On January 12, 2021 Blue Earth Diagnostics, a Bracco company and recognized leader in the development and commercialization of innovative PET radiopharmaceuticals, reported that the first patient has been dosed in its Phase 3 REVELATE clinical trial of 18F-fluciclovine, a positron emission tomography (PET) imaging radiopharmaceutical being studied for potential use in detecting recurrent brain metastases (Press release, Blue Earth Diagnostics, JAN 12, 2021, View Source [SID1234573901]). The REVELATE study is a Phase 3, multi-center, single-arm imaging study being conducted in the United States. Its purpose is to assess the diagnostic performance of 18F-fluciclovine PET in detecting recurrent brain metastases in patients previously treated with radiation therapy. The first patient dosed in the study was at Yale University, New Haven, Conn., under the auspices of Dr. Mariam Aboian, Assistant Professor of Radiology.

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Note: 18F-fluciclovine, under the tradename Axumin (fluciclovine F 18) injection, is an FDA-approved and commercially available molecular imaging radiopharmaceutical for use in PET imaging in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following prior treatment. The safety and efficacy of 18F-fluciclovine PET imaging for the detection of recurrent brain metastases has not been established.

Blue Earth Diagnostics has two clinical studies underway to investigate the use of 18F-fluciclovine PET in the detection of recurrent brain metastases. The Phase 2 PURSUE trial is designed to establish image interpretation criteria for 18F-fluciclovine PET in detecting recurrent brain metastases. REVELATE is a Phase 3 study designed to evaluate its diagnostic performance in the detection of recurrent brain metastases in patients previously treated with radiation therapy. Further information about these trials, including a current list of clinical trial sites, can be found on www.clinicaltrials.gov (PURSUE, NCT04410367; REVELATE, NCT04410133).

"The mission of Blue Earth Diagnostics is to develop novel PET radiopharmaceuticals to address unmet medical needs and inform the management and care of patients with cancer. With these two clinical trials now underway, we are hopeful that our efforts may help patients with recurrent metastatic brain cancer," said Jonathan Allis, D. Phil., Executive Chairman of Blue Earth Diagnostics. "Blue Earth Diagnostics’ initial focus for 18F-fluciclovine has been on the successful development and commercialization of Axumin in the United States and Europe for the detection and localization of recurrent prostate cancer, where it has become widely adopted as the standard of care and commercially administered to more than 110,000 U.S. patients. Broadening our 18F-fluciclovine franchise into neuro-oncology is part of our overall growth strategy for the company. This rapid advancement of 18F-fluciclovine into Phase 3 clinical development marks a significant milestone for Blue Earth Diagnostics and is testimony to the proven expertise of the team."

"Brain metastases occur in up to 40% of patients with cancer, and approximately 200,000 patients in the United States are affected by brain tumors each year," said Samuel T. Chao, MD, Department of Radiation Oncology, Cleveland Clinic; Professor at the Cleveland Clinic Lerner College of Medicine of Case Western Reserve University, Cleveland, Ohio; and Coordinating Investigator on the REVELATE Phase 3 study. "Due to the severity of disease, accurate and timely evaluation of the presence or absence of recurrent disease is essential for informing treatment decisions, as well as facilitating much-needed research into effective therapies for these patients. Conventional magnetic resonance imaging (MRI) is considered the "gold standard" for patient follow-up, but is unable to reliably differentiate recurrent disease from necrotic (dead) tissue which can result from radiation therapy. This can present challenges for physicians in determining appropriate patient management and care. The Phase 3 REVELATE clinical study is designed to investigate the diagnostic performance of 18F-fluciclovine PET imaging as a potential decision-making aid in assessing a patient’s disease status, and we look forward to seeing the results of this clinical study."

