On November 7, 2019 MedX Health Corp. ("MedX" or the "Company") (TSX-V:MDX) reported that, pursuant to a non-brokered Private Placement Offering (the "Placement Offering"), it has completed an initial Closing of 1,251,000 Units effective November 4, 2019, to raise $150,120 from accredited investors pursuant to a Private Placement Offering announced on November 1, 2019 (Press release, MedX Health, NOV 7, 2019, View Source [SID1234550679]). Each Unit, priced at $0.12, comprises one fully paid common share and one share purchase warrant; each warrant entitles the holder to purchase one additional share at a price of $0.20 during the period up to two years from the closing date of the placement. The securities issued as a result of the Placement Offering will be restricted from trading for four months following each Closing. The Placement Offering is still open to subscribers, and further subscriptions may be accepted for further Closings. This Closing, and any further Closing of the Placement Offering, is subject to all relevant regulatory and other consents and approvals, including acceptance by the TSX Venture Exchange. In connection with the first Closing, a cash commission of $5,136 was paid and 42,800 Agent’s Warrants were issued.

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Following this Closing, MedX has 143,169,762 common shares issued and outstanding.

On November 7, 2019 Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL), reported that data related to TAVALISSE (fostamatinib disodium hexahydrate) tablets has been accepted for two poster presentations at the 61st American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition to be held December 7-10, 2019, in Orlando, FL (Press release, Rigel, NOV 7, 2019, View Source;exposition-300953564.html [SID1234550696]).

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Rigel conducted a post-hoc data analysis from a Phase 3 clinical program of TAVALISSE in adult patients with immune thrombocytopenia (ITP). In this analysis, 32 patients received fostamatinib as a second-line therapy, and 78% (25/32) achieved ≥1 platelet count of ≥50,000/µL (without rescue therapy). Adverse events were manageable and consistent with those previously reported with fostamatinib.

"These data show a high response rate in the early-line treatment of adult ITP," said Raul Rodriguez, Rigel’s President and CEO. "We believe that these data, coupled with TAVALISSE’s differentiated and targeted mechanism of action, provide an attractive treatment approach for early-line patients. These patients represent the vast majority of the adult ITP population."

Additionally, in a Phase 2 open-label study of fostamatinib in patients with warm antibody autoimmune hemolytic anemia (wAIHA), data showed that 44% (11/25) of evaluable patients met the primary efficacy endpoint of a hemoglobin (Hgb) level >10 g/dL with an increase of ≥2 g/dL from baseline by week 24. Including one late responder at week 30, the overall response rate was 48% (12/25). Adverse events were manageable and consistent with those previously reported with fostamatinib.

Fostamatinib disodium hexahydrate is an oral drug designed to inhibit spleen tyrosine kinase (SYK), a key signaling component of the body’s immune process that leads to platelet destruction in ITP and proposed red blood cell destruction in AIHA. Fostamatinib is commercially available in the U.S. under the brand name TAVALISSE (fostamatinib disodium hexahydrate) tablets and is the first and only SYK inhibitor indicated for the treatment of thrombocytopenia in adult patients with chronic ITP who have had an insufficient response to a previous treatment. TAVALISSE is currently being investigated in a Phase 3 trial for wAIHA, a rare, serious blood disorder for which there are no approved therapies.

Poster Presentations
Abstract #1069
Enhanced Responses to Fostamatinib as Second-Line Therapy and in Persistent Immune Thrombocytopenia (ITP) Patients
Session Name: 311. Disorders of Platelet Number or Function: Poster I
Presenter: Ralph Boccia
Date: Saturday, December 7, 2019
Presentation Time: 5:30 PM-7:30 PM EST
Location: Hall B (Orange County Convention Center)

Abstract #3518
Fostamatinib1, a Spleen Tyrosine Kinase (SYK) Inhibitor, for the Treatment of Warm Antibody Autoimmune Hemolytic Anemia (wAIHA): Final Results of the Phase 2, Multicenter, Open-Label Study
Session Name: 101. Red Cells and Erythropoiesis, Structure and Function, Metabolism, and Survival, Excluding Iron: Poster III
Presenter: Kerry Rogers
Date: Monday, December 9, 2019
Presentation Time: 6:00 PM – 8:00 PM EST
Location: Hall B (Orange County Convention Center)

The conference abstracts can be accessed here.

