Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Next catalyst (Q2 2019):
- Data from intitial clinical cohort (safety, immune reaponse) for ADXS-NEO and ADXS-HOT (ADXS-503).
Slides from the Innate Killer Summit
https://www.affimed.com/190320_innate-killer-summit_final/
They don`t mention AFM11 anymore.
ADXS-NEO: Data from initial clinical cohort (safety, immune response) will be presented in Q1/2019 (it used to be 1H 2019; see page 27).
"new" corporate presentation (uploaded today)
=> https://www.advaxis.com/wp-content/uploads/2019/02/Corporate-Presentation-February-2019.pdf
LPTX: Announces Proposed Public Offering of Common Stock and Warrants
[...] The offering is subject to market, regulatory and other conditions and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.
Raymond James & Associates, Inc. and Ladenburg Thalmann will act as book-running managers for the offering.
Leap intends to use the net proceeds from the offering for general corporate purposes, which may include, without limitation, funding new clinical trials of DKN-01 and TRX518 and the continuation of ongoing studies, capital expenditures, working capital and general and administrative expenses. [...]
source: https://finance.yahoo.com/news/leap-therapeutics-announces-proposed-public-213200198.html
PS: On twitter there is a discussion about "baby shelf rules" =>
IF $LPTX can use highest price last 60 days of $4.50, then it could issue 7.7m shares in this offering, as follows: $4.50 * 9m shares free float = $40.5m/3 (1/3 rule) = $13.5m/$1.75 (assumed offering price) = 7.7m shares. No shares listed because baby shelf limits depends on OP.
— Jordan Alexander (@JD4for4) February 1, 2019
AFMD: new Corporate Presentation (January 7, 2019)
source: https://www.affimed.com/wp-content/uploads/20190107_afmd_corp_pres__final.pdf
Upcoming Anticipated Milestones:
AFM13
• H1 2019: 12-month data for AFM13 + Keytruda®(pembrolizumab)
• H1 2019: Initiate registration study (monotherapy in TCL)
• H1 2019: Initiate combination study with cbNK cells in CD30+ lymphomas (IST)
• H1 2020: Interim data for monotherapy in TCL
AFM24
• Mid-2019: IND filing
• H2 2019: Initiate first-in-human study
• 2020: Clinical data
re: TRIL
TRIL - Morgan Stanley reports 5.3% passive stake in Trillium Therapeutics In a regulatory filing, Morgan Stanley disclosed a 5.3% stake in Trillium Therapeutics, which represents over 780,000 shares. The filing does not allow for activism.
Source:
https://thefly.com/landingPageNews.php?id=2840841
December 12, 2018
-----------------------------------------------------
(Date Of Event which Requires Filing of this Statement)
https://www.sec.gov/Archives/edgar/data/895421/000089542118000638/0000895421-18-000638.txt
I wonder who was selling all those shares for US$1.75...
ADXS / AMGN: termination of ADXS-NEO program
On December 10, 2018, Advaxis, Inc., a Delaware Corporation (the “Company”) received a written notice of termination from Amgen Inc. (“Amgen”) with respect to the License and Collaboration Agreement, dated as of August 1, 2016 (the “Amgen Agreement”) pertaining to the development and commercialization of the Company’s ADXS-NEO program, a novel, preclinical investigational immunotherapy, using the Company’s proprietary Listeria monocytogenes attenuated bacterial vector, which activates a patient’s immune system to respond against unique mutations, or neoepitopes, contained in and identified from an individual patient’s tumor. The termination is effective as of February 8, 2019. The Company’s ADXS-NEO study is currently enrolling patients and the Company will evaluate whether to re-partner the ADXS-NEO program.
