The American Society for Clinical Oncology (ASCO) has endorsed the Society for Integrative Oncology (SIO) guideline on the use of integrative therapies during and after breast cancer treatment, according to a special article published online June 11 in the Journal of Clinical Oncology.
Gary H. Lyman, M.D., M.P.H., from the University of Washington in Seattle, and colleagues address the use of integrative therapies for the management of symptoms and side effects during and after breast cancer treatment. Interventions of interest included mind and body practices, natural products, and lifestyle modifications. The SIO systematic reviews focused on randomized controlled trials; the guideline was reviewed by ASCO content experts for clinical accuracy and by ASCO methodologists for developmental rigor.
After determining that the SIO guideline recommendations were clear, thorough, and based on the most relevant scientific evidence, the ASCO Expert Panel endorsed the guideline with a few added points of discussion. Key recommendations include music therapy, meditation, stress management, and yoga for reduction of anxiety/stress. For depression/mood disorders, meditation, relaxation, yoga, massage, and music therapy are recommended. To improve quality of life, meditation and yoga are recommended. For reducing chemotherapy-induced nausea and vomiting, acupressure and acupuncture are recommended. Because of a possibility of harm, acetyl-L-carnitine is not recommended to prevent chemotherapy-induced peripheral neuropathy.
“No strong evidence supports the use of ingested dietary supplements to manage breast cancer-treatment related adverse effects,” the authors write.
Several authors disclosed financial ties to the biopharmaceutical industry.
Ultra-early neurological deterioration (U-END) occurs in one in eight ambulance-transported patients with acute cerebrovascular disease and is associated with significantly worse outcomes, according to a study published online July 23 in JAMA Neurology.
Kristina Shkirkova, from the University of California in Los Angeles, and colleagues performed an exploratory analysis of the prehospital, randomized Field Administration of Stroke Therapy-Magnesium Trial involving 315 ambulances and 60 hospitals receiving stroke patients. The authors assessed neurological deterioration among 1,690 consecutively enrolled patients with suspected acute stroke who were transported by ambulance within two hours of stroke onset.
The researchers found that a final diagnosis of acute cerebral ischemia occurred in 73.2 percent of patients, intracranial hemorrhage in 22.8 percent of patients, and neurovascular mimic in 4 percent of patients. From prehospital to early post-arrival, U-END occurred in 11.8 percent of patients, more often among those with intracranial hemorrhage than those with acute cerebral ischemia (30.8 versus 6.1 percent). U-END patterns include: prehospital U-END without early recovery (3.1 percent), stable prehospital course but early emergency department deterioration (5.1 percent), and continuous deterioration in both prehospital and early emergency department phases (2.8 percent). U-END was associated with worse three-month outcomes.
“Averting U-END may be a target for future prehospital therapeutics,” the authors write.
Portola Pharmaceuticals, Inc. (Nasdaq: PTLA) today announced that the U.S. Centers for Medicare and Medicaid Services (CMS) has granted a New Technology Add-on Payment (NTAP) for Andexxa [coagulation factor Xa (recombinant), inactivated-zhzo], the first and only antidote approved by the U.S. Food and Drug Administration (FDA) for patients treated with rivaroxaban and apixaban, when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding.
In the final rule concerning the Hospital Inpatient Prospective Payment System and CMS Fiscal Year 2019 (scheduled for publication in the Federal Register on August 17, 2018), CMS states that Andexxa meets all criteria for approval for new technology add-on payments. Additional information on the CMS final rule and its discussion of NTAP and Andexxa can be found on pages 783-806 of the pre-publication on the Federal Register.
We are pleased that CMS has recognized the breakthrough innovation of Andexxa and the substantial clinical value of rapidly reversing the anticoagulating effects of the Factor Xa inhibitors. rivaroxaban and apixaban, in the event of life-threatening or uncontrolled bleeding, said John T. Curnutte, M.D., Ph.D., interim co-president of Portola and head of research and development. The establishment of a NTAP for Andexxa is an important decision for a very vulnerable patient population, as it both broadens Medicare beneficiary access to Andexxa, and supports the hospitals who are incorporating this important therapy into their treatment protocols.
Leap Therapeutics partners with Merck KGaA and Pfizer for Phase I/II clinical trial for immunotherapy regime for solid tumors.