"Guidelines and recommendations established by the Response Assessment in Neuro-Oncology (RANO) group recognize the limitations of conventional MRI. Recent recommendations in 2019 cite the potential utility of amino acid PET radiopharmaceuticals in distinguishing brain tissue changes after radiation therapy from recurrent brain metastases, while noting that data have been derived mainly from single center, retrospective studies. Consequently, a call for prospective multi-center studies has been re-iterated to validate these observations," said Peter Gardiner, MB ChB, MRCP, FFPM, Chief Medical Officer of Blue Earth Diagnostics. "In addition to its proven performance in the detection and localization of recurrent prostate cancer and, based on its mechanism of action, 18F-fluciclovine holds potential clinical utility for the detection of other cancers. Being an amino acid-based PET radiopharmaceutical, 18F-fluciclovine is designed to visualize the increased amino acid transport that occurs in malignant tumors, including in brain metastases that can recur after radiation therapy. The preferential uptake of 18F-fluciclovine into cancer cells should enable this recurrent disease to be reliably detected."

About the REVELATE and PURSUE Clinical Trials in Brain Metastases

The REVELATE study ("Study to Establish the Diagnostic Performance of 18F-fluciclovine PET in Detecting Recurrent Brain Metastases") is an open-label, single-arm, single-dose, prospective, multi-center Phase 3 study designed to establish the diagnostic performance of 18F-fluciclovine PET in detecting recurrent brain metastases after radiation therapy. The study is planned to enroll approximately 150 patients at clinical sites in the United States. The primary endpoint of the REVELATE study is to assess the Negative Percent Agreement (NPA) and Positive Percent Agreement (PPA) of 18F-fluciclovine PET in detecting recurrent brain metastases on a patient level. Secondary endpoints will assess the Positive Predictive Value (PPV) and Negative Predictive Value (NPV) of 18F-fluciclovine PET for detecting recurrent brain metastases, among others. Additional information about the Phase 3 REVELATE trial is available at: www.clinicaltrials.gov (NCT04410133).

Blue Earth Diagnostics’ PURSUE study ("Study to Establish Image Interpretation Criteria for 18F-fluciclovine PET in Detecting Recurrent Brain Metastases") is an open-label, single-arm, single-dose, prospective, multi-center Phase 2b study designed to establish image interpretation criteria for 18F-fluciclovine PET in detecting recurrent brain metastases after radiation therapy.The primary endpoint of the PURSUE study is to assess the diagnostic performance of various thresholds of 18F-fluciclovine uptake in lesions based on visual reads versus histopathological analysis. It is anticipated to enroll approximately 40 patients at sites in the United States. More information about the PURSUE trial is available at: www.clinicaltrials.gov (NCT04410367).

About 18F-Flucivlovine PET and Recurrent Brain Metastases

18F-flucivlovine PET is a novel diagnostic imaging radiopharmaceutical for PET imaging to visualize the increased amino transport that occurs in malignant tumors. It consists of a synthetic amino acid that is preferentially taken up by cancer cells compared with surrounding normal tissues and is labeled with the radioisotope 18F for PET imaging. 18F-flucivlovine is under investigation by Blue Earth Diagnostics for potential use in adults for the detection of recurrent brain metastases in patients who have previously undergone radiation therapy. 18F-fluciclovine, under the tradename Axumin (fluciclovine F 18), is approved by the U.S. Food and Drug Administration (FDA) and in the EU for PET imaging in men with recurrent prostate cancer. 18F-fluciclovine was invented at Emory University, in Atlanta, Ga., with much of the fundamental clinical development carried out by physicians at Emory University’s Department of Radiology and Imaging Sciences. Blue Earth Diagnostics licensed 18F-fluciclovine from GE Healthcare and is investigating the molecule for other potential cancer indications, including in neuro-oncology.

About Metastatic Brain Tumors

Brain metastases occur in up to 40% of patients with cancer, and are the most common intracranial tumor in adults. Approximately 200,000 patients in the United States are affected by brain tumors each year. The most frequent causes for metastatic spread to the brain arise from lung, breast, colorectal or kidney cancers or from melanoma.

