News In Brief | Nature Biotechnology

You have full access to this article via your institution. Download PDF ANTISENSE SUFFERS NEW SETBACK On September 6 the Oncologic Drugs Advisory Committee of the US Food and Drug

Administration (FDA) voted 7–3 not to recommend approval for Genta's Genasense for the treatment of chronic lymphocytic leukemia. It was the second such rejection of the antisense drug,

after failure in melanoma in 2004, and another setback for the struggling field of antisense therapy. Although the drug, which targets Bcl-2, shrank more tumors than chemotherapy alone,

patients did not live longer. Meanwhile, phase 3 trials of Genasense continues for acute myeloid leukemia. Since the 1998 FDA approval of Isis Pharmaceuticals' Vitravene (fomivirsen)

for treating certain viral eye infections in AIDS patients, no other antisense drug has reached market, and the list of clinical failures is long. Several companies have exited the field.

Other RNA-based therapies, especially siRNA, have now overtaken antisense in popularity. “One of these types of compounds...will make it,” predicts Brian Rye, an analyst with Janney,

Montgomery Scott in Philadelphia. “I just don't know if it will be something that prospectively has got the label of antisense.” _KG_ NEW JERSEY RENEWS BIOTECH BACKING The governor of

New Jersey vowed in September to bring $500 million to life sciences and other technology sectors in the state. Governor Jon Corzine promised an initial $150 million, which he says will be

leveraged to reap an additional $350 million in private capital. The money will go to projects in all stages of development, whether they are startups or still incubated at university

technology transfers units. Experts note that the plan is only the most recent step in a long line of attempts to boost biotech in the state. “New Jersey has always been very creative in

their approach to biotech and life sciences,” says Stephen Mulloney, a spokesman for the Massachusetts Biotechnology Council in Cambridge. “Since 1999, they have had a tax transfer program

that is the envy of the country.” This program allows biotech businesses to sell their Unused Net Operating Loss (NOL) Carryover and Unused Research and Development Tax Credits to corporate

taxpayers in the state. Forty-one US states now have economic plans that identify biotech or life sciences as a growth sector. “If you want to retain your best and brightest university

students, you have to have an industry in the state to keep them there,” says Patrick Kelly, a state government specialist at the Biotechnology Industry Organization in Washington, DC. _EW_

SELECTIVELY BRED CAT OFFERS RELIEF TO ALLERGY SUFFERERS Cats selected for hosting a variant of the common cat allergen have yet to prove non allergenic for their owner. Credit: Allerca

Independent exposure trials at the University of California, Los Angeles, have confirmed that a hypoallergenic cat, newly available from Californian company Allerca, does not elicit an

allergic response in human subjects. The San Diego firm identified cats that naturally express a variant form of the allergenic protein Fel d1, and used these variant cats to build up their

breeding stock. Gene silencing and genetic modification were not necessary to create the cats. This approach to create a new generation of pets differs from that used to create the first

cloned cat (_Nat. Biotechnol._ 20, 327, 2002) and the first genetically modified pet fish that glows, which made the headlines in 2004 (_Nat. Biotechnol._ 22, 11, 2004). The Allerca kittens

do not, however, come with a guarantee that the owner won't have an allergic reaction. Harold Nelson, a professor of medicine at the National Jewish Medical and Research Center in

Denver, Colorado, points out that people could develop a sensitivity to the variant form of Fel d1. “The question is, is there anything about this molecule that makes it intrinsically less

apt to sensitize? Or, is it just that it's fairly uncommon and therefore people have not been exposed to it and people are not sensitive to it?...If the variant of Fel d1 is just as

capable of causing IgE [Immunoglobulin E] sensitization, there is a good chance people will become sensitized once the cat is in the house.” _CaS_ BIOMARKERS CONSORTIUM FORMS A broad

consortium of government agencies, the pharmaceutical industry and patient advocates groups has launched The Biomarkers Consortium to speed the development of clinical biomarkers. Biomarkers

help assess drug safety and efficacy, and are listed as a priority “public health challenge” in the US Food and Drug Administration's blueprint Critical Path to New Medical Products.

