As it transitions from a discovery and technology platform-focused organization to a clinical stage biotech company, Critical Outcome Technologies (OTCQB:COTQF; TSX-V:COT) is approaching a critical inflection point by mid-2017 with its lead program, COTI-2, in in gynaecological cancers.
COTI-2 is currently being evaluated in a Phase 1 clinical study at two premier cancer centers in the U.S.
“We’ve assembled an impressive amount of supportive preclinical data in the past for COTI-2, and are excited to be evaluating in the clinic this potentially significant therapeutic option for women suffering from debilitating gynecological cancers, such as ovarian cancer,” Alison Silva, president, says in an interview with BioTuesdays.com.
In the more than 30 months since its startup, Knight Therapeutics (TSX:GUD) has shown an uncanny knack for raising equity at increasing valuations, building a portfolio of some 20 innovative products for its pipeline, expanding internationally and investing in life science funds to gain access to new pharmaceuticals.
“Over the next 30 months, we want to get real and demonstrate that we are good at commercializing and selling innovative pharmaceuticals that touch people's lives,” CEO, Jonathan Ross Goodman, says in an interview with BioTuesdays.com.
“In the highly competitive Canadian licensing landscape, we have been more creative and are adding more horsepower to our licensing capabilities,” he adds, noting that all of Knight’s products are sourced through partnerships and acquisitions.
Mateon Therapeutics (NASDAQ:MATN) is developing vascular disrupting agents (VDAs) that selectively disrupt abnormal tumor blood vessels, which supply nutrients to cancer cells, with an initial clinical focus on platinum-resistant ovarian cancer and acute myeloid leukemia.
“VDAs have been around for a long time but we’re taking them in a new direction: in combination with anti-angiogenic (AA) therapies,” president and CEO, Dr. William Schwieterman, says in an interview with BioTuesdays.com.
As president and CEO of The Lupus Foundation of America (LFA), a role she has held for 15 years, Sandra Raymond is an outspoken advocate for the plight of lupus patients. She has worked with the board of directors and the lupus research community to bring national attention and resources to lupus research and education. Ms. Raymond came to the LFA after serving as the founding CEO of the National Osteoporosis Foundation, beginning in 1986. She envisions great progress in lupus treatment and care over the next 10 years but recognizes the urgent need to elevate lupus on the national healthcare agenda by increasing federal and private investment in research on lupus and developing constructive public policies aimed at bringing support and services to all people affected by lupus. In this interview with BioTuesdays.com, Ms. Raymond discusses the state of the disease and results of a recent clinical study by Aurinia Pharmaceuticals (NASDAQ:AUPH; TSX:AUP).
BioSyent (OTC:BIOYF; TSX-V:RX) is actively building its international pharmaceutical sales and marketing business, adding products licensed and sold internationally to products already being shipped from Canada.
“We’re working on a couple of international deals now,” René Goehrum, chairman, president and CEO, says in an interview with BioTuesdays.com.
Mr. Goehrum explains that BioSyent hopes to commercialize new product deals in the Middle East, Latin America and Southeast Asia. “These products may not be licensed for sale in Canada.”
After posting positive Phase 2b results with its oral insulin drug candidate, ORMD-0801 in Type 2 diabetes, Oramed Pharmaceuticals (NASDAQ:ORMP) hopes to meet with the FDA before the end of 2016 to discuss proceeding with a Phase 3 clinical trial in 2017.
“We believe that our data set shows that oral insulin works, which is a first in history,” Josh Hexter, COO and VP of business development, says in an interview with BioTuesdays.com.
“While currently under development, our Phase 3 program will focus on safety and long-term HbA1c lowering efficacy, and will include both active comparator and placebo controlled trials,” he adds. HbA1c is an important three-month average of plasma glucose concentration in blood.
Galectin Therapeutics (NASDAQ:GALT) has completed enrollment one month early in its NASH-CX Phase 2b trial with 162 subjects with nonalcoholic steatohepatitis (NASH).
The Phase 2b study is testing the company’s GR-MD-02 drug candidate and is being conducted with a primary endpoint of hepatic venous pressure gradient, which the FDA may view as an acceptable surrogate for outcomes for registration trials in this patient population. Top-line results are expected in December 2017.
3D Signatures (TSX-V:DXD) has appointed Jason Flowerday as CEO. He succeeds Ferenc Somogyvari, who will remain on the board.