Current treatment options for patients with metastatic brain tumors include surgery, and radiation therapy, which is sometimes combined with systemic treatment. Assessment of metastatic brain tumors typically involves magnetic resonance imaging (MRI). More than half of patients have at least one lesion increase in size on MRI following radiation therapy, which may indicate either recurrent disease or necrotic (dead) tissue resulting from the radiation therapy. Accurate and timely evaluation for the presence or absence of recurrent disease is essential for informing management decisions. However, diagnostic uncertainty exists, arising from limitations of MRI to reliably differentiate recurrent disease from necrotic tissue. This can present challenges for physicians in making determining appropriate patient management and care.

Indication and Important Safety Information About Axumin

INDICATION

Axumin (fluciclovine F 18) injection is indicated for positron emission tomography (PET) imaging in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following prior treatment.

IMPORTANT SAFETY INFORMATION

Image interpretation errors can occur with Axumin PET imaging. A negative image does not rule out recurrent prostate cancer and a positive image does not confirm its presence. The performance of Axumin seems to be affected by PSA levels. Axumin uptake may occur with other cancers and benign prostatic hypertrophy in primary prostate cancer. Clinical correlation, which may include histopathological evaluation, is recommended.
Hypersensitivity reactions, including anaphylaxis, may occur in patients who receive Axumin. Emergency resuscitation equipment and personnel should be immediately available.
Axumin use contributes to a patient’s overall long-term cumulative radiation exposure, which is associated with an increased risk of cancer. Safe handling practices should be used to minimize radiation exposure to the patient and health care providers.
Adverse reactions were reported in ≤ 1% of subjects during clinical studies with Axumin. The most common adverse reactions were injection site pain, injection site erythema and dysgeusia.
To report suspected adverse reactions to Axumin, call 1-855-AXUMIN1 (1-855-298-6461) or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

On January 12, 2021 Theratechnologies Inc. ("Theratechnologies" or the "Company") (TSX: TH) (NASDAQ: THTX) ), a biopharmaceutical company focused on the development and commercialization of innovative therapies, reported that it has entered into an agreement with a syndicate of Canadian underwriters (collectively, the "Underwriters"), pursuant to which the Underwriters have agreed to purchase, on a bought-deal basis, 14,546,000 units of the Company (the "Units") for aggregate gross proceeds to the Company of US$40,001,500 (equivalent to approximately C$51,081,915) (the "Offering") at a price of US$2.75 per Unit (equivalent to approximately C$3.51 per Unit) (Press release, Theratechnologies, JAN 12, 2021, View Source [SID1234573900]).

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Each Unit shall be comprised of one common share of the Company (each a "Common Share") and one-half of one Common Share purchase warrant of the Company (each whole warrant, a "Warrant"). Each Warrant shall entitle the holder thereof to purchase one Common Share at an exercise price of US$3.18 (equivalent to approximately C$4.06) at any time up to 36 months from the closing of the Offering.

The Company has granted to the Underwriters an option (the "Over-Allotment Option") to increase the size of the Offering by up to an additional number of Units, and/or the components thereof, that in aggregate would be equal to 15% of the total number of Units to be issued under the Offering, to cover over-allotments, if any, and for market stabilization purposes, exercisable at any time and from time to time up to 30 days following the closing of the Offering.

The net proceeds from the Offering will be used primarily to fund research and development activities, commercialisation initiatives, general and administrative expenses, working capital needs and other general corporate purposes.

The closing of the Offering is expected to occur on or about January 19, 2021 (the "Closing") and is subject to the Company receiving all necessary regulatory approvals, including the approval of the Toronto Stock Exchange (the "TSX") to list, on the date of Closing, the Common Shares and the Common Shares issuable upon exercise of the Warrants thereon. The Company agreed to use its commercial reasonable efforts to list the Warrants on the TSX on the date of Closing.

This press release is not an offer to sell or the solicitation of an offer to buy the securities in the United States or in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to qualification or registration under the securities laws of such jurisdiction. The securities being offered have not been, nor will they be, registered under the United States Securities Act of 1933, as amended, and such securities may not be offered or sold within the United States or to, or for the account or benefit of, U.S. persons absent registration or an applicable exemption from U.S. registration requirements and applicable U.S. state securities laws.