Under the terms of the Amgen Agreement, Amgen received an exclusive worldwide license to develop and commercialize the ADXS-NEO program. Amgen previously made an upfront payment to the Company of $40 million, purchased $25 million of the Company’s common stock and reimbursed the Company for certain research and development costs in support of the ADXS-NEO program. Under the Amgen Agreement, the Company and Amgen collaborated through a joint steering committee for the development and commercialization of ADXS-NEO. The Company was eligible to receive future contingent payments based on development, regulatory and sales milestones as well as high single digit to double digit royalty payments based on worldwide sales of licensed products by Amgen. Pursuant to the terms of the Amgen Agreement, upon Amgen’s termination, the license to Amgen will terminate and the Company will regain worldwide rights for the development and commercialization of its ADXS-NEO program. In addition, Amgen will have certain obligations as set forth in the Amgen Agreement, including promptly deleting or destroying any materials related to the development or manufacturing of the ADXS-NEO program. During the fiscal years ended October 31, 2018 (unaudited) and 2017, the Company recorded reimbursements of approximately $5.8 million and $7.5 million, respectively, relating to the Amgen Agreement
source: https://www.sec.gov/Archives/edgar/data/1100397/000149315218017447/form8-k.htm
Comparison of U.S. and International Prices for Top Medicare Part B Drugs by Total Expenditures
You can download the report here:
https://aspe.hhs.gov/pdf-report/comparison-us-and-international-prices-top-medicare-part-b-drugs-total-expenditures
The following drugs are mentioned:
Alimta
Aranesp
Avastin
Cimzia
Eligard/ Multiple Products
Eylea
Gammagard
Gamunex-c/gammaked
Herceptin
Kadcyla
Keytruda
Lucentis
Neulasta
Opdivo
Orencia
Privigen
Prolia/Xgeva
Remicade
Rituxan
Sandostatin LAR
Soliris
Treanda
Tysabri
Velcade
Xolair
Yervoy
Zaltrap
AFMD: new Corporate Presentation
- only AFM26 is partnered, not AFM13 and AFM24
- $96 million in an upfront payment and other near-term funding, all of which is committed within the first 12 months
source: http://affimed.com/pdf/20180827_afmd_corp_pres_final.pdf
AFMD - Affimed Announces Pricing of Public Offering of Common Stock
Heidelberg, Germany February 13, 2018 - Affimed N.V. (Nasdaq:AFMD), a clinical stage biopharmaceutical company focused on discovering and developing highly targeted cancer immunotherapies, today announced the pricing of its previously announced public offering of 11,500,000 of its common shares at a public offering price of $2.00 per common share. In addition, Affimed has granted the underwriters a 30-day option to purchase up to an additional 1,725,000 common shares at the public offering price less underwriting discounts. After deducting the underwriting discounts, the net proceeds of the public offering are expected to be approximately $21.6 million. The offering is expected to close on or about February 15, 2018, subject to customary closing conditions.
Jefferies LLC and Wells Fargo Securities, LLC are acting as joint book-running managers.
source: https://finance.yahoo.com/news/affimed-announces-pricing-public-offering-080109395.html
PRELIMINARY PROSPECTUS SUPPLEMENT
http://services.corporate-ir.net/SEC/Document.Service?id=P3VybD1hSFIwY0RvdkwyRndhUzUwWlc1cmQybDZZWEprTG1OdmJTOWtiM2R1Ykc5aFpDNXdhSEEvWVdOMGFXOXVQVkJFUmlacGNHRm5aVDB4TWpBME5EQTRPQ1p6ZFdKemFXUTlOVGM9JnR5cGU9MiZmbj1BZmZpbWVkVGhlcmFwZXV0aWNzQUdfNDI0QjVfMjAxODAyMTIucGRm
Neither DVAX nor BMY have made an announcement about the results and the clinical trial. Why are they so quiet about it?!
DVAX - Cancer ‘vaccine’ eliminates tumors in mice
Injecting minute amounts of two immune-stimulating agents directly into solid tumors in mice can eliminate all traces of cancer in the animals, including distant, untreated metastases, according to a study by researchers at the Stanford University School of Medicine.
The approach works for many different types of cancers, including those that arise spontaneously, the study found.
The researchers believe the local application of very small amounts of the agents could serve as a rapid and relatively inexpensive cancer therapy that is unlikely to cause the adverse side effects often seen with bodywide immune stimulation.
