Intravenous Busulfan-Based Myeloablative Conditioning Regimens Prior to Hematopoietic Cell Transplantation for Hematologic Malignancies.

Busulfan (Bu)-containing regimens are commonly used in myeloablative regimens prior to allogeneic hematopoietic cell transplantation (HCT). Yet, there is considerable variability on how Bu is administered related to frequency (four times a day, Q6 or daily, Q24) and the combination with other chemotherapeutic agents (cyclophosphamide, Cy or fludarabine, Flu). A prospective cohort study of recipients of Bu-based conditioning according to contemporary practices was used to compare different approaches in using Bu (BuCy Q6 N=495; BuFlu Q24 N=331; BuCy Q24 N=96; BuFlu Q6 N=91) in patients with myeloid malignancies from 2009 to 2011. BuFlu Q24 recipients were more likely to be older and tended to have worse performance status and higher comorbid burden. The cumulative incidence of hepatic veno-occlusive disease (p=0.4), idiopathic pneumonia (p=0.5) and seizures (p=0.5) did not differ across groups. One-year HCT related mortality ranged from 12% to 16% (P=0.8), three-year relapse incidences ranged from 32% to 36% (p=0.8) and three-year overall survival ranged from 51% to 58% (p=0.2) across groups. This study demonstrates that the use of intravenous Bu Q6 or Q24 or accompanied by Cy or Flu have similar outcomes in the myeloablative setting for treatment of myeloid malignancies.
Copyright © 2016 The American Society for Blood and Marrow Transplantation. Published by Elsevier Inc. All rights reserved.

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Spectrum Pharmaceuticals Highlights an Oral Presentation on Apaziquone at the 2016 Annual Meeting of the American Urological Association Education and Research Inc. (AUA) in San Diego, California, May 6-10, 2016

On May 6, 2016 Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in Hematology and Oncology, reported presentations of clinical data for apaziquone to be presented at an oral presentation and a moderated poster session at the American Urological Association Education and Research Inc., being held in San Diego, California, from May 6-10, 2016 (Press release, Spectrum Pharmaceuticals, MAY 6, 2016, View Source [SID:1234512013]).

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For more information about the AUA Meeting and for a complete list of abstracts, please refer to the conference web site at View Source

Friday, May 6, 2016 1:00 PM-3:00 PM PT (Moderated Poster Session)

Abstract # Type Title First Author Location

MP13-07
Poster
Improved Efficacy of Adjuvant, Single Dose Intravesical Apaziquone by Timing post-Resection in Two Double
blind, Randomized, Placebo-Controlled Phase 3 Studies in Non-Muscle Invasive Bladder Cancer
Fred Witjes
Room 28 ABC

Saturday, May 7, 2016, 8:00 AM-10:00 AM PT (Podium Presentation)

Abstract # Type Title First Author Location

PD11-07
Podium
Integrated Results of Two Multicenter, Randomized, Placebo Controlled, Double Blind, Phase 3 Trials (SPI-611/612) of Single-Dose Intravesical Apaziquone Immediately Following Resection in Patients with Non-Muscle Invasive Bladder Cancer

6-K – Report of foreign issuer [Rules 13a-16 and 15d-16]

On May 6, 2016 Oncolytics Biotech Inc. (TSX: ONC) (OTCQX: ONCYF) (FRA: ONY) ("Oncolytics" or the "Company") reported its financial results and operational highlights for the first quarter ended March 31, 2016 (Filing, Q1, Oncolytics Biotech, 2016, MAY 6, 2016, View Source [SID:1234512055]).

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"We recently reported data from two sponsored, randomized Phase 2 studies, highlighting reduced tumor burden in ovarian cancer and improved longer term survival in pancreatic cancer," said Dr. Brad Thompson. "The data from these studies will be very useful in identifying potential indications and study designs that we could advance into later stage studies in the future."

