On March 6, 2020 AstraZeneca reported that the Phase III DANUBE trial for Imfinzi (durvalumab) and Imfinzi plus tremelimumab in unresectable, Stage IV (metastatic) bladder cancer did not meet the primary endpoints of improving overall survival (OS) versus standard-of-care (SoC) chemotherapy for Imfinzi monotherapy in patients whose tumour cells and/or tumour-infiltrating immune cells express high levels (≥25%) of PD-L1, or for Imfinzi plus tremelimumab in patients regardless of their PD-L1 expression (Press release, AstraZeneca, MAR 6, 2020, View Source [SID1234555262]).

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José Baselga, Executive Vice President, Oncology R&D, said: "AstraZeneca remains committed to addressing unmet needs in bladder cancer and the potential for immunotherapy to improve outcomes for these patients. The results from this trial will inform our comprehensive Phase III development programme in bladder cancer. We look forward to the results of the Phase III NILE trial also in the 1st-line metastatic setting, and we continue to advance clinical trials for patients at earlier stages of the disease."

The safety and tolerability profiles for Imfinzi and the combination with tremelimumab were consistent with previous trials. The data will be presented at a forthcoming medical meeting.

Imfinzi is being developed in patients with unresectable, locally advanced or metastatic bladder cancer in the Phase III NILE trial either in combination with chemotherapy or with chemotherapy and tremelimumab. Imfinzi is also being tested in earlier stages of bladder cancer in the Phase III NIAGARA trial in combination with chemotherapy, and in the Phase III POTOMAC trial in combination with SoC Bacillus Calmette-Guerin immunotherapy.

Imfinzi is approved for patients with locally advanced or metastatic bladder cancer previously treated with platinum-containing chemotherapy in 15 countries, including the US.

Bladder cancer

In 2018, approximately 550,000 people were diagnosed with bladder cancer around the world and 200,000 died from the disease.1 Locally advanced and metastatic bladder cancer remains an area of unmet medical need and typically only one in seven patients are alive five years after diagnosis.2 Urothelial cancer (UC) is the most common form of bladder cancer.3 UC is the 10th most common cancer worldwide and the 13th most common cause of cancer death.1,4 PD-L1 is widely expressed in tumour and immune cells in patients with bladder cancer and helps tumours evade detection from the immune system.5

DANUBE

DANUBE is a randomised, open-label, multi-centre, global, Phase III trial in the 1st-line treatment of both cisplatin eligible and ineligible patients with unresectable, Stage IV (metastatic) UC. The trial compared Imfinzi monotherapy or Imfinzi plus tremelimumab versus cisplatin and gemcitabine or carboplatin and gemcitabine chemotherapy. The trial was conducted in more than 220 centres across 24 countries, including centres in the US, Canada, Europe, South America, Asia, Australia and the Middle East.

Eligible patients included those with transitional cell carcinoma of the urothelium, including renal pelvis, ureters, urinary bladder, and urethra. High PD-L1 was defined as ≥25% of tumour cells (TC) or tumour-infiltrating immune cells (IC) expressing membrane PD-L1 if ICs involved >1% of the tumour area, or TC≥25% or IC=100% if ICs involved ≤1% of the tumour area.

The primary endpoints of the trial were OS in high PD-L1 patients treated with Imfinzi monotherapy, and OS in patients treated with Imfinzi plus tremelimumab regardless of their PD-L1 status. The DANUBE trial addresses a post-approval commitment in agreement with the US Food and Drug Administration from the May 2017 accelerated US approval of Imfinzi in previously treated patients with advanced bladder cancer.

Imfinzi

Imfinzi (durvalumab) is a human monoclonal antibody that binds to PD-L1 and blocks the interaction of PD-L1 with PD-1 and CD80, countering the tumour’s immune-evading tactics and releasing the inhibition of immune responses.

Imfinzi is approved in the curative-intent setting of unresectable, Stage III non-small cell lung cancer (NSCLC) after chemoradiation therapy in 61 countries, including the US, Japan, China and across the EU, based on the Phase III PACIFIC trial. Imfinzi recently received its first global approval for the 1st-line treatment of extensive-stage small cell lung cancer (ES-SCLC) in combination with SoC chemotherapy in Singapore.