“When we use these two agents together, we see the elimination of tumors all over the body,” said Ronald Levy, MD, professor of oncology. “This approach bypasses the need to identify tumor-specific immune targets and doesn’t require wholesale activation of the immune system or customization of a patient’s immune cells.”
...
Levy’s method works to reactivate the cancer-specific T cells by injecting microgram amounts of two agents directly into the tumor site. (A microgram is one-millionth of a gram). One, a short stretch of DNA called a CpG oligonucleotide, works with other nearby immune cells to amplify the expression of an activating receptor called OX40 on the surface of the T cells. The other, an antibody that binds to OX40, activates the T cells to lead the charge against the cancer cells. Because the two agents are injected directly into the tumor, only T cells that have infiltrated it are activated. In effect, these T cells are “prescreened” by the body to recognize only cancer-specific proteins.
Some of these tumor-specific, activated T cells then leave the original tumor to find and destroy other identical tumors throughout the body.
The approach worked startlingly well in laboratory mice with transplanted mouse lymphoma tumors in two sites on their bodies. Injecting one tumor site with the two agents caused the regression not just of the treated tumor, but also of the second, untreated tumor. In this way, 87 of 90 mice were cured of the cancer. Although the cancer recurred in three of the mice, the tumors again regressed after a second treatment. The researchers saw similar results in mice bearing breast, colon and melanoma tumors.
...
The current clinical trial is expected to recruit about 15 patients with low-grade lymphoma. If successful, Levy believes the treatment could be useful for many tumor types.
source: https://med.stanford.edu/news/all-news/2018/01/cancer-vaccine-eliminates-tumors-in-mice.html
CpG SD-101 was provided by Dynavax Technologies.
source: http://stm.sciencemag.org/content/10/426/eaan4488.full
Here is the link to the interesting answers from Advaxis' IR Noelle Heber: https://investorshub.advfn.com/boards/read_msg.aspx?message_id=138171027
Thanx to dafreaks!!!
DVAX: Dynavax Announces FDA Approval of HEPLISAV-B(TM) for Prevention of Hepatitis B in Adults
BERKELEY, CA--(Marketwired - November 09, 2017) - Dynavax Technologies Corporation (DVAX) today announced that the U.S. Food and Drug Administration (FDA) has approved HEPLISAV-B [Hepatitis B Vaccine, Recombinant (Adjuvanted)] for prevention of infection caused by all known subtypes of hepatitis B virus in adults age 18 years and older. HEPLISAV-B is the first new hepatitis B vaccine in the United States in more than 25 years and the only two-dose hepatitis B vaccine for adults.
[...]
Dynavax expects to commercially launch HEPLISAV-B in the United States in the first quarter of 2018. In preparation for launch, Dynavax has been building commercial infrastructure and optimizing manufacturing processes to meet anticipated demand.
[...]
Conference Call Details
The Dynavax management team will host a conference call and webcast today, Thursday, November 9, 2017 at 5:00 p.m. Eastern Time, to provide more information about the FDA approval of HEPLISAV-B. The live call can be accessed by phone by dialing (877) 479-1857 from the U.S. and Canada or +1 (503) 343-6309 internationally and using the passcode 5357789. The live call is being webcast and can be accessed in the "Investors and Media" section of the Company's website at www.dynavax.com. A replay of the webcast will be available for 30 days following the live event.
[...]
Important Safety Information (ISI)
Do not administer HEPLISAV-B to individuals with a history of severe allergic reaction (e.g., anaphylaxis) after a previous dose of any hepatitis B vaccine or to any component of HEPLISAV-B, including yeast.
Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of HEPLISAV-B.
Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to HEPLISAV-B.
Hepatitis B has a long incubation period. HEPLISAV-B may not prevent hepatitis B infection in individuals who have an unrecognized hepatitis B infection at the time of vaccine administration.
