|An early Christmas present, albeit a long awaited one...
FOSTER CITY, CA AND MISSISSAUGA, ON, Dec. 12, 2012 /CNW/ - Gilead Sciences, Inc. (Nasdaq: GILD) and YM BioSciences Inc. (NYSE MKT: YMI, TSX: YM) announced today that the companies have signed a definitive agreement under which Gilead will acquire YM for U.S.$2.95 per share in cash. The transaction has received the unanimous approval of YM's Board of Directors, and values YM at approximately U.S.$510 million, with YM reporting C$125.5 million in cash and cash equivalents as of September 30, 2012. Gilead plans to fund the acquisition with cash on hand. The transaction is expected to close in the first quarter of 2013.
Terms of the Transaction
Under the terms of the agreement, upon closing of the proposed transaction, shareholders of YM will receive U.S.$2.95 per common share in cash, and holders of warrants and stock options will receive a cash payment equal to the difference between U.S.$2.95 and the exercise price of such warrant or stock option. The proposed transaction will be completed through a plan of arrangement under the provisions of the Companies Act (Nova Scotia).
The transaction will require the approval of YM shareholders at a special meeting of YM shareholders, to be held as soon as reasonably practicable and in any event on or before February 11, 2013. In addition to YM's shareholder approval, closing of the transaction is subject to the satisfaction of certain other customary conditions, including court approval of the transaction, and applicable government and regulatory approvals, including expiration or termination of the waiting period under the United States Hart Scott Rodino Antitrust Improvements Act, and the review period under the Competition Act (Canada). The approval of Gilead shareholders is not required in connection with the proposed transaction.
The arrangement agreement contains customary non-solicitation provisions, but permits YM, in certain circumstances, to terminate the arrangement and accept an unsolicited superior proposal, subject to fulfilling certain conditions.
BofA Merrill Lynch and Bloom Burton & Co. serve as financial advisors, and Gowling Lafleur Henderson LLP, Heenan Blaikie LLP and Dorsey & Whitney LLP serve as legal advisors to YM in connection with the transaction. Gilead is advised by Wilson Sonsini Goodrich & Rosati, Professional Corporation and Blake Cassels and Graydon LLP.|
|Plenty of news to flow in 2011...
Highlights from the second quarter:
- Mayo Clinic announced positive interim data from the first
60 patients enrolled in the Phase I/II trial for CYT387 in
myelofibrosis. The results were reported in an oral presentation at
the 52nd American Society of Hematology (ASH) Annual Meeting.
- The Overall Response Rate (spleen, anemia), as per the
International Working Group for Myeloproliferative Neoplasms
Research and Treatment (IWG-MRT) criteria, was 62%.
- Of the 53 evaluable subjects who had splenomegaly at baseline,
47% achieved a minimum 50% decrease in palpable spleen size,
qualifying for Clinical Improvement (CI) per IWG-MRT criteria.
- CYT387 controlled constitutional symptoms in a significant
percentage of patients (night sweats: 88%, bone pain 80%,
pruritus: 92%, fever: 100%).
- Of 42 subjects who were evaluable for anemia response, 50% had
achieved CI as per IWG-MRT criteria. A 57% response rate was
observed in transfusion-dependent patients.
- Full enrollment of 140 patients into the trial is anticipated in
calendar Q1 2011. To date, 111 patients have been enrolled into the
study. The Company anticipates that an additional set of updated
interim data will be reported in the second quarter of calendar 2011
and a full data set will be reported by the end of calendar 2011. The
Company is also working towards completing in calendar 2011 any
preclinical and manufacturing activities required to enable CYT387 to
commence a Phase III pivotal trial in calendar Q1 2012.
- Daiichi Sankyo Co., Ltd., CIMYM's licensee for nimotuzumab in Japan,
previously initiated a randomized trial with nimotuzumab in second
line gastric cancer, together with Kuhnil Pharma Co. Ltd., CIMYM's
licensee in Korea. Data from this trial were presented in January
2011 at the ASCO Gastrointestinal Cancers Symposium and demonstrated
an improvement in Progression Free Survival in a subset of patients
whose tumors were EGFR-positive. Should Daiichi Sankyo indicate an
interest in advancing nimotuzumab into a Phase III clinical trial in
gastric cancer, it could initiate in calendar 2012 subject to
achieving commercial-scale production. Daiichi Sankyo also launched a
Phase II trial in first-line treatment of advanced NSCLC for which YM
has been advised that recruitment has been completed, with data
expected during the first half of calendar 2011.
