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Friday, January 3, 2020

‘Shock Jock’ Don Imus: Prostate cancer tack worth emulating

Legendary radio talk show host Don Imus, 79, who died in a hospital in College Station, Texas, over the Christmas weekend, made his name with misogynistic, racist, homophobic, off-color, and antagonistic on-air comments. He was a pioneer “shock jock.”
I didn’t listen to his show, “Imus in the Morning.” But to me, as a man on active surveillance (AS) for low-risk cancer, Imus also made a mark as a pioneer celebrity on AS, a subject most showbiz types shun.
Imus was diagnosed in 2009 with a cancer confined to the prostate gland. It was called stage II cancer. There was no mention then of his Gleason score. Entertainment reporters and showbiz publicists aren’t well-informed or especially interested in such details.
Imus’ family said he was admitted to Baylor Scott and White Medical Center with a lung ailment. He had been treated for emphysema in the past.
At least one news outlet suggested — apparently incorrectly — that Imus’s death stemmed from his prostate cancer. The accompanying story said the exact cause of death was unknown.
When he was diagnosed with stage II cancer with a digital rectal exam, Imus made the rounds of urologists at high-profile institutions trying to discuss his options.
Peter Carroll, MD, MPH, a long-time leader in AS and chairman of urology at the University of California San Francisco, had fond memories of Imus as a patient. “When he and I met, I found him to be seriously interested in understanding all treatment options in great detail,” Carroll told me.
The private Imus projected a different image than the public shock jock.
Carroll said Imus “was intelligent, respectful, and warm. I enjoyed working with him at the time. He had a great sense of humor, but crossed no lines when I was with him. I think his wit and sense of humor were likely an asset when dealing with his cancer.”
Imus said in a broadcast that some famed urologists urged him to undergo radiation. Imus declined. He likely figured that all things considered, active surveillance was a good choice because it had a favorable survival rate and avoided some nasty side effects, such as incontinence and impotence. The 10-year survival rate for his stage II cancer was 98% with AS as well as for radiation and surgery.
Aaron Katz, MD, a self-described “holistic urologist,” invited Imus to be treated at Columbia University’s Center for Holistic Urology.
Katz, who now is urology chairman at New York University’s Winthrop University Hospital, could not be reached for comment. Imus used to give him a health spot on his radio show.
Katz said on the program that the other doctors had told Imus “immediate treatment or else what? That something bad would happen.” Nothing happened.
Katz put Imus on a plant-based diet, prescribed him 80 vitamins, and ordered a rigorous exercise plan. Imus groused that he spent hours and hours on a treadmill. In September 2011, Imus said he has been on the treadmill 1,297 days in a row.
Imus was especially impressed with active hexose correlated compound (AHCC), a Japanese medicinal mushroom product, aimed at enhancing the immune system. AHCC apparently had some extra benefits.
“You know, I haven’t had a cold in three years?” Imus told Katz on a broadcast in 2011 promoting the urologist’s book, The Definitive Guide to Prostate Cancer: Everything You Need to Know about Conventional and Integrative Therapies.