The most common patient reported adverse reactions reported within 7 days of vaccination were injection site pain (23% to 39%), fatigue (11% to 17%) and headache (8% to 17%).
source: https://finance.yahoo.com/news/dynavax-announces-fda-approval-heplisav-214519448.html
STML: Side Effect Kills Cancer Patient in Stemline Therapeutics Drug Trial, the Company Raises Money
Stemline's SL-401 has demonstrated robust overall tumor response rates in its clinical trial but the drug is also now tied to three patient deaths from capillary leak syndrome.
Adam Feuerstein
Feb 2, 2017 6:00 AM EST
Investors who bought into a $45 million Stemline Therapeutics (STML) stock offering on Jan. 19 were not told that one day prior to the financing, a cancer patient in a clinical trial died from a severe side effect, a type of low blood pressure, tied to the company's drug SL-401.
Stemline has disclosed two previous patient deaths related to the same SL-401 toxicity -- capillary leak syndrome.
The third death in Stemline's SL-401 study due to capillary leak syndrome, not yet reported by the company but confirmed by a member of the patient's family, is potentially troubling because it occurred after Stemline had already increased safety monitoring and added new dosing rules to reduce the incidence and severity of the side effect.
More at:
https://www.thestreet.com/story/13975695/1/side-effect-kills-cancer-patient-in-stemline-therapeutics-drug-trial-the-company-raises-money.html?puc=yahoo&cm_ven=YAHOO
FYI: Tick Size Pilot Program
Today, some of my orders were denied.
My broker told me, that "The Limit Price entered is invalid for the selected security. The security is part of the SEC's Tick Size Pilot Program and quotes in nickel increments. Your Limit Price must be entered in increments of $0.05."
I found more info and the list of the Pilot securities at: http://www.nasdaqtrader.com/Trader.aspx?id=TickPilot
re: OCRX
They have updated their investor presentation.
OCRX - Ocera Announces Enrollment Completion From Phase 2a NIH-Sponsored Study of OCR-002 in the Treatment of Patients with Acute Liver Failure
PALO ALTO, Calif. and RESEARCH TRIANGLE PARK, N.C., Sept. 21, 2016 (GLOBE NEWSWIRE) -- Ocera Therapeutics, Inc. (OCRX), today announced completion of enrollment in STOP-ALF, a Phase 2a clinical trial to evaluate the Safety and Tolerability of Ornithine Phenylacetate in patients with Acute Liver Failure. The study was conducted by the Acute Liver Failure Study Group, an NIH-sponsored network of university tertiary care liver transplant sites, with support and supply of study medication from Ocera.
“We are excited to announce the completion of STOP-ALF and to report there were no serious safety issues attributable to study medication observed at any dose level,” said William M. Lee, M.D., principal investigator of the study. “We are currently examining additional safety and tolerability parameters, and pharmacokinetic findings for OCR-002 in these acutely ill patients. A late-breaker abstract of top-line findings has been submitted to the American Association for the Study of Liver Diseases (AASLD) for presentation at “The Liver Meeting®” being held in mid-November.
source: https://finance.yahoo.com/news/ocera-announces-enrollment-completion-phase-200500094.html
AUPH:
AUPH : Voclosporin Meets Primary Endpoint in Phase IIB AURA-LV Study in Lupus Nephritis
The trial achieved its primary endpoint, demonstrating statistically significantly greater complete remission (CR) (as defined by confirmed urinary protein/creatinine ratio of ≤0.5 mg/mg at 24 weeks and confirmed at 26 weeks) in patients treated with 23.7 mg of voclosporin twice daily (p=0.045). Both treatment arms, 23.7 mg and 35.9 mg twice daily also showed a statistically significant improvement in the rate of achieving partial remission (PR) at 24 weeks (p=0.007; p=0.024). Each arm of the study included the current standard of care of mycophenolate mofetil (MMF) as background therapy and a forced steroid taper to 5 mg/day by week 8 and 2.5 mg by week 16. No unexpected safety signals were observed and voclosporin was shown to be well tolerated.