As part of a broad development programme, Imfinzi is also being tested as a monotherapy and in combinations including with tremelimumab, an anti-CTLA4 monoclonal antibody and potential new medicine, as a treatment for patients with NSCLC, SCLC, bladder cancer, head and neck cancer, liver cancer, biliary tract cancer, cervical cancer and other solid tumours.

Tremelimumab

Tremelimumab is a human monoclonal antibody and potential new medicine that targets the activity of cytotoxic T-lymphocyte-associated protein 4 (CTLA-4). Tremelimumab blocks the activity of CTLA-4, contributing to T cell activation, priming the immune response to cancer and fostering cancer cell death. Tremelimumab is being tested in a clinical trial programme in combination with Imfinzi in NSCLC, SCLC, bladder cancer, head and neck cancer and liver cancer.

AstraZeneca’s approach to Immuno-Oncology (IO)

Immuno-oncology (IO) is a therapeutic approach designed to stimulate the body’s immune system to attack tumours. The Company’s IO portfolio is anchored by immunotherapies that have been designed to overcome anti-tumour immune suppression. AstraZeneca believes that IO-based therapies offer the potential for life-changing cancer treatments for the clear majority of patients.

The Company is pursuing a comprehensive clinical-trial programme that includes Imfinzi as a monotherapy and in combination with tremelimumab in multiple tumour types, stages of disease, and lines of therapy, and where relevant using the PD-L1 biomarker as a decision-making tool to define the best potential treatment path for a patient. In addition, the ability to combine the IO portfolio with radiation, chemotherapy, small targeted molecules from across AstraZeneca’s Oncology pipeline, and from research partners, may provide new treatment options across a broad range of tumours.

AstraZeneca in Oncology

AstraZeneca has a deep-rooted heritage in oncology and offers a quickly growing portfolio of new medicines that has the potential to transform patients’ lives and the Company’s future. With six new medicines launched between 2014 and 2020, and a broad pipeline of small molecules and biologics in development, the Company is committed to advance oncology as a key growth driver for AstraZeneca focused on lung, ovarian, breast and blood cancers. In addition to AstraZeneca’s main capabilities, the Company is actively pursuing innovative partnerships and investments that accelerate the delivery of our strategy, as illustrated by the investment in Acerta Pharma in haematology.

By harnessing the power of four scientific platforms – Immuno-Oncology, Tumour Drivers and Resistance, DNA Damage Response and Antibody Drug Conjugates – and by championing the development of personalised combinations, AstraZeneca has the vision to redefine cancer treatment and one day eliminate cancer as a cause of death.

On March 6, 2020 Cumberland Pharmaceuticals Inc. (NASDAQ: CPIX) reported the rescheduling of its fourth quarter and annual 2019 financial results and company update from Wednesday, March 11, 2020 to Wednesday, March 18, 2020 after market close (Press release, Cumberland Pharmaceuticals, MAR 6, 2020, View Source [SID1234555284]). A conference call and live Internet webcast will be held on Wednesday, March 18, at 4:30 p.m. Eastern Time to discuss the results.

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To participate in the call, please dial 877-303-1298 (for U.S. callers) or 253-237-1032 (for international callers). A rebroadcast of the teleconference will be available for one week and can be accessed by dialing 855-859-2056 (for U.S. callers) or 404-537-3406 (for international callers). The Conference ID for the rebroadcast is 9759981. The live webcast and rebroadcast can be accessed via Cumberland’s website at View Source

Cumberland Pharmaceuticals Inc. is a specialty pharmaceutical company focused on the delivery of high quality prescription brands to improve patient care. The Company develops, acquires and commercializes brands for the hospital acute care, gastroenterology and oncology market segments. These medical specialties are categorized by moderately concentrated prescriber bases that we believe can be penetrated effectively by targeted sales forces. The Company’s portfolio of FDA approved brands includes:

