On December 3, 2015 CTI BioPharma Corp. ("CTI") (NASDAQ and MTA: CTIC) reported that it intends to offer and sell, subject to market and other conditions, shares of its Series N-2 Preferred Stock in an underwritten public offering (the "Offering") (Press release, CTI BioPharma, DEC 3, 2015, View Source;p=RssLanding&cat=news&id=2120113 [SID:1234508395]). Each share of Series N-2 Preferred Stock will have a stated value of $1,000 per share and will be convertible at the option of the holder, at any time after issuance and subject to certain limitations, into shares of common stock.

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Subject to the consummation of the Offering, we have agreed to grant to BVF Partners L.P. the right to nominate two members of our board of directors, one of whom must both qualify as an "independent" director, as defined under the applicable rules and regulations of the U.S. Securities and Exchange Commission and The NASDAQ Stock Market LLC, and must not be considered an "affiliate" of BVF Partners.

CTI plans to use the net proceeds from this Offering to support the commercial launch of pacritinib in the U.S. for patients with myelofibrosis, to conduct additional research concerning the possible application of pacritinib in indications outside of myelofibrosis, to advance the commercialization of PIXUVRI and to support the development of tosedostat in registration-directed trials, as well as for general corporate purposes, which may include funding research and development, conducting preclinical and clinical trials, acquiring or in-licensing potential new pipeline candidates, preparing and filing possible new drug applications and general working capital.

Piper Jaffray & Co. is acting as sole book-running manager for the Offering. The securities described above are being offered by CTI pursuant to a shelf registration statement previously filed with the Securities and Exchange Commission (the "SEC"), which the SEC declared effective on December 8, 2014. A preliminary prospectus supplement related to the Offering will be filed with the SEC and will be available on the SEC’s website located at View Source Copies of the preliminary prospectus supplement and the accompanying prospectus relating to the Offering, when available, may be obtained from Piper Jaffray & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, by email to [email protected] or by telephone at (800) 747-3924.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these 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. The shares of Series N-2 Preferred Stock (and the shares of common stock into which each share of Series N-2 Preferred Stock will be convertible) will not be offered, sold or distributed, directly or indirectly, in Italy in an offer to the public of financial products under the meaning of Article 1, paragraph 1, letter t) of Legislative Decree No. 58 of February 24, 1998, as amended (the "Financial Services Act"), unless an express exemption from compliance with the restrictions on offers to the public, including, without limitation, as provided under Article 100 of the Financial Services Act and Article 34-ter of CONSOB Regulation No. 11971 of May 14, 1999, as amended, applies.

On December 3, 2015 Cellectis (Alternext: ALCLS – Nasdaq: CLLS) reported that it will host a conference call with Pfizer Inc. (PFE) and Servier on Monday, December 7, 2015 at 8:00 a.m. Eastern Time to discuss their previously announced UCART19 development collaboration (Press release, Cellectis, DEC 3, 2015, View Source [SID:1234508394]).

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UCART19 is a TALEN gene-edited allogeneic Chimeric Antigen Receptor T-Cell (CAR-T) immunotherapy developed by Cellectis. On November 19, 2015, Servier exercised its worldwide licensing option with Cellectis to UCART19 and entered into a global UCART19 license and collaboration agreement with Pfizer.

Conference Call Information
Cellectis, Pfizer and Servier management will host a conference call on Monday, December 7, 2015 at 8:00 a.m. ET to discuss UCART19 three-party collaboration.

Dial-In Numbers:
Live Participant Dial-In (Toll-Free US & Canada): 877-407-3104
Live Participant Dial-In (International): +1 201-493-6792
Replay Information:
Conference ID #: 13625168
Replay Dial-In (Toll Free US & Canada): 877-660-6853
Replay Dial-In (International): +1 201-612-7415
Expiration Date: 12/21/15
Webcast URL (Archived for 12 months):
http://cellectis.equisolvewebcast.com/12-7-UCART19

On December 3, 2015 Sunesis Pharmaceuticals, Inc. (NASDAQ:SNSS) reported that it has initiated a Compassionate Use Program for vosaroxin. The Compassionate Use Program will be made available to eligible patients in the U.S. and selected European countries diagnosed with relapsed or refractory acute myeloid leukemia (AML) and will be managed by Clinigen Group plc’s (AIM:CLIN) Idis Managed Access (MA) division (Press release, Sunesis, DEC 3, 2015, View Source;p=RssLanding&cat=news&id=2119850 [SID:1234508393]). Clinigen Group plc’s (AIM:CLIN) Idis Managed Access (MA) division.

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Vosaroxin is an investigational treatment and is currently not approved for use by any regulatory agency. Compassionate use programs are put in place to provide access to medicines for patients who have serious, or immediately life-threatening illnesses, and for whom no alternative treatment options are available. Access is provided in response to an unsolicited request from a physician for his/her patient with an unmet medical need.