To learn more about Rigel Pharmaceuticals and TAVALISSE visit booth #415 during ASH (Free ASH Whitepaper) 2019.

About ITP
In patients with ITP (immune thrombocytopenia), the immune system attacks and destroys the body’s own blood platelets, which play an active role in blood clotting and healing. Common symptoms of ITP are excessive bruising and bleeding. People suffering with chronic ITP may live with an increased risk of severe bleeding events that can result in serious medical complications or even death. Current therapies for ITP include steroids, blood platelet production boosters (TPO-RAs) and splenectomy. However, not all patients respond to existing therapies. As a result, there remains a significant medical need for additional treatment options for patients with ITP.

About AIHA
Autoimmune hemolytic anemia (AIHA) is a rare, serious blood disorder in which the immune system produces antibodies that result in the destruction of the body’s own red blood cells. AIHA affects approximately 40,000 adult patients in the U.S. and can be a severe, debilitating disease. To date, there are no disease-targeted therapies approved for AIHA, despite the unmet medical need that exists for these patients. Warm antibody AIHA (wAIHA), the most common form of AIHA, is characterized by the presence of antibodies that react with the red blood cell surface at body temperature.

About TAVALISSE
Indication
TAVALISSE (fostamatinib disodium hexahydrate) tablets is indicated for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment.

Important Safety Information
Warnings and Precautions

Hypertension can occur with TAVALISSE treatment. Patients with pre-existing hypertension may be more susceptible to the hypertensive effects. Monitor blood pressure every 2 weeks until stable, then monthly, and adjust or initiate antihypertensive therapy for blood pressure control maintenance during therapy. If increased blood pressure persists, TAVALISSE interruption, reduction, or discontinuation may be required.
Elevated liver function tests (LFTs), mainly ALT and AST, can occur with TAVALISSE. Monitor LFTs monthly during treatment. If ALT or AST increase to >3 x upper limit of normal, manage hepatotoxicity using TAVALISSE interruption, reduction, or discontinuation.
Diarrhea occurred in 31% of patients and severe diarrhea occurred in 1% of patients treated with TAVALISSE. Monitor patients for the development of diarrhea and manage using supportive care measures early after the onset of symptoms. If diarrhea becomes severe (≥Grade 3), interrupt, reduce dose or discontinue TAVALISSE.
Neutropenia occurred in 6% of patients treated with TAVALISSE; febrile neutropenia occurred in 1% of patients. Monitor the ANC monthly and for infection during treatment. Manage toxicity with TAVALISSE interruption, reduction, or discontinuation.
TAVALISSE can cause fetal harm when administered to pregnant women. Advise pregnant women the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment and for at least 1 month after the last dose. Verify pregnancy status prior to initiating TAVALISSE. It is unknown if TAVALISSE or its metabolite is present in human milk. Because of the potential for serious adverse reactions in a breastfed child, advise a lactating woman not to breastfeed during TAVALISSE treatment and for at least 1 month after the last dose.
Drug Interactions

Concomitant use of TAVALISSE with strong CYP3A4 inhibitors increases exposure to the major active metabolite of TAVALISSE (R406), which may increase the risk of adverse reactions. Monitor for toxicities that may require a reduction in TAVALISSE dose.
It is not recommended to use TAVALISSE with strong CYP3A4 inducers, as concomitant use reduces exposure to R406.
Concomitant use of TAVALISSE may increase concentrations of some CYP3A4 substrate drugs and may require a dose reduction of the CYP3A4 substrate drug.
Concomitant use of TAVALISSE may increase concentrations of BCRP substrate drugs (eg, rosuvastatin) and P-Glycoprotein (P-gp) substrate drugs (eg, digoxin), which may require a dose reduction of the BCRP and P-gp substrate drug.
Adverse Reactions

Serious adverse drug reactions in the ITP double-blind studies were febrile neutropenia, diarrhea, pneumonia, and hypertensive crisis, which occurred in 1% of TAVALISSE patients. In addition, severe adverse reactions occurred including dyspnea and hypertension (both 2%), neutropenia, arthralgia, chest pain, diarrhea, dizziness, nephrolithiasis, pain in extremity, toothache, syncope, and hypoxia (all 1%).
Common adverse reactions (≥5% and more common than placebo) from FIT-1 and FIT-2 included: diarrhea, hypertension, nausea, dizziness, ALT and AST increased, respiratory infection, rash, abdominal pain, fatigue, chest pain, and neutropenia.
Please see www.TAVALISSE.com for full Prescribing Information.