Acetadote (acetylcysteine) Injection, for the treatment of acetaminophen poisoning;
Caldolor (ibuprofen) Injection, for the treatment of pain and fever;
Kristalose (lactulose) for Oral Solution, a prescription laxative, for the treatment of chronic and acute constipation;
Omeclamox-Pak, (omeprazole, clarithromycin, amoxicillin) for the treatment of Helicobacter pylori (H. pylori) infection and related duodenal ulcer disease;
Vaprisol (conivaptan) Injection, to raise serum sodium levels in hospitalized patients with euvolemic and hypervolemic hyponatremia;
Vibativ (telavancin) Injection, for the treatment of certain serious bacterial infections including hospital-acquired and ventilator-associated bacterial pneumonia, as well as complicated skin and skin structure infections.
RediTrex (methotrexate) Injection, for the treatment of active rheumatoid, juvenile idiopathic and severe psoriatic arthritis, as well as disabling psoriasis.
For more information on Cumberland’s approved products, including full prescribing information, please visit the individual product websites, links to which can be found on the Company’s website www.cumberlandpharma.com.

The Company has Phase II clinical programs underway evaluating its ifetroban product candidates in patients with cardiomyopathy associated with Duchenne Muscular Dystrophy ("DMD"), Systemic Sclerosis ("SSc"), and Aspirin-Exacerbated Respiratory Disease ("AERD"), Hepatorenal Syndrome ("HRS") and Portal Hypertension ("PH").

On March 6, 2020 Bio-Path Holdings, Inc., (NASDAQ:BPTH), a biotechnology company leveraging its proprietary DNAbilize antisense RNAi nanoparticle technology to develop a portfolio of targeted nucleic acid cancer drugs, reported its financial results for the full year ended December 31, 2019 and provided an update on recent corporate developments (Press release, Bio-Path Holdings, MAR 6, 2020, View Source [SID1234555265]).

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"The significant progress we made throughout 2019 has laid the foundation for Bio-Path to achieve a number of key clinical milestones in the coming year and beyond. Importantly, we strengthened our balance sheet in 2019, giving us the financial underpinning to support our clinical programs through to a number of value-creating inflection points," stated Peter Nielsen, President and Chief Executive Officer of Bio-Path Holdings.

"We entered 2020 well positioned to execute on our clinical development strategy. Following the successful completion of the safety testing in Stage 2 of our Phase 2 Clinical Trial of prexigebersen in Acute Myeloid Leukemia (AML), we now plan to advance this program to its next stage in the first half of 2020. In addition, we filed an Investigational New Drug (IND) application for prexigebersen in the treatment of solid tumors including ovarian and endometrial cancer and expect to start that study later this year.

"We also are in the process of initiating a Phase 1 study of our second pipeline candidate, BP1002 (liposomal Bcl-2), in the first half of this year to evaluate the ability of BP1002 to treat refractory/relapsed lymphoma and chronic lymphocytic leukemia patients. Finally, we are nearing completion of IND-enabling studies of BP1003, our novel liposome-incorporated STAT3 oligodeoxynucleotide inhibitor, for the treatment of solid tumors, and expect to file an IND application for a Phase 1 study of BP1003 for the treatment of solid tumors, including pancreatic cancer, in 2020," concluded Mr. Nielsen.

Recent Corporate Highlights

·Raised $8.0 Million in Registered Direct Offering. In November 2019, Bio-Path issued and sold 808,080 shares of its common stock and warrants to purchase up to 606,060 shares of its common stock, at a combined purchase price of $9.90 per share and associated warrant, for aggregate gross proceeds of approximately $8.0 million.

·Announced Clearance of Investigational New Drug Application for BP1002. In November 2019, Bio-Path announced that the U.S. Food and Drug Administration (FDA) has reviewed and cleared the IND application for BP1002 (liposomal Bcl-2), the Company’s second drug candidate. An initial Phase 1 clinical trial will evaluate the ability of BP1002 to treat refractory/relapsed lymphoma and chronic lymphocytic leukemia patients.

·Successfully Completed Safety Testing in Stage 2 of Phase 2 Clinical Trial in Acute Myeloid Leukemia. In November 2019, Bio-Path announced the successful completion of the safety testing of prexigebersen in combination with decitabine in acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) patients in Stage 2 of the Phase 2 clinical study. The safety segment of Stage 2 of the Phase 2 clinical trial comprised six evaluable patients who were treated with the combination of prexigebersen and decitabine.

