On March 25, 2019 PharmaMar (PHM:MSE) reported that its Phase II trial of lurbinectedin as a single agent for the treatment of relapsed small cell lung cancer (SCLC) has achieved its primary endpoint, by both investigator review and IRC (Independent Review Committee) (Press release, PharmaMar, MAR 25, 2019, View Source [SID1234534599]).

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The primary endpoint of this trial was to measure the Overall Response Rate (ORR), with other secondary endpoints such as Duration of Response (DOR), Progression-Free Survival (PFS), Overall Survival (OS) and safety.

This multicenter, single arm, phase II clinical trial, involving 105 patients from 38 centers in nine different countries in Europe and the US, assessed the safety and efficacy of lurbinectedin in patients with relapsed SCLC.

The results will be submitted for presentation at a major medical meeting.

Around 15% to 20% of lung cancers are small cell, and it is one of the cancer types with the worst prognosis. The treatment of relapsed SCLC has not changed substantially in more than two decades. The last FDA approved new chemical entity in second line small cell lung cancer was topotecan, in 1996.

In the lurbinectedin clinical program, the SCLC indication is currently PharmaMar’s first priority. PharmaMar completed the recruitment in July 2018 of its Phase III ATLANTIS study for the treatment of relapsed SCLC. The Company is awaiting results.

Lurbinectedin was designated an Orphan Drug by the FDA in August 2018, and a positive opinion for Orphan Drug Designation by EMA was received in January 2019 for the treatment of SCLC.

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This press release does not constitute an offer to sell or the solicitation of an offer to buy securities, and shall not constitute an offer, solicitation or sale in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of that jurisdiction

On March 25, 2019 Aprea Therapeutics, a clinical-stage biotechnology company developing novel anticancer therapies targeting the p53 tumor suppressor protein, reported the appointment of Dr. Eyal C. Attar as Senior Vice President and Chief Medical Officer (Press release, Aprea, MAR 25, 2019, View Source [SID1234534615]). A trained physician in medical hematology and oncology, Dr. Attar brings nearly 20 years of medical research and clinical development experience to Aprea.

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"Dr. Attar’s deep medical and biotech industry experiences will strengthen our clinical development efforts as we continue to advance our first-in-class p53 reactivating agents in late-stage clinical studies," said Christian S. Schade, President and Chief Executive Officer of Aprea Therapeutics. "His proven leadership and focus on improving outcomes for patients with limited therapeutic alternatives is an excellent fit with Aprea’s determined strategy to advance novel oncology therapies."

"I am thrilled to join the Aprea team at this exciting time in the company’s evolution," said Dr. Attar. "I believe Aprea’s leading scientific approach in reactivating the mutated tumor suppression gene, p53, represents a new paradigm in anti-cancer treatment and a promising novel therapeutic approach for patients for whom there is tremendous need."

Dr. Attar joins Aprea from Agios Pharmaceuticals, where he was Senior Medical Director and IDH Hematology Medical Lead. Having served at Agios since 2014, Dr. Attar played a leadership role in the clinical development and approval of IDHIFA and TIBSOVO for patients with relapsed/refractory AML. Prior to Agios, he served on the clinical staff at the Massachusetts General Hospital Cancer Center, where Dr. Attar was a member of the Center for Leukemia and Assistant Professor of Medicine at Harvard Medical School. He completed his residency in Internal Medicine at Brigham and Women’s Hospital and held fellowships in hematology and oncology in the Dana-Farber Partners Cancer Care Hematology/Oncology Fellowship Program. Dr. Attar received his medical degree from the University of North Carolina School of Medicine.

On March 25, 2019 Oragenics, Inc. (NYSE American: OGEN), a leader in the development of new antibiotics against infectious diseases and effective treatments for oral mucositis, reported the closing of its previously announced underwritten public offering of 16,666,668 shares of common stock, short-term warrants to purchase up to 8,333,334 shares of common stock, and long-term warrants to purchase up to 8,333,334 shares of common stock, at a price to the public of $0.75 per share and accompanying warrants (Press release, Oragenics, MAR 25, 2019, View Source [SID1234534633]).