The clinical trial will evaluate Leaps TRX518 in combination with Bavencio (avelumab), approved by the FDA last year for metastatic Merkel cell carcinoma, and cyclophosphamide chemotherapy.
According to Leap Therapeutics representative, Doug Onsi, It will be conducted by Leap Therapeutics with the use of a contract research organization (CRO). Per the agreement, the trial will be conducted in advanced solid tumors in patient populations who have relapsed/refractory ovarian, breast, and prostate cancers.
The clinical trial will be led by Jedd Wochok from Memorial-Sloan Kettering Cancer Center and is based on the preclinical work that members of his lab presented at the American Association for Cancer Research Annual Meeting earlier this year, said Onsi.
TRX518 was developed by Leap as a humanized glucocortid-induced TNFR family related gene agonist monoclonal antibody, said to improve an anti-tumor response in the immune system.
We believe that the use of TRX518 could enhance the activity of an immune checkpoint inhibitor like Bavencio [avelumab]. The checkpoint inhibitors, like Bavencio have been described as taking the brake off of the immune system so that the immune cells can target the tumor, and the agonist antibodies, like TRX518, are described as stepping on the gas pedal to accelerate the immune systems activity to target cancer, said Onsi.
TRX518 has demonstrated positive results in early clinical activity in combination with immune checkpoint inhibitors and is believed to be enhanced by the addition of cyclophosphamide chemotherapy, suggested Onsi.
According to Jennifer Smith, global media relations of Pfizer, Merck KGaA and Pfizerare in a partnership to jointly develop and commercialize Avelumab, which the companies refer to as the Avelumab Alliance.
If the study is successful it could lead to additional studies and collaboration. The clinical collaboration announced between Leap and the Avelumab Alliance does not contain rights to each others compounds, said Smith.
Enrollment in the study is set to occur in Q1 of next year.
Two agricultural researchers from China were charged on Friday in connection with a 2013 attempt to steal U.S. rice technology for use in the medical field.
A U.S. grand jury indicted Liu Xuejun, 49, and Sun Yue, 36, for conspiracy to steal trade secrets and conspiracy to commit interstate transportation of stolen property, according to the U.S. Attorney’s Office for the Eastern District of Arkansas.
Lawyers for Liu and Sun could not immediately be reached for comment. The Chinese Embassy in Washington also could not immediately be reached.
The charges come as the United States and China have slapped tariffs on imports of billions of dollars’ worth of each other’s goods in an escalating trade war. The United States alleges that China steals U.S. corporate secrets and wants it to stop doing so.
“Today’s indictment of Liu and Sun should not go unnoticed by those who seek to steal our trade secrets and technology,” said Diane Upchurch, special agent in charge of the FBI’s field office in Little Rock, Arkansas.
In recent years, U.S. law enforcement officials have urged agriculture executives and security officers to increase their vigilance and report suspicious activity involving farm products, citing a growing economic and national security threat to the sector.
Liu and Sun travelled to the United States to visit rice research and production facilities, including those in Arkansas and Kansas, U.S. officials said. On their way back to China, U.S. customs agents found stolen rice seeds in their luggage, they said.
The seeds were engineered by a company named Ventria Bioscience to contain certain proteins that can be removed from the rice and used in medicines and pharmaceutical products.
“It is important that this intellectual property be respected and protected from would-be thieves in order for Ventria to sustain itself and continue to thrive as a business,” Scott Deeter, Ventria’s chief executive officer, told Reuters in an email.
The researchers’ trip was organised by two other agricultural scientists from China, Weiqiang Zhang and Wengui Yan, according to prosecutors. Zhang and Yan, who were working in the United States, have previously been convicted in connection with the case and sentenced to prison.
“We remain vigilant in our efforts at protecting both intellectual and real property from theft by other nations,” said Cody Hiland, U.S. Attorney for the Eastern District of Arkansas.
This was a big week for cannabis legalization on the international plane, with the country of Georgia decriminalizing cannabis use and possession though a court ruling, and the Argentine province of Jujuy announcing the local government would start producing marijuana for medicinal and research uses.