- Oncoscience AG (OSAG), CIMYM's licensee for Europe, has advised that
data from a Phase III trial in adult glioma patients may be reported
in the first half of calendar 2011. OSAG continues to recruit
patients into a Phase IIb/III trial in pancreatic cancer patients.
- YM's two randomized, Phase II, double-blind trials of nimotuzumab
(for brain metastasis from non-small cell lung cancer and for
palliative treatment of NSCLC) are lagging recruitment targets and
consequently these programs are under review as the Company focuses
support on the more advanced trials involving Daiichi Sankyo, which
have the prospect of earlier registration trial initiation. YM's
Phase II, second-line, single-arm study in children with progressive
diffuse intrinsic pontine glioma (DIPG) has concluded recruitment at
multiple sites in the US, Canada, and Israel and YM should report
results in calendar Q1 2011.
- CYT997 is a small molecule therapeutic capable of being developed in
IV and oral dose formulations with dual mechanisms of vascular
disruption and cytotoxicity. Preliminary data from YM's current Phase
I/II trial of CYT997 given IV in glioma patients are expected in
calendar H2 2011.|
|has been going well and gathering increasing interest since last post...
MISSISSAUGA, ON, Dec. 23 /PRNewswire/ - YM BioSciences Inc. (YMI) announced today that, in connection with its previously announced public offering for total net proceeds before expenses of US $37,650,000, the underwriters have exercised in full their Over-Allotment Option to purchase an additional 3,750,000 common shares of YM at US $1.60 per share for additional net proceeds of US $5,665,000.|
|Am still hanging on in there. Current mkt cap only £77m, so plenty of upside...
|Pharmagap symbol GAP can be found in Canada.
an interesting board on www.stockhouse.ca
site of the company www.pharmagap.com|
|I was refeering to this stock you pointed out!!!
"If you want some action and have a strong stomic take a look at Pharmagap Canada symbol GAP"|
On Canada symbol YM
On US symbol YMI
Also on Germany but I have no symbol of that
Also quoted in London symbol YMBA
Liquidity is best in US
On the run again today. I am happy.|
|good to see the old dog bark again. Nimo was the primary reason i bought into these in the distant past and the hope always was that its non rash results could equal or better erbitux. Hasta la Victoria siempre!
Is that a Canadian stock?
Seems like a stupid question but can't find it on LSE.
Not into Pharma's at all .. all my holdings are oil now so need to do some research.|
|Keep it on your radar. It is believed nimotuzumab could become first of choice
in a billion market. If so present value is still very low.
If you want some action and have a strong stomic take a look at Pharmagap Canada
|I think we have missed all the fun... pretty staggering three month climb!|
|I think you mis all the fun.|
|YMI on fire - Griffin sec. gives a 12 months target of 5$US
# ERBITUX® AND VECTIBIX® LIKELY TO BE SUPPLANTED BY YMI'S NIMOTUZUMAB AS THE EGFR MONOCLONAL ANTIBODY OF CHOICE IN A GREAT MAJORITY OF TUMORS. There has been a profound change in the scientific understanding of nimotuzumab, as described in a poster presented at the recent AACR annual meeting entitled, "Binding properties of the anti-EGFR monoclonal antibody nimotuzumab limit its interaction with the EGFR in renal and epidermal cells."1 Nimotuzumab is an affinity-optimized antibody that, by virtue of its lower affinity than the marketed EGFR mAbs, depends on avidity (bivalent binding) for definitive attachment to the receptors, avoids normal tissue, and is clinically effective in those circumstances where there is a moderate-to-high expression of EGF receptor. As demonstrated by YMI, this occurs naturally in high-expressing tumor cells, such as in head and neck, glioma, cervical, and gastric cancers, and also in indications where any radiation-containing treatment is utilized (e.g., NSCLC). The low-expressing tumor cell type tumors other than those treated with radiation-containing regimens are not targets for nimotuzumab. While refractory colorectal cancer would be a low-expressing cancer not amenable to treatment with nimotuzumab, the rectal cancer component (approximately 20%) would fit the radiation-treated category. We believe the implications of these findings and the related value to both cancer patients and shareholders are potentially substantial given that nimotuzumab will prospectively be an important competitor to Erbitux®, whose 2008 sales were $1.5 billion, and for which Eli Lilly (NYSE: LLY) recently acquired ImClone Systems for $6 billion.
