Advanced Cell Technology has also been in the running to launch an ESC trial, which they hope to get approval for this year.

- check out Geron's release
- read the report from the San Jose Mercury News

What's in store for stem cell treatments?

Fri, 11 Apr 2008 06:59:55 -0400

At yesterday's hearing on stem cells, the FDA set a high bar for the treatments, saying that any therapies would have to have very compelling data in order to move into human trials. The FDA's wariness is due to uncertainty about stem cells effects on the body. While the treatments show promise, researchers do not yet have all the answers regarding the long-term effects of such treatments. Tumors, in particular, are a concern. Geron, Novocell, Neuralstem and Advanced Cell Technology are nearing human trials--uncharted territory for stem cell therapies.

The FDA took a key step as it began drafting a blueprint for how the stem cell therapy trials would be conducted. "We've talked about how long we need to monitor people for, and the answer is forever," said Gordon Weir, a panelist on the advisory committee. "We're putting in these cells, and we don't know what they're going to cause in terms of trouble." Drug developers are looking to the FDA to elucidate the regulatory hurdles they'll face as stem cell therapies move through clinical trials. Without clear guidelines, drugmakers will face an unclear development process complicated by uncertainty and controversy.

- check out the CNNMoney article
- read this Wall Street Journal report for more

Related Articles:
Stem cell developers shift focus to FDA hearings. FDA report
Stem cell outfits a winner in upcoming election. Election report
NIH chief breaks with Bush on stem cell research. Report
Stem cell advance runs into conservative roadblock. Stem cell report
Stem cell market shows signs of fast growth. Stem cell report