On December 23, 2019 Mateon Therapeutics Inc. (OTCQB:MATN), dedicated to the development of innovative treatments for cancer, reported that the multi-institutional OXI1222 study in people with previously treated relapsed acute myeloid leukemia (AML) met its primary endpoint (Press release, Mateon Therapeutics, DEC 23, 2019, View Source [SID1234552601]).

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Patients were treated by participating leukemia experts affiliated with the University of Florida, University of Kansas Cancer Center, David Geffen School of Medicine at UCLA, and University of Miami Sylvester Comprehensive Cancer Center, Miami. This trial was registered at www.clinicaltrials.gov as NCT02576301.

The study showed that adding Mateon’s lead anti-AML drug Combretastatin A1, also known as OXi4503, to the standard chemotherapy drug cytarabine was generally well tolerated by AML patients and a maximum tolerated dose level of OXi4503 was identified as the recommended dose for further clinical development of this novel two-drug combination. In 26 evaluable AML patients, there were 4 complete remissions (CR/CRi) and one partial remission (PR). The CR responses were associated with >1-year overall survival times. The combination therapy exhibited a manageable toxicity and a promising benefit to risk profile in older adults with relapsed AML. Four of the 5 objective responders were in the ≥65-years poor prognosis age category with adverse cytogenetic features. The safety, feasibility, and early clinical activity of this new treatment in R/R AML deserves further clinical validation in a randomized registration study. Results from the study will be presented at an upcoming medical meeting and discussed with health authorities, including the U.S. Food and Drug Administration (FDA). A peer-reviewed article detailing the clinical data was accepted for publication last Friday in the oncology journal Cancers (Basel).

"This work emphasizes our commitment to advance our investigational drug OXi4503 which shows clinical impact potential to address unmet needs in relapsed/recurrent hematologic malignancies, especially AML," stated Dr. Vuong Trieu, Chairman and Chief Executive Officer of Mateon Therapeutics.

OXi4503 has received orphan drug designation for AML in both the US and the European Union. Further, the US FDA has granted fast-track designation to OXi4503 for the treatment of relapsed/refractory AML.

"The greatest challenge in AML is relapsed or refractory disease. For relapsed or refractory AML, there is no consensus on a single re-induction regimen. By combining OXi4503 with the standard chemotherapy drug cytarabine, we hope to develop an innovative approach that improves outcomes for patients with relapsed AML, especially those who are older and have a dismal prognosis," explained Fatih Uckun, M.D., Ph.D., Chief Medical Officer of Mateon Therapeutics.

AML is the most common form of adult acute leukemia with >20,000 estimated new cases and >10,000 deaths in the United States (US) for 2019 (SEER Program, www.seer.cancer.gov). Despite recent advances in therapy, the five-year overall survival remains <30% and prognosis is grim in patients who experience a recurrence of their disease after first-line induction therapy, with <10% surviving five years after relapse. There is an urgent need for effective new treatment strategies for relapsed AML. Therefore, clinical development of new therapies has been the focal point of AML research over the last decade.

OXi4503 is cis-combretastatin A1 dipotassium diphosphate, a water-soluble prodrug of cis‑combretastatin A1 (OXi4500), a naturally occurring derivative of the South African bush willow tree, Combretum caffrum, that reversibly binds tubulin at the colchicine binding site to inhibit microtubule assembly. OXi4503 is a dual-function drug with vascular disrupting and cytotoxic properties that has exhibited single-agent anti-leukemia activity in animal models of AML and in a prior Phase 1A clinical study for relapsed/refractory (R/R) AML. Notably, the combination of OXi4503 with cytarabine in xenografted human AML models was more effective than either drug alone. The clinical safety profile of OXi4503 as a single agent has previously been evaluated in Phase 1A clinical trials. In the NCT00977210 Phase 1 dose-finding study in 43 advanced solid tumor patients, OXi4503 doses were escalated from 0.06 to 15.4 mg/m2, and 8.5 mg/m2 was defined as the MTD. In the NCT01085656 Phase 1A trial designed to evaluate the safety profile, MTD, and recommended Phase 2 dose (RP2D) of OXi4503 in patients with R/R AML and MDS, a total of 18 patients were treated with single agent OXi4503 and showed a manageable safety profile at single-agent dose levels up to of 7.81 mg/m2. There was early evidence of possible single-agent activity as one relapsed AML patient treated at the 2.5 mg/m2 dose level achieved a CRi. The primary purpose of the present multicenter Phase 1B study was to define the maximum tolerated dose and safety profile of OXi4503 and cytarabine administered in combination (OXA) in patients with relapsed/refractory R/R AML.