Aurinia will host a conference call and webcast today, August 15, 2016 at 8:00 a.m.
source: https://finance.yahoo.com/news/aurinia-pharmaceuticals-announces-voclosporin-meets-100000140.html
OCRX: new investor presentation (June 21. 2016)
http://ir.ocerainc.com/common/download/download.cfm?companyid=ABEA-5YQ58G&fileid=897202&filekey=E4A8FCBC-5D5C-4616-A426-AB0BE2DA5BD1&filename=Ocera_Presentation_June_20_2016.pdf
What I meant is that insiders will have a great opportunity to buy cheap shares.
re: AUPH: Well, management wouldn't get that many shares for this price on the open market
;o)
The terms of the License Agreement also include an option for an acquirer of ARIAD to buy back the rights to Iclusig by repaying the upfront and milestone payments, plus paying an additional amount based on Iclusig sales during the previous 12 months and royalties of 20 to 25 percent on sales for the remaining royalty term. The buy-back provision cannot be exercised before two years or after six years from the closing of this transaction, and includes a transition period of up to one year.
ARIA: Incyte and ARIAD Announce Agreement for Incyte to Acquire ARIAD’s European Operations and In-license Iclusig® (ponatinib) in Europe
Incyte to Accelerate the Expansion of its European Organization to Optimize the Potential of Future Product Launches in Europe
ARIAD to Receive $140 Million Upfront Payment, Plus Tiered Royalties on European Sales of Iclusig and Potential Milestones on Future Indications for Iclusig
[...] Pursuant to the terms of a share purchase agreement (the “SPA”), Incyte will acquire all shares of ARIAD Pharmaceuticals (Luxembourg) S.a.r.l., the parent company of ARIAD’s European subsidiaries responsible for the commercialization of Iclusig in the licensed territory, for a payment to ARIAD of $140 million that will be funded by Incyte through available cash on hand.
In addition to the SPA, the parties have agreed to enter into a license agreement (the “License Agreement”), upon the closing of the SPA, pursuant to which Incyte will be granted an exclusive license to develop and commercialize Iclusig in the European Union and 22 other countries, including Switzerland, Norway, Turkey, Israel and Russia. ARIAD will be entitled to receive tiered royalties of between 32 and 50 percent on net sales of Iclusig in the territory and up to $135 million in potential development and regulatory milestones for Iclusig in new oncology indications in the territory. ARIAD may also become eligible to receive additional milestones for non-oncology indications, if approved, in the territory. Incyte has also agreed to fund a portion of the ongoing clinical development of Iclusig in ARIAD’s OPTIC and OPTIC-2L clinical trials through cost-sharing payments of up to $7 million in each of 2016 and 2017.
The terms of the License Agreement also include an option for an acquirer of ARIAD to buy back the rights to Iclusig by repaying the upfront and milestone payments, plus paying an additional amount based on Iclusig sales during the previous 12 months and royalties of 20 to 25 percent on sales for the remaining royalty term. The buy-back provision cannot be exercised before two years or after six years from the closing of this transaction, and includes a transition period of up to one year, [...]
source: https://finance.yahoo.com/news/incyte-ariad-announce-agreement-incyte-110000336.html
EXEL: Exelixis and Ipsen Enter into Exclusive Licensing Agreement to Commercialize and Develop Novel Cancer Therapy Cabozantinib in Regions Outside the United States, Canada and Japan
Exelixis, Inc. (EXEL) and Ipsen (Euronext: IPN; ADR: IPSEY) today jointly announced an exclusive licensing agreement for the commercialization and further development of cabozantinib, Exelixis’ lead oncology drug. Under the agreement, Ipsen will have exclusive commercialization rights for current and potential future cabozantinib indications outside of the United States, Canada and Japan. This agreement includes rights to COMETRIQ®, which is currently approved in the European Union (EU) for the treatment of adult patients with progressive, unresectable, locally advanced or metastatic medullary thyroid cancer (MTC). The companies have agreed to collaborate on the development of cabozantinib for current and potential future indications. Exelixis will maintain exclusive commercial rights for cabozantinib in the United States and Canada, and continue its discussions to partner commercial rights in Japan.