Katz described his holistic protocol for the broadcaster on “Imus in the Morning”: “The risk of doing just an active, holistic surveillance is that maybe the cancer could get worse…. [We are] monitoring it. We’re managing it. We’re getting a PSA every three months. We do an MRI every so often. But the upside is you feel healthy. You look great. You have great energy. Your sexual function, urinary function, none of that is impaired.”
Then shock jock Imus emerged, noting that he had a digital rectal exam every three months and asking Katz: “You’re going to check me today.”
Imus asked Katz if he had brought his gloves along for a DRE. Katz admitted he didn’t have the gloves, but he said, playing along, “I brought the lubrication.” Rimshot. Badum-ching.
Imus pressed his doctor about whether he was honest in his book about impotence. The shock jock called it “the wiener warranty,” meaning the odds Viagra could help men after a radical prostatectomy. They agreed about half of men could be helped with the Little Blue Pill, Viagra.
Katz said: “In medicine, you have to weigh the risk-and-the-benefit ratio.” Imus responded simply: “You just have to be honest.”
I know several other men on versions of holistic active surveillance. They drink alkalized water, shun meat, eat plant-based foods, and take loads of vitamins and exotic herbal remedies. They seem to be doing fine.
They tend to be evangelistic, strong believers in what they are doing.
I am following a different path with AS. I am still experimenting with diet, having tried low-fat, keto, and Paleo diets. I take a few vitamins based on counseling at the University of California San Francisco. My PSA scans, DREs, MRIs, and biopsies have been okay, whatever I have done.
My own urologist, Brian Helfand, MD, PhD, of NorthShore University Health System in suburban Chicago, told me he is skeptical about holistic urology.
He said, “There are many things that you can label anything. Certainly, the concept of holistic urology is not considered standard of care. As is true of many parts of holistic medicine, we do not have evidence from randomized trials demonstrating superiority of a holistic approach to prostate cancer compared to traditional medical approaches. Further studies have to be performed before we offer these type of interventions as ‘standard of care.'”
Still, he said he encourages his patients on AS or those undergoing definitive treatment to meet with a dietitian and to exercise. “I believe that tight sugar control, exercise, and a cardiac-healthy diet have been proven to be good for overall health. There is emerging evidence that this may also be true for men with advanced prostate cancer. Finally, the reason why this supplement to standard therapies (such as active surveillance, surgery, radiation, etc.) is good is that it gives the patients some feeling of control of their overall health.”
Imus appeared to do well in the intervening years. He retired in 2018 after 50 years on air. He died in his 10th year after being diagnosed.
The thing that impressed me about Imus was that he opted publicly for active surveillance — unlike other celebs who, for various reasons, opt for a “definitive cure.”
Kudos to Imus for being public and talking about his cancer and his decision to live with it on holistic active surveillance. He ought to be a role model for other celebs who could guide fans to consideration of non-invasive choices.