On the markets front, Scythian Biosciences sold its Caribbean and Latin American assets to Aphria and then turned around to use that money to get into the Florida market. Looking at the transaction, Debra Borchardt, CEO of Green Market Report said, “If they really believed these were great markets to be in, then why would they sell them? I feel like one of these parties got snookered, but I’m not sure who. Florida could be huge, but then it seems like the competition will be tough. The international markets are untested yet, so it’s an unknown.”
She then moved on to talk earnings reports.
“Of all the earnings that came out this week, the one thing that really struck me was Scott’s Miracle-Gro comment about California over-production of cannabis putting pressure on its Hawthorne division. Too much supply must’ve caused the prices to fall and that means growers can’t spend as much with companies like Scott’s. I wonder how many more companies have felt this and didn’t say anything publicly,” Borchardt said.
Marijuana Indexes & ETFs
In the capital markets realm, the United States Marijuana Index, which tracks 18 of the largest marijuana stocks in the U.S., dropped roughly 2.2 percent this week, while the North American Marijuana Index, which also includes Canadian stocks, also lost about 2.2 percent of its value.*
Over the last five trading days, the Horizons Marijuana Life Sciences Index ETFHMLSF 1.18% (TSE:HMMJ) slipped 1.2 percent, while the ETFMG Alternative Harvest ETF MJ 0.04% gained 0.9 percent. The SPDR S&P 500 ETF Trust SPY 0.45% was up 0.7 percent.
Stock Moves
Here are some of the top marijuana stocks (market cap above $100 million) in U.S. exchanges and how the performed over the last five trading days:
Zynerba Pharmaceuticals Inc ZYNE 2.44%: down 20.4 percent
In Other News
NMS Capital Advisors said it would be leading High Times’ Reg A+ IPO raise.
“We’re very excited to lead the Reg A+ raise for High Times,” Trevor M. Saliba, Chairman of NMS Capital Advisors told Benzinga. “Their company is a pioneer in the cannabis news and media space, with a 43-year history. With the proceeds from this capital raise, they will grow their presence globally as they look to acquire other quality companies and host more events throughout the world. We believe the Reg A+ format is a great method of raising capital for High Times, as it allows everybody to become a shareholder of such an exciting company. With the expected growth of the cannabis industry in years to come, High Times is positioning itself for a bright future.”
Season 3 of “The Marijuana Show” debuted on Amazon Prime. The show boasts a 5-star rating so far. You can watch it here.
A Detroit judge dropped felony charges against six people arrested in the raid of a cannabis grow operation with a reported $1 million in plants, owned by former NBA player Al Harrington. The judge said the facility was within the bounds of its temporary state license.
The world’s largest cannabis compliance firm, Toronto-based CannabisCompliance Inc. became the newest founding member of the Global Cannabis Partnership (GCP). The consulting firm joins 16 other founding members in the creation of a worldwide social responsibility standard for the safe and responsible production, distribution and consumption of legal, adult-use recreational cannabis.
“With Canada leading the world on medical and legal, adult-use recreational cannabis cultivation, production and distribution, it’s no surprise that other nations are looking at us for expertise from an industry, as well as policy legislation, perspective,” said Deepak Anand, Vice President of Business Development and Government Relations at CCI. “CCI looks forward to contributing, through policy and regulatory development, to the overarching CSR mandate within the GCP. We believe that social responsibility standards in the global cannabis industry are imperative, and that the CSR piece is critical to the success and progress of the industry and for society.”
The GCP is the first of its kind in the growing global recreational cannabis industry. To date, 17 well-respected organizations have joined the Partnership, representing a cross-section of organizations that play – or will play – a role in the legal, adult-use recreational cannabis supply chain.
Speakeasy Cannabis Club Ltd SPBBF 5.77%, a late stage ACMPR applicant, announced its plans to begin work on its first 60 acre outdoor plantation and process facility in Rock Creek BC for the spring of 2019. CEO Marc Geen stated, “The recent release of regulations allowing outdoor production is a dream come true for us. It has always been our plan to grow outdoors on a large scale, but we did not expect regulations to allow it to happen this soon. The climate here in Rock Creek is absolutely perfect for growing cannabis outdoors and we are thrilled at the opportunity to begin as soon as possible.”
Development cost are forecast to be under $10.00 per square foot for the outdoor plantation and processing facility, by comparison, greenhouse and indoor facilities cost approximately 20 to 30 times more per square foot.