# ? STRONG GLOBAL PARTNERS SUPPORT NIMOTUZUMAB CLINICAL DEVELOPMENT. Nimotuzumab has completed 20 clinical trials around the world, and, notably, nimotuzumab is already approved for sale in India, China, Indonesia, the Philippines and 16 other developing countries, Importantly, the drug is in later stage clinical trials in major global markets with YMI's licensees, which include Daiichi-Sankyo in Japan, Oncoscience AG in Western Europe, Kuhnil Pharma Co. in Korea, and Innogene Kalbiotech/Kalbe Farma in Singapore. Each licensee is funding clinical trials in their respective regional markets, and YMI is entitled to a royalty on revenue upon commercialization. There are another 32 clinical trials ongoing worldwide in various solid tumors.2
# ? U.S. GOVERNMENT CLEARS THE WAY FOR NIMOTUZUMAB SOLID TUMOR TRIALS. On August 10, 2009, YMI announced that the Company's wholly-owned subsidiary YM BioSciences USA, Inc. received permission from the U.S. Department of the Treasury's Office of Foreign Assets Control (OFAC) to develop nimotuzumab, in solid tumors in the U.S.3 This permission allows YMI to undertake multiple clinical trials in the U.S. and provides positive momentum towards realizing its eventual commercial goals in the U.S. The Company has already commenced discussions with the FDA for permission to include U.S. patients in its current palliative lung cancer and brain metastases from lung cancer trials. The Company has also applied for a license to market nimotuzumab if approved by the FDA, which would be necessary to commercialize the product in the U.S. Plans to commence commercialization discussions with pharmaceutical companies are underway.
# ? EFFICACY DATA FROM NIMOTUZUMAB'S PHASE IIB TRIAL IN HEAD & NECK CANCER PRESENTED AT ASCO. The Phase IIb ("BEST") randomized clinical trial demonstrated that the efficacy of nimotuzumab compares favorably to results reported for Erbitux® and showed a statistically significant difference in overall survival (p=0.0018) between the arms. Significantly, this randomized trial supports the mechanism data that demonstrates that patients showed essentially
1. equivalent clinical benefit from nimotuzumab in high-EGFR expressing cells (SCCHN >80%) without the numerous severe toxicities of Erbitux®.4
2. ? YMI SHARES REPRESENT EXCEPTIONAL VALUE. Given that the Company is trading near its cash balances of approximately $37 million as of March 31, 2009, nimotuzumab's recent green light by the U.S. government for its development in the U.S., and the prospect of being best-in-class in an established and currently marketed class of billion dollar drugs, we believe the upside for the nimotuzumab asset and YMI is exceptional. Our valuation model supports a 12-month target price of $5.00 per share; therefore, we reiterate our BUY recommendation on YM BioSciences, Inc. and establish a new 12-month target price of $5.00 per share.|
|Could better be followed in the States symbol YMI and interesting board on Yahoo|
|Next move up around the corner.|
|YM BIOSCIENCES USA RECEIVES CLEARANCE FROM US TREASURY DEPARTMENT TO EXTEND CLINICAL PROGRAM FOR NIMOTUZUMAB
8/10/2009 7:00 AM - Canada NewsWire
MISSISSAUGA, ON, Aug. 10, 2009 (Canada NewsWire via COMTEX News Network) --
YM BioSciences Inc. (NYSE Amex:YMI, TSX:YM, AIM:YMBA), a life sciences product development company that identifies and advances a diverse portfolio of promising cancer-related products at various stages of development, today announced that its wholly-owned subsidiary, YM BioSciences USA Inc. (YM-USA) has received a license from the US Department of the Treasury's Office of Foreign Assets Control (OFAC) to further develop its lead product, nimotuzumab, for patients with solid tumor cancers in the United States.
