Silicon Investor (SI) -- The First Internet Community

STOCKTALK

We've detected that you're using an ad content blocking browser plug-in or feature. Ads provide a critical source of revenue to the continued operation of Silicon Investor. We ask that you disable ad blocking while on Silicon Investor in the best interests of our community. If you are not using an ad blocker but are still receiving this message, make sure your browser's tracking protection is set to the 'standard' level.

Biotech / Medical : INCR -- Incara Pharmaceuticals -- Ignore unavailable to you. Want to Upgrade?

To: scaram(o)uche who wrote (177)	7/30/2002 7:57:09 PM
From: mopgcw	Respond to of 196

Incara IND for Liver Cell Transplantation Allowed by FDA RESEARCH TRIANGLE PARK, N.C., July 30 /PRNewswire-FirstCall/ -- Incara Pharmaceuticals Corporation (Nasdaq: INCR - News) today announced it has been notified by the Food and Drug Administration (FDA) of their allowance of Incara's Investigational New Drug Application (IND) to begin Phase 1 clinical trials of cryopreserved human liver cells for the treatment of patients with cirrhosis and end-stage liver disease. Assuming adequate financial resources, the company intends to initiate clinical trials this fall. "Allowance of our IND for liver cell therapy by the FDA is a tribute to the quality of the work performed by Incara's development team. Developing a pharmaceutical grade cell therapy product is a difficult task that applies the traditional pharmaceutical industry skills of scale-up manufacturing, preclinical pharmacology and toxicology, and clinical trial design to the new discipline of regenerative medicine," said Clayton I. Duncan, President and CEO of Incara. "The clinical trial program will target patients with cirrhosis and end- stage liver disease whose severity is such that the patients would be candidates for placement on a whole liver transplant waiting list," stated David P. Ward, M.D., Executive Vice President, Research and Development of Incara. "The goal of our therapy will be to improve the quality of life of these patients, delay a whole liver transplant or even avoid the need of a whole liver transplant. In the initial clinical trial, a subset of this patient population, those with limited options, will be studied. These patients will have coexisting cardiac, pulmonary or other medical conditions that make them ineligible for whole liver transplantation. Assuming the initial clinical trial demonstrates safety and bioactivity, Incara plans to evaluate the cells in a broader range of patients in later clinical trials." Chronic liver disease leads to approximately 300,000 hospitalizations and 30,000 deaths each year in the United States. Liver cell transplantation is an experimental procedure in which a physician injects a suspension of donor liver cells into the blood vessels leading to a patient's liver or spleen in a minimally invasive procedure. The injected cells are expected to create new functioning liver tissue, which could improve symptoms, extend the time a patient can live without a liver transplant, or possibly eliminate the need for a liver transplant entirely. Initial preliminary human clinical trials of liver cell transplantation by academic investigators outside of Incara have shown improvement of liver function in some patients with liver failure. Over 50 patients have been given this experimental procedure to date. Incara believes that for liver cell transplantation to become a conventional therapeutic procedure and a viable treatment option for a significant number of patients, a commercial program must be established to demonstrate clinical efficacy and safety with a well defined, consistently produced product. Incara's liver cell transplantation product is a well-characterized mixture of cryopreserved human liver cells that are obtained from the livers of organ donors that are not suitable for whole organ transplant. Incara's strategy is to create a product that can be shipped overnight to clinical sites where it will be thawed, diluted and infused into the patient. One donor liver may provide sufficient numbers of liver cells for multiple recipients. Incara Pharmaceuticals Corporation (www.incara.com) is focused on disease therapies based on tissue protection, repair and regeneration. The company is developing cell therapy for treatment of liver failure and in addition is investigating the use of liver stem cells. Incara is also developing a series of catalytic antioxidants as treatments for protection of cells from damage occurring in stroke and cancer radiation therapy, and for protection of cells from transplant rejection. In addition, Incara is conducting a Phase 2/3 multicenter clinical trial for deligoparin, an ultra-low molecular weight heparin being developed with Elan Corporation for treatment of ulcerative colitis. Results of this pivotal trial should be available around March 2003.