Selected Highlights

Since January 1, 2016, selected highlights announced by the Company include:

Clinical Program

· Treatment of the first patients in a Phase Ib study of pembrolizumab (KEYTRUDA) in combination with REOLYSIN and chemotherapy in patients with advanced pancreatic adenocarcinoma, the Company’s first trial examining REOLYSIN in combination with a checkpoint inhibitor;
· Updated results from a randomized Phase 2 clinical trial of its lead product, REOLYSIN, in combination with paclitaxel in patients with ovarian cancer (GOG-0186H), where an intent-to-treat analysis, as assessed by CA-125 antigen levels, showed statistically significantly reduction in tumor burden;
· Updated results from a randomized Phase 2 clinical trial of its lead product, REOLYSIN, in combination with carboplatin and paclitaxel in patients with pancreatic cancer (NCI-8601), where an intent-to-treat analysis of overall survival on patients with confirmed treatment regimes, as assessed by the percentage of patients surviving for two years, showed a statistically significantly higher percentage of patients surviving two years in the test arm versus the control arm (p = 0.001), the crossover arm versus the control arm (p = 0.03) and the test plus crossover arms versus the control arm (p = 0.0004);
Basic Research

· Two poster presentations covering preclinical work in multiple myeloma and colorectal cancer being made by the Company’s research collaborators at the 2016 American Association of Cancer Research annual meeting;
Financial

· Entry into an "at-the-market" equity distribution agreement with Canaccord Genuity Corp. permitting Oncolytics at its sole discretion, from time to time and until March 16, 2018, to sell common shares having an aggregate offering value of up to $4.6 million; and
· At March 31, 2016 the Company reported $22.3 million in cash, cash equivalents and short-term investments. At May 5, 2016, the Company had approximately $21.4 million in cash, cash equivalents and short-term investments, which is expected to provide sufficient funds to support several small early-stage immunotherapy combination studies as well as both a run-in and a registration study in muscle-invasive bladder cancer.

ONCOLYTICS BIOTECH INC.
INTERM CONSOLIDATED STATEMENTS OF FINANCIAL POSITION

As at March 31,
2016
$ December 31,
2015
$
Assets
Current assets
Cash and cash equivalents 20,233,408 24,016,275
Short-term investments 2,088,800 2,060,977
Accounts receivable 59,648 340,059
Prepaid expenses 229,288 506,669
Total current assets 22,611,144 26,923,980

Non-current assets
Property and equipment 411,762 459,818
Total non-current assets 411,762 459,818

Total assets 23,022,906 27,383,798

Liabilities And Shareholders’ Equity
Current Liabilities
Accounts payable and accrued liabilities 2,554,338 2,709,492
Total current liabilities 2,554,338 2,709,492

Shareholders’ equity
Share capital
Authorized: unlimited
Issued:
March 31, 2016 – 118,697,122
December 31, 2015 – 118,151,622 261,224,148 261,324,692
Contributed surplus 26,359,606 26,277,966
Accumulated other comprehensive income 590,919 760,978
Accumulated deficit (267,706,105) (263,689,330)
Total shareholders’ equity 20,468,568 24,674,306
Total liabilities and equity 23,022,906 27,383,798

ONCOLYTICS BIOTECH INC.
INTERIM CONSOLIDATED STATEMENTS OF LOSS AND COMPREHENSIVE LOSS

2016 2015
For the three month period ending March 31 $ $
Expenses
Research and development 2,726,129 2,425,539
Operating 1,360,412 1,182,734
Operating loss (4,086,541) (3,608,273)
Interest 69,621 56,435
Loss before income taxes (4,016,920) (3,551,838)
Income tax expense 145 —
Net loss (4,016,775) (3,551,838)
Other comprehensive income items that may be
reclassified to net loss
Translation adjustment (170,059) 225,591

Net comprehensive loss (4,186,834) (3,326,247)
Basic and diluted loss per common share (0.03) (0.04)

Weighted average number of shares (basic and diluted) 118,199,985 99,557,654

ONCOLYTICS BIOTECH INC.
INTERIM CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY


Share Capital
$

Contributed
Surplus
$

Accumulated
Other
Comprehensive
Income
$

Accumulated
Deficit
$

Total
$

As at December 31, 2014 237,657,056 25,848,429 280,043 (249,966,335) 13,819,193

Net loss and comprehensive income — — 225,591 (3,551,838) (3,326,247)
Issued, pursuant to Share Purchase
Agreement 1,925,596 — — — 1,925,596
Issued, pursuant to "At the Market"
Agreement 14,636,918 — — — 14,636,918
Share based compensation — 114,970 — — 114,970
As at March 31, 2015 254,219,570 25,963,399 505,634 (253,518,173) 27,170,430