"This license from OFAC to develop nimotuzumab in any cancer indication is a major step forward in our US development program and will allow us to immediately discuss our IND submissions with the FDA to include US patients in our randomized, double-blinded lung cancer and brain metastases trials," said David Allan, Chairman and CEO of YM BioSciences. "Our development plans may also include extending some of the Phase III trials being conducted worldwide into the US. There are quantifiable physical, emotional and financial costs that result from the numerous and severe toxicities of the currently available EGFR-targeting drugs which are not evident with the administration of our drug. Nimotuzumab has been demonstrating efficacy in trials throughout the world and we are very pleased that US patients will now have the opportunity to receive the drug and that a broader group of US oncologists will gain experience with it. Our goal is to bring this therapeutic option, already approved for marketing in 18 countries, to patients in the US as rapidly as possible."
Mr. Allan added, "We have also applied to OFAC for a license to make nimotuzumab available to US patients upon marketing approval by the FDA. This is consistent with a 2009 Staff Report to the US Senate Committee on Foreign Relations (SCFR) entitled 'Changing Cuba Policy - In the United States' National Interest,' which recommended pharmaceutical imports from Cuba's rapidly developing biotech industry. We are most appreciative of the extensive support we have received for our application from SCFR Chairman Senator John Kerry (D-MA), Western Hemisphere Subcommittee Chairman Senator Chris Dodd (D-CT) and SCFR Ranking Member Senator Richard Lugar (R-IN) and for their acute understanding of the needs of cancer patients. Such licenses have been previously granted to two companies seeking to commercialize Cuban-origin therapeutics in the US and we have ongoing discussions with OFAC in this regard."
YM USA previously received a license from OFAC to import nimotuzumab into the US to conduct a study of nimotuzumab in children suffering from recurrent diffuse intrinsic pontine glioma. This trial is ongoing at 10 of the principal oncology hospitals in the US and data is expected in 2010. Nimotuzumab is also available on a compassionate use basis in the US for children with this condition and is designated an Orphan Drug for adult and pediatric glioma by the FDA as well as the EMEA for Europe.
Nimotuzumab is a humanized monoclonal antibody that targets the epidermal growth factor receptor (EGFR), licensed to YM's majority-owned subsidiary, CIMYM BioSciences Inc., by CIMAB S.A., and developed at the Center of Molecular Immunology in Cuba. The drug has demonstrated efficacy in clinical trials without the serious side effects observed with the marketed EGFR-targeting drugs. Nimotuzumab has been administered to approximately 5,000 patients worldwide and is currently in 32 trials internationally of which 11 are being conducted by YM and its four licensees. Three of the latter are Phase III trials, including one being conducted by the internationally recognized National Cancer Center of Singapore, which selected nimotuzumab over the alternative antibodies because of its benign side effect profile.
About YM BioSciences
YM BioSciences Inc. is a life sciences product development company that identifies and advances a diverse portfolio of promising cancer-related products at various stages of development. The Company is currently developing two late-stage products: nimotuzumab, an EGFR-targeting Affinity-Optimized Antibody(TM), and AeroLEF(R), a proprietary, inhaled-delivery composition of free and liposome-encapsulated fentanyl. YM has proven regulatory and clinical trial expertise and a diversified business model designed to reduce risk while advancing clinical products toward international approval, marketing and commercialization.
This press release may contain forward-looking statements, which reflect the Company's current expectation regarding future events. These forward-looking statements involve risks and uncertainties that may cause actual results, events or developments to be materially different from any future results, events or developments expressed or implied by such forward-looking statements. Such factors include, but are not limited to, changing market conditions, the successful and timely completion of clinical studies, the establishment of corporate alliances, the impact of competitive products and pricing, new product development, uncertainties related to the regulatory approval process and other risks detailed from time to time in the Company's ongoing quarterly and annual reporting. Certain of the assumptions made in preparing forward-looking statements include but are not limited to the following: that nimotuzumab will continue to demonstrate a competitive safety profile in ongoing and future clinical trials; that AeroLEF(R) will continue to generate positive efficacy and safety data in future clinical trials; and that YM and its various partners will complete their respective clinical trials within the timelines communicated in this release. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.|
|Time to take a closer look at this one.