The Green Organic Dutchman announced the record date for the spinout of TGOD Acquisition Corporation: on about September 28, 2018. The arrangement will require approval by a two-thirds majority of the votes cast by TGOD shareholders at a special meeting of TGOD shareholders expected to take place in September.
New Jersey is now accepting applications for up to six new vertically integrated, medical marijuana facilities. There’s a mandatory applicant meeting in Trenton on August 9, and applications are due by August 31.
“However, those who have not been long preparing to file an application may have little chance as it requires exhaustive personal and corporate disclosures, identification of qualifying real estate and site control, floor plans, grow and processing protocols, and financials, among other things – all within 30 days,” said Joshua S. Bauchner, a partner with the law firm of Ansell Grimm & Aaron, PC who heads the firm’s Cannabis Law Practice Group.
Cannabis-focused Phyto Partners recently launched its second fund, Phyto II, and has now started planting seed capital in a budding industry, by investing in physician and patient focused businesses, Managing Partner Larry Schnurmacher told Benzinga. The firm recently invested in Sail and Marijuana Doctor.
“Our investment thesis has taken us to the demand side of the medical cannabis industry by helping physicians and patients navigate a new medicine. Physicians need the resources and services to help their patients incorporate CaaM into their treatment protocols and patients need knowledgeable healthcare professionals to educate them about CaaM for their healthcare needs. Sail and Marijuana Doctor solve those problems,” Schnurmacher said
TheraCann announced the launch of its breakthrough ETCH biotrace (TM) technology. The molecular “tag and trace” system is poised to further refine and transform the cannabis regulatory environment by adding capabilities that allow for forensic tracking of cannabis and cannabis derivatives across the supply chain.
“TheraCann International together with our partner, Applied DNA Science, are poised to deliver what we consider is the future of cannabis ‘seed-to-sale’ solutions. ETCH biotrace™ combines the CertainT® platform to tag cannabis and its derivative products at the point of cultivation and processing and track it throughout the entire supply chain using TheraCann’s integrated software and block-chain infrastructure to ensure true traceability,” CEO Jason Warnock told Benzinga. “The benefits of implementing ETCH biotrace ranges from proof of origin, strain and product licensing, government compliance, intellectual property and brand protection, anti-counterfeiting, added security for labels and packaging as well as physical security for facilities.”
Humboldt Apothecary said it’s releasing a new line of tinctures rich in CBD and amplified with organic herbs. The tinctures are well-suited for microdosing and should help cannabis consumers with insomnia and unwanted tension.
Maine, which became the eighth state to legalize cannabis for adult use in 2016, is expected to roll out its adult use program in 2019. In the meantime, cultivation product and service provider Growlife IncPHOT 16.71% opened a new retail location in Portland, Maine.
“The timing could not be better for the opening of a retail storefront for GrowLife Hydroponics in Portland, Maine,” said GrowLife CEO Marco Hegyi. “Expanding our physical presence in the Northeast is a strategic move as legislation in the region continues to evolve.”
Kannalife Sciences, a company focused on the search for an effective chronic traumatic encephalopathy (CTE) treatment, announced a share exchange agreement with TYG Solutions OTCTYYG, coming one step closer to being the only publicly traded company in the cannabinoid therapeutics space with an exclusive license to a U.S. government patent from the National Institutes of Health.
“The transaction with TYYG allows us to look toward the future as a publicly traded company and continue our research into developing disruptive cannabinoid-based therapeutics for neurodegenerative and oxidative stress-related diseases,” said CEO Dean Petkanas.
Growing Talent announced it’s launching LASER, Los Angeles Social Equity Reform. LASER is a digital incubator that provides application support, technical assistance and investment capital.
Seven months after the launch of its B2B networking and marketing platform for the cannabis industry, Cannabiz Connection announced a networking event series for the top 10 cities in Michigan. The first networking events will take place in Ann Arbor and Detroit, followed by Grand Rapids, Lansing, Traverse City, Kalamazoo, Flint, Bay City and the Upper Peninsula.
“Over the last several months, the Cannabiz Connection platform has seen tremendous growth and we are actively helping people grow and build successful cannabis careers in Michigan,” said Jamie Cooper, founder and CEO of Cannabiz Connection. “The networking event series is a natural next step for us, as the demand in the industry to meet the right contacts at the right time has increased. The old adage, ‘it’s not what you know, it’s who you know’ holds true in this industry.”