Financial Results for the Full Year Ended December 31, 2019

·The Company reported a net loss of $8.6 million, or $3.24 per share, for the year ended December 31, 2019, compared to a net loss of $8.6 million, or $14.38 per share, for the year ended December 31, 2018.

·Research and development expense for each of the years ended December 31, 2019 and December 31, 2018 was $4.6 million.

·General and administrative expense for the year ended December 31, 2019 increased to $4.1 million, compared to $3.4 million for the year ended December 31, 2018, primarily due to increased legal fees and salaries and benefits expense.

·As of December 31, 2019, the Company had cash of $20.4 million, compared to $1.0 million at December 31, 2018. Net cash used in operating activities for the year ended December 31, 2019 was $8.4 million compared to $6.1 million for the comparable period in 2018. Net cash provided by financing activities for the year ended December 31, 2019 was $27.8 million.

Conference Call and Webcast Information

Bio-Path Holdings will host a conference call and webcast today at 8:30 a.m. ET to review these full-year 2019 financial results and to provide a general update on the Company. To access the conference call, please call (844) 815-4963 (domestic) or (210) 229-8838 (international) and refer to conference ID 7152658. A live audio webcast of the call and the archived webcast will be available on the Company’s website at www.biopathholdings.com.

On March 6, 2020 Ardelyx, Inc. (Nasdaq: ARDX), a specialized biopharmaceutical company focused on developing first-in-class medicines to improve treatment choices for people with cardiorenal diseases, reported business highlights and financial results for the fourth quarter and full year ended December 31, 2019 (Press release, Ardelyx, MAR 6, 2020, View Source [SID1234555285]).

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"2019 was a year of significant progress at Ardelyx. We successfully hit all of our key milestones bringing us closer to submitting a New Drug Application to the FDA for tenapanor for the control of serum phosphorus in adult patients with CKD on dialysis in mid-2020 and potentially providing this first in class agent to patients in need," said Mike Raab, president and chief executive officer of Ardelyx. "We enter 2020 well-positioned with data from three successful Phase 3 trials for tenapanor in hyperphosphatemia, key ex-U.S. partnerships and two years of cash on hand to prepare for U.S. commercialization of our novel therapy."

Key Accomplishments in 2019

Published positive Phase 3 results of tenapanor for the treatment of hyperphosphatemia in the Journal of the American Society of Nephrology.
Appointed renowned nephrologist, Geoffery A. Block, M.D., to the company’s board of directors.
Began the process of building a highly talented and experienced cardiorenal commercial team.
Announced positive, statistically significant results from the Phase 3 AMPLIFY study evaluating tenapanor in dialysis patients who have uncontrolled hyperphosphatemia despite phosphate binder treatment.
Received FDA approval for IBSRELA (tenapanor). The company continues to seek a strategic partner to market IBSRELA in the United States.
Expanded collaborative partnership with Kyowa Kirin Co., Ltd (KKC) with a new research agreement and a $20.0 million equity investment in Ardelyx under a Stock Purchase Agreement.
Announced positive topline results from the PHREEDOM study evaluating tenapanor as a monotherapy for the control of serum phosphorus in patients with chronic kidney disease (CKD) on dialysis. The PHREEDOM study met its primary endpoint demonstrating a statistically significant difference in least square (LS) mean serum phosphorus change (-1.4 mg/dL, p<0.0001), as compared to placebo.
Raised approximately $135 million, net of underwriting discounts and commissions, following a successful underwritten public offering of 23,000,000 shares of common stock to support commercial launch preparation for tenapanor for the control of serum phosphorus in patients with CKD on dialysis. The capital raised in the fourth quarter of 2019 extends the company’s cash runway into early 2022, based on its current operating plan.
Initiated the Phase 4 NORMALIZE study and announced initial results demonstrating that a significant number of patients achieved normal serum phosphorus levels with tenapanor alone or with tenapanor and only one to three sevelamer tablets a day.
On-Track to Submit NDA for Tenapanor for the Control of Serum Phosphorus in mid-2020: Ardelyx is on-track to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for tenapanor for the control of serum phosphorus in mid-2020.