This week they have overcome a mayor hurdle in the US.|
|YM BioSciences USA cleared by US FDA to initiate Phase II clinical trial of
nimotuzumab in children with inoperable, recurrent brain cancer MISSISSAUGA, ON, Aug. 30 /CNW/ - YM BioSciences Inc. (AMEX: YMI, TSX: YM, AIM: YMBA), an oncology company that identifies, develops and commercializes differentiated products for patients worldwide, today announced that its wholly-owned US subsidiary, YM BioSciences USA Inc. ("YM-USA") has been cleared by the US Food and Drug Administration (FDA) to initiate a Phase II trial investigating nimotuzumab in pediatric patients with recurrent diffuse
intrinsic pontine glioma (DIPG), a form of inoperable, treatment-resistant
brain cancer. Nimotuzumab is a humanized monoclonal antibody that targets the
epidermal growth factor receptor (EGFR). Eight leading US pediatric clinical
centers will be participating in the study. YM BioSciences previously
announced that it had received a No Objection Letter from Health Canada in
June 2007 to initiate this single-arm trial, which will enrol 44 patients with
DIPG who will be treated with nimotuzumab as monotherapy. This is the first occasion, to the knowledge of the Company, in which a clinical trial has been cleared by the FDA for a drug of Cuban origin.Clearance for importation of nimotuzumab into the US for this trial was authorized by a Special License issued to YM-USA by the US Treasury Department's Office of Foreign Assets Control (OFAC). Nimotuzumab has already been administered to a number of children in the US under licenses from the US Treasury Department and under single-patient INDs from the FDA. "The clearance of this US IND by the FDA is a significant step in the development of nimotuzumab," said David Allan, Chairman and CEO of YM BioSciences. "In addition to the US investigatory sites, the global development program for nimotuzumab includes ongoing and planned clinical
trials involving this and various other indications of cancer in Canada,
Europe, Japan, Korea, Singapore, India, Argentina, and Brazil."
The trial design is based on a previous trial conducted in Germany. In
that trial, which was the subject for an oral presentation at ASCO 2007, eight
of 21 children with recurrent DIPG had a clinical benefit from treatment with
nimotuzumab as monotherapy - one Partial Response (PR) and seven Stable
Disease (SD) were reported in 21 patients, at the end of the induction phase
at the eighth week. Those eight patients continued on maintenance therapy and,
at week 21, three patients were declared PR and one was evaluated SD. No
reports of OR in this patient population has, to the knowledge of the Company,
been previously reported. The primary endpoint of the current trial is Response Rate, with a target of 15%, and recruitment is expected to be completed within approximately 18 months from initiation. The principal investigatory site is the Hospital for Sick Children in Toronto, Canada where Drs. Eric Bouffet, Sylvain Baruchel, and Ute Bartels lead the international program. The US investigatory
sites at which the trial will be conducted include leading pediatric neuro-oncology centers that are members of the "POETIC" consortium (Pediatric Oncology Experimental Therapeutics International Consortium). Members of POETIC include Vanderbilt Children's Hospital/Vanderbilt-Ingram Cancer Center, M.D. Anderson Cancer Center, Memorial Sloan-Kettering Cancer Center, the Sidney Kimmel Cancer Center at Johns Hopkins, Children's Healthcare of Atlanta at Egleston, the Children's Hospital at the University of Colorado and the University of Florida and Alberta's Children's Hospital in Calgary. In addition, the University of Rochester Medical Center and the New York University Medical Center will also be included in the trial. YM BioSciences' European partner for the development of nimotuzumab, Oncoscience AG, recently announced the enrolment of the 40th and final patient in its international Phase III trial combining nimotuzumab with radiation for the first-line treatment of children and adolescents with newly diagnosed DIPG.
|YM BioSciences announces preclinical data confirming nimotuzumab binds to the
EGF receptor and potentiates radiotherapy
MISSISSAUGA, ON, July 9 /CNW/ - YM BioSciences Inc. (AMEX: YMI, TSX: YM,
AIM: YMBA), an oncology company that identifies, develops and commercializes
differentiated products for patients worldwide, today announced that a study
presented by investigators from Kinki University School of Medicine and Kyoto
University at the 11th meeting of The Japanese Association for Molecular
Target Therapy of Cancer held on July 5-6, 2007 demonstrated the increased
radiosensitivity of human NSCLC cell lines in the presence of nimotuzumab both
in vitro and in vivo. The study also confirms previous observations that
nimotuzumab inhibits ligand-dependent EGF receptor downstream signaling.