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Oragenics expects to receive gross proceeds of approximately $12.5 million from the offering.

H.C. Wainwright & Co. is acting as sole book-running manager for the offering.

Each short-term warrant has an exercise price of $0.75 per share of common stock, is immediately exercisable, and will expire on the earlier of (1) the eighteen-month anniversary of the date of issuance and (2) twenty-one trading days following the Company’s release of top-line data related to its Phase 2 double blind, placebo controlled clinical trial of AG013. Each long-term warrant has an exercise price of $0.90 per share of common stock, is immediately exercisable and will expire five years following the date of issuance.

The Company has granted the underwriter a 30-day option to purchase up to 2,500,000 additional shares of common stock and/or short-term warrants to purchase 1,250,000 shares of common stock and long-term warrants to purchase 1,250,000 shares of common stock of the Company at the public offering price, less underwriting discounts and commissions. The underwriter exercised its option to purchase the short-term warrants to purchase 1,250,000 shares of common stock and long-term warrants to purchase 1,250,000 shares of common stock effective as of the closing.

The Company intends to use the net proceeds of the offering to fund its AG013 research, clinical trials, pre-clinical development of the lantibiotics program, and for working capital and general corporate purposes.

The securities described above were offered pursuant to a shelf registration statement (File No. 333-213321), which was declared effective by the United States Securities and Exchange Commission ("SEC") on September 7, 2016, and additional registration statement filed pursuant to Rule 462(b) (File No. 333-230422). A final prospectus supplement relating to the offering has been filed with the SEC and is available on the SEC’s website at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to the offering may be obtained from H.C. Wainwright & Co., LLC, 430 Park Avenue, 3rd Floor, New York, NY 10022, or by calling (646) 975-6996 or by emailing [email protected] or at the SEC’s website at View Source

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the Company’s securities, nor shall there be any sale of these securities in any state or other 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 other jurisdiction

On March 25, 2019 Oasmia Pharmaceutical AB (NASDAQ: OASM) reported that the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of a type II variation application to add efficacy data to the Apealea product information (Press release, Oasmia, MAR 25, 2019, View Source [SID1234556567]).

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The marketing authorisation approval for Apealea in the EEA was based on the phase III pivotal study OAS‑07OVA. The study was conducted on 789 randomized patients with relapse of ovarian cancer disease that were treated with paclitaxel in combination with carboplatin. The results of the subpopulation analysis of the patients corresponding to the approved indication, i.e patients experiencing their first relapse, were based on 301 patients (Apealea arm) and 298 patients (Comparator arm).

The positive opinion of the application allows the product information to present all available efficacy data for Apealea for the approved indication in addition to the data describing the entire population. This change may be implemented after completion of the review process of the translation into all EU languages (and Norwegian and Icelandic) by the end of April 2019.

– This provides complete transparency to the physicians, as well as patients, regarding differences in efficacy between Apealea and solvent-based paclitaxel, says Mikael Asp, CEO

Information on subgroup analysis by relapse:

Subgroup analyses were conducted to investigate efficacy by relapse (first and second) in the per protocol (PP) and the intention-to-treat (ITT) populations. Progression free survival (PFS) and overall survival (OS) results in the PP population are presented in the tables below. In the intention-to-treat population, the hazard ratios (HR) for PFS in the subgroups of patients with first relapse and second relapse were 0.80 (95% confidence interval (CI): 0.66;0.97) and 1.04 (95% CI: 0.74;1.47), respectively. The hazard ratios for OS in patients with first and second relapse were 0.98 (95% CI: 0.79;1.21) and 1.18 (95% CI: 0.79;1.75), respectively. Thus, the results in the subgroup of patients with first relapse are consistent with the results in the overall population and in addition, there was an indication of PFS benefit for Apealea.

About epithelial ovarian cancer

Ovarian cancer is the seventh most common cancer in women. Approximately 239,000 women are annually diagnosed with ovarian cancer globally and 152,000 dies from the disease. Epithelial ovarian cancer is the most common form and accounts for about 90% of ovarian cancers. The disease is often diagnosed at an advanced staged since it has no symptoms at early stages. The five-year survival rate (i.e. survival of patients with ovarian cancer compared to survival in the general population at the same age) for ovarian cancer has been estimated to 38% in Europe. During 2018, approximately 68,000 women will be diagnosed with ovarian cancer in Europe and 45,000 are predicted to die from the disease. Carboplatin and paclitaxel are common chemotherapy drugs for treatment of ovarian cancer and are often used in combination.