"Mr. Flowerday is a highly respected biotech entrepreneur with more than 20 years of executive life sciences management and startup experience. He has the entrepreneurial and management skills we need to drive us to commercialization," John Swift, chairman, said in a statement.
Today’s edition of USA Today carried a profile of Sarah Wilson, wife and mother of four, who became addicted to opioid pain medications after she suffered severe injuries from being hit by an intoxicated driver about eight-years-ago.
Ms. Wilson started her recovery when she entered a clinical trial that tested Titan Pharmaceuticals’ (NASDAQ:TTNP) Probuphine six-month implant of buprenorphine.
Stereotaxis (NASDAQ:STXS) has signed definitive agreements for multiple transactions that significantly strengthen its financial position and help accelerate and enhance its strategic market growth initiatives.
The transactions include an equity financing of $24-million, satisfaction in full of outstanding debt to Healthcare Royalty Partners for a payment of $13-million, and the addition to the board of three new directors with significant operational and financial experience in the medical device industry.
Dresner Partners has opened a new office in Fort Lauderdale, FL to be headed by Mitchell Stern, managing director and head of Dresner Partners’ healthcare practice. Mr. Stern will also continue to spend a portion of his time in Dresner’s New York office.
Dresner is a leading, FINRA-registered, middle-market investment bank focused on mergers and acquisitions, as well as capital raising and valuations to closely-held, family-owned and sponsor-backed companies for over 25 years.
The FDA has granted orphan drug designation to closely-held Soricimed Biopharma’s peptide, SOR-C13, for the treatment of pancreatic cancer, following a similar designation for ovarian cancer
In a statement, Paul Gunn, president and CEO of Soricimed, said receiving orphan drug status in both ovarian and pancreatic cancer highlights the unmet medical need and the potential of SOR-C13 to address these devastating cancers.
US Oncology Research will participate in Mateon Therapeutics’ (NASDAQ:MATN) FOCUS clinical trial in platinum-resistant ovarian cancer.
In a statement, Dr. William Schwieterman, president and CEO of Mateon, said US Oncology Research is selective about the studies it participates in. “So we are pleased they recognize the importance of developing CA4P for women with platinum-resistant ovarian cancer,” he added.
Ladenburg Thalmann has initiated coverage of BioTime (NYSE MKT, TASE:BTX) with a “buy” rating and $6 price target. The stock closed at $3.59 on Thursday.
“We view BioTime as roughly halfway through a restructuring designed to unlock shareholder value through separation of non-core assets and accelerated development of the company's cell therapy programs in ophthalmetry, aesthetics and orthopedics,” writes analyst Kevin DeGeeter.
Australia-based Global Kinetics has received 510(k) marketing clearance from the FDA for its next generation, wrist-worn Parkinson’s KinetiGraph (PKG) System.
The new PKG technology enables a shift to “anywhere, anytime” monitoring 24/7/365 as well as data capture for people with Parkinson’s disease.
Roth Capital Partners has initiated coverage of Kiadis Pharma (Euronext Amsterdam and Brussels: KDS) with a “buy” rating and price target of €17. The stock closed at €11.32 on Wednesday.
“We believe Kiadis Pharma warrants attention from investors because it has zeroed in on an area of high unmet medical need and is planning to take its lead program, ATIR-101, into a well-designed Phase 3 trial later this year,” writes analyst Mark Breidenbach.
A new study of Antibe Therapeutics’ (OTCQB:ATBPF; TSX-V:ATE) ATB-346 drug candidate has shown promising results in the chemoprevention and treatment of melanoma in mice.
The article was published online in the September issue of the peer-reviewed journal, Pharmacological Research. It can be viewed here.
H.C. Wainwright has launched coverage of OncoMed Pharmaceuticals (NASDAQ:OMED) with a “buy” rating and $20 price target. The stock closed at $11.87 on Wednesday.
“We believe OncoMed is entering a year of dramatic changes with upcoming opt-in decisions for its lead drug candidates expected from its three partners: Celgene, Bayer and GlaxoSmithKline,” writes analyst Shaunak Deepak.
The first patient has been treated in Profound Medical’s (TSX-V:PRN) TACT pivotal trial at Vanderbilt University Medical Center in Nashville, TN.
TACT is a prospective, single-arm pivotal clinical study of 110 patients aimed at further evaluating the safety and efficacy of TULSA-PRO to ablate prostate tissue in patients with localized, organ-confined prostate cancer. Multiple sites in the U.S., Germany, Netherlands, Spain and Canada will participate in the trial.