To report side effects of prescription drugs to the FDA, visit www.fda.gov/medwatch or call 1-800-FDA-1088 (800-332-1088).

TAVALISSE is a trademark of Rigel Pharmaceuticals, Inc.

On November 7, 2019 Checkpoint Therapeutics, Inc. ("Checkpoint") (NASDAQ: CKPT), a clinical-stage, immunotherapy and targeted oncology company, reported financial results and recent corporate highlights for the third quarter ended September 30, 2019 (Press release, Checkpoint Therapeutics, NOV 7, 2019, View Source [SID1234550712]).

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James F. Oliviero, President and Chief Executive Officer of Checkpoint, said, "We achieved a key inflection point in September with the presentation of positive interim clinical results for cosibelimab (formerly CK-301), our fully human anti-PD-L1 antibody, at the European Society for Medical Oncology ("ESMO") Congress 2019. These compelling clinical data demonstrated anti-tumor activity across multiple advanced cancers, with a 50% objective response rate observed in cutaneous squamous cell carcinoma ("CSCC"), a 40% objective response rate observed in non-small cell lung cancer ("NSCLC"), as well as a well-tolerated safety profile across all cohorts. These results highlight the potential of cosibelimab to be potentially differentiated from other drugs in its class, in addition to our intended commercial strategy to position cosibelimab as a lower-cost alternative to available anti-PD-1/L1 mAbs. Enrollment in this trial is ongoing and, with additional data, could support the submission of an initial Biologics License Application ("BLA") for cosibelimab in CSCC. We also look forward to soon reporting additional clinical data for CK-101, our novel, oral, third-generation epidermal growth factor receptor ("EGFR") inhibitor, in order to support the potential initiation of a Phase 3 clinical trial in first-line EGFR mutation-positive NSCLC."

Financial Results:

Cash Position: As of September 30, 2019, Checkpoint’s cash and cash equivalents totaled $13.1 million, compared to $13.2 million as of June 30, 2019, and $22.0 million as of December 31, 2018, a decrease of $0.1 million for the quarter and a decrease of $8.9 million year-to-date.
R&D Expenses: Research and development expenses for the third quarter of 2019 were $3.9 million, compared to $7.8 million for the third quarter of 2018, a decrease of $3.9 million. Research and development expenses for the third quarter of 2019 included $0.2 million of non-cash stock expenses, compared to $0.6 million in stock compensation expense for the third quarter of 2018. The Company expects that for the balance of 2019, research and development expenses will continue to remain lower than the comparable period in 2018.
G&A Expenses: General and administrative expenses for the third quarter of 2019 were $1.6 million, compared to $1.5 million for the third quarter of 2018, an increase of $0.1 million. General and administrative expenses for the third quarters of 2019 and 2018 each included $0.7 million of non-cash stock expenses.
Net Loss: Net loss attributable to common stockholders for the third quarter of 2019 was $5.2 million, or $0.15 per share, compared to a net loss of $9.3 million, or $0.32 per share, for the third quarter of 2018. The net loss for the third quarter of 2019 included $0.9 million of non-cash stock expenses, compared to $1.3 million for the third quarter of 2018.

On November 7, 2019 Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) reported that management will present at the Credit Suisse Healthcare Conference on Tuesday, November 12, 2019 at 1:30 p.m. ET (Press release, Vertex Pharmaceuticals, NOV 7, 2019, View Source [SID1234550792]).

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Management’s remarks will be available live through Vertex’s website at www.vrtx.com in the "Investors" section under the "News and Events" page. A replay of the conference webcast will be archived on the company’s website.

On November 7, 2019 To raise awareness of lung cancer—the leading cancer killer of women and men—the American Lung Association and the Ad Council have launched a new phase of work this November during Lung Cancer Awareness Month for their successful "Saved By The Scan" campaign (Press release, American Lung Association, NOV 7, 2019, View Source [SID1234550847]). The campaign, created pro bono by advertising agency Hill Holliday, educates current and former smokers about the low-dose CT scan that can detect lung cancer in the early stages, when the disease is more curable.