To: scaram(o)uche who wrote (177)	12/29/2006 2:03:25 PM
From: scaram(o)uche	Read Replies (1) \| Respond to of 196

Ercole? Oh yeah, I'm going to get in line to invest in a Duncan company. Not. Clean slate after funds controversy David Ranii, Staff Writer Biotechnology company Entegrion is counting on new leadership, a new strategy and a new type of bandage to boost its fortunes following a tense few months that divided shareholders of the privately held company. The Research Triangle Park company is banking it will be able to begin selling a substitute for gauze called AlphaBandage to the military in the second half of next year after winning regulatory approval. That would be the four-year-old company's first product. Entegrion, which licenses some of its technology from the University of North Carolina at Chapel Hill and East Carolina University, recently restructured while it gears up to introduce AlphaBandage. Among the developments: * CEO Clayton Duncan resigned, and the company installed a new board of directors. Duncan -- former CEO of several Triangle biotech companies, including Incara Pharmaceuticals and Sphinx Pharmaceuticals -- is succeeded by co-founder Stan Eskridge. Eskridge continues to hold the title of president. * Entegrion has eliminated two full-time positions and two part-time jobs, leaving it with six full-time employees and one part-timer. The goal is conserving cash until the company starts selling AlphaBandage. * Entegrion, which negotiated a $15 million venture capital deal in the summer only to see it fall through, has abandoned plans to raise a boatload of financing. Instead, it expects to raise another $2 million in the next six months. "We're no longer focused on being a well-heeled, venture-backed company," Eskridge said. "We're going to build a company from the ground up." That cash infusion, Eskridge said, should be sufficient to keep the four-year-old company running at least until AlphaBandage hits the market. Duncan said he supports the new direction the company is taking, but chose to resign because of it. "My skills at fundraising ... really weren't needed," he said. "And I had something else I wanted to do." Duncan has joined Ercole Biotech, a four-year-old RTP drug discovery company, as CEO. He previously was the company's chairman. In the summer, Entegrion arranged for $15 million in financing from a Boston venture capital firm. But the deal was contingent on Entegrion merging with a European company -- a union that ultimately fell through. Entegrion has raised $5.1 million to date, including $1.4 million earlier this year. Divisive funding Even before the $15 million financing collapsed, it was controversial among the company's 90 private shareholders. Some supported the deal, including Duncan. Others didn't like it for several reasons, including the fact that the venture capitalists would have gained control of Entegrion and that the terms placed a lower value on the company than prior financings. The venture capital firm also didn't want to finance the development of Stasix, an experimental blood-clotting medication. Stasix was the raison d'etre for Entegrion. "We were like two mule teams pulling in [different] directions rather than pulling together," said co-founder Arthur Bode, a research scientist at ECU. Duncan, however, said he no longer believes the company needs to raise a ton of money. He said his perspective changed because, after the $15 million venture deal was negotiated, the AlphaBandage test data came in and was unexpectedly strong. "With 20-20 hindsight," Duncan continued, "I'm glad we didn't do the deal. At the time, I was in favor of it, and it made sense." Aligned for future Eskridge is optimistic that the internal turmoil is a thing of the past. "I think everybody has rallied around the flag," he said. "We had a shareholders' meeting right before Christmas, and there was very enthusiastic support." The AlphaBandage is made from a weave of rayon-like fibers and glass fibers. It would be much more expensive than gauze but much less expensive than "the other high-tech alternatives out there" used for severe injuries, Eskridge said. He said AlphaBandage would cost less than $20 per application, compared with other alternatives made from biological materials such as potato starch that start at $100 per application. Eskridge believes testing will show that AlphaBandage has other advantages in addition to reducing blood loss. Entegrion has found a distributor that will handle sales to the military, and manufacturing will be outsourced. The company also is seeking a deal with a nonmilitary distributor. With the aid of government grants, Entegrion also is continuing to develop Stasix, which hasn't yet been tested in humans and is years away from seeking regulatory approval.