Full Year 2019 Financial Results

Cash Position: As of December 31, 2019, Ardelyx had total capital resources including cash, cash equivalents and short-term investments of $247.5 million compared to total capital resources including cash, cash equivalents and short-term investments of $168.1 million as of December 31, 2018.
Revenue and Cost of Revenue: Total revenues were $5.3 million for the year ended December 31, 2019 related to the company’s ex-U.S. collaboration partnerships, and cost of revenues was $0.6 million related to payments due to AstraZeneca in accordance with the company’s termination agreement entered into with AstraZeneca in June 2015 compared to total revenues of $2.6 million and cost of revenues of $0.5 million for the year ended December 31, 2018.
R&D Expenses: Research and development expenses were $71.7 million for the year ended December 31, 2019, an increase of $2.3 million, or 3%, compared to $69.4 million for the year ended December 31, 2018. The increase consisted of a $3.7 million increase in our internal program costs and a $1.4 million decrease in our external program costs. The increase in our internal costs of $3.7 million was primarily due to an increase in headcount and related personnel costs and an increase in stock-based compensation expenses. The decrease in our external program costs of $1.4 million included a $4.6 million decrease in expenses primarily related to manufacturing of tenapanor and regulatory expenses related to our IBS-C NDA in 2018, partially offset by $2.5 million increase in clinical development expenses related to our RDX013 program and a $0.7 million increase primarily related to our tenapanor clinical trial expenses that includes an out-of-period adjustment recorded during the second quarter of 2019 that reduced clinical trial expenses by $3.6 million related to our tenapanor clinical trials.
G&A Expenses: General and administrative expenses were $24.3 million for the year ended December 31, 2019, an increase of $0.6 million, or 2%, compared to $23.7 million for the year ended December 31, 2018.
Net Loss: Net loss for the year ended December 31, 2019, was $94.9 million compared to a net loss of $91.3 million for the year ended December 31, 2018.
Financial Guidance

Ardelyx maintains its expectation that its cash, cash equivalents and short-term investments will be sufficient to fund the company’s operations until early 2022 based on its current operating plans.

On March 6, 2020 Milestone Pharmaceuticals Inc. (Nasdaq: MIST), a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines, reported financial results for the fourth quarter and year ended December 31, 2019 and provided a clinical and corporate update (Press release, Milestone Pharmaceuticals, MAR 6, 2020, View Source [SID1234555286]).

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"Our team is keenly focused on delivering the near-term topline readout of the pivotal Phase 3 efficacy and safety trial, NODE-301," said Joseph Oliveto, President and Chief Executive Officer of Milestone Pharmaceuticals. "Results from NODE-301, if favorable, have the potential to serve as the sole efficacy registration trial required for an NDA submission with the United States (U.S.) Food and Drug Administration (FDA), bringing us one step closer to providing paroxysmal supraventricular tachycardia (PSVT) patients with a much-needed novel therapeutic option. Supported by compelling results from the Phase 2 NODE-1 trial, we believe etripamil has the potential to alter the PSVT treatment paradigm as the first self-administered therapy for the rapid termination of supraventricular tachycardia (SVT) episodes wherever and whenever they occur."

Mr. Oliveto added, "As we focus on topline results from NODE-301, we remain diligent in executing on the balance of our Phase 3 program of etripamil for PSVT, including the NODE-302 and NODE-303 safety studies, preparing for the potential commercialization of etripamil, and building out our pipeline beyond PSVT. This includes the expected initiation of our first clinical trial of etripamil in patients with atrial fibrillation and rapid ventricular rate."

Recent Updates

Topline Data from NODE-301 Trial Expected This Month. Milestone expects to report topline data for the NODE-301 trial this month. The NODE-301 trial is a Phase 3, multicenter, randomized, double-blind, placebo-controlled trial of etripamil, the Company’s novel short-acting calcium channel blocker, designed to terminate SVT episodes in the at-home setting. The primary endpoint of the NODE-301 trial is time to conversion of PSVT to sinus rhythm after the administration of trial drug, as confirmed by a central independent adjudication committee. A statistically significant result for NODE-301 would support the trial’s ability to fulfill the U.S. FDA’s previously guided efficacy review requirement for etripamil.