On December 23, 2019 Mallinckrodt plc (NYSE: MNK), a global biopharmaceutical company, reported that Mark Trudeau, President and Chief Executive Officer, and other members of management will represent the company at the 38th Annual J.P. Morgan Healthcare Conference at the Westin St. Francis on Union Square, 335 Powell St., San Francisco (Press release, Mallinckrodt, DEC 23, 2019, View Source [SID1234552598]). Mallinckrodt is scheduled to present on Monday, Jan. 13, 2020 from 9:00 a.m. to 9:55 a.m. Pacific Time.

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On December 23, 2019 Portola Pharmaceuticals, Inc. (Nasdaq: PTLA) reported that it will host an investor event to discuss expected corporate and product milestones in 2020 (Press release, Portola Pharmaceuticals, DEC 23, 2019, https://www.prnewswire.com/news-releases/portola-pharmaceuticals-to-webcast-corporate-update-on-january-14-2020-300978499.html [SID1234552597]). The event is scheduled to take place on Tuesday, January 14, at 7 a.m. PT (10 a.m. ET) and will be simultaneously webcast.

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Portola will provide updates on Andexxa and Ondexxya and its investigational hematologic compound, the oral SYK/JAK inhibitor cerdulatinib.

Webcast Details
To access the live investor webcast on Tuesday, January 14, at 7 a.m. PT (10 a.m. ET), go to the investor section of the company’s website at View Source A replay will be available for 30 days.

On December 23, 2019 Neogen Corporation (NASDAQ: NEOG) reported that its revenues for the second quarter of its 2020 fiscal year, which ended Nov. 30, were $107,803,000, compared to the previous year’s second quarter revenues of $107,098,000 (Press release, Neogen, DEC 23, 2019, View Source [SID1234552596]). Current year-to-date revenues were $209,227,000, compared to $206,724,000 for the same period a year ago.

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The second quarter was the 111th of the past 116 quarters that Neogen reported revenue increases as compared with the previous year — including all consecutive quarters in the last 14 years.

Second quarter net income was $16,276,000, or $0.31 per share, compared to the prior year’s $16,051,000, also $0.31 per share. Net income for the second quarter was benefitted by an effective tax rate of 15.3%; the rate in last year’s second quarter was 18.5%. Current year-to-date net income was $30,928,000, or $0.59 per share, compared to $31,288,000, or $0.60 per share, for the same period a year ago.

"For the quarter, we had strong performance in a number of our businesses, but we continue to fight challenges in our animal safety markets," said John Adent, Neogen’s president and chief executive officer. "Our overall genomics business continued to grow nicely, with revenues up 17%, driven by strong performance at our U.S. operations; these results were augmented by significant revenue increases at our newest global genomics locations in Australia and Canada.

"Our second quarter featured solid growth from our core food safety diagnostic product lines, including our food allergen, general sanitation, and foodborne pathogen testing products," Adent continued. "Despite continuing currency headwinds, our international revenues, which now include sales into 129 countries, increased 6% in the quarter."

Neogen’s gross margin was 47.3% of sales in its second quarter of the current year, compared to 46.7% recorded in the same quarter of the prior fiscal year. The change in margin percentage was the result of a product mix shift towards Food Safety products, which have higher margins, and gross margin improvements within our domestic genomics business. Operating income was $18,272,000, or 16.9%, for the second quarter, compared to $18,246,000, or 17.0%, in the same quarter a year ago.

"We continue to generate strong operating cash flow, but our sales results were again adversely affected by the impact of the strong dollar. In a neutral currency environment, we would have reported approximately $1 million more in revenues in the current quarter," said Steve Quinlan, Neogen’s chief financial officer. "Our balance sheet is strong, and our acquisition team is working on a number of opportunities that have the potential to drive future growth."

Revenues for the company’s Food Safety segment increased 6%, all organic, during the second quarter compared to the prior year quarter, from $53,750,000 to $56,854,000. The segment’s increase was led by a 14% rise in global sales of test kits to detect food allergens, with particular strength in sales of gluten, milk, egg and tree nut kits. This sales increase was aided by the introduction of a test kit for coconut in the past year, which represented the 19th allergen for Neogen’s comprehensive line of food allergen test kits.

Of note in the Food Safety segment’s current second quarter results was a 21% increase in sales of general sanitation tests. These tests include the product line to detect adenosine triphosphate (ATP) on food contact surfaces and in liquids. Sales of Neogen’s line of foodborne pathogen (e.g., Listeria and Salmonella) detection products also increased 11% in the current quarter compared to the prior year quarter. The increase was led by a 25% increase in sales of tests to detect Listeria, including Listeria Right Now, which detects and reports the bacteria in environmental samples in under 60 minutes — without the need to enrich samples. These increases were partially offset by a 29% decrease in sales of the company’s drug residue product line, the result of lower demand at our European distributor.

