Tagged Clinical Trials

Congressman’s Ties To Foreign Biotech Draw Criticism

When a small Australian biotechnology company, Innate Immunotherapeutics, needed a clinical trial for an experimental drug it hoped to turn into a huge moneymaker, the company landed a U.S. partner where it had high-level connections: Roswell Park Cancer Institute in Buffalo, N.Y.

The company is partly owned by Rep. Chris Collins, a wealthy Republican entrepreneur from Buffalo, whose enthusiasm for Innate helped persuade others to invest. Former Rep. Tom Price, now secretary of Health and Human Services, bought Innate stock after Collins told him about it, Price said at his Senate confirmation hearing. Other shareholders include Collins’ campaign supporters, some of whom are key figures in Buffalo’s medical corridor, company and government documents reveal.

Federal money is in play, too: National Cancer Institute funds are being used to test an application for Innate’s drug that could make the company more attractive to potential buyers. Innate has said in presentations to investors that it hopes to sell itself to a major pharma company by the end of 2017.

The Roswell clinical trial, which could start this month, will investigate whether MIS416 might have an application as an ingredient in a vaccine for ovarian cancer. Innate’s primary strategy, however, is to develop the drug for advanced multiple sclerosis and it has told investors that the results of early-stage human trials in Australia and New Zealand against MS will be reported by this fall.

With its tangled web of medicine, politics and money, Innate’s story has proven irresistible for U.S. news media, whose initial reports in December that Price received discounts on Innate stock purchases helped place the secretary on the hot seat as he won confirmation. Now, the story is exploding half a world away, and the focus is shifting to Collins. The Australian newspaper’s website reported Feb. 6 that a former securities regulator there alleged Collins may have violated disclosure requirements in the country’s securities laws in acquiring his Innate stake and also by not reporting his close relationships with other large shareholders. The Australian government’s Takeovers Panel said Feb. 15 that it has not decided whether to convene a panel to investigate the allegations.

Innate CEO Simon Wilkinson said in a statement that company financial documents “fully informed” financial markets about Collins’ investments. The company was “not in the slightest bit concerned” about the allegations, which “are politically motivated and have been peddled by hack journalism,” he said.

Compared with Price, the potential conflicts could run even deeper for Collins who — along with two children — owns more than 21 percent of Innate’s shares. He is its largest shareholder, company reports show.

Collins, who is ranked by the Center for Responsive Politics as the 14th-wealthiest member of Congress, sits on the health subcommittee of the Energy and Commerce Committee, where he helps oversee health care funding. He was a member of President Donald Trump’s transition team and is a liaison between the new administration and Capitol Hill.

Congressional ethics rules do not prohibit Collins and other members from investing in companies whose businesses overlap with the committees they serve on and the government agencies those committees oversee, legal experts said. Even so, they added, members must take care to disclose possible conflicts of interest because they can erode the public’s trust in government.

“Members should not have large holdings in health care stocks while serving on committees that oversee health policy,” said Richard Painter, former chief ethics lawyer for President George W. Bush.

Collins’ spokesman said his boss has done nothing improper.

“Congressman Collins is not going to apologize because a company he has a relationship with is attempting to help conquer cancer,” said Collins communications director Michael McAdams. “It’s sad the media is attempting to launch partisan attacks insinuating otherwise.”

‘I Talk About It All The Time’

Collins has been candid about his promotional efforts on Innate’s behalf.

In an interview with CNN, Collins said he often talks to people about Innate. “I talk about it all the time, just as you would talk about your children,” he said.

Last month, Collins was overheard by reporters boasting on a cellphone call just off the House floor about the “many millionaires” he had made talking up Innate, according to Politico.

Innate’s drug is an immune response stimulator discovered in the 1990s that had initially been developed as a potential treatment for HIV/AIDS or to boost the efficacy of childhood vaccines.

Founded in 2000, the company later tried MIS416 in a number of medical uses, but never found a marketable niche, Innate’s financial reports and news reports show.

Collins’ ties to Innate go back to 2005 — seven years before he was first elected to Congress — when the successful Buffalo businessman decided to invest after meeting Wilkinson while the CEO was in the U.S. seeking investors, Wilkinson said.

Collins joined the board in 2006 and the company first sold shares to the public in 2013. From 2013 to 2016, he bought Innate shares then worth between $3.5 million and $16 million and has not sold any, according to his congressional disclosure statements. Collins now owns nearly 38 million shares of the company, worth about $25 million based on the stock’s recent closing prices on the Australian stock exchange. That price peaked at $1.35 a share on Jan. 25 and is now under $1.

Innate has never had a revenue-producing product and has relied mainly on investor capital for funds. The congressman made four personal loans to Innate in 2012 and 2013 totaling $1.3 million that were later converted to shares and options to buy more shares at discounted prices, according to company financial reports.

Collins also promoted Innate among people in his professional and social circles, drawing investors whose share purchases have helped keep the company afloat.