Incyte’s pain is Equillium’s gain, up 12%

Thinly traded nano cap Equillium (EQ +11.5%) is up on average volume, a modest 44K shares, diverging from Incyte’s (INCY -10.1%) selloff after itacitinib failed a late-stage study in acute graft versus host disease (GvHD).
Equillium is developing lead candidate EQ001 (itolizumab) for the same indication. A Phase 1/2 clinical trial, EQUATE, is in process with an estimated primary completion date in May 2021.
Itolizumab is a monoclonal antibody that binds to (inhibits) an immune checkpoint receptor called CD6 that plays a key role in a range of immuno-inflammatory diseases.

1Life Healthcare files for IPO

1Life Healthcare (ONEM) has filed a prospectus for a $100M IPO.
The San Francisco, CA-based company has developed a membership-based primary care platform that provides around-the-clock access to digital health services paired with in-office care in convenient locations. It currently has 397K members and 77 physical offices across nine U.S. markets.
2019 Financials (9 mo.): Revenue: $198.9M (+29%); Net Loss: ($33.1M) (-27%); CF Ops: ($24.1M) (-111%).

Janssen Doesn’t Want Crohn’s Asset Back from Provention Post Trial Failure

Shares of Provention Bio took a slight hit in premarket trading before rebounding after it was revealed that Janssen has no wish to buy back the rights to a mid-stage Crohn’s disease treatment following a mid-stage trial failure.
In a recent filing with the U.S. Securities and Exchange Commission, Provention said it was told by Janssen that the Johnson & Johnson subsidiary will not take up an option to buy back the rights to PRV-6527, an oral Colony Stimulating Factor-1 Receptor (CSF-1R) small molecule inhibitor that was developed by Janssen and licensed to Provention in 2017. Janssen said it will “support and expand the field” of the agreement between the two companies to allow continued development of the asset. The expansion of the agreement will give Provention the right to aim the asset at other indications or possibly sublicense it to another company – which means Janssen does not want the property back.
According to the filing, Janssen will assist Provention in transferring the manufacturing rights of PRV-6527 to either Provention for continued development or assist in the transference of rights to a third party. Additionally, Janssen said it will “irrevocably waive its rights to assume distribution and pricing decision making authority” of PRV-6527, Provention said in the federal filing. Provention said it has no real intention of attempting to develop the asset any longer and could explore sublicensing the compound to a third party.
In 2017, Janssen licensed PRV-6527 to Provention, along with PRV-300, an anti-Toll-Like Receptor 3 (TLR3) monoclonal antibody.
In October, Provention announced that PRV-6527 failed to hit endpoints in the Phase IIa PRINCE trial. The trial included patients with moderate-to-severe Crohn’s disease, the majority of which had never been treated with a biologic. The primary efficacy endpoint of the trial was change in the Crohn’s Disease Activity Index score at 12 weeks. At the end of the trial, the drug did not differentiate itself from placebo, although Provention sought to put a positive spin on it saying PRV-6527 demonstrated a “substantial improvement in this symptom-driven score” at 12 weeks. As BioSpace reported at the time, Provention said the “high placebo response” is related to the background medication about 85% of the biologic-naïve patient population were on. In the Phase IIa trial, PRV-6527 did show improvement in several key secondary objective endpoints in the steroid-free population, which was about 75% of the patients, as was previously reported. Those endpoints included mucosal endoscopy and tissue histology.
Following the Phase IIa failure, Provention said it was shifting its resources to focus on PRV-031 (teplizumab) for the prevention or delay of type 1 diabetes.

Avadim Health on deck for IPO

Avadim Health (AHI) has filed a prospectus for a $50M IPO.
The Asheville, NC-based healthcare and wellness company sells topical products aimed at improving immune health, neuromuscular health and skin barrier health targeted to institutional and self-care markets.
Currently marketed brands are: Theraworx pre-saturated towelettes, foams and sprays, Combat One pre-saturated towelettes and Phuel pre-saturated towelettes.
2019 Financials (9 mo.): Revenues: $34.4M (+73.7%); Net Loss: ($31.8M) (-21.4%); CF Ops: ($20.0M) (+8.7%).

Analyst action, Dec. 3

Kodiak Sciences (NASDAQ:KOD) initiated with Buy rating and $100 (47% upside) price target at Jefferies. Shares up 1% premarket.
Tivity Health (NASDAQ:TVTY) initiated with Neutral rating and $22 (6% upside) price target at Credit Suisse.
Endo International (NASDAQ:ENDP) upgraded to Overweight with a $7 (56% upside) price target at Piper Jaffray. Shares up 4% premarket.
Humana (NYSE:HUM) added to Conviction Buy List at Goldman Sachs.
Zimmer Biomet Holdings (NYSE:ZBH) named a Top Pick at BTIG Research.
Incyte (NASDAQ:INCY) downgraded to Neutral with a $79 (8% downside risk) price target at Mizuho Securities. Shares down 12% premarket after failed itacitinib study in GvHD.
MEDNAX (NYSE:MD) downgraded to Neutral with a $29 (5% upside) price target at Citigroup. Shares down 2% premarket.
Novo Nordisk (NYSE:NVO) downgraded to Neutral at Guggenheim. Shares down 1% premarket.

Acorda up on Point72 stake

Nano cap Acorda Therapeutics (NASDAQ:ACOR) is up 16% premarket on light volume in reaction to disclosure from Steve Cohen’s Point72 Asset Management, L.P. of 9.8% stake of ~4.7M common shares.
The company currently markets two products: Ampyra (dalfampridine) to improve walking in MS patients and Inbrija (levodopa inhalation powder) for OFF episodes in Parkinson’s patients. The company is expecting the latter to be the growth driver since the former now has generic competition.
Q3 revenue was $47.7M, down 67%.