Daiichi Sankyo Co., Ltd is the licensee for nimotuzumab in Japan.
In addition, YM BioSciences announced that a paper on the structure of
nimotuzumab entitled 'Modeling the interaction between the anti-tumor antibody
h-R3 and its target, the epidermal growth factor receptor' was presented at
the 11th annual meeting of the SBNet (Structural Biology Network), held on
June 15-18, 2007 in Tallberg, Sweden. The paper demonstrated that nimotuzumab
specifically competes with cetuximab for binding to the EGF receptor. The
authors noted that, "According to our models, nimotuzumab inhibits the EGFr
signaling both by inhibiting the binding of EGF to domain III of EGFr and by a
conformational change of EGFr that is necessary to shape the EGF binding
"These two studies provide independent confirmation of earlier research
indicating that nimotuzumab directly binds to the EGF receptor," said Dr. Igor
Sherman, Director of Clinical Research at YM BioSciences. "The very rare
incidence, in patients treated with nimotuzumab, of the commonly seen
side-effects of EGFr-targeting therapy, such as rash and diarrhea, has raised
questions about whether nimotuzumab is truly interacting with the EGF
receptor. The data presented at SBNet provides further evidence that
nimotuzumab binds to the receptor, while the independent data from Kinki and
Kyoto demonstrated the synergistic effect of nimotuzumab and radiation on
cancer cells and inhibition of EGFr down-stream signaling in the presence of
"We conclude that nimotuzumab behaves no differently than the other
EGFr-targeting antibodies and that the limited and rare incidences of the
debilitating side-effects that are commonly seen with other antibodies and
small molecules targeting the tyrosine kinase pathway indicates that
nimotuzumab has the prospect of being "best-in-class" without compromised
efficacy," said David Allan, Chairman and CEO of YM BioSciences.
|ho humm. well, it was the cuban nimotuzumab that originally attracted me! let's hope that it fairs better in the brutal world of the fda drug trial...
3:20 PM ET
Trading Day with Pat Bolland
YM BioSciences Shares Plunge on Halted Trials
David Allan, chairman and CEO, YM Biosciences
Duration: 6 m 13 s
|TORONTO (Dow Jones)--Versant Partners has chosen five companies as its top picks for 2007, attaching its highest "strong buy" rating to one of the five and "buy" ratings to the remaining four.
Versant's top picks for the year are:
Allen Vanguard Corp. (VRS.T)
-Rated strong buy, with a C$10.50 target.
-A seven-year agreement with Lockheed Martin Corp. (LMT) for Electronic Counter Measures products to be used by the U.S. military is expected to result in additional orders in 2007. Versant notes the U.S military has budgeted to spend more than $1.4B on ECM this fiscal year.
-Allen Vanguard is off 2% at C$3.75 in Toronto.
Jazz Air Income Fund (JAZ.UN.T)
-Rated buy, with a C$10.60 target.
-Despite trusts losing favor with investors in late 2006, Versant said a long-term capacity purchase agreement with Air Canada (AC.A.T) guarantees Jazz Air's revenue and earnings stream at aset margin and allows any uncontrollable costs to pass through to Air Canada.
-Jazz Air is up 1.2% at C$8.35 in Toronto.
Matrkion Inc. (MTK.T)
-Rated buy, with a C$4.50 target
-With many of its previous top picks moving close to "fair value," Versant now favors Matrkion from a risk/reward standpoint, noting it has yet to make a "significant" move. Versant believes the company will continue to leverage plant deployments into corporate-wide deals.
-Matrikon is off 1.5% at C$3.35 in Toronto.