Americans own 44 percent of Innate, according to a company-funded research report on its website. Many of those shareholders seem to come from an interconnected circle of prominent Buffalo investors with Collins at the center, based on company documents, congressional disclosure statements and political contributions reported in Federal Election Commission filings.

Investors who bought stock in two private placements by Innate have contributed at least $105,000 to Collins’ congressional campaigns, according to the Public Accountability Initiative in Buffalo, a nonprofit that investigates politics and government, which compared an Innate shareholders’ document with FEC filings.

One was Glenn Arthurs, an executive in the Buffalo office of UBS, the Swiss financial services giant. Another was Paul Harder, who runs a private investment firm in Buffalo, CHEP II. Arthurs and CHEP II both ranked among Innate’s top 20 shareholders last year, according to the company’s annual report. Both have also contributed to Collins since 1998, the year of his first — and unsuccessful — congressional campaign, FEC records show.

Collins’ congressional chief of staff, Michael Hook, who began working for Collins early last year, bought shares of Innate 28 times last year, according to his disclosure statements. Sometimes he purchased thousands of dollars of stock multiple times in a single day, those filings show.

Bill Paxon, a former congressman from Buffalo and a lobbyist whose clients include PhRMA, the major drug makers’ trade group, has invested in Innate. So has Lindy Ruff, the former coach of the Buffalo Sabres hockey team, who is now head coach of the Dallas Stars. Both were identified in a public company document for shareholders.

Ruff declined to comment on his Innate investment. Paxon, Arthurs, Harder and Hook did not reply to repeated requests from KHN for comment.

Mark Lema, Roswell’s head of anesthesiology, told The Buffalo News recently that he became an Innate investor after overhearing Collins discussing it at a meeting for Buffalo visitors that Collins hosted in Washington, D.C. But he’s never discussed Innate or MIS416 with study researchers at Roswell, he said in a subsequent interview with KHN.

A Complaint In Australia

Recent published reports in the U.S. detailing Collins’ ties with Innate are what provoked Sydney lawyer — and Innate shareholder — James Wheeldon to question Collins’ adherence to Australian securities laws, according to the 10-page letter that he sent Feb. 3 to Innate and the Australian Securities and Investment Commission.

Wheeldon alleged that Collins failed to disclose his large holdings in Innate to the Australian Securities Exchange within two business days of becoming a substantial stockholder, as the country’s law requires.

Stating that Collins owned more than 15 percent of the company before Innate went public in December 2013, Wheeldon alleged that Collins did not inform the exchange how much he owned until almost 18 months later.

Wheeldon also said that published reports about Collins’ “family, professional, political and financial relationships” with other Innate shareholders like Price had never been disclosed to the Australian financial market to his knowledge, “but rather has only come to light as a consequence of these press reports.”

Collins, his children, political allies and his donors control at least 27.25 percent of the company — giving Collins greater influence over the company than has been disclosed to shareholders, Wheeldon wrote.

“Mr. Collins duty is not to enrich the business and political elite of Buffalo, New York. His overarching duty is to the company,” read Wheeldon’s letter.

The stakes may be high, but the data from the Roswell study might not produce strong conclusions. Twelve people will be in the study, which is to be completed in August 2018, according a listing on clinicaltrials.gov. The start of the trial has been postponed five times since July and is now scheduled for this month. Recruiting for participants has not started yet, according to the listing.

Innate and Roswell began collaborating in 2009 and as both sides tell the story, Collins — the man who first connected the Australian biotech firm to Buffalo — had nothing to do with it. According to Roswell, the doctor running the trial, Kunle Odunsi, learned about MIS416 that year when Wilkinson, the CEO, pitched the drug at a presentation in Buffalo to prospective collaborators. Roswell researchers have been testing the vaccine in mice with tumors since first receiving the National Cancer Institute grant in 2011.

The trial is called an “investigator-initiated” trial, meaning that Odunsi has an agreement with Innate to explore the use of MIS416 for a cancer vaccine for free. Innate donates the drug, Roswell sponsors for the trial and if it’s successful, researchers could approach a medical journal to publish the results.

“A publication by a reputable clinical center (e.g., Roswell) in a prestigious journal […] would almost certainly increase off-label usage, thus increasing sales,” Kenneth Kaitin, director of the Tufts Center for the Study of Drug Development, wrote in an email.

Wilkinson said Collins has played no role in lining up the clinical trial at Roswell or getting the NCI funds to pay for it. McAdams, Collins’ spokesman, said Collins had “zero involvement” in the grant.

Categories: Health Industry, Syndicate

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Pursuing the Dream of Healthy Aging

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Credit Paul Rogers

Given their druthers, most people would opt for a long and healthy life. Few relish the idea of spending years, even decades, incapacitated by illness, dependent on caregivers and unable to enjoy the people, places and activities that make life worth living.

In 1980, Dr. James F. Fries, a Stanford University physician who studied chronic disease and aging, proposed that a “compression of morbidity” would enable most people to remain healthy until a certain age, perhaps 85, then die naturally or after only a brief illness.

