On February 11, 2020 BrainCool AB, a Swedish medical device innovator, and a world leader in medical cooling technology for therapeutic hypothermia (brain cooling) and oncology, is reported that it has completed patient recruitment in the Scandinavian multi-center pivotal trial of 180 patients to investigate the patented Cooral System for prevention of Oral Mucositis (OM), one of the most debilitating side-effects of both standard and high-dose chemotherapeutic oncology treatments (Press release, BrainCool, FEB 11, 2020, View Source [SID1234554152]).

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In the United States (U.S.), BrainCool is conducting a De Novo 510 k regulatory process, with the aim of obtaining product and market clearance for the Cooral System in the U.S. by the Food and Drug Administration (FDA). The De Novo process was introduced by the FDA for instances where a device is novel and there is therefore no suitable predicate device to support a standard 510(k) submission. To qualify for the De Novo pathway, the new device must also present no more than moderate risk.

BrainCool has been granted FDA "Expedited Access Pathway" (EAP) status and will be given priority review for the Cooral System. EAP projects address unmet medical needs for life threatening or irreversibly debilitating diseases or conditions that are subject to premarket approval applications (PMA), or are eligible for de novo requests.

"With full patient recruitment for our pivotal trial, we are opening an important new door in cancer care and treatment," said Martin Waleij, CEO BrainCool AB. "Conclusive validation that cryotherapeutic intervention with the Cooral System can safely and effectively prevent the excruciating side-effects of oral mucositis is not just a major medical milestone, it’s actually a matter of life and death."

The Cooral System intra-oral cooling device includes a disposable and thermostatically controlled mouthpiece that fills with a hypothermic liquid, which circulates through the system’s channels. As the coolant gradually reaches and maintains a consistently controlled temperature, the system reduces blood flow and exposure of tissue to radiation or chemotherapeutic agents, thus preventing adverse mucosal erythema and ulcerative reactions.

Details of the Clinical Study and the Expedited Access Pathway (EAP)

The Nordic clinical trial of 180 patients has been selected by the U.S. FDA as part of the De Novo 510 process for obtaining market clearance in the U.S. Patients have been recruited over a period of two years across five important medical centers, including the lead site, Karolinska Universitetsjukhuset in Stockholm, Sweden.

Clinical data from the Nordic trial will be applicable for FDA submission. BrainCool is currently working on a module-based application wherein the first two modules contain quality routines for product development and manufacturing. The third and final module will contain clinical data from the completed Pivotal trial and will be submitted as soon as the results are available. Thereafter FDA will review the documentation and decide on a product and market approval.

About Oral Mucositis (OM)

Oral Mucositis significantly affects the quality of life for cancer patients in terms of pain, ability to eat, swallow and talk. The symptoms are often of such severity that they result in an interruption and curtailment of therapy. OM can also lead to dose reduction of the cancer therapy and treatment delays. In many cases these patients require hospitalization. OM has a direct and significant effect on the duration of disease remission and cure rates due to its dose-limiting toxicity. In some cases, risk for infection threatens survival, and there is a significant impact on quality of life and cost of care. The presence of OM is a major driver of health-care cost. Read more: View Source

On February 11, 2020 FibroGen, Inc. (NASDAQ: FGEN) reported that it will participate in the 9th Annual SVB Leerink Global Healthcare Conference on February 25, 2020 (Press release, FibroGen, FEB 11, 2020, View Source [SID1234554170]). Enrique Conterno, Chief Executive Officer, will participate in a fireside chat at 3:30 PM Eastern Time. A live audio webcast will be available on the "Events & Presentations" section of the FibroGen website at www.fibrogen.com. A replay of the webcast will be available for 30 days.

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On February 11, 2020 Cannabics Pharmaceuticals Inc. (OTCQB: CNBX), a leader in personalized cannabinoid medicine focused on cancer and its side effects, reported that it has signed a Memorandum Of Understanding with RCK Medical Cannabis to develop cannabis chemovars targeted to treat gastro intestinal cancers (Press release, Cannabics Pharmaceuticals, FEB 11, 2020, View Source [SID1234554186]).

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RCKMC is an Israeli company, focused on breeding stable cannabis hybrid-seeds, tailor-made cannabis strains and genetic research, and a provider of a host of technologies, expertise and know-how throughout the entire medical cannabis grow cycle.

Cannabics and RCKMC plan to develop cannabis chemovars with cannabinoid profiles previously found to have antitumor properties in preclinical studies on Gastrointestinal cancers. These strains of the cannabis will be the source genetics for the development of botanically derived active pharmaceutical ingredients (API’s).

Dr. Noam Chehanovsky, CTO and Co-Founder of RCKMC commented: "We are intrigued to be involved in strain development designed to target cancer biopsies. We have a large variety of strains and nurturing expertise, which together with our proprietary breeding technologies, lead to a wide range of chemotypes to be examined by Cannabics."

Dr. Eyal Ballan, CTO and Co-Founder of Cannabics Pharmaceuticals said: "RCKMC is a pioneer in the field of plant genetics and breeding. Its expertise will synergize with Cannabics’ clinical capabilities to create the bases for proprietary drug development from seed to formulation."