On January 12, 2021 AbbVie (NYSE: ABBV) reported that it will announce its fourth-quarter and full-year 2020 financial results on Wednesday, February 3, 2021, before the market opens (Press release, AbbVie, JAN 12, 2021, View Source [SID1234573899]). AbbVie will host a live webcast of the earnings conference call at 8 a.m. Central time. It will be accessible through AbbVie’s Investor Relations website investors.abbvie.com. An archived edition of the session will be available later that day.

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On January 12, 2021 Inspyr Therapeutics, Inc. (OTC: NSPX), a pharmaceutical company focused on the research and development of novel targeted precision therapeutics for the treatment of cancer, reported the sale of $500,000 of a senior convertible debenture ("Debenture") from an existing institutional investor to pursue the research and development of the company’s novel portfolio of adenosine receptor antagonists and for general corporate purposes (Press release, Inspyr Therapeutics, JAN 12, 2021, View Source [SID1234573897]).

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The Debenture (i) is non-interest bearing, (ii) has a maturity date of January 12, 2022, (iii) is convertible into shares of common stock at the election of the Investor at any time, subject to beneficial ownership limitations and (iv) has a conversion price equal to the lesser of $0.33 and 85% of the lowest Volume Weighted Average Price (VWAP) during the five (5) Trading Days immediately prior to the conversion date, subject to adjustment, as further described in the Debenture.

The securities offered have not been registered under the Securities Act of 1933, as amended, and may not be offered or sold in the United States absent registration or an applicable exemption from registration requirements. This current report shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state.

The company continues to execute on implementing its new corporate strategy by strengthening its portfolio and securing additional capital to pursue long-term strategic objectives and create value for stakeholders. Recently the company announced it strengthened its global intellectual property with the expansion of 18 additional issued patents in potential future commercial markets including the United States, Europe, the United Kingdom, Asia and other geographies. This newly issued intellectual property supports the research and development of RT-AR001, a potential first-in-class adenosine receptor modulator, and further business development initiatives.

The company is now in the process of commencing corporate operations including: pre-clinical research and development, manufacturing, regulatory and business development. The company is dedicated to continuing to execute its new corporate strategy and will provide timely updates to shareholders.

For a further description of the Debenture, please refer to the company’s Form 8-K filed on January 12, 2021.

On January 12, 2020 Boston Scientific Corporation (NYSE: BSX) reported net sales, based upon preliminary unaudited financial information, of approximately $2.71 billion during the fourth quarter of 2020 (Press release, Boston Scientific, JAN 12, 2021, View Source [SID1234573896]). This represents a decline of approximately (6.8) percent on a reported basis, approximately (8.3) percent on an operational1 basis and approximately (8.0) percent on an organic2 basis, all compared to the prior year period. Included within organic results is a negative 370 basis point impact associated with the conversion of U.S. WATCHMAN customers to a consignment inventory model and transition to the next-generation WATCHMAN FLX Left Atrial Appendage Closure (LAAC) Device.

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For the full year 2020, the company generated net sales, based upon preliminary unaudited financial information, of approximately $9.91 billion. This represents a decline of approximately (7.7) percent on a reported basis, approximately (7.8) percent on an operational basis and approximately (11.3) percent on an organic basis, all compared to the prior year period. Included within organic results is a negative 170 basis point impact from WATCHMAN discussed above.

Fourth quarter preliminary financial results and recent developments:

Delivered the following fourth quarter sales growth/(declines) in each reportable segment3 compared to the prior year period:
MedSurg: 1.5 percent reported, 0.1 percent operational and 1.1 percent organic
Rhythm and Neuro: (6.1) percent reported, (7.7) percent operational and organic
Cardiovascular: (12.0) percent reported, (13.5) percent operational and organic

Accelerated sequential organic growth in the Peripheral Interventions business (4.8 percent organic growth), including 12 percent growth within the Interventional Medicine3 portfolio.