Share Capital
$

Contributed
Surplus
$

Accumulated
Other
Comprehensive
Income
$

Accumulated
Deficit
$

Total
$

As at December 31, 2015 261,324,692 26,277,966 760,978 (263,689,330) 24,674,306

Net loss and comprehensive income — — (170,059) (4,016,775) (4,186,834)
Issued, pursuant to Share Purchase
Agreement
— — — — —
Issued, pursuant to "At the Market"
Agreement (100,544) — — — (100,544)
Share based compensation — 81,640 — — 81,640
As at March 31, 2016 261,224,148 26,359,606 590,919 (267,706,105) 20,468,568

ONCOLYTICS BIOTECH INC.
INTERIM CONSOLIDATED STATEMENTS OF CASH FLOWS

2016 2015
For the three month period ending March 31 $ $

Operating Activities
Net loss for the period (4,016,775) (3,551,838)
Amortization – property and equipment 45,942 45,130
Share based compensation 81,640 114,970
Impact of unrealized foreign exchange (gains) losses 141,295 (305,156)
Net change in non-cash working capital 724,655 949,705
Cash used in operating activities (3,023,243) (2,747,189)

Investing Activities
Acquisition of property and equipment — (11,940)
Purchase of short-term investments (27,823) (29,292)
Cash used in investing activities (27,823) (41,232)

Financing Activities
Proceeds from Share Purchase Agreement — 1,925,596
Proceeds from "At the Market" equity distribution agreement (100,544) 14,636,918
Cash provided by financing activities (100,544) 16,562,514
(Decrease) increase in cash (3,151,610) 13,774,093
Cash and cash equivalents, beginning of period 24,016,275 14,152,825
Impact of foreign exchange on cash and cash equivalents (631,257) 651,105
Cash and cash equivalents, end of period 20,233,408 28,578,023

To view the Company’s Fiscal 2016 First Quarter Consolidated Financial Statements, related Notes to the Consolidated Financial Statements, and Management’s Discussion and Analysis, please see the Company’s quarterly filings, which will be available under the Company’s profile at www.sedar.com and on Oncolytics’ website at View Source

ReCyte Therapeutics, a BioTime Subsidiary, Announces Peer-Reviewed Publication on Pericyte-Like Progenitor Cells

On May 6, 2016 ReCyte Therapeutics, a subsidiary of BioTime, Inc., a clinical-stage regenerative medicine company with a focus on pluripotent stem cell technology, reported the publication of a scientific paper titled, "A novel lineage restricted, pericyte-like cell line isolated from human embryonic stem cells," by Midori Greenwood-Goodwin, Jiwei Yang, Mohammad Hassanipour, and David Larocca (Press release, BioTime, MAY 6, 2016, View Source;p=RssLanding&cat=news&id=2166093 [SID:1234512020]). The article was released in the peer-reviewed online publication in Scientific Reports. The online version of the article can be found at www.nature.com/articles/srep24403.

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In the article, researchers at ReCyte Therapeutics demonstrate the successful isolation of a new type of human blood vessel support cell that is involved in the formation and stabilization of blood vessels, a process known as angiogenesis. Unlike typical angiogenic support cells which are multi-talented and can turn into other types of tissues such as bone, these precursor cells, termed PC-M cells, are highly specialized to support and strengthen blood vessels.

"When you want a specific job done, its best to call a specialist for treatment," said Dr. David Larocca, Vice President of Research and Development. "That’s why we believe these novel pericyte-like cells may be an ideal source of cells for promoting new blood flow in patients suffering from ischemic vascular disease (IVD) where clogged arteries have blocked blood flow to limbs or the heart."

Left unchecked, IVD often leads to amputation or heart failure for patients that have failed, or are not candidates for surgical interventions. Thus, there is a critical unmet medical need for new angiogenic therapies. Importantly, PC-M cells are highly stable and have a high capacity to replicate under standard laboratory conditions. They therefore can be manufactured on an industrial scale needed to treat a large patient population. At ReCyte, we are currently investigating the use of PC-M cells for treating critical limb ischemia, a late stage of IVD that afflicts diabetics and the elderly.

We have also developed a PC-M cell based co-culture assay kit called VascuNet (sold by Ascendance Biotechnology, Inc.) that’s designed to be used to screen for drugs that affect human blood vessel growth and stability. This novel assay mimics the body’s own angiogenic mechanisms for growing blood vessels which involves both supporting pericytes, and the endothelial cells that line the vessel walls. This biomimetic VascuNet assay can be used to discover new anti-angiogenic cancer drugs that kill tumors by cutting off or destabilizing their blood supply. It can also be used to screen for pro-angiogenic drugs that increase blood flow for treating ischemia.