Now, a prescient group of experts on aging envisions a route to realizing Dr. Fries’s proposal: one or more drugs that can slow the rate of aging and the development of the costly, debilitating chronic ailments that typically accompany it. If successful, not only would their approach make healthy longevity a reality for many more people, but it could also save money. They say that even a 20 percent cut in how fast people age could save more than $7 trillion over the next half-century in the United States alone.

“Aging is by far the best predictor of whether people will develop a chronic disease like atherosclerotic heart disease, stroke, cancer, dementia or osteoarthritis,” Dr. James L. Kirkland, director of the Kogod Center on Aging at the Mayo Clinic, said in an interview. “Aging way outstrips all other risk factors.”

He and fellow researchers, who call themselves “geroscientists,” are hardly hucksters hawking magic elixirs to extend life. Rather, they are university scientists joined together by the American Federation for Aging Research to promote a new approach to healthier aging, which may — or may not — be accompanied by a longer life. They plan to test one or more substances that have already been studied in animals, and which show initial promise in people, in hopes of finding one that will keep more of us healthier longer.

As Dr. Kirkland wrote in a new book, “Aging: The Longevity Dividend”: “By targeting fundamental aging processes, it may be possible to delay, prevent, alleviate or treat the major age-related chronic disorders as a group instead of one at a time.”

His colleague S. Jay Olshansky, a gerontology specialist in the School of Public Health at the University of Illinois in Chicago, said it is often counterproductive to treat one disease at a time. Preventing cardiac death, for example, can leave a person vulnerable to cancer or dementia, he explained.

A better approach, Dr. Kirkland said, would be to target the processes fundamental to aging that underlie all age-related chronic diseases: chronic low-grade inflammation unrelated to infection; cellular degradation; damage to major molecules like DNA, proteins and sugars; and failure of stem cells and other progenitor cells to function properly.

The team, which includes Dr. Nir Barzilai, director of the Institute for Aging Research at Albert Einstein College of Medicine in The Bronx, and Steven N. Austad, who heads the biology department at the University of Alabama at Birmingham, plans to study one promising compound, a generic drug called metformin already widely used in people with Type 2 diabetes. They will test the drug in a placebo-controlled trial involving 3,000 elderly people to see if it will delay the development or progression of a variety of age-related ailments, including heart disease, cancer and dementia. Their job now is to raise the $50 million or so needed to conduct the study for the five years they expect it will take to determine whether the concept has merit.

The project represents a radical departure from ordinary drug studies that test treatments for single diseases. However, the group, spearheaded by Dr. Barzilai, said the Food and Drug Administration has endorsed their idea to test a single substance for effectiveness against a range of ailments.

“If metformin turns out not to work, there are several other substances in the pipeline that could be tried,” Dr. Barzilai said. “Under the auspices of the National Institute on Aging, three research centers have tested 16 substances in different animal models and got incredible results with four of them.”

Green tea, one of those tested, bestowed no health or life span benefits, despite its popularity. But the drug rapamycin, an immune modulator used following organ transplants, was most effective among those tested, Dr. Barzilai said.

The team is starting with metformin because it is a cheap oral drug — costing about two cents a pill — with six decades of safe use in people throughout the world. Among those with Type 2 diabetes who have taken it for years, there is evidence suggesting that, in addition to diabetes, it protects against cardiovascular disease, cancer and possibly cognitive impairment, Dr. Kirkland said, adding that “it targets the fundamental processes of aging, which tend to be linked.”

Dr. Barzilai said, “Our goal is to establish the principle of using a drug, or two in combination, to extend health span. The best we can expect from metformin is two or three additional years of healthy aging. But the next generation of drugs will be much more potent.”

Dr. Barzilai is already conducting a complementary study of centenarians, the results of which could identify more drugs to delay age-related diseases. He and colleagues are isolating genes that appear to keep these long-lived men and women healthy for 20 to 30 years longer than other people and shorten the length of illness at life’s end. Several studies have already found that individuals with exceptional longevity experience a compression of morbidity and spend a smaller percentage of their life being ill, Dr. Barzilai and his colleague Dr. Sofiya Milman wrote in the “Aging” book.

By analyzing the action of genes that extend health span, “it should be possible to devise drugs that mimic the genes’ effects,” he said. Two such gene-based drugs that show early promise against age-related diseases are already being tested.

But until definitive studies are completed and substances are shown to be safe as well as effective in prolonging health, Dr. Olshansky cautioned against dosing oneself prematurely with widely touted substances like resveratrol, the antioxidant found in red grapes and wine, or growth hormone.

Consumers must exercise caution, he warned, because “there’s an entire industry out there trying to market the products we’re testing before they are adequately evaluated.”

He also emphasized that taking a drug found to ward off age-related ills is not a license to abandon a healthy lifestyle. Doing so “could completely negate the benefit of a compound that slows aging,” he said.

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