Returned to growth in the MedSurg reportable segment3 (1.1 percent organic growth) in the fourth quarter, driven by recovering procedural trends and favorable site of service mix. This includes a broad-based recovery in the Endoscopy business (1.5 percent organic growth), and growth within the stone and benign prostatic hyperplasia (BPH) franchises in Urology and Pelvic Health (0.6 percent organic growth).

WATCHMAN and WATCHMAN FLX Left Atrial Appendage Closure (LAAC) Device portfolio experienced strong customer demand in the fourth quarter. Organic sales declined 56 percent, which includes a negative 74 percent impact due to the conversion to a consignment inventory model and transition discussed above, and surpassed 150,000 cumulative implants worldwide.

Achieved key milestones for the Neuromodulation business with the WaveWriter Alpha portfolio of Spinal Cord Stimulator (SCS) systems including recent U.S. Food and Drug Administration (FDA) approval and third quarter 2020 launch in Europe.

1. Operational net sales growth rates exclude the impact of foreign currency fluctuations.

2. Organic net sales growth rates exclude the impact of foreign currency fluctuations and net sales from the recent acquisitions of Vertiflex, Inc. and BTG plc (BTG), each with no prior year comparable net sales. Organic net sales growth rates also exclude the impact of the divestiture of our global embolic microspheres portfolio, a transaction entered into in connection with obtaining the antitrust clearances required to complete the BTG transaction, as well as prior period net sales associated with our intrauterine health franchise, which we divested in Q2 2020.

3. We have three historical reportable segments comprised of Medical Surgical (MedSurg), Rhythm and Neuro, and Cardiovascular, which represent an aggregation of our operating segments that generate revenues from the sale of medical devices (Medical Devices). As part of our acquisition of BTG on August 19, 2019, we acquired an Interventional Medicine business, which is now included in our Peripheral Interventions operating segment’s revenues from the date of acquisition.

4. As part of our acquisition of BTG on August 19, 2019, we acquired a specialty pharmaceuticals business (Specialty Pharmaceuticals). Subsequent to acquisition, Specialty Pharmaceuticals is now a stand-alone operating segment presented alongside our Medical Device reportable segments. Specialty Pharmaceuticals net sales are substantially U.S. based. Our chief operating decision maker (CODM) reviews financial information of our globally managed Specialty Pharmaceuticals operating segment at the worldwide level without further disaggregation into regional results. As such, Specialty Pharmaceuticals net sales are presented globally, and our Medical Devices reportable segments regional net sales results do not include Specialty Pharmaceuticals. In Q4 2020, we signed a definitive agreement to sell Specialty Pharmaceuticals. The sale is expected to close in the first half of 2021, pending customary closing conditions.

J.P. Morgan Healthcare Conference on Tuesday, January 12, 2021
Also as previously announced, Boston Scientific will participate in the virtual J.P. Morgan Healthcare Conference today. Mike Mahoney, chairman and chief executive officer, will present at approximately 8:20 a.m. EST. At 8:40 a.m. EST, Mike will be joined by Dan Brennan, executive vice president and chief financial officer, Dr. Ian Meredith, executive vice president and global chief medical officer, and Susie Lisa, vice president, Investor Relations, in a question-and-answer session with the host analyst and audience members.

A live webcast of the presentation and question-and-answer session will be available on the Investor Relations section of the Boston Scientific website at investors.bostonscientific.com. A replay of the webcast will be accessible at investors.bostonscientific.com beginning approximately one hour following the completion of the event.

Conference Call on Wednesday, February 3, 2021
As previously announced, Boston Scientific will webcast its conference call discussing financial results and business highlights for the fourth quarter and full year 2020 on Wednesday, February 3, 2021 at 8:00 a.m. EST. A live webcast of the conference call will be available on the Investor Relations section of the website at investors.bostonscientific.com. A replay of the webcast will be archived and available at investors.bostonscientific.com beginning approximately one hour following the completion of the meeting.