The paper, based off of BioTime/ReCyte’s extensive research and discoveries involving iPS cells, if developed, could potentially bring value to the pharmaceutical industry interested in developing cardiovascular and cancer therapies. This development ties into BioTime’s broader strategy to allow its non-core therapeutic assets to mature into successful regenerative cell therapies, for a wide variety of degenerative diseases, to help address the critical unmet medical needs of patients worldwide.

CytomX Announces First Quarter 2016 Financial Results

On May 06, 2016 CytomX Therapeutics, Inc. (Nasdaq:CTMX), a biopharmaceutical company developing investigational Probody therapeutics for the treatment of cancer, reported financial results for the first quarter ending March 31, 2016 (Press release, CytomX Therapeutics, MAY 6, 2016, View Source;p=RssLanding&cat=news&id=2165975 [SID:1234511991]).

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"Since our IPO, we have maintained strong strategic and operational momentum as demonstrated by our partnership with AbbVie and the advancement of our wholly-owned programs towards the clinic," said Sean McCarthy, D.Phil., president and chief executive officer of CytomX Therapeutics. "With this progress and our strong cash position we are well-positioned to build a multi-product company to transform antibody therapeutics for the treatment of cancer."

As of March 31, 2016, CytomX had cash and cash equivalents and short-term investments of $180.6 million. The Company has updated its financial guidance and expects net cash utilization of $20.0 to $25.0 million in 2016, reduced from its previous guidance of $45.0 to $50.0 million. The Company is maintaining its guidance that its existing capital resources will be sufficient to fund its anticipated operations through 2018.

Business Highlights and Recent Developments

On April 21, 2016, the Company announced that it had entered into a collaboration with AbbVie to co-develop and co-commercialize Probody Drug Conjugates against CD71, with CytomX leading pre-clinical and early clinical development. AbbVie will lead later development and commercialization, with global late-stage development costs shared between the two companies. CytomX received an upfront payment of $30 million and is eligible to receive up to $470 million in development, regulatory and commercial milestones, pending the achievement of pre-determined outcomes. AbbVie will lead global commercial activities with CytomX eligible to receive a profit share in the U.S. and tiered double-digit royalties on net product sales outside of the U.S. CytomX retains an option to co-promote in the U.S.

On April 19, 2016, the Company presented data from its PD-1 and CD71 programs at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting evidencing efficacy and improved tolerability for Probody therapeutics in preclinical models.

The Company remains on track to file an IND for CX-072, a Probody therapeutic targeting PD-L1, in the second half of 2016 and an IND for CX-2009, a Probody drug conjugate targeting CD166, in the first half of 2017.

During the first quarter, the Company announced selection of a third target by Bristol-Myers Squibb in accordance with the companies’ strategic oncology collaboration established in May 2014, triggering a $10 million milestone payment.

First Quarter Financial Results

Cash, cash equivalents and investments totaled $180.6 million as of March 31, 2016, compared to $186.7 million as of December 31, 2015. The decrease reflects cash used in operations offset by a $10.0 million milestone payment received from Bristol-Myers Squibb in connection with their third target selection in January 2016.

Research and development expenses were $13.4 million for the first quarter of 2016, compared to $4.7 million for the first quarter of 2015. The increase was primarily attributable to $4.9 million in manufacturing costs for the Company’s CX-072 and CX-2009 programs in preparation for preclinical and clinical studies, $1.3 million in laboratory and professional services, $1.3 million in non-cash stock based compensation due to higher stock valuation, $0.8 million in personnel-related expenses due to an increase in headcount and $0.4 million in royalty payments to a third party triggered by Bristol-Myers Squibb’s milestone payment in connection with its third target selection. The Company expects the manufacturing costs for the two programs to continue into the second quarter and the costs related to preparation for CX-072 clinical trials to increase in the third quarter.

General and administrative expenses were $5.0 million for the first quarter of 2016, compared to $1.9 million for the first quarter of 2015. The increase was primarily attributable to $1.2 million in additional consulting and professional service expenses associated with operating as a public company, $1.1 million in non-cash stock based compensation due to higher stock valuation and $0.7 million in personnel-related expenses due to an increase in headcount.