Honest Marijuana Company said it’s bringing one of the first nano-sized products into the industry for an all-new way to use cannabis. After working with a European company that has patent-pending technology over the past year and a half, Honest Marijuana Company now has the ability to turn non-water-soluble substances like cannabinoids into nano-size so they can be added into transdermal patches, topical lotions, and more for the cleanest, most efficient, healthiest, and most discreet cannabis consumption.
Sproutly Canada Inc SRUTF 6.75% announced it has completed the acquisition of Infusion Biosciences Canada Inc. and SSM Partners Inc.
MassRoots Inc MSRT 23.7% said it Registration Statement on Form S-1 was declared effective, permitting the re-sale of shares of common stock and warrants to purchase shares of common stock issued as part of capital raised during the past year. The company recently re-launched its mobile applications and business portal to address the increasing needs of cannabis consumers and businesses across the country while improving their network infrastructure to support incoming growth.
“With the launch of our revamped mobile applications and business portal, we believe we now have the product necessary to generate solid monthly recurring revenue. With the ongoing development and release of additional value-add features to the business portal, we believe our continued execution could enable us to have several hundred paying clients by the end of the year,” CEO Isaac Dietrich told Benzinga.
Find out more about these news and others on Maricann Group Inc MRRCF 0.66%, CV Sciences Inc CVSI 4.75%, Isodiol International Inc ISOLD 0.96%, and Zynerba with our friends atMarijuana Money,who make a weekly video summary of the top financial and business news in the cannabis industry.
More From Benzinga’s Cannabis Newsdesk
Over the week, Benzinga’s Elizabeth Balboa reported that:
Segra International Corp. closed an oversubscribed private placement offering for about C$7.2 million. The units sold were composed of one common share, one liquid penalty warrant, and half of a common share purchase warrant, two of which enable the purchase of one common share at $1.
OrganiGram Holdings IncOGRMF 0.77% reported record third-quarter financial results with net income rising 162 percent sequentially to C$2.8 million. Sales increased 95 percent year over year to set another quarterly record.
ABcann Global CorpABCCF 2.04%announced its $133 million purchase of BC-based Canna Farms, the first licensed producer in British Columbia. [And] Canopy Growth Corp shareholders voted to acquire all yet-unowned interest in Canopy Health and Canopy Animal Health Inc. Management will seek approval from the Ontario Superior Court of Justice on Thursday in order to complete the transaction Friday.
The Global Cannabis Stock Index struck a 2018 low as it fell 10 percent in July. Only eight of 53 components posted gains,” while “Pharmacies in Italy were given a green light to sell medical cannabis.
Molson Coors Brewing CoTAP 0.52% and The Hydropothecary Corporation, a Canadian cannabis producer, announced “the formation of a joint venture Wednesday to develop non-alcoholic, cannabis-infused beverages.”
Interesting Data
According to Viridian Capital Advisors’ Cannabis Deal Tracker, capital raises in the industry surpassed $4.8 billion as of July 27. See details of the investments by type, week and sub-segment in the charts below.
Investments tripled year-over-year.
A lot more money was raised with equity than with debt.
Cultivation and retail was the investor favorite by far.
Events Calendar
August 3-4: Coco Loco will hold its opening in Aurora, Colorado. A fresh alternative to juice, smoothie and “to go” eats, this family owned and operated eatery provides the option of adding hemp-derived CBD oil or Irish sea moss to any item.
August 4: The 5th Annual 420 Games will take place at Golden Gate Park. Yoga, 4.20 mile run, cannabis companies, music, Lagunitas Beer Garden and keynote speeches from UFC Legend Frank Shamrock and Harborside’s Steve DeAngelo.
August 6: The Minority Cannabis Business Association is hosting a Happy Hour in Washington D.C., in partnership with the National Cannabis Bar Association. Attendance will get you $100 off of registration for the Cannabis Law Institute, a “two-day event in continuing legal education and equity within the cannabis industry” that will be hosted in September.
August 6-9: Thinking of a career change? Be sure to tune into Green Flower’s free Cannabis Career Summit here.