On February 10, 2020 Seelos Therapeutics, Inc. (Nasdaq: SEEL), a clinical-stage biopharmaceutical company focused on the development of therapies for central nervous system disorders and rare diseases, reported the pricing of an underwritten public offering of 6,666,667 shares of its common stock, at a price to the public of $0.75 per share (Press release, Apricus Biosciences, FEB 10, 2020, View Source [SID1234554135]). In addition, the Company granted the underwriters a 45-day option to purchase up to 999,999 additional shares of its common stock to cover over-allotments, if any. All of the shares of common stock in the offering are being sold by Seelos.

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Raj Mehra, Ph.D., the President, Chief Executive Officer and Chairman of the Board of Directors of Seelos, intends to purchase shares in the offering at the public offering price.

Benchmark Company is acting as sole book-running manager for the offering.

Seelos anticipates the aggregate net proceeds from the offering will be approximately $4.3 million, after deducting the underwriting discounts and commissions and estimated offering expenses payable by Seelos, but excluding any exercise of the underwriters’ option to purchase additional shares of common stock. Seelos intends to use the net proceeds from the offering for general corporate purposes and to advance the development of its product candidates. This offering is expected to close on or about February 13, 2020, subject to the satisfaction of customary closing conditions.

The securities described above were offered by Seelos pursuant to a registration statement on Form S-1 (File No. 333-236002) previously filed with the Securities and Exchange Commission (the "SEC") and declared effective by the SEC on February 10, 2020. The securities may be offered only by means of a prospectus forming part of the effective registration statement. A preliminary prospectus relating to and describing the offering has been filed with the SEC. Electronic copies of the preliminary prospectus and, when available, copies of the final prospectus relating to the offering may be obtained by visiting the SEC’s website at www.sec.gov or by contacting The Benchmark Company, LLC, Attn: Prospectus Department, 150 E. 58th Street, 17th floor, New York, NY 10155, by calling (212) 312-6700 or by e-mail at [email protected].

This press release does 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 or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction.

On February 11, 2020 AIVITA Biomedical, Inc., a biotech company specializing in innovative stem cell applications, reported that it will be featured as a presenting company at the BIO CEO & Investor Conference conference taking place February 10-11 at the New York Marriott Marquis in New York, N.Y (Press release, AIVITA Biomedical, FEB 11, 2020, View Source [SID1234554153]). Dr. Hans S. Keirstead, AIVITA’s Chairman and CEO, will present at the following time and location:

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Date: Monday, February 10, 2020
Time: 11:15 AM ET
Location: Ziegfeld Room

The BIO CEO & Investor Conference is one of the largest independent investor conferences focused on established and emerging publicly traded and select private biotech companies. Dr. Keirstead will be presenting details on AIVITA’s platform cancer technology, a next generation immunotherapy targeting the tumor-initiating stem cells, with strong clinical data evidencing 72% survival at 2-years, and 54% survival at 5-years post-treatment. AIVITA is currently conducting three clinical studies investigating its platform immunotherapy in patients with ovarian cancer, glioblastoma and melanoma.

CLINICAL TRIAL DETAIL

OVARIAN CANCER

AIVITA’s ovarian Phase 2 double-blind study is active and enrolling approximately 99 patients who are being randomized in a 2:1 ratio to receive either the autologous tumor-initiating cell-targeting immunotherapy or autologous monocytes as a comparator.

Patients eligible for randomization and treatment will be those (1) who have undergone debulking surgery, (2) for whom a cell line has been established, (3) who have undergone leukapheresis from which sufficient monocytes were obtained, (4) have an ECOG performance grade of 0 or 1 (Karnofsky score of 70-100%), and (5) who have completed primary therapy. The trial is not open to patients with recurrent ovarian cancer.

For additional information about AIVITA’s AVOVA-1 trial patients can visit: www.clinicaltrials.gov/ct2/show/NCT02033616

GLIOBLASTOMA

AIVITA’s glioblastoma Phase 2 single-arm study is active and is enrolling approximately 55 patients to receive the tumor-initiating cell-targeting immunotherapy.

Patients eligible for treatment will be those (1) who have recovered from surgery such that they are about to begin concurrent chemotherapy and radiation therapy (CT/RT), (2) for whom an autologous tumor cell line has been established, (3) have a Karnofsky Performance Status of > 70 and (4) have undergone successful leukapheresis from which peripheral blood mononuclear cells (PBMC) were obtained that can be used to generate dendritic cells (DC). The trial is not open to patients with recurrent glioblastoma.

For additional information about AIVITA’s AV-GBM-1 trial please visit: www.clinicaltrials.gov/ct2/show/NCT03400917

MELANOMA

AIVITA’s melanoma Phase 1B open-label, single-arm study will establish the safety of administering anti-PD1 monoclonal antibodies in combination with AIVITA’s tumor-initiating cell-targeting immunotherapy in patients with measurable metastatic melanoma. The study will also track efficacy of the treatment for the estimated 14 to 20 patients. This trial is not yet open for enrollment.

Patients eligible for treatment will be those (1) for whom a cell line has been established, (2) who have undergone leukapheresis from which sufficient monocytes were obtained, (3) have an ECOG performance grade of 0 or 1 (Karnofsky score of 70-100%), (4) who have either never received treatment for metastatic melanoma or were previously treated with enzymatic inhibitors of the BRAF/MEK pathway because of BRAF600E/K mutations and (5) are about to initiate anti-PD1 monotherapy.

For additional information about AIVITA’s AV-MEL-1 trial please visit: www.clinicaltrials.gov/ct2/show/NCT03743298