About Apealea

Apealea is a Cremophor- and albumin-free formulation of the well-known cytostatic paclitaxel combined with Oasmia’s excipient technology XR17. Paclitaxel is one of the most widely used anticancer substances and is included in the standard treatment of a variety of cancers such as lung cancer, breast cancer and ovarian cancer. Apealea consists of a freeze-dried powder, which is dissolved in conventional solutions for infusion.

On March 25, 2019 Australian oncology-focused biotech company Kazia Therapeutics Ltd (ASX: KZA,NASDAQ: KZIA) reported that it has been selected to present data from the Phase I study of Cantrixil in ovarian cancer at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2019 Annual Meeting (Press release, Kazia Therapeutics, MAR 25, 2019, View Source [SID1234534572]).

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AACR’s Annual Meeting is one of the top-tier academic conferences worldwide and brings together around 20,000 representatives from academia, industry, government and advocacy organisations from across the globe. The meeting is being held from 29 March to 3 April at the Georgia World Congress Center in Atlanta, Georgia, USA.

Clinical Program Director, Daniel Berg will be presenting on Kazia’s Cantrixil Phase I in ovarian cancer at the event on 1 April 2019. Mr Berg will present data from Part A of the study — the dose escalation component — which completed recruitment in October 2018.

TRX-E-002-1 (Cantrixil), is a third-generation benzopyran molecule with activity against cancer stem cells and is being developed to treat ovarian cancer. It was developed in Australia and initial preclinical studies were conducted at Yale University. Cantrixil was granted orphan designation for ovarian cancer by the US FDA in April 2015.

The abstract presentation is entitled: Phase I Study of Intraperitoneal TRX-E-002-1 in Patients with Persistent or Recurrent Ovarian Cancer, Fallopian Tube Cancer or Primary Peritoneal Cancer: Results of Dose-Escalation Phase.

The abstract has been authored by the trial’s Principal Investigators (PIs) – led by the two primary PIs in Australia and the US: Associate Professor Jermaine Coward at the ICON Cancer Care in Brisbane, Queensland and Dr Don Dizon at the Lifespan Cancer Institute at Rhode Island Hospital. The trial is being conducted across six sites in the US and Australia as follows:

Country

State

Site

Principal Investigator

US

Rhode Island

Lifespan Cancer Institute, Providence

Dr. Don Dizon

US

Oklahoma

Stephenson Cancer Center, Oklahoma City

Assoc. Prof. Kathleen Moore

US

Texas

Mary Crowley Cancer Research Centre, Dallas

Dr. Minal Barve

Australia

Queensland

ICON Cancer Care, Brisbane

Assoc. Prof. Jermaine Coward

Australia

New South Wales

Westmead Hospital, Sydney

Prof. Paul Harnett

Australia

South Australia

Flinders Medical Centre, Adelaide

Dr. Ganessan Kichenadasse

"The key objective with Part A of the Phase I study was to assess the safety of the drug and find the right dose level to take the study to the next stage. We are delighted to be presenting our data at the AACR (Free AACR Whitepaper) meeting and we look forward to discussing our findings with clinicians and potential partners," said Cantrixil Program Director Daniel Berg.

The presentation session details are as follows:

Session Title: Phase I Clinical Trials: Part 3
Date and Time: Monday April 1, 2019 1:00 PM – 5:00 PM
Location: Georgia World Congress Center, Exhibit Hall B, Poster Section 16
Poster Board Number: 15
Permanent Abstract Number: CT091

Interested parties are encouraged to attend and can add the session to their itinerary here: View Source!/6812/session/1315

Meanwhile, the link to the abstract is here: View Source!/6812/presentation/9899

The content of the abstract and presentation is embargoed until the start of the conference when it will be available through the above link and on the Kazia website.