August 14-16: MJBizCon will host MJBizConINTL at the Metro Toronto Convention Centre.
August 30: Gassposts.com is hosting the second event in its GP Connect Series at The Majestic in Los Angeles. The experience “will provide an environment for cannabis brands, distributors and retailers to engage face to face to conduct business.”
September 7-9: Oklahoma is getting its first Hempfest ever. “After a year of working with Oklahoma politicians and venues we finally get to announce the world’s largest hemp festival is coming to Oklahoma. With Dj Snoopadelic [Snoop Dogg] coming for a free show in Oklahoma and the massive 4-stage 3-day lineup we are about to announce, we are hoping to bring out the masses and educate on what the hemp industry really is,” Scott Mckinley, event organizer and CEO of Hi Tunes Distribution told Benzinga.
September 14: New York City will see the “Green Market Summit – The Advanced Economic State Of Cannabis,” the first of a series of conferences titled Green Market Summit. This event hosted by Green Market Report will be held in partnership with The Street at One World Trade Center. The keynote speaker is CNBC and TheStreet’s Jim Cramer, who will interview Kevin Murphy CEO of Acreage Holdings. Tickets can be purchased on this website.
September 21-22: Anaheim, CA will get the CBD Expo West 2018. Powered by CBD Health and Wellness Magazine, the CBD-focused event will feature 75 exhibitors, along with a large lineup of presentations and panel discussions from experts in the production, distribution and sale of CBD products. Tickets and can be purchased online; check out cbdexpo.net for more detail.
The term “administrative offset” brings to mind meaningless governmental jargon. It is governmental jargon. But if you are affected, it’s not meaningless at all.
In layman’s terms, administrative offset is the government’s way of applying money that would normally be owed to you, such as tax refunds and certain Social Security benefits, to outstanding debts that you owe. State payments to you may also be subject to administrative offset. If you are a federal government employee, a portion of your wages may be garnished in this fashion.
Administrative offsets are handled by the Department of Treasury through the Treasury Offset Program (TOP). Types of debt subject to offset include defaulted federal student loans, delinquent taxes and child support payments.
The payments subject to administrative offset depend on the type of debt and whether the action is being taken through the Administrative Offset Program or the Federal Tax Refund Offset Program. Income streams that may be offset include tax refunds, federal wages, military pay, retirement pay, Social Security benefits, some disability benefits and other federal payments that aren’t specifically exempted.
The long list of federal payments exempt from administrative offset includes SSI, Tier 2 railroad retirement benefits, Black Lung benefits other than part B, and various emergency and low-income payment programs.
Social Security Disability Benefits (SSDI) are subject to offset, but Supplemental Security Income (SSI) benefits are not. SSDI is based on your work record while SSI is based on financial need. The administrative offset program exempts garnishment beyond a certain level of financial need.
Generally, administrative offsets are limited to no more than 15 percent of your total benefits and can’t be applied to total benefit amounts below $750 per month, or $9,000 per year.
Before any administrative offset is initiated, you’ll receive a written notice from the government explaining the amount and nature of the debt. Generally, you will have sixty days from the date of the notice — not the date you receive it — to take any defensive actions.
You have the right to review the records relating to the debt, and request copies if you or your representative can’t personally review the records. You can request a review of your case within twenty days of receipt of the notice. If you request and receive documents regarding the case, you have fifteen days from the receipt of those documents to request a review – but all this must take place within the sixty-day window.
If you feel the debt is in error, you can submit copies of evidence showing you owe only part or none of the debt.
If the debt is yours, you can pay the debt within the 60-day period, request a hardship reduction or negotiate an installment payment plan. To claim hardship, you will need to provide detailed financial information and a letter explaining the “exceptional circumstances” that caused the hardship.
Otherwise, garnishments will begin and continue until the debt is fully paid off, with interest. For high levels of debt such as defaulted student loans, garnishments can run for years – even decades.
If you receive an administrative offset notice, it’s important to react as soon as possible. To resolve any questions not covered in your notice, consult the TOP website.
Don’t ignore an administrative offset notice. If you feel the notice has been sent in error, seek legal advice immediately. Unless you have the time, patience, and expertise to sift through the exceptions in thick legalese, you’ll need assistance that’s tailored to your situation.
