Medical Device Dailys

Five months after the discouraging public markets prompted Light Sciences Oncology (Bellevue, Washington) to yank plans for an initial public offering, the firm bolstered its cash position with a $40.1 million Series C round to support ongoing trials with its Light Infusion Therapy (Litx).

That latest round is expected to fund the completion of two ongoing Phase III studies of Litx, a drug-device combo product designed to kill target tissues using light-emitting diodes that activate LS11 (talaporfin sodium). The company is "near completion" in a hepatocellular carcinoma study, with patient enrollment expected to conclude by the end of 2008, said Robert Littauer, VP/CFO of Light Sciences.

That trial, which is being conducted under a special protocol assessment with the FDA, aims to assess the survival of patients treated with Litx vs. standard-of-care therapies. Pending positive results, Light Sciences anticipates filing a new drug application next year, Littauer said.

The second Phase III study, which also is being conducted under an SPA, is designed to enroll about 450 colorectal cancer patients whose diseases have metastasized to the liver. The trial will compare the Litx system plus standard chemotherapy to chemotherapy alone and will measure progression-free survival and overall survival as its endpoints.

"We expect to complete that study in 2009," Littauer said.

The company's existing cash plus funds from the Series C should "take us to the point of having data from the metastatic colorectal cancer study," he told Medical Device Daily's sister publication, BioWorld Today, and through a regulatory filing of Litx in hepatocellular carcinoma.

Light Sciences also has plans to initiate a Phase III study of Litx in glioblastoma in the second half of this year, and is gearing up to launch a Phase IIa study later this quarter in benign prostatic hyperplasia. Though BPH, also known as an enlarged prostate, is a non-cancerous indication, the company believes the Litx therapy will be able to kill prostate tissue via apoptosis within localized areas of the prostate without producing inflammation.

"Light Infusion Therapy can be used in a number of indications," Littauer said. "Cancer is just one of them." He said the company is exploring Litx's use in other areas, such as cardiovascular disease and dermatology.

Littauer said the firm anticipates partnering its oncology programs, though it has not yet determined whether it also will seek partners for other indications.

Overall, the recent financing round provides Light Sciences with solid financial footing and allows the company the chance to consider several different strategic options down the road, including possibly seeking another IPO if the markets improve. The firm initially filed to go public in 2006, hoping, at the time, to raise as much as $86 million to fund its operations, but the shrinking IPO window forced Light Sciences to rethink entering the public markets.

"Thanks to this Series C, we're not in a position of having to raise money now," Littauer said. "So we'll see what transpires in the market" before deciding the next move.

The company did not disclose names of the investors involved who participated in the Series C. Light Sciences previously raised a total of $97 million $67 million in a late 2005 Series A round and $30 million in a Series B round in July 2007.

In other financing news:

• The Hospitalist Company (THC; North Hollywood, California), a national hospitalist physician group practice, reported the pricing of its public offering of 3.5 million shares of common stock to the public at $18.50 per share.

The company has agreed to sell 1,135,231 shares of common stock and the selling stockholders have agreed to sell the remaining 2,364,769 shares of common stock. The selling stockholders have also granted the underwriter an option for 30 days following the closing to purchase up to an additional 525,000 common shares to cover any over-allotments.

The offering is expected to close on July 21, subject to customary closing conditions.

Credit Suisse Securities (USA) and Jefferies & Co. acted as joint book-running managers for the offering. William Blair & Co., Deutsche Bank Securities, and Wachovia Capital Markets acted as co-managers for the offering.

• Almost Family (Louisville, Kentucky), a regional provider of home health nursing services, reported that it has established a new senior secured multi-bank credit facility replacing its previous facility. The credit facility is secured by substantially all of the company's assets and the stock of its subsidiaries.

The new facility provides for up to $75 million in borrowings with a maturity date of July 2011. It also provides an interest rate varying from Libor plus 1.60% to Libor plus 2.60% depending on leverage, and an accordion feature providing for potential future expansion of the facility to $100 million

The syndication was led by J.P. Morgan Securities.

Almost Family is a regional provider of home health nursing services, with branch locations in Florida, Kentucky, Ohio, Connecticut, Massachusetts, Missouri, Alabama, Illinois, and Indiana. Almost Family and its subsidiaries operate a Medicare-certified segment and a personal care segment.

The company reported in June that it had reached an agreement to purchase Patient Care which operates eight offices in New Jersey, Pennsylvania and Connecticut, for $45.2 million.

The sale is expected to close in 3Q08. When it closes, Almost Family will operate 89 branches in 11 states.