Under the agreement, Exelixis will receive a $200 million upfront payment. Exelixis is eligible to receive regulatory milestones, including $60 million upon the approval of cabozantinib in Europe for advanced renal cell carcinoma (RCC) and $50 million upon the filing and approval of cabozantinib in Europe for advanced hepatocellular carcinoma (HCC), as well as additional regulatory milestones for potential further indications. The agreement also includes up to $545 million of potential commercial milestones and provides for Exelixis to receive tiered royalties up to 26% on Ipsen’s net sales of cabozantinib in its territories.
http://finance.yahoo.com/news/exelixis-ipsen-enter-exclusive-licensing-210100117.html
CMRX: Chimerix Announces Presentation of Detailed Results From Phase 3 SUPPRESS Trial at BMT Tandem Meetings
Brincidofovir Shows On-Treatment Antiviral Effect in HCT Setting Despite Trial Not Meeting Primary Endpoint
Company to Host Conference Call on February 22 at 8:00 a.m. EST to Provide Additional Analyses and Plans for Further Clinical Development
DURHAM, N.C., Feb. 20, 2016 (GLOBE NEWSWIRE) -- Chimerix (CMRX), a biopharmaceutical company developing novel, oral antivirals in areas of high unmet medical need, today announced detailed results from its Phase 3 SUPPRESS trial of brincidofovir for the prevention of cytomegalovirus (CMV) in patients undergoing hematopoietic cell transplantation (HCT).
As reported in December 2015, the SUPPRESS trial did not meet the primary endpoint of prevention of clinically significant CMV infection at Week 24 following HCT; however, a clear antiviral effect was seen at the end of the on-treatment period at Week 14, with patients who received brincidofovir experiencing fewer clinically significant CMV infections than patients in the placebo group (24 percent versus 38 percent, p=0.002). At the Week 24 primary endpoint assessment, the proportion of patients with clinically significant CMV infection on brincidofovir (51 percent) was similar to placebo (52 percent).
[...]
The failure to meet the SUPPRESS trial’s endpoint of prevention of CMV infection at Week 24 appears to be associated with CMV events in the post-treatment period among subjects on the brincidofovir arm, driven by higher use of corticosteroids and other immune suppressing therapies for the treatment of presumptive graft versus host disease (GVHD). GVHD is a potentially life-threatening condition in which donated bone marrow or stem cells view the recipient’s body as foreign and attack the host. Diarrhea can be a symptom of GVHD in the gut, and is also a known side effect associated with brincidofovir that can be managed by a temporary dose-interruption, as described in the safety monitoring and management plan (SMMP) developed during the Phase 2 trial. In the SUPPRESS trial, diarrhea in brincidofovir-treated patients was more frequent and often presumed to be gut GVHD and was treated with corticosteroids, rather than temporarily interrupting study drug according to the SMMP. Among patients who were managed according to the SMMP, significantly fewer CMV infections and lower mortality were observed.
[...]
In light of the unexpected results in SUPPRESS, including the lack of confirmation of the activity against BK virus, Chimerix has elected to close the Phase 3 SUSTAIN and SURPASS trials, and to pursue Phase 2 trials of brincidofovir in kidney transplant recipients to confirm activity against BK virus and to explore management of brincidofovir-related adverse events in this population. The Company intends to apply learnings from SUPPRESS, as well as perspectives from investigators, key opinion leaders and regulators to refine and guide the development of potential future studies in solid organ transplant recipients.
[...]
http://finance.yahoo.com/news/chimerix-announces-presentation-detailed-results-021551604.html
presentation slides: http://ir.chimerix.com/common/download/download.cfm?companyid=AMDA-1QNA05&fileid=876238&filekey=E6BF3107-8B16-487D-B5A7-ED4A905C54E6&filename=Chimerix_BMT_Tandem_Meeting_Presentation_February_2016.pdf
FGEN: new Corporate Presentation
https://www.sec.gov/Archives/edgar/data/921299/000119312516458401/d133008dex991.htm
OCRX: new investor presentation (pdf-file created Jan 11. 2016)
http://ir.ocerainc.com/common/download/download.cfm?companyid=ABEA-5YQ58G&fileid=849986&filekey=22428A24-0BA2-4EBC-BD7C-3CBCDD4D2D5C&filename=Ocera_Investor_Presentation.pdf
DVAX: Dynavax Reports Top Line Results of Phase 3 HEPLISAV-B(TM) Study
Both co-primary endpoints were met. The rates of clinically significant adverse events were consistent with randomization and similar to rates in prior trials and HEPLISAV-B provided a statistically significant higher rate of seroprotection than Engerix-B in diabetic participants and in all participants as a group.