"Sunesis is committed to providing patients and healthcare providers around the globe with more options for treating relapsed and refractory AML, a disease for which the standard of care has changed little in the last four decades," said Par S Hyare, VP Global Oncology Operations, Sunesis. "We are pleased to be working with Idis MA, a recognized leader in providing ethical access to medicines that address unmet needs and will be working towards gaining approval for vosaroxin in the U.S. and Europe for the treatment of relapsed and refractory AML."

Simon Estcourt, Managing Director of Idis Managed Access, Clinigen Group said: "AML is the most common acute leukemia affecting adults, with a very low survival rate, so there is a real need for new treatment options in these patients. By using our global logistical and regulatory expertise we will work with Sunesis and the AML community to provide ethical access to vosaroxin to help eligible patients who have no alternative treatment options."

For more information about Idis’ services and its Managed Access Programs, healthcare professionals may contact Idis via telephone on +44 (0)1932 824 135, fax on +44 (0)1932 824 335. To contact Idis by e-mail, U.S. physicians only use [email protected]. Physicians from all other countries please use [email protected].

About vosaroxin
Vosaroxin is an anti-cancer quinolone derivative (AQD), a class of compounds that has not been used previously for the treatment of cancer. Preclinical data demonstrate that vosaroxin both intercalates DNA and inhibits topoisomerase II, resulting in replication-dependent, site-selective DNA damage, G2 arrest and apoptosis. Both the U.S. Food and Drug Administration (FDA) and European Commission have granted orphan drug designation to vosaroxin for the treatment of AML. Additionally, vosaroxin has been granted fast track designation by the FDA for the potential treatment of relapsed or refractory AML in combination with cytarabine. Vosaroxin is an investigational drug that has not been approved for use in any jurisdiction.

On December 3, 2015 CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical research and development company specializing in oncology, reported that Daniel Levitt, MD, PhD, Executive Vice President and Chief Medical Officer, will present a corporate update at the 26th Annual Oppenheimer Healthcare Conference on Tuesday, December 8th at 3:55p.m. Eastern Time (Press release, CytRx, DEC 3, 2015, View Source;p=RssLanding&cat=news&id=2119926 [SID:1234508391]). The conference will take place at the Westin Grand Central Hotel in New York, NY.

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A live and archived webcast of the presentation will be available on the Company’s website at www.cytrx.com/investors/presentations.

About Soft Tissue Sarcoma

Soft tissue sarcoma is a cancer occurring in muscle, fat, blood vessels, tendons, fibrous tissues and connective tissue, and can arise anywhere in the body at any age. According to the American Cancer Society, there are approximately 50 types of soft tissue sarcomas. In 2013 more than 11,400 new cases were diagnosed in the U.S. and approximately 4,400 Americans died from this disease. In addition, approximately 40,000 new cases and 13,000 deaths in the U.S. and Europe are part of a growing underserved market.

About SCLC

An estimated 1.6 million new cases of lung cancer are diagnosed worldwide each year. In the Western world, approximately 13-15% of cases are SCLC, a deadly form of lung cancer associated with tobacco use. The five year survival rate is less than 7%, in part because an estimated 70% of patients have extensive disease at diagnosis. According to the National Cancer Institute, more than 30,000 new cases will be diagnosed in the USA in 2014. The estimated 2014 SCLC incidences for Europe and Asia are over 58,000 and 136,000, respectively.

About Glioblastoma Multiforme

Glioblastoma is the most common and most malignant primary brain tumor in adults and afflicts more than 12,000 new patients in the U.S. annually. The median survival after diagnosis is approximately 14 months, despite patients subsequently receiving surgical resection, radiotherapy and chemotherapy. Limited efficacy of chemotherapeutic agents has been attributed to several contributing factors including insufficient drug delivery to the tumor site through the blood / brain barrier.

About Aldoxorubicin

The widely used chemotherapeutic agent doxorubicin is delivered systemically and is highly toxic, which limits its dose to a level below its maximum therapeutic benefit. Doxorubicin also is associated with many side effects, especially the potential for damage to heart muscle at cumulative doses greater than 450 mg/m2. Aldoxorubicin combines doxorubicin with a novel single-molecule linker that binds directly and specifically to circulating albumin, the most plentiful protein in the bloodstream. Protein-hungry tumors concentrate albumin, thus increasing the delivery of the linker molecule with the attached doxorubicin to tumor sites. In the acidic environment of the tumor, but not the neutral environment of healthy tissues, doxorubicin is released. This allows for greater doses (3 ½ to 4 times) of doxorubicin to be administered while reducing its toxic side effects. In studies thus far there has been no evidence of clinically significant effects of aldoxorubicin on heart muscle, even at cumulative doses of drug well in excess of 2,000 mg/m2.

On December 3, 2015 Aptose Biosciences Inc. (NASDAQ:APTO) (TSX:APS) reported that its collaborator, Moffitt Cancer Center, will present preclinical data for its dual-targeting bromodomain (BRD) / kinase inhibitor, MA2-014, at the 57th Annual American Society of Hematology (ASH) (Free ASH Whitepaper) Meeting and Exposition being held December 5-8, 2015, in Orlando, FL (Filing, 6-K, Aptose Biosciences, DEC 3, 2015, View Source [SID:1234508389]).