Milestone’s pivotal Phase 3 program of etripamil in PSVT, which was designed in consultation with U.S. and European Union regulatory authorities, consists of three distinct trials: NODE-301, the sole efficacy trial; NODE-302, the ongoing open-label safety extension trial; and NODE-303, the ongoing global safety trial and the largest trial ever conducted in PSVT. Additional blinded data will be collected from randomized patients who have not yet experienced an event at the time the NODE-301 trial reaches its target number of adjudicated SVT events. These data will be analyzed separately as a secondary data set, referred to as NODE-301B, and may contribute further to sub-population analyses and pharmacoeconomic assessments of the NODE-301 trial.

Enrolled First Patient in NODE-303 Trial. In October 2019, Milestone announced enrollment of the first patient in the Company’s Phase 3 open-label, global safety trial of etripamil in patients with PSVT. The trial will primarily evaluate the safety of etripamil when self-administered without medical supervision during single or multiple SVT episodes. Important secondary measures include efficacy, patient quality of life and pharmacoeconomic assessments. The trial will enroll up to 3,000 patients in order to collect data on approximately 1,000 patients who did not participate in NODE-301 or its open-label safety extension trial, NODE-302.

Jeff Nelson Promoted to Chief Operating Officer. Milestone reported the recent promotion of Jeff Nelson to Chief Operating Officer. Mr. Nelson, who joined the Company in 2018 as Vice President of Program Management, brings to this new role over 15 years of experience in the pharmaceutical and biotech field, working primarily in project management, clinical operations, regulatory affairs, drug supply and distribution and public finance.

Richard C. Pasternak, M.D. Appointed to Board of Directors. In November 2019, Milestone announced the appointment of Richard C. Pasternak, M.D. to its Board of Directors. Dr. Pasternak brings to Milestone over 40 years of clinical, academic, and biopharmaceutical industry experience in the area of cardiology.
Fourth Quarter 2019 Financial Results

As of December 31, 2019, Milestone had cash, cash equivalents, and short-term investments of $119.8 million compared to $86.0 million as of December 31, 2018, and 24.5 million shares outstanding.
Research and development expense for the fourth quarter of 2019 was $14.1 million compared with $7.3 million for the prior year period. For the full year ended December 31, 2019, research and development expense was $42.0 million compared with $16.8 million for the prior year.
General and administrative expense for the fourth quarter of 2019 was $2.3 million compared with $1.2 million for the prior year period. For the full year ended December 31, 2019, general and administrative expense was $7.0 million compared with $3.1 million for the prior year.
Commercial expense for the fourth quarter of 2019 was $2.5 million compared with $1.6 million for the prior year period. For the full year ended December 31, 2019, commercial expense was $8.9 million compared with $3.9 million for the prior year.
For the fourth quarter of 2019, operating loss was $18.9 million compared to $10.1 million for the prior year period. For the full year ended December 31, 2019, Milestone’s operating loss was $57.9 million compared to $23.8 million for the prior year.
About Paroxysmal Supraventricular Tachycardia

Paroxysmal supraventricular tachycardia (PSVT) is a rapid heart rate condition characterized by intermittent episodes of supraventricular tachycardia (SVT) that start and stop suddenly and without warning. Episodes of SVT are often associated with symptoms including palpitations, sweating, chest pressure or pain, shortness of breath, sudden onset of fatigue, lightheadedness or dizziness, fainting, and anxiety. Certain calcium channel blockers have long been approved for the treatment of PSVT as well as other cardiac conditions; however, when calcium channel blockers are used for the termination of SVT episodes, they must be administered intravenously under medical supervision, usually in an emergency department or other acute care setting.

About Etripamil

Etripamil, the Company’s lead investigational product, is designed to be a rapid response therapy for episodic cardiovascular conditions. The novel calcium channel blocker is self-administered via a nasal spray which may shift the current treatment paradigm for many patients with PSVT from the emergency department to the at-home setting. Milestone is conducting a comprehensive development program for etripamil, with Phase 3 trials underway in PSVT, and plans to commence a Phase 2 proof-of-concept trial in atrial fibrillation patients with rapid ventricular rate, with subsequent studies expected in other conditions where calcium channel blockers are utilized.