In the current quarter, revenues from international sources increased to 41% of total revenues, compared to 39% in the prior year quarter. Highlights of the current quarter included a 20% increase in revenues in our Brazilian operations, largely due to increased insecticide sales to governmental agencies, which overcame the loss of a large commercial lab customer that performs drug testing of truck and bus drivers in that country. Other international highlights within the quarter included a 7% revenue increase at our Neogen Europe operations; revenues that rose 5% at Mexico-based Neogen Latinoamerica; Neogen China’s increase of 40%, albeit from a smaller base; and Neogen Australasia’s quarterly revenue increase of 18%.

Neogen’s Animal Safety segment reported revenues of $50,949,000 for the second quarter of the 2020 fiscal year, compared to $53,348,000 in the prior year second quarter, a decrease of 4%, primarily the result of continued soft market conditions in our animal protein markets and inventory destocking within our distribution channels. Partially offsetting this was strong growth in the genomics testing business, a 28% increase in sales of the company’s disposable syringes, and a 15% increase in veterinary marking products.

Revenues from Neogen’s worldwide animal genomics business increased 17% in the second quarter of fiscal 2020 compared to the prior year. In the quarter, revenues from Neogen’s companion animal genomics business more than doubled as the company gained market share within the veterinary market. Neogen’s cattle genomics business remained strong, both for associations and for commercial producers, with revenues up from the prior year, and the company’s swine genomics business rose compared to the prior year quarter.

Neogen Corporation develops and markets products dedicated to food and animal safety. The company’s Food Safety Division markets dehydrated culture media and diagnostic test kits to detect foodborne bacteria, natural toxins, food allergens, drug residues, plant diseases and sanitation concerns. Neogen’s Animal Safety Division is a leader in worldwide biosecurity products, animal genomics testing, and the manufacturing and distribution of a variety of animal healthcare products, including diagnostics, pharmaceuticals and veterinary instruments.

On December 23, 2019 SciTech Development reported that the U.S. Food and Drug Administration (FDA) has accepted Investigational New Drug (IND) Application for ST-001 nanoFenretinide, an experimental treatment for T-cell non-Hodgkin’s lymphoma (NHL) (Press release, SciTech Development, DEC 23, 2019, View Source [SID1234552595]).

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The FDA approved IND provides clearance for ST-001 nanoFenretinide to enter the clinic. SciTech’s Phase I clinical trial will be conducted at the Rush University Medical Center (Chicago, IL) under the guidance and direction of Timothy M. Kuzel, MD, FACP, Samuel G Taylor III MD Professor of Oncology, Chief, Division of Hematology/Oncology/Cell Therapy; Deputy Director, Clinical Affairs, Rush University Cancer Center (Principal Investigator, PI). The study is planned to enroll patients with relapsed/refractory (R/R) T-Cell NHL and is scheduled to begin in mid-2020 with the potential to advance to a registration trial in late 2021.

"The IND approval is an important step to enabling the collection of first-in-human safety data for nanoFenretinide. We hope to provide required data for eventual full registration of this potential treatment for cutaneous T-cell lymphoma to meet the continuing unmet needs of this rare disease population," said Dr. Kuzel.

SciTech’s ST-001 nanoFenretinide technology is a cancer drug employing a nanoparticle suspension for intravenous administration. ST-001 is comprised of nanoparticle-sized fenretinide in a patented combination with carefully selected phospholipids. SciTech’s product pipeline includes nanoFenretinide formulations for the treatment of several cancer indications.

"FDA approval of our IND for ST-001 is a significant milestone in the development of our SciTech Drug Delivery Vehicle (SDV) program," said Earle Holsapple, President of SciTech Development. "Moving forward, and in addition to the previously granted Orphan Drug Status (Feb. 1, 2018) for the treatment of peripheral T-cell lymphoma (PTCL) and cutaneous T-cell lymphoma (CTCL), we intend to make use of other FDA expedited programs including fast track designation, priority review and expedited new drug application (NDA) approval in bringing ST-001 nanoFenretinide to market."

SciTech Development will present an update at the Biotech Showcase on Monday, January 13, 2020 at 11:15am (PST) at the Hilton San Francisco Union Square Hotel (Room: Franciscan B), 333 O’Farrell Street, San Francisco, CA. Qualified investors can register to attend Biotech Showcase free of charge and SciTech personnel will be available during the annual JPMorgan Healthcare Conference in San Francisco. For ST-001 nanoFenretinide investment and partnering opportunities contact Earle Holsapple | +1-313-263-4887 | [email protected]