Medical Device Daily Contributing Writer and Staff Reports

ZICHRON YA’AKOV, Israel — TransPharma Medical (Lod, Israel) reported “promising results” of its Phase I clinical trial demonstrating the safety and pharmacokinetic profile of its ViaDerm-hPTH (1-34) product to treat osteoporosis.

The company said the trial also demonstrated that ViaDerm could effectively deliver hPTH (1-34) to the bloodstream in 48 healthy, elderly, post-menopausal women. hPTH (1-34) is a synthetic version of Eli Lilly & Co.’s (Indianapolis) Forteo drug that is delivered by injection.

Most important, the women were able to tolerate multiple doses of ViaDerm hPTH (1-34) at blood levels comparable to Forteo, delivered by injection.

The ViaDerm drug-device combination system incorporates a pocket-sized electronic control unit, which provides a radio frequency electrical current to the skin that opens micro-channels through which the drug is delivered, and a patch containing hPTH (1-34).

TransPharma CEO Dr. Daphna Heffetz said, “We plan to initiate a Phase II study, bringing this product to an advanced clinical stage before seeking a partner to take it to market.” She had previously said that she thought the first product would reach the market by 2010.

The start-up was founded in 2000, and has raised $34 million in three rounds led by Argonaut Private Equity, Biomedical Investments, Evergreen Partners, Pitango Venture Capital, Teva Pharmaceuticals and Vitalife Partners.

TransPharma’s device allows even large compounds to enter the skin. Its dry-foam patch preserves complex drugs, so it has the great advantage of logistics, longer shelf life and consistency, compared with other traditional patches that contain gel. The company has partnered with Teva Pharmaceuticals on drug candidates for osteoporosis and human growth hormone.

TransPharma is still in early-phase testing and is competing directly with Alza (Mountain View, California), a company that was acquired by Johnson & Johnson (New Brunswick, New Jersey) for $10.5 billion.

New Alfred Mann Institute opened

The Mann Foundation for Biomedical Engineering (Valencia, California) reported the opening of the most recent Alfred Mann Institute, this one at the Technion-Israel Institute of Technology (AMIT) in Haifa. The AMIT, standing for Alfred Mann Institute at Technion, is a university-based institute designed to enable commercialization of innovative biomedical technologies that improve human health.

AMIT has a double meaning in Hebrew of “friend, colleague or partner.” The partnership between the Mann Institute and the Technion will focus on advances in the biomedical, medical device and life sciences industries.

Mann, a well-known entrepreneur and philanthropist, created the first AMI at the University of Southern California (Los Angeles), which became operational in 2001 as a test-bed for the development for future AMIs. In 2004, he announced his foundation’s plans to establish a group of AMIs at a number of select universities over the coming years.

Mann’s vision has been to establish AMIs in an effort to make further advances in the biomedical field and bring new biomedical products to the public. AMIT is the second institute to open its doors and the only one established internationally.

A gift of $100 million for the creation of the third AMI on the campus of Purdue University (West Lafayette, Indiana) was unveiled earlier this year.

“We are delighted to partner with the Technion due to the university’s technological innovation and tremendous contribution to Israel’s economy,” Mann said. “The Technion already has achieved impressive results and we believe it will continue to thrive in the areas of medicine, science, engineering and technology.”

Rosetta expands Israeli facility

Rosetta Genomics (Rehovot, Israel), a microRNA company, reported the expansion of its Israeli research facility. The company is adding the new laboratories to its existing facilities in order to meet its research and development needs for its microRNA-based diagnostic programs. The company expects to grow to approximately 70 employees by the end of the year.

“This expansion will enable us to advance new development programs, and accommodate the large number of scientists that have joined Rosetta recently and those we expect to add in the future,” said Amir Avniel, Rosetta Genomics CEO.

He added: “Our proprietary discovery platform is capable of utilizing over 12,000 predicted and validated microRNAs, including over 1,000 proprietary microRNAs, which are expressed in different tissues. This platform provides us with the foundation upon which we can advance microRNA-based diagnostic products in key oncology indications. The new lab space is essential for the success of these efforts.”

Bikur Holim hospital to be saved

What might be described as a neck-and-neck horse race, featuring Arcadi Gaydamak vs. Africa-Israel Investment Housing’s Lev Leviev, ended in a photo finish when Gaydamak signed a contract to buy Jerusalem’s landmark Bikur Holim hospital, with a bid of $35 million.

The hospital’s liquidator, Shlomo Shahar, told the Knesset Finance Committee that contracts would be fully completed within the deadline set by Jerusalem District Court Judge Joseph Shapira.

Although, Leviev offered $2 million more for the sought-after property in downtown Jerusalem, where some of the most famous Israeli cardiologists made their names, Globes, the Financial Times of Israel, reported that Gaydamak won the tender because he not only promised to renovate and reopen the facility, but agreed also to leave all of the original dedications on the buildings.

Positive results for Lubo Cervical Collar

Hadasit, the technology transfer company of Hadassah University Hospitals (Jerusalem), and Ramot at Tel Aviv University Ltd., the technology transfer company of Tel Aviv University, said that the Lubo Cervical Collar, designed for use in trauma situations, has demonstrated positive results in a two-part Phase I safety study.

The Institutional Review Board-approved study was registered with the National Institute of Health (NIH; Bethesda, Maryland) and operated under the guidelines of both the NIH and the Israeli Ministry of Health.