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Consider the facts about lung cancer:

Lung cancer kills 422 people every day – approximately 18 deaths each hour, or 1 death every 3.4 minutes.
Early detection can save lives. In fact, survival rates are more than four times higher when lung cancer is detected early, but most cases are not diagnosed until later stages.
If the 8 million Americans considered at high-risk were screened, an estimated 48,000 lives would be saved.
Screening is currently underutilized, with less than 5% of those eligible getting screened.
The television spot features a pair of lungs made of matches, which slowly burn and dissolve as a narrator proclaims, "You quit smoking and thought ‘That’s that.’ But here’s the thing about lung cancer: by the time you see the symptoms, it could be too late." Revealing a room with a CT machine at its center, an uplifting voice is then heard saying, "But now, thanks to a new scan, lung cancer can be detected earlier when it is more curable. If you smoked, get scanned," ultimately encouraging current and former smokers to talk to their doctor and visit SavedByTheScan.org.

"Lung cancer screening is a powerful tool, but its lifesaving potential will never be fully realized if it’s underutilized," said Harold P. Wimmer, National President and CEO, American Lung Association. "Spreading the word about screening is essential, and the American Lung Association is proud to continue partnering with the Ad Council and Hill Holliday to raise awareness of this lifesaving test."

This iteration of the campaign raises awareness of the benefits of early detection through lung cancer screening and drives current and former smokers to take a lung cancer screening eligibility quiz at SavedByTheScan.org (SalvaTuPulmon.org in Spanish). The site also provides information about lung cancer screening and insurance coverage, and includes a section for people to share their personal stories about how they were "saved by the scan."

In the two years since "Saved By The Scan" was launched, the campaign has been flooded with stories from people who saw the ads and as a result spoke with their doctors, got the scan and caught the disease early – saving their lives.

"I saw the first Saved By The Scan video while I was watching my favorite show one night. I saw a woman climbing a mountain of cigarette butts and learned that I was potentially at high risk for lung cancer," said Milli Wilson, a 62-year-old singer and now a lung cancer screening advocate. "At my next doctor’s visit, I requested the low-dose CT scan. While I had no symptoms, I was diagnosed with early stage lung cancer and my doctor recommended a procedure to remove the mass. Today I’m a living example of how screening can save your life."

"We continue to hear reports from consumers who saw ‘Saved By The Scan’ materials, got the scan and caught the disease early," said Michelle Hillman, Chief Campaign Development Officer of the Ad Council. "When it comes to the power of communications, there’s nothing greater than saving a life and we are eager to share this new round of work, hopefully inspiring more high-risk individuals to talk to their doctors and get the scan if they are eligible."

To extend the campaign’s message further, the American Lung Association and Ad Council are releasing new TV, print, billboard, bus shelter and digital work.

"When smokers hear the words lung cancer, they are rightfully scared. But with this new scanning technology, there’s hope. With the help of our production partner, Psyop, we created a visually arresting film that will let people know lung cancer doesn’t have to be so terrifying. There’s hope," said Lance Jensen, Hill Holliday Chief Creative Officer. "Hill Holliday is proud to work with the American Lung Association and the Ad Council for the second year in a row on this amazing project."

The "Saved By The Scan" campaign has received more than $46 million in donated media support to date and has collaborated on lung cancer screening content with top-tier content platforms, including Facebook Creative Shop, The New York Post, USA Today and WebMD. The lung cancer screening eligibility quiz on SavedByTheScan.org also continues to effectively reach qualified respondents; there have been more than 291,000 quiz completions since the campaign launch, 90,000 people were found to be at high risk and were encouraged to speak with their doctor. Additionally, awareness of the lung cancer screening method has increased 75% since launch and continues to grow year over year.

The campaign targets the estimated 8 million people in the U.S. who are at high risk for lung cancer and should talk to their doctor about getting screened. A person is considered high risk for lung cancer if they: are between 55–80 years old (or between 55–77 years old and on Medicare), have a 30 pack year history of smoking (this means 1 pack a day for 30 years, 2 packs a day for 15 years, etc.), and are a current smoker, or have quit within the last 15 years.

Individuals who may be at high risk are encouraged to visit SavedByTheScan.org (English) or SalvaTuPulmon.org (Spanish), where they can take the lung cancer screening eligibility quiz and find additional information on the campaign and lung cancer.