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The dual-targeting inhibitor MA2-014 is a representative candidate from a new family of small molecule, dual-targeting BRD / kinase inhibitors licensed to Aptose from Moffitt Cancer Center. The MA2-014 program was developed to inhibit both the bromodomain 4 (BRD4) protein and the Janus kinase 2 (JAK2) for the potential treatment of various hematologic and solid tumor cancers. The data being presented by Moffitt researchers reflect in vitro activity of MA2-014 in myeloproliferative neoplasm (MPN) cell lines. MPNs are rare blood cancers including polycythemia vera (PV), essential thrombocythemia (ET) and myelofibrosis (MF).

Clinically, JAK2 inhibitors alone have demonstrated the ability to improve symptoms of MPNs, but have not been shown to induce remission. Further, combining a bromodomain inhibitor and a JAK2 inhibitor has been shown to be more effective against MPN cells than JAK2 inhibition alone. This provided rationale to develop a single molecule with potent activity against both the bromodomain family proteins and JAK2. Moffitt researchers will present data for MA2-014, a single molecule that exhibits similar anti-JAK2 activity as a known JAK2 inhibitor, TG101209, with an approximate ten-fold improvement in anti-BRD activity. Moffitt researchers also demonstrated a ten-fold improvement in the ability of MA2-014 to inhibit JAK2-V617F signaling over TG101209, and comparable to ruxolitinib. Ruxolitinib is the only FDA approved JAK inhibitor for MPNs. However, MA2-014 retained its potency against ruxolitinib-resistant cells. Moffitt researchers also determined in long-term culture assays that JAK2-V617F driven MPN Uke1 cells do not experience resistance to MA2-014 as readily as they do to TG101209 or ruxolitinib.

"We are excited to continue development of MA2-014 and other candidates in our collaboration with Moffitt and to advance highly differentiated dual-targeting BRD / kinase inhibitors for the treatment of rare blood cancers into the clinic," said William G. Rice, Ph.D., Chairman, President and CEO. "We share Moffitt’s optimism about the potential for dual-targeting BRD / kinase inhibitors as high-value epigenetic drug candidates to provide the benefits of combination therapy for hematologic cancers."

"The development and optimization of a single drug designed to simultaneously inhibit JAK2 kinase and bromodomains of the bromodomain and extraterminal proteins may improve therapy for myeloproliferative neoplasms (MPN), by delivering a potentially effective combination therapy with a single agent," said Gary Reuther, Associate Member of the Cancer Biology and Evolution Program at Moffitt. "Such dual inhibition of these targets and their respective pathways may provide a new effective MPN therapy and reduce the development of drug resistance seen with JAK2 inhibitors."

Abstract Details

Title: "Single Molecule Dual JAK2-BET Inhibition as an MPN Therapeutic"
* Date/Time: Sunday, December 6, 2015, 6:00 – 8:00 p.m.
* Location: Orange County Convention Center, Hall A, Level 2
* Abstract #: 2826
* Session: 635. Myeloproliferative Syndromes: Basic Science: Poster II

The abstract is available in the online edition of Blood, the official Journal of the American Society of Hematology (ASH) (Free ASH Whitepaper) and on the ASH (Free ASH Whitepaper) conference website.

Aptose previously announced additional ASH (Free ASH Whitepaper) abstracts on its lead clinical candidate APTO-253:

Title: "Broad Activity of APTO-253 in AML and Other Hematologic Malignancies Correlates with KLF4 Expression Level"
* Date/Time: Saturday, December 5, 2015, 5:30-7:30 p.m.
* Location: Orange County Convention Center, Hall A
* Abstract #: 83676
* Session: 616. Acute Myeloid Leukemia: Novel Therapy, excluding Transplantation: Poster I

Title: "Clinical Pharmacokinetics of APTO-253 Support its Use as a Novel Agent for the Treatment of Relapsed or Refractory Hematologic Malignancies"
* Abstract #: 4934
* Location: Publication

Strategic Collaboration with Moffitt Cancer Center

Aptose recently entered into a definitive agreement with Moffitt Cancer Center for exclusive global rights to potent, multi-targeting, single-agent inhibitors for the treatment of hematologic and solid tumor cancers. These small molecule agents are highly differentiated inhibitors of the Bromodomain and Extra-Terminal motif (BET) protein family members, which simultaneously target specific kinase enzymes. The molecules developed by Moffitt exhibit single-digit nanomolar potency against the BET family members and specific oncogenic kinases which, when inhibited, are synergistic with BET inhibition. Under the agreement, Aptose gains access to the drug candidates developed by Moffitt and the underlying intellectual property covering the chemical modifications enabling potent bromodomain (BRD) inhibition on the chemical backbone of a kinase inhibitor. Aptose expects lead clinical candidates to emerge from the collaboration by late 2016.