Transition Therapeutics Inc. (TTH.T)
-Rated buy, with a C$3 target.
-Transition has a diversified project pipeline, but Versant notes the main value drivers are its Islet Cell Neogenesis Therapy program in diabetes and its small molecule Alzheimer's diease program. Versant said both projects have "blockbuster" potential.
-Transition is off 2.8% at C$1.40 in Toronto.
YM Biosciences Inc. (YMI)
-Rated buy, with a C$10 target.
-Approvable data is expected from co.'s lead breast cancer drug tesmilifene by mid-2007. Versant also sees upside from co.'s TharaCIM antibody drug in multiple cancer markets.
-YM is up 2% at C$3.40 in Toronto.|
|YM BioSciences announces results of AeroLEF(TM) Phase IIb open-label study
- Data presented at ASA Annual Meeting show inhaled AeroLEF(TM) produced
clinically meaningful, highly-individualized analgesia for acute pain -
MISSISSAUGA, ON, Oct. 17 /CNW/ - YM BioSciences Inc. (AMEX:YMI, TSX:YM,
AIM:YMBA), a company engaged in the acquisition, development and
commercialization of oncology and acute care products, today announced results
from the open-label portion of its Phase IIb trial (DLXLEF-AP4) of
AeroLEF(TM). The results demonstrated that the majority of the patients were
able to achieve effective analgesia for episodes of moderate to severe acute
post-surgical pain by self-titrating the amount of medication they inhaled
using AeroLEF(TM). Results of the study were presented at the American Society
of Anesthesiologists (ASA) Annual Meeting in Chicago, IL.
AeroLEF is a unique, inhaled-delivery composition of free and
liposome-encapsulated fentanyl, in development for the treatment of moderate
to severe pain, including cancer pain. AeroLEF is designed to permit patients
to match dosage to their individual pain intensity and experience rapid and
extended pain relief.
"The time course of analgesia demonstrated in this study suggest that
AeroLEF is suitable for the stabilization of acute post-operative pain," said
Sugantha Ganapathy, MD, director, regional anesthesia, Department of
Anesthesia and Perioperative Medicine, University of Western Ontario, London,
Ontario, Canada, who presented the results. "Furthermore, differences in
median times to effective analgesia for patients taking second and third doses
of AeroLEF suggests that patients were capable of safely self-limiting dosing
to match the intensity of each pain episode."
In the study, patient self-titrated dosing with AeroLEF provided
clinically meaningful analgesia in 81 percent, 100 percent and 87.5 percent of
treated pain episodes during doses 1, 2 and 3 respectively. Within 10 minutes
of initiating dosing with AeroLEF, 38 percent, 73 percent and 63 percent of
patients reported a reduction in pain intensity to mild pain during doses 1, 2
and 3 respectively. Achieving effective pain relief was the reason for
stopping AeroLEF dosing in 35 of 40 (88 percent) treated pain episodes.
Study results also suggested that multiple doses of AeroLEF were well
tolerated. No treatment-emergent adverse events were reported in 9 of 21
(43 percent) of patients. The majority ((greater than)70 percent) of
treatment-emergent adverse events were mild and considered typical of those
associated with opioid analgesia in the post-operative setting. Adverse events
of a respiratory nature were reported in 4 patients. These events were mild
and transient and resolved with minimal intervention.
"We are pleased that AeroLEF performed well in this open-label portion of
our Phase IIb study, providing highly-individualized, episode-specific pain
relief in the post-operative setting," said David Allan, Chairman and CEO of
YM BioSciences. "We continue to enroll patients in the randomized portion of
the trial based on an interim analysis that showed benefit versus placebo."
The Phase IIb of AeroLEF in moderate to severe post-surgical pain
consists of two parts. Part I, reported today, was an open label trial
designed to allow investigators to gain familiarity with administration of the
product. Part I enrolled 21 patients who underwent a variety of elective
orthopedic surgical procedures at eight centers. Part II, currently underway,
is a randomized, double-blind, and placebo-controlled trial of 99 patients and
is designed to evaluate the safety and efficacy of AeroLEF compared to placebo
for management of pain following elective orthopedic surgery.