Initial projects include fluorescent positron emission tomography to evaluate response to anticancer drugs, gene markers that predict positive response to treatment for major depression and

the protein adiponectin to predict positive response to treatment for type 2 diabetes. The consortium will be coordinated by the Foundation for the National Institutes of Health (NIH), which

was chartered by Congress to help fulfill NIH's medical mission through linkages to the private sector and philanthropists. To date, $1.2 million in coordinating funds have been

committed by the consortium's members, which include the Pharmaceutical Research and Manufacturers of America, the Biotechnology Industry Organization, Bristol-Myers Squibb,

GlaxoSmithKline, AstraZeneca, Johnson & Johnson, Eli Lilly & Company, Pfizer, F. Hoffmann-La Roche, the Alzheimer's Association and the Leukemia & Lymphoma Society. _BV_ NEW

PRODUCT APPROVAL Table 1 IMCLONE LOSES PATENT CASE ImClone executives are fighting for rights on a patent that covers their only drug on the market, Erbitux (cetuximab), after a US federal

judge said it belonged to three academic scientists in Israel represented by Yeda Research and Development Co., the commercial arm of the Weizmann Institute. On September 18, US District

Court Judge Naomi Reice Buchwald in New York substituted the name of the inventors on patent number 6,217,866 to include three researchers at the Weizmann Institute of Science in Rehovot,

Israel. The judge ruled that they were the only true inventors of a method of inhibiting the growth of human cancer cells by administering a particular class of monoclonal antibodies

targeted at the epidermal growth factor (EGF) receptor when given in combination with chemotherapy. New York-based ImClone licensed the patent from Bridgewater, New Jersey-based Aventis

Pharmaceuticals, a subsidiary of Paris-based Sanofi-Aventis. According to the court decision, Joseph Schlessinger, a scientist at Meloy Laboratories, and its successor Rorer Biotechnology,

now part of Sanofi-Aventis, asked researchers at Weizmann in 1987 to experiment with two antibodies. In 14 months of testing, the Weizmann scientists discovered that one of the antibodies

had an effect on tumors when administered in conjunction with chemotherapy. In 1988, Schlessinger applied for a patent on this invention. The Weizmann scientists say they did not know until

12 years later that their research findings had been copied into the patent application. _EW_ MS TRIALS SHOW THAT LESS IS MORE When Acorda Therapeutics, of Hawthorne, New York, announced at

the end of September exceptional results from their phase 3 trials of Fampridine-SR (4-aminopyridine, or 4-AP), used to treat symptoms of multiple sclerosis (MS), the company not only

brought hope to sufferers of MS, but may have opened a floodgate of new investigations in potassium channel blockers for central nervous system (CNS) disorders. Hesketh, CEO of Ion Channel

Media Group, a biotech marketing firm, located in Montreal, notes that until now potassium channel blockers were shown to be efficacious mainly in the treatment of heart disorders. There are

a host of ion channel blockers already on the market for treatment of hypertension, diabetes, epilepsy and mood disorders. According to Phil Nadeau, a research analyst at Cowen and Co. in

New York, Fampridine-SR “could be broadly applicable” to other CNS diseases as well. The compound presents real difficulties, however, according to Nelson Arispe, a research professor with

the Uniformed Services University of the Health Sciences, located in Bethesda, Maryland. “The amount of secondary effect could be tremendous,” says Arispe who has conducted research on

blocking the beta-amyloid ion channels for Alzheimer disease. He notes that potassium channels are ubiquitous and therefore prone to excitement wherever they are. “You'd have to show me

that the potassium channel involved is specific to MS,” he concludes. _JR_ FOLLOW-ON BIOLOGIC BILL DROPPED Before the US Congress broke for mid-term elections at the end of September, a

coalition of Democratic lawmakers introduced a bill to speed production of follow-on biologic medicines. The Access to Life-Saving Medicine Act did not make it to the floor of either house

for a vote, but Senators Charles Schumer and Hillary Clinton, both of New York, pledged to reintroduce the bill next year. Bill co-sponsor, Congressman Henry Waxman, of California, said in a

statement, “There is currently no statutory pathway for approving lower cost versions of biotech drugs...even after all patents have expired. As a result, the manufacturers of biotech drugs

can charge monopoly prices, indefinitely.” The bill would allow expedited approval of follow-on biologics if they share the “principal molecular structural features” and the same mechanism

of action as the brand name product. Manufacturers wishing to introduce follow-on biologics could rely on safety and efficacy data from studies of the brand name product without having to

launch new clinical trials. In a statement, Jim Greenwood, president and CEO of the Washington, DC-based Biotechnology Industry Organization, criticized the bill. “It is imperative that the

US Food and Drug Administration continue to require a full complement of data, including clinical evidence, to demonstrate safety and effectiveness for all biotechnology products.” _BV_

SELECTED RESEARCH COLLABORATIONS Table 2 _News in Brief written by Ken Garber, Alla Katsnelson, John Ransom, Catherine Shaffer, Brian Vastag & Emily Waltz_ RIGHTS AND PERMISSIONS

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