Dynavax plans to resubmit the HEPLISAV-B Biologics License Application (BLA) at the end of the first quarter of 2016 and anticipates a six-month review by the FDA.
source: http://finance.yahoo.com/news/dynavax-reports-top-line-results-120000851.html
STEM: StemCells, Inc. Interim Trial Data Show Motor Improvement in Patients With Cervical Spinal Cord Injury
Positive Six-Month Results, With Gains in Both Strength and Motor Function, for the First Cohort in the Phase II Pathway Study
[...]
Patients eligible for the study have complete loss of motor control below the level of injury, the most severe degree of SCI as defined by the American Spinal Injury Association Impairment Scale (AIS). Clinicians used both ISNCSCI (International Standards for Neurological Classification of Spinal Cord Injury) and GRASSP (Graded Assessment of Strength Sensibility and Prehension) measures to establish a pre-transplant baseline for each patient and to assess post-transplant progress.
This first cohort of the Pathway Study was designed to assess the safety, and preliminary signs of efficacy, of cell administration into the cervical cord and select the dose level for the 40-patient second cohort, a randomized, controlled and single-blinded arm of the trial, which is already underway.
Based on six-month follow-up, for the first cohort, an overall pattern of motor improvement was detected in four of the six patients as measured by gains in both strength and function on the collective ISNCSCI and GRASSP outcomes.
Additional highlights of the six-month interim results include:
- Muscle strength was improved in five of the six patients.
- Four of the five patients with gains in muscle strength also demonstrated improved performance on functional tasks assessing dexterity and fine motor skills.
- Four of the six patients had improvement in the spinal level of injury as defined by the ISNCSCI assessment; three upgraded one level and one upgraded two levels.
- Based on a Patient Global Impression of Change (PGIC) assessment, four of the six patients reported that their condition had improved post-transplant.
- Changes in muscle strength and function were observed around three months post-transplant, consistent with the onset of sensory improvements seen in the Company's Phase I/II thoracic study.
- No adverse events were attributed to the cells.
- The timing of the transplants ranged from ten to 23 months post-injury.
Link to webcast: http://edge.media-server.com/m/p/zmuy6r4y
source: https://finance.yahoo.com/news/stemcells-inc-interim-trial-data-210500169.html
OCRX: Ocera Announces Positive Phase 1 Results for Oral OCR-002 in Development for the Prevention of Chronic Hepatic Encephalopathy
The results demonstrated a robust, extended-release pattern for all three pilot OCR-002 extended-release formulations, with mean plasma phenylacetate (PAA) concentrations exceeding those achieved with RAVICTI at all timepoints for at least 12 hours post-dose. In addition, mean plasma phenylacetylglutamine (PAGN) concentrations and urinary PAGN excretion were greater for all three OCR-002 extended release dosage forms than for RAVICTI at an equivalent molar PAA dose. PAGN is formed by conjugation of PAA with glutamine, an end product of the ammonia scavenging activity of PAA.
source: http://finance.yahoo.com/news/ocera-announces-positive-phase-1-210500324.html
FPRX - Bristol-Myers, Five Prime enter licensing deal of up to $1.74 bln
source: http://finance.yahoo.com/news/bristol-myers-five-prime-enter-091717137.html
re: OCRX: Most of the volume (330k) was when it sold of to $3.80 ...
and when it went from $4.16 to $4.39 in the last hour it was only 18.4k
re Clackson: He has probably fixed selling limits -> $ 8 (02/20/2015) and now $ 9.5
re: Clackson: This sale was effected pursuant to a rule 10b5-1 trading plan